ABBV

Menstrual migraine is a recurrent, debilitating migraine pattern, with attacks occurring around or during the menstrual period, a predictable time of increased biological vulnerability2,4 Atogepant demonstrated statistically significant reductions in migraine days associated with the menstrual period, meeting the primary and all eight ranked secondary endpoints versus placebo in the Phase 3 LUNA study (p1 No treatment options are currently approved for menstrual migraine, underscoring the urgent need for care approaches specifically designed for this patient population2,5 NORTH CHICAGO, Ill., Sept. 10, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from the Phase 3 LUNA study, which evaluated atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, for the preventive treatment of menstrual migraine in adults.1 These results reinforce AbbVie's scientific expertise in migraine and its focus on advancing solutions for people living with complex and disabling migraine attacks. "These positive Phase 3 LUNA results represent an important advancement for people living with menstrual migraine, with atogepant demonstrating superior efficacy versus placebo across the primary endpoint and all eight ranked secondary endpoints," said Primal Kaur, M.D., senior vice president, global development of immunology, neuroscience, eye care and specialty at AbbVie. "Menstrual migraine attacks can be severe, long lasting and disruptive to daily life. These data bring us closer to our goal of bringing a potential treatment option for women living with this debilitating disease." Atogepant Met Primary and All Ranked Secondary Endpoints in Phase 3 LUNA The study evaluated atogepant taken for seven consecutive days starting three days before the onset of menses over three menstrual cycles.1 Atogepant met the primary endpoint, demonstrating a greater reduction than placebo in migraine days during the perimenstrual period, averaged across three menstrual cycles during the double-blind period. The average reduction was 1.20 days with atogepant versus 0.40 days with placebo, corresponding to 0.80 fewer migraine days versus placebo (p1 Atogepant also demonstrated statistically significant and clinically meaningful improvements versus placebo across all eight ranked secondary endpoints (p1 Safety results were consistent with the known safety profile of atogepant, with no new safety signals observed.1,7 Menstrual Migraine Can Carry a Significant Burden Survey data from the European Migraine and Headache Alliance Migraine in Women Survey provide additional context on the burden of headache attacks occurring around menstruation. Respondents described these attacks as more painful, longer lasting or more resistant to medication than non-menstrual attacks, and 68% reported they had never been offered a tailored treatment approach.3 "Menstrual migraine attacks are generally more severe and more difficult to treat, making timely intervention particularly important," said Cristina Tassorelli, M.D., Ph.D., professor of neurology and director of the Headache Science Centre at IRCCS Mondino Foundation, University of Pavia, Italy. "LUNA is the first study of a CGRP-targeted treatment to report positive results specifically in menstrual migraine and meets an important unmet need for women." AbbVie plans to submit these data to health authorities worldwide and present findings at future medical congresses. About Menstrual Migraine Menstrual migraine includes pure menstrual migraine and menstrually-related migraine, with attacks occurring around menstruation during a period of increased biological vulnerability.2,4 In the Chronic Migraine Epidemiology and Outcomes–International (CaMEO-I) study, 66% (n=4,220/6,395) of eligible respondents reported migraine attacks around menstruation.8 About the LUNA (M24-859) Study LUNA is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension evaluating the efficacy, safety and tolerability of atogepant for the preventive treatment of menstrual migraine.1,6 The study enrolled 468 adult female participants with pure menstrual migraine or menstrually-related migraine, with or without aura, as defined by the International Classification of Headache Disorders, 3rd edition (ICHD-3), at study locations across Europe and Asia.4,6 The primary endpoint assessed change from baseline in migraine days during the perimenstrual period, averaged across three menstrual cycles during the double-blind period. Secondary endpoints assessed headache days, moderate or severe headache days, acute medication use days, migraine days with moderate or severe headache, responder outcomes, functional disability and cognitive function.1,6 More information on the LUNA trial can be found at www.clinicaltrials.gov (NCT06806293).6 About Atogepant Atogepant is an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist, a class of treatments that targets a pathway involved in migraine.7 For preventive treatment, atogepant is taken once daily; for acute treatment, it is taken as needed.7 Atogepant, marketed as AQUIPTA® in the EU and QULIPTA® in the U.S., Canada, Israel and Puerto Rico, is approved in 60 countries. U.S. Uses and Important Safety Information What is QULIPTA® (atogepant)? QULIPTA is a prescription medicine used for the preventive treatment of migraine in adults. IMPORTANT SAFETY INFORMATION Do not take QULIPTA if you have had an allergic reaction to atogepant or any ingredients in QULIPTA. Before taking QULIPTA, tell your healthcare provider about all your medical conditions, including if you: Have high blood pressure Have circulation problems in your fingers and toes Have kidney problems or are on dialysis Have liver problems Are pregnant or plan to become pregnant Are breastfeeding or plan to breastfeed Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. QULIPTA may affect the way other medicines work, and other medicines may affect how QULIPTA works. Your healthcare provider may need to change the dose of QULIPTA when taken with certain other medicines. QULIPTA can cause serious side effects, including: Allergic (hypersensitivity) reactions, including anaphylaxis: Serious allergic reactions can happen when you take QULIPTA or days after. Stop taking QULIPTA and get emergency medical help right away if you get any of the following symptoms, which may be part of a serious allergic reaction: swelling of the face, lips, or tongue; itching; trouble breathing; hives; or rash. High blood pressure: New or worsening of high blood pressure can happen. Contact your healthcare provider if you have an increase in blood pressure. Raynaud's phenomenon: A type of circulation problem can worsen or happen. Raynaud's phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale, to blue, to red. Contact your healthcare provider if these symptoms occur. The most common side effects of QULIPTA are nausea, constipation, and fatigue/sleepiness. These are not all the possible side effects of QULIPTA. QULIPTA is available in 10 mg, 30 mg, and 60 mg tablets. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more. Please see full Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information. About AbbVie in Migraine At AbbVie, we are committed to empowering people living with migraine disease. We advance science that enables healthcare providers to care for people impacted across the spectrum of migraine. Through education and partnerships with the migraine community, we strive to help those with migraine navigate barriers to care, access effective treatments and reduce the impact of migraine on their lives. About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References Data on file. AbbVie Inc. Study M24-859 (LUNA), Phase 3 primary analysis of the double-blind treatment period. 21 August 2026. ABVRRTI8388. Vetvik, K. G., & MacGregor, E. A. (2021). Menstrual migraine: A distinct disorder needing greater recognition. The Lancet Neurology, 20(4), 304–315. https://doi.org/10.1016/S1474-4422(20)30482-8 European Migraine & Headache Alliance. (n.d.). The invisible hormonal pattern in women: Migraine in women survey. Retrieved August 26, 2026, from https://www.emhalliance.org/project/the-invisible-hormonal-pattern-in-women/ Headache Classification Committee of the International Headache Society. (2018). The International Classification of Headache Disorders, 3rd edition. Cephalalgia, 38(1), 1–211. https://doi.org/10.1177/0333102417738202 Puledda, F., Sacco, S., Diener, H. C., et al. (2024). International Headache Society global practice recommendations for preventive pharmacological treatment of migraine. Cephalalgia, 44(9), 3331024241269735. https://doi.org/10.1177/03331024241269735 ClinicalTrials.gov. (n.d.). Study of oral atogepant to assess adverse events and change in disease activity in adult participants with menstrual migraine (ATO MM) (NCT06806293). Retrieved August 26, 2026, from https://clinicaltrials.gov/study/NCT06806293 European Medicines Agency. (n.d.). AQUIPTA (atogepant): EPAR product information. Retrieved August 26, 2026, from https://www.ema.europa.eu/en/medicines/human/EPAR/aquipta Ailani, J., Pavlovic, J. M., Kuruvilla, D., Naccara, N., Fanning, K. M., Contreras-De Lama, J., & Buse, D. C. (2026, April 18–22). Characterizing a population reporting menstrually related migraine: Multi-country results from the Chronic Migraine Epidemiology and Outcomes–International (CaMEO-I) study [Conference presentation abstract]. 78th Annual Meeting of the American Academy of Neurology, Chicago, IL, United States. https://doi.org/10.1212/WNL.0000000000215508. https://www.aan.com/msa/Public/Events/AbstractDetails/64507 View original content:https://www.prnewswire.com/news-releases/abbvie-extends-migraine-leadership-with-positive-phase-3-atogepant-results-in-menstrual-migraine-302874436.html

A month has gone by since the last earnings report for Eli Lilly (LLY). Shares have lost about 2.7% in that time frame, underperforming the S&P 500. But investors have to be wondering, will the recent negative trend continue leading up to its next earnings release, or is Lilly due for a breakout? Well, first let's take a quick look at its most recent earnings report in order to get a better handle on the recent drivers for Eli Lilly and Company before we dive into how investors and analysts have reacted as of late. Lilly reported second-quarter 2026 adjusted earnings per share (“EPS”) of $8.38, which comprehensively beat the Zacks Consensus Estimate of $6.01 per share. Earnings rose 33% year over year. Adjusted earnings in the second quarter included acquired IPR&D charges of $3.03 per share compared with 14 cents in the year-ago quarter.Revenues of $22.97 billion rose 48% year over year, driven by robust volume growth of Mounjaro and Zepbound. Lilly’s other new products also contributed significantly to sales growth. Total revenues beat the Zacks Consensus Estimate of $20.26 billion.Lilly’s key new products (Ebglyss, Foundayo, Inluriyo, Jaypirca, Kisunla, Mounjaro, Omvoh, and Zepbound) contributed $15.7 billion to revenues in the second quarter. Within key products, Lilly’s Immunology, Oncology and Neuroscience medicines collectively grew by 121% year over year in the second quarter.While U.S. revenues rose 33% to $14.4 billion, ex-U.S. revenues increased 80% to $8.6 billion.In the reported quarter, net realized prices declined 13%, while volumes rose 60%. Mounjaro recorded sales of $9.94 billion during the quarter, up 91% year over year. The reported sales figure beat the Zacks Consensus Estimate of $8.94 billion.U.S. Mounjaro revenues increased 45% to $4.8 billion on strong demand, partly offset by lower realized prices. International revenues jumped 172% to $5.2 billion, as volume growth was offset by lower realized prices as the drug was added to China's National Reimbursed Drug List.On the call, Lilly said that U.S. obesity incretin prescriptions increased 78% year over year. Lilly represented roughly 60% of total obesity prescriptions and 70% of injectable prescriptions. International incretin-market gross sales increased 74% year over year and Lilly's global share reached approximately 55%, up almost 2 percentage points sequentially.On the call, Lilly said that though Mounjaro’s revenue growth was robust in the second quarter, future growth will depend increasingly on market expansion rather than share gains.Zepbound recorded second-quarter sales of $4.93 billion, up 46% from the year-ago period, driven by strong demand in the United States. However, growth was partly offset by lower realized prices, including previously announced reductions in cash-pay prices. Adjustments to rebate and discount estimates provided some support. Zepbound revenues beat the Zacks Consensus Estimate of $4.72 billion.Self-pay accounted for approximately 45% of total Zepbound prescriptions in the second quarter and approximately 55% of new prescriptions.Lilly’s newly launched once-daily oral GLP-1 pill, Foundayo (orforglipron), generated $98 million in second-quarter sales following its April launch.Lilly expects to launch Foundayo in most international markets by 2027. For the type II diabetes indication, Lilly has filed regulatory applications in several countries including the United States.Regarding Foundayo’s launch, Lilly said that the U.S. launch of Foundayo continued to gain momentum, supported by physician education and commercial access secured across all three major PBMs in June. The U.S. prescriber base expanded to 36,000 from 8,000 mentioned on the first-quarter call. On the second-quarter conference call, Lilly said that Foundayo’s prescriptions nearly doubled in the final week of July from a month earlier and Foundayo represented nearly 1 in 4 new starts.The Medicare GLP-1 Bridge program was launched on July 1. It covers 20 million eligible Americans, with a stated patient out-of-pocket cost of $50/month. Management said this increased the number of people with access to Lilly obesity medicines by 35%. Among the newer drugs, Jaypirca recorded $192.0 million in sales, up 56% year over year. Omvoh recorded $102 million in sales, up 36% year over year, while Ebglyss sales were $201 million, up 131% year over year, driven by increased new patient starts.Sales of Kisunla were $167.0 million in the second quarter compared with $124.0 million in the previous quarter, driven by increased market share, growth in diagnostic testing and strong performance in China and Japan.New breast cancer drug, Inluriyo (imlunestrant), recorded sales of $75 million in the second quarter, compared with $35 million in the previous quarter. Trulicity generated revenues worth $1.22 billion million, up 12% year over year. Sales of Trulicity significantly beat the Zacks Consensus Estimate of $852 million.Sales of Trulicity are being hurt due to competitive dynamics, including patient switches to Mounjaro and lower realized prices.Jardiance sales surged 79% to $1.23 billion and significantly beat the Zacks Consensus Estimate of $699 million. International revenues included a $250 million sales-based milestone associated with Lilly’s collaboration with Boehringer Ingelheim.Taltz brought in sales of $856 million, up 1% year over year. The reported figure marginally beat the Zacks Consensus Estimate of $846 million.Verzenio generated revenues of $1.47 billion, down 1% year over year. Sales missed the Zacks Consensus Estimate of $1.56 billion.Emgality generated revenues of $191.0 million in the quarter, down 5% year over year. Olumiant generated second-quarter revenues of $258 million, up 5% year over year. Cyramza’s revenues of $256.0 million were up 1% year over year. Among the established products, Humalog sales declined 18% to $410.0 million. Humulin sales declined 13% to $153.0 million. Adjusted gross margin was 86.3%, up 1.3 percentage points year over year, due to favorable product mix and improved cost of production.Marketing, selling and administrative expenses increased 25% to $3.4 billion to support the launch of new products and indications. R&D expense increased 14% to $3.8 billion in the quarter due to higher costs for early- and late-stage pipeline portfolios. Adjusted performance margin, which is gross margin less R&D, marketing, selling and administrative expenses, was 54.8%, up approximately 9 percentage points year over year, driven by revenue growth. The adjusted effective tax rate was 22.2% compared with 16.5% in the year-ago quarter. Lilly raised its full-year 2026 revenue guidance to a range of $85 billion to $87 billion from the previous projection of $82 billion to $85 billion. The increase reflects continued strong revenue performance in the first half of 2026, which also benefited from sales-based milestones and adjustments for rebates and discounts.However, the recent U.S. rebate/discount estimate adjustments are not expected to recur in the second half. Moreover, the second half faces tougher comparisons from prior-year international launches and normal vacation seasonality in Europe. Moreover, U.S. diabetes has also historically shown fourth-quarter seasonality. Due to these factors, second-half percentage growth may appear to decelerate, though Lilly expects significant absolute-dollar growth in the second half.The company now expects 2026 adjusted earnings between $35.50 and $36.50 per share, compared with the prior expectation of $35.50 to $37.00 per share. Strong underlying business growth added $2.78 to the midpoint of Lilly’s previous expectation, but this benefit was more than offset by $3.03 per share of acquired in-process research and development charges associated with the several acquisitions that the company has done this year.The company provides guidance for performance margin, which represents margin after subtracting R&D costs, marketing and administrative costs from gross margin and dividing that figure by revenues. This ratio is expected to be in the range of 49.0% to 50.0% compared with the previous expectation of 47.0% to 48.5% in 2026.The adjusted tax rate is expected to be in the range of 18% to 19%. Since the earnings release, investors have witnessed a upward trend in fresh estimates. At this time, Lilly has a strong Growth Score of A, though it is lagging a lot on the Momentum Score front with a C. Following the exact same course, the stock was allocated a score of C on the value side, putting it in the middle 20% for this investment strategy. Overall, the stock has an aggregate VGM Score of B. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending upward for the stock, and the magnitude of these revisions looks promising. Interestingly, Lilly has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Lilly is part of the Zacks Large Cap Pharmaceuticals industry. Over the past month, AbbVie (ABBV), a stock from the same industry, has gained 6.7%. The company reported its results for the quarter ended June 2026 more than a month ago. AbbVie reported revenues of $16.99 billion in the last reported quarter, representing a year-over-year change of +10.2%. EPS of $3.65 for the same period compares with $2.97 a year ago. AbbVie is expected to post earnings of $3.86 per share for the current quarter, representing a year-over-year change of +107.5%. Over the last 30 days, the Zacks Consensus Estimate has changed -0.5%. The overall direction and magnitude of estimate revisions translate into a Zacks Rank #3 (Hold) for AbbVie. Also, the stock has a VGM Score of C. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Eli Lilly and Company (LLY) : Free Stock Analysis Report AbbVie Inc. (ABBV) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

A month has gone by since the last earnings report for Pfizer (PFE). Shares have added about 12.4% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Pfizer due for a pullback? Well, first let's take a quick look at the most recent earnings report in order to get a better handle on the recent catalysts for Pfizer Inc. before we dive into how investors and analysts have reacted as of late. Pfizer reported second-quarter 2026 adjusted earnings per share of 77 cents, which beat the Zacks Consensus Estimate of 68 cents per share. Earnings were flat year over year.Revenues came in at $15.03 billion, up 3% from the year-ago quarter on a reported basis and 1% on an operational basis. Total revenues beat the Zacks Consensus Estimate of $14.45 billion. Growth in Eliquis, Padcev, the Vyndaqel family and Lorbrena offset steep declines in COVID-19 products. International revenues rose 3% on an operational basis to $6.18 billion. U.S. revenues were flat at $8.86 billion.Excluding BioNTech-partnered Comirnaty and Paxlovid, revenues increased 5% operationally. Pfizer’s newly launched and acquired products delivered $3.2 billion in revenues and grew 18% operationally in the quarter. Excluding one-time items recorded in the second quarter of 2025, primarily related to the legacy Seagen in-line portfolio, this operational growth would have been 27%.Adjusted selling, informational and administrative (SI&A) expenses declined 3% (operationally) in the quarter to $3.34 billion due to lower spending in corporate enabling functions. Adjusted R&D expenses rose 12% to $2.73 billion due to higher spending on oncology and obesity pipeline. Pfizer reports its revenues under three broad sub-segments of its Biopharma operating segment — Primary Care, Specialty Care and Oncology. In first-quarter 2026, Pfizer created a new Hospital and Biosimilars Division within its Biopharma segment, moving certain off-patent brands, generic sterile injectables and biosimilars out of Specialty Care and Oncology. Primary Care sales declined 2% on an operational basis to $5.5 billion. Oncology revenues rose 2% to $4.17 billion, while Specialty Care sales increased 7% to $3.35 billion. Hospital and Biosimilars revenues declined 2% to $1.64 billion. In Primary Care, alliance revenues and direct sales from Eliquis increased 19% to $2.43 billion as higher demand trends globally were partially offset by price and generic erosion in some ex-U.S. markets. Eliquis sales beat the Zacks Consensus Estimate of $1.98 billion.Global Prevnar family revenues declined 4% to $1.34 billion and missed the consensus estimate of $1.39 billion. U.S. sales fell 13%, more than offsetting a 10% increase in the international market. U.S. sales declined due to lower vaccination rates in the pediatric and adult indications. International sales rose due to continued increases in demand in both the adult and pediatric indications.Direct sales and alliance revenues from partner BioNTech for Comirnaty were $261.0 million in the quarter, down 34% year over year, missing the consensus estimate of $278 million. The decrease reflected a smaller favorable adjustment to the returns provision and lower U.S. utilization following narrower vaccination recommendations.Paxlovid revenues plunged 95% to $21 million due to lower COVID-19 infections and reduced government purchases in some international markets. Sales fell well short of the consensus estimate of $119 million.Nurtec ODT/Vydura contributed $421.0 million in the quarter, up 17% year over year, driven by strong demand and prescription growth. Among the new products, Pfizer’s RSV vaccine, Abrysvo, recorded sales of $208 million, up 43% on an operational basis, driven by launch uptake and favorable timing of deliveries in some international markets and favorable buying patterns in the United States. In Oncology, Ibrance revenues were flat at $1.06 billion, exceeding the Zacks Consensus Estimate of $1.05 billion.Padcev sales climbed 23% to $667 million and surpassed the consensus estimate of $661 million. Padcev benefited from strong demand trends mainly due to market share gains in first-line metastatic urothelial cancer and launch momentum from the new muscle-invasive bladder cancer indication. Xtandi alliance revenues declined 6% to $534 million. Lorbrena revenues rose 37% to $354 million, driven by market share gains in the first-line ALK-positive metastatic NSCLC treatment setting in the United States, China, and some other international countries. Adcetris sales fell 23% to $196 million. Inlyta revenues decreased 12% to $218 million. Braftovi/Mektovi revenues rose 23% to $223 million.New drug, Elrexfio, generated sales of $89 million in the quarter, up 5% year over year. Vyndaqel family revenues increased 8% to $1.76 billion, slightly exceeding the Zacks Consensus Estimate of $1.75 billion. The Vyndaqel family includes global revenues from Vyndaqel as well as revenues from Vyndamax in the United States and Vynmac in Japan. Growth reflected continued patient diagnosis and improved access in international markets, along with U.S. market expansion, which partially offset the impact of price erosion as a result of new payer contracts in the United States.Xeljanz sales declined 23% to $251 million, while Enbrel revenues fell 10% to $142 million. Cibinqo sales rose 34% to $94 million. Within Hospital and Biosimilars, oncology biosimilar sales increased 1% to $359 million, and Inflectra revenues rose 23% to $171 million. Pfizer raised the lower end of its 2026 revenue guidance, backed by continued strong performance of its new and acquired products. The company now expects revenues between $60.5 billion and $62.5 billion, compared with the previous range of $59.5 billion to $62.5 billion. The range indicates a decline from 2025 revenues of $62.6 billion due to lower revenues from COVID products and loss of revenues from the upcoming patent cliff. The revised outlook reflects approximately $1.5 billion of better-than-expected non-COVID product performance, partly offset by a $1 billion reduction in expected COVID-19 product revenues. Pfizer now expects around $4 billion from COVID-19 products in 2026, lower than the prior expectation of around $5 billion.Paxlovid demand is expected to be limited due to low COVID infection levels. Meanwhile, most sales of Comirnaty are expected later in the year, in line with the seasonal vaccination period.The adjusted earnings guidance was reaffirmed at $2.80-$3.00 per share. However, the guidance now absorbs a 10 cents per share charge related to its licensing deal with Chinese biotech Innovent Biologics that will be recorded in the third quarter of 2026.Adjusted gross margin is expected to be in the mid-70s range, similar to the past several years. Adjusted R&D expenses are expected to be in the range of $10.5 billion to $11.5 billion in 2026, while adjusted SI&A spending is targeted between $12.5 billion and $13.5 billion. The adjusted effective tax rate is expected to be approximately 15% in 2026. Pfizer also said it expects additional cost savings of $2.5 billion, which it expects to realize from 2027 through 2029.Pfizer remains on track to achieve approximately $5.7 billion in net savings from its ongoing cost realignment program by the end of 2026 and has expanded the initiative with an additional $1 billion in expected SG&A savings through 2029, bringing total savings from the program to about $6.7 billion through 2029. Separately, the company has expanded its multi-year manufacturing optimization program, which is now expected to generate approximately $3 billion in cumulative cost-of-goods savings by 2029. Overall, Pfizer expects approximately $9.7 billion in total net savings from its productivity enhancement initiative through 2029. In the past month, investors have witnessed a downward trend in estimates review. The consensus estimate has shifted -8.39% due to these changes. At this time, Pfizer has a average Growth Score of C, a grade with the same score on the momentum front. Charting a somewhat similar path, the stock was allocated a grade of B on the value side, putting it in the second quintile for this investment strategy. Overall, the stock has an aggregate VGM Score of B. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Notably, Pfizer has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Pfizer is part of the Zacks Large Cap Pharmaceuticals industry. Over the past month, AbbVie (ABBV), a stock from the same industry, has gained 6.3%. The company reported its results for the quarter ended June 2026 more than a month ago. AbbVie reported revenues of $16.99 billion in the last reported quarter, representing a year-over-year change of +10.2%. EPS of $3.65 for the same period compares with $2.97 a year ago. For the current quarter, AbbVie is expected to post earnings of $3.86 per share, indicating a change of +107.5% from the year-ago quarter. The Zacks Consensus Estimate has changed -0.5% over the last 30 days. AbbVie has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of D. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Pfizer Inc. (PFE) : Free Stock Analysis Report AbbVie Inc. (ABBV) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

This article first appeared on GuruFocus. Robert Bruce (Trades, Portfolio), founder of Bruce & Co. and co-manager of the Bruce Fund (BRUFX) alongside his son Robert Jeffrey Bruce, recently filed his 13F for the second quarter of 2026. Known for a value-oriented, long-term approach, Bruce focuses primarily on small- and mid-cap common stocks, often targeting distressed companies trading at significant discounts with turnaround potential. His portfolio also includes high-yield and distressed debt, with occasional U.S. government securities when attractive equity opportunities are scarce. This quarter, his most impactful move was reducing his stake in Vicor Corp (NASDAQ:VICR), a decision that trimmed 0.78% from his portfolio's value. Warning! GuruFocus has detected 7 Warning Signs with PM. Is ABBV fairly valued? Test your thesis with our free DCF calculator. During the second quarter of 2026, Robert Bruce (Trades, Portfolio) initiated positions in 4 new stocks, signaling fresh conviction in select opportunities. While specific details on each new holding were not fully disclosed in the filing, the additions align with his strategy of seeking undervalued assets with recovery potential. Investors tracking Bruce's moves may find these new positions particularly noteworthy, as they often represent his highest-conviction ideas at the time of purchase. The Bruce Fund's flexibility across market caps and asset classes allows for such tactical entries, though the fund's long-term holding philosophy suggests these are not short-term trades. Robert Bruce (Trades, Portfolio) also increased stakes in a total of 4 stocks, with the most notable adjustments being: The most notable increase was Supernus Pharmaceuticals Inc (NASDAQ:SUPN), with an additional 50,000 shares, bringing the total to 150,000 shares. This adjustment represents a significant 50% increase in share count, a 0.63% impact on the current portfolio, and a total value of $6,976,500. The second largest increase was Beta Bionics Inc (NASDAQ:BBNX), with an additional 115,000 shares, bringing the total to 665,700. This adjustment represents a significant 20.88% increase in share count and a total value of $10,431,520. These increases reflect Bruce's confidence in the healthcare and medical technology sectors, which remain core areas of his portfolio. The substantial boost in Supernus Pharmaceuticals, a specialty pharmaceutical company, suggests a belief in its long-term growth prospects despite potential near-term volatility. Similarly, the larger position in Beta Bionics, a medical device firm, indicates a strategic bet on innovative healthcare solutions. In the second quarter of 2026, Robert Bruce (Trades, Portfolio) completely exited positions in 3 stocks, a move that simplifies his portfolio and reallocates capital toward higher-conviction ideas. While the specific names were not detailed in the filing, such exits typically occur when the thesis has played out, fundamentals have deteriorated, or better opportunities have emerged. For value investors, these sold-out positions can offer clues about sectors Bruce may be avoiding or rotating away from. The Bruce Fund's disciplined approach suggests these exits were deliberate, freeing up resources for the increases and new buys noted above. Robert Bruce (Trades, Portfolio) also reduced positions in 18 stocks, with the most significant changes including: Reduced Vicor Corp (NASDAQ:VICR) by 17,000 shares, resulting in a -26.15% decrease in shares and a -0.78% impact on the portfolio. The stock traded at an average price of $271.28 during the quarter and has returned -20.83% over the past 3 months and 109.86% year-to-date. Reduced U-Haul Holding Co (NYSE:UHAL.B) by 35,000 shares, resulting in a -7.74% reduction in shares and a -0.45% impact on the portfolio. The stock traded at an average price of $49.71 during the quarter and has returned 43.21% over the past 3 months and 40.21% year-to-date. The reduction in Vicor Corp, a power electronics company, is particularly notable given its strong year-to-date performance of 109.86%. Bruce's decision to trim this position, despite its recent gains, may reflect profit-taking or a valuation concern after such a significant run-up. Similarly, the reduction in U-Haul Holding Co, which has also performed well with a 40.21% year-to-date return, suggests a pattern of locking in gains in winners. These moves align with his value-oriented approach, where selling into strength is as important as buying undervalued assets. At the second quarter of 2026, Robert Bruce (Trades, Portfolio)'s portfolio included 41 stocks, with top holdings including 8.24% in AbbVie Inc (NYSE:ABBV), 7.89% in Allstate Corp (NYSE:ALL), 7.3% in AerCap Holdings NV (NYSE:AER), 6.99% in NextEra Energy Inc (NYSE:NEE), and 6.64% in Merck & Co Inc (NYSE:MRK). The holdings are mainly concentrated in 9 of the 11 industries: Healthcare, Utilities, Industrials, Financial Services, Technology, Consumer Defensive, Basic Materials, Communication Services, and Energy. This diversification across sectors reflects Bruce's balanced approach, though healthcare remains a dominant theme given the top positions in AbbVie and Merck. The portfolio's mix of defensive sectors like utilities and consumer defensive, alongside growth-oriented technology and industrials, underscores a strategy designed to weather various market conditions while seeking long-term appreciation.

AbbVie's growth engine is firing on all cylinders, but on its latest earnings call, analysts focused on whether the company can defend its turf and execute on its next big pipeline bet. AbbVie (ABBV) is on a roll, with the stock up 29% in the past year and trading about 6% below its 52-week high. The company just posted a quarter of solid sales growth, beating expectations and raising its full-year guidance. But its latest call wasn't a victory lap. Instead, analysts focused sharply on whether this powerful momentum is built to last, probing the defensibility of its growth in the face of emerging competition and complex trials ahead. Is The SKYRIZI Moat Holding? The first test came on SKYRIZI, the immunology drug driving much of the company’s success with sales up 24% this quarter. The worry is straightforward: a new oral competitor has entered the psoriasis market, threatening to chip away at SKYRIZI’s dominance. For investors, this is a direct challenge to the durability of AbbVie’s primary growth engine. Management’s answer was direct and backed by data. They reported seeing “no degradation in any of our NBRx trends” since the competitor launched in March. In fact, they claimed that new prescription growth for SKYRIZI has actually accelerated. The company’s read is that the new drug is expanding the market for advanced therapies rather than stealing share. It was a confident, numbers-backed defense of their most important franchise. A Blind Spot In The Pipeline? The second challenge was more forward-looking, aimed at the next potential blockbuster franchise in hidradenitis suppurativa (HS), a chronic skin condition. AbbVie has two major assets, lutikizumab and RINVOQ, with crucial data coming soon. But one analyst highlighted a uniquely modern risk: the widespread use of GLP-1 weight-loss drugs. Because weight loss can reduce inflammation, the concern is that these drugs could “contribute to high placebo rates” in the trials, potentially masking the true benefit of AbbVie’s drugs and jeopardizing the studies. Management acknowledged the dynamic, explaining that the trials are large enough that any GLP-1 effect should appear in both the placebo and treatment groups, effectively canceling it out. The response was logical, but it left the risk on the table. Unlike the clear-cut defense of SKYRIZI, this answer underscored a real, external variable that could complicate a critical pipeline readout. Execution Now, Execution Next Ultimately, AbbVie’s management team successfully argued that its current commercial execution is holding strong against new competition. The stock's outperformance has been notable, and we recently looked at how ABBV stock moved away from its peer group. The call, however, shifted the focus from today's precision to tomorrow's pipeline. For investors who like the theme but not the single-stock risk, a broad healthcare ETF like XLV offers diversified exposure. The answer will come from the data. Management confirmed that results from the pivotal HS trials for both RINVOQ and lutikizumab are expected “later this year.” Investors should watch for any sign of elevated placebo rates in those HS trial results, as that will be the first real test of whether AbbVie’s pipeline execution is as solid as its current sales machine. Where One Stock's Open Questions Fit A Bigger Plan Every stock carries unresolved questions like these, and no earnings call settles all of them. Owning a sector fund spreads that risk across more names, but it is still one bet on one theme: when the theme wobbles, the whole basket wobbles with it. The Trefis High Quality (HQ) Portfolio takes the next step out. It holds about 30 businesses diversified across sectors, selected not on a theme but on quality itself: consistent cash generation, strong margins, and resilient balance sheets. No single unresolved debate, and no single industry, carries your result. It has a track record of outpacing a benchmark that combines the three major indices - the S&P 500, S&P Mid-cap, and Russell 2000. Track the debates on names you like, on top of a core built on quality rather than any one story.

Leading healthcare company AbbVie (NYSE: ABBV) is coming off a strong quarter. Last month, the Illinois-based business posted yet another round of solid quarterly results, putting on display its robust and diversified healthcare operations. That wasn't, however, enough to give the stock a boost. And although it has risen in value this year, its gains of 8% trail the market, with the S&P 500 up by 13% thus far in 2026. Could the healthcare stock be a good buy right now? Missed Nvidia in 2009? This Rare Signal Is Flashing Again. In 2009, a "Double Down" signal flashed for a little-known chipmaker called Nvidia. For the first time in years, that same "Total Conviction" signal is flashing for a company 1/100th the size of Nvidia. Continue » On July 31, AbbVie posted its second-quarter results for the period ending June 30. Its net revenue came in at just under $17 billion, which was up more than 10% year over year. While the growth rate dipped slightly from the previous quarter, it has been rising over the past couple of years, with the healthcare industry returning to normal after the pandemic disrupted its usual operations. What was particularly impressive this past quarter was that AbbVie achieved double-digit growth in multiple areas of its business: immunology revenue rose by 15%, and neuroscience sales were up by more than 20%. While it did experience a slight decline of nearly 2% in its oncology segment, AbbVie's diversified business allows it to not have to rely on a single area of healthcare for growth, which is why it can be a better investment than the average healthcare stock, with plenty of growth opportunities to tap into. Part of the reason many investors may be overlooking AbbVie stock today is due to its seemingly high price-to-earnings (P/E) multiple, which is at nearly 70. That would be an extremely high valuation to pay for a business that's growing at AbbVie's rate. However, acquisition-related expenses have weighed on its earnings in prior periods, making the business appear less profitable than it truly is. This is where looking at the forward P/E multiple can be more helpful, as it is based on analyst projections for the coming year. And at a forward P/E of around 18, AbbVie doesn't look to be nearly as expensive a buy. For long-term investors, it can be an excellent value buy at its current levels. And its dividend, which yields 2.8%, may sweeten the deal even further. Before you buy stock in AbbVie, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and AbbVie wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $399,832!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,374,595!* That performance is why people listen. With a track record of beating the S&P 500 by 4x, Stock Advisor offers a distinct advantage. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built for the long haul. See the 10 stocks » *Stock Advisor returns as of August 10, 2026. David Jagielski, CPA has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends AbbVie. The Motley Fool has a disclosure policy. Is AbbVie Stock a Buy After Posting Strong Q2 Earnings? was originally published by The Motley Fool

Eli Lilly's growth is huge, but on its latest call, analysts tested whether the next chapter can possibly live up to the last one. After around 85% run over the past year, Eli Lilly (LLY) just posted a quarter with 48% revenue growth, numbers that can make a stock feel invincible. But for a company trading at this valuation, the only question that matters is what comes next. On its latest call, analysts repeatedly circled one central worry: with growth this strong, are the first cracks starting to show in the forward-looking story? The sharpest questions were not about the quarter that just closed, but about the new products and guidance that have to carry the momentum from here. The first challenge centered on Foundayo, the company’s new oral obesity drug and a critical piece of its future. If the injectable drugs built the franchise, the pill is supposed to broaden it to millions more. The problem, as one analyst framed it, is that the U.S. launch curve has looked “somewhat slower than anticipated.” This is a direct challenge to execution on a product investors are counting on to be the next large growth engine. The stakes are simple: a blockbuster launch keeps the story going, while a stumble gives competitors an opening and spooks investors in a high-multiple stock. Management’s response was to argue the inflection point is happening right now. The company reported that in the last week of July, it saw a significant uptick, “almost doubling the volume that we had just a month ago.” They added that new patient starts on Foundayo are now approaching one out of every four. It counters the “slow start” narrative by pointing to very recent momentum, but it also implicitly concedes the early weeks were softer. The answer was confident, but the proof will be in the coming months. The second point of pressure came on guidance. Lilly raised its full-year revenue forecast to a range of $85 billion to $87 billion, up from its prior estimate of $82.5 billion to $84.5 billion. But the math behind that raise seemed to imply a revenue deceleration in the second half of the year compared to the rapid pace of Q2. For a growth story this strong, any hint of a slowdown gets scrutinized. It forces the question of whether the current trajectory is truly sustainable. The CFO’s answer was direct and technical. He explained the apparent slowdown was an illusion created by a few factors: one-off items and prior-period rebate adjustments that artificially boosted first-half results, which won’t repeat. More importantly, he noted the second half of 2025 was unusually strong due to the “bolus” of Mounjaro launches in international markets, making for a tougher year-over-year comparison. This was a credible, numbers-driven explanation that defused the concern by reframing it as an issue of accounting and timing, not a fundamental weakening of the business. Management met the key challenges head-on, arguing that the growth story is fully intact. They answered the guidance question convincingly and provided specific, near-term data to counter worries about the Foundayo launch. But what remains an open question is whether the recent Foundayo inflection is a durable trend or just a short-term blip from new marketing and access programs. The one thing to watch next quarter is that prescription data. It will be the clearest signal of whether Lilly’s next growth engine has truly gained traction. For investors who want to look at a basket of similar names, a healthcare ETF like XLV offers broader exposure to the sector. Every stock carries unresolved questions like these, and no earnings call settles all of them. Owning a sector fund spreads that risk across more names, but it is still one bet on one theme: when the theme wobbles, the whole basket wobbles with it. The Trefis High Quality (HQ) Portfolio takes the next step out. It holds about 30 businesses diversified across sectors, selected not on a theme but on quality itself: consistent cash generation, strong margins, and resilient balance sheets. No single unresolved debate, and no single industry, carries your result. It has a track record of outpacing a benchmark that combines the three major indices - the S&P 500, S&P Mid-cap, and Russell 2000. Track the debates on names you like, on top of a core built on quality rather than any one story.

AbbVie’s second quarter results reflected robust product performance but were met with cautious investor sentiment. Management credited double-digit sales growth to strong execution in core immunology therapies, especially SKYRIZI and RINVOQ, and notable gains in the neuroscience portfolio. CEO Robert Michael emphasized that “each [portfolio] delivered growth above 20%,” with SKYRIZI achieving market leadership in multiple countries. However, the quarter also saw persistent biosimilar pressure on legacy products and a competitive landscape in key markets. Is now the time to buy ABBV? Find out in our full research report (it’s free). Revenue: $16.99 billion vs analyst estimates of $16.79 billion (10.2% year-on-year growth, 1.2% beat) Adjusted EPS: $3.65 vs analyst estimates of $3.61 (1.2% beat) Management lowered its full-year Adjusted EPS guidance to $13.97 at the midpoint, a 1.5% decrease Operating Margin: 37.9%, up from 31.7% in the same quarter last year Market Capitalization: $430.9 billion While we enjoy listening to the management’s commentary, our favorite part of earnings calls is the analyst questions. Those are unscripted and can often highlight topics that management teams would rather avoid or topics where the answer is complicated. Here is what has caught our attention. Terence Flynn (Morgan Stanley) asked about SKYRIZI’s subcutaneous induction approval timeline and manufacturing readiness. EVP Roopal Thakkar assured that the “review is going according to plan” and no manufacturing issues have emerged. Carter Lewis Gould (Cantor Fitzgerald) questioned the strategy for large-scale IBD trials and whether interim data could accelerate phase 3 initiation. Thakkar explained the intent to move rapidly into phase 3 based on promising interim results from the ongoing combination studies. Christopher Schott (JPMorgan) pressed on SKYRIZI’s growth prospects in psoriasis amid new competition. EVP Jeffrey Stewart stated that SKYRIZI’s momentum remains robust, with new patient starts actually increasing since competitor launches. Michael Yee (UBS) inquired about expectations for the Tevapadon launch in Parkinson’s disease and differentiation of AbbVie’s brain shuttle technology. Stewart predicted a modest initial ramp for Tevapadon due to formulary timing, while Thakkar described the brain shuttle as enabling higher drug penetration and improved patient convenience. Mohit Bansal (Wells Fargo) asked for evidence supporting lutikizumab’s efficacy in hidradenitis suppurativa and the handling of GLP-1 use in trials. Thakkar pointed to strong phase 2 data and large trial sizes to account for GLP-1 effects, noting a dual strategy with RINVOQ and lutikizumab. Looking ahead, the StockStory team will monitor (1) the outcome of regulatory reviews for SKYRIZI’s subcutaneous induction and new dermatology indications for RINVOQ, (2) the commercial launch progress of Tevapadon in Parkinson’s disease and Bowie in aesthetics, and (3) the integration of Apogee Therapeutics and the impact of new immunology assets. Progress in the oncology pipeline and margin management will also be key indicators. AbbVie currently trades at $243.95, down from $257.41 just before the earnings. At this price, is it a buy or sell? Find out in our full research report (it’s free for active Edge members). WHILE YOU’RE HERE: Top 9 Market-Beating Stocks. The best stocks don’t just beat the market once. They do it again. And again. Robust revenue growth, rising free cash flow, returns on capital that leave their competition in the dust. The market has already rewarded these businesses. But our AI platform says the party isn’t over. Find out which 9 stocks made the cut this week — FREE. Get Our Top 9 Market-Beating Stocks for Free HERE. Stocks that have made our list include now familiar names such as Nvidia (+1,460% between June 2020 and June 2025) as well as under-the-radar businesses like the once-micro-cap company Kadant (+214% between June 2020 and June 2025). Find your next big winner with StockStory today.

Interested in REGENXBIO Inc.? Here are five stocks we like better. RGX-202 Duchenne program advanced toward filing: REGENXBIO completed enrollment and dosing in its confirmatory study and plans to submit the first BLA module in Q3 2026, with a complete filing expected in Q1 2027 and potential approval in the second half of 2027. RGX-121 resubmission received FDA alignment: The FDA indicated that existing data support an accelerated-approval review for Hunter syndrome and that no additional studies will be required. REGENXBIO plans to resubmit the BLA in Q3 with longer-term efficacy, safety, imaging and neurocognitive data. Financing and AbbVie milestones strengthened liquidity: A $100 million AbbVie payment and approximately $108 million in follow-on offering proceeds lifted pro forma liquidity above $310 million, extending the cash runway into Q4 2027. The AbbVie collaboration also began dosing its pivotal diabetic retinopathy study, while wet AMD pivotal-study results are expected in Q4. REGENXBIO (NASDAQ:RGNX) reported second-quarter 2026 progress across its late-stage gene-therapy pipeline, highlighting completed enrollment in its Duchenne muscular dystrophy confirmatory study, an agreed path to resubmit its Hunter syndrome therapy application, and the start of a pivotal diabetic retinopathy study under its AbbVie collaboration. President and Chief Executive Officer Curran Simpson said the company strengthened its balance sheet through more than $200 million in financing and milestone proceeds subsequent to the quarter. REGENXBIO ended the quarter with $106 million in cash, cash equivalents and marketable securities, and said it had more than $310 million on a pro forma basis after receiving a $100 million AbbVie milestone payment and completing a follow-on public offering that generated about $108 million in net proceeds. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Chief Financial Officer Mitch Chan said the company expects its cash runway to extend into the fourth quarter of 2027, encompassing expected milestones including wet age-related macular degeneration data and the anticipated PDUFA date for RGX-202. The guidance excludes potential funding from additional non-dilutive sources, including a HealthCare Royalty agreement, partner-program milestones and a possible sale of an RGX-121 priority review voucher. REGENXBIO said it completed enrollment and dosing in the confirmatory study for RGX-202, its wholly owned gene-therapy candidate for Duchenne muscular dystrophy, ahead of schedule. The pivotal and confirmatory trials have enrolled more than 60 patients in total, providing the safety database intended to support a planned biologics license application. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High The company plans to submit the first BLA module to the U.S. Food and Drug Administration during the third quarter of 2026 and expects to complete the BLA filing in the first quarter of 2027. Simpson said potential U.S. approval could come during the second half of 2027. Management cited pivotal data reported in May, including microdystrophin expression, functional improvement and a favorable safety profile. Chief Medical Officer Steve Pakola said the results included a statistically significant correlation between microdystrophin expression and improvement in North Star Ambulatory Assessment scores. → Sandisk Just Delivered a Blowout Quarter—Here's Why the Stock Is Falling At the time of the clinical-module submission, REGENXBIO expects roughly half of the 30 patients treated in the pivotal portion of the study to have completed 12-month functional assessments, Simpson said. He added that the FDA has not specified a minimum amount of functional data required for an accelerated-approval submission. The company also plans to begin AFFINITY RISE, an ex-U.S., double-masked, placebo-controlled randomized study, in the first half of 2027. The study is designed to enroll about 100 patients using a 2-to-1 active-treatment-to-placebo randomization. Pakola said the trial is expected to include a crossover opportunity for patients initially assigned to placebo, though the company did not provide further design details or identify enrollment regions. REGENXBIO said it is manufacturing intended commercial supply for RGX-202 at its FDA-inspected, commercial-ready Rockville, Maryland, facility and is investing in U.S. launch preparation. For RGX-121, a potential treatment for mucopolysaccharidosis type II, or Hunter syndrome, REGENXBIO said it reached alignment with the FDA following a June discussion and a Type A meeting in July. According to Simpson, the FDA confirmed that the company’s available data are sufficient for review under the accelerated-approval pathway and that no additional studies, including a randomized controlled trial, will be required for BLA resubmission. The resubmission, planned for the third quarter, will include longer-term efficacy and safety data, including participant imaging. Simpson said the package incorporates two-year biomarker and neurocognitive data, along with updated safety information, rather than requiring newly dosed patients or data beyond the two-year horizon. Chief Legal Officer Patrick Christmas also addressed REGENXBIO’s royalty portfolio. He said the company’s U.S. patent coverage for Zolgensma has expired, though it retains coverage in about 20 countries outside the United States. He added that the company has coverage for Evrysdi in the U.S. and internationally. REGENXBIO and AbbVie dosed the first patient in the Phase IIb/III NAAVIGATE study of sura-vec for diabetic retinopathy, triggering the $100 million milestone payment to REGENXBIO. The company said the partnership’s near-term focus has shifted to fourth-quarter top-line results from the ATMOSPHERE and ASCENT pivotal studies of subretinal sura-vec in wet age-related macular degeneration. Pakola said long-term data presented at the American Society of Retina Specialists meeting showed that sura-vec maintained or improved visual acuity and reduced treatment burden through five years in a Phase I/II wet AMD study. In diabetic retinopathy, 2.5-year ALTITUDE data showed durable improvements in disease severity, continued prevention of vision-threatening complications and a favorable long-term safety profile following a single administration, he said. REGENXBIO said the two wet AMD pivotal trials are designed with 90% power and use a 4.5-letter non-inferiority margin. Simpson said ATMOSPHERE and ASCENT results will be released together because their timing is closely aligned. The companies expect to disclose the primary endpoints, while details on secondary-endpoint disclosure will be determined closer to the data release. AbbVie will take the primary commercial leadership role for subretinal wet AMD if the program advances, Simpson said. Pakola added that more than 500 surgeons globally have been trained on the procedure. REGENXBIO Inc is a clinical‐stage biotechnology company specializing in the development of gene therapies using its proprietary NAV® AAV (adeno‐associated virus) platform. The company engineers next‐generation AAV vectors designed to deliver functional genes to targeted cells, aiming to address a range of rare genetic diseases and ocular, metabolic and neurologic disorders. REGENXBIO's pipeline features several product candidates in various stages of preclinical and clinical development, including RGX-314 for wet age‐related macular degeneration, RGX-121 for mucopolysaccharidosis II (Hunter syndrome) and RGX-121 for other rare lysosomal storage diseases. In addition to its internally funded programs, REGENXBIO has established partnerships with major biopharmaceutical companies to advance its NAV technology. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "REGENXBIO Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Ironwood Pharmaceuticals IRWD reported adjusted earnings of 31 cents per share for the second quarter of 2026, surpassing the Zacks Consensus Estimate of 26 cents. The company had reported adjusted earnings of 14 cents per share in the year-ago quarter. Total revenues in the second quarter were $113 million, which missed the Zacks Consensus Estimate of $120 million. Revenues, however, surged by around 32.6% year over year. Year to date, shares of Ironwood have risen 26.4% against the industry’s decline of 3.7%. Image Source: Zacks Investment Research As reported by its partner AbbVie ABBV, Ironwood’s sole marketed product, Linzess (linaclotide), generated net sales of $282.3 million in the United States, up 14% year over year. Linzess sales were boosted by higher demand and better pricing, helped by the removal of inflation-related rebates and the favorable timing of rebate adjustments. Total prescription demand for Linzess increased 4% year over year during the second quarter. IRWD and ABBV share Linzess’ brand collaboration profits and losses equally. Ironwood’s share of net profit from sales of Linzess in the United States (included in collaborative revenues) totaled $110 million, reflecting a 28% year-over-year increase. Ironwood also has agreements with two partners, Astellas Pharma and AstraZeneca AZN, related to the development and commercialization of Linzess in Japan and China, respectively. Astellas and AstraZeneca have exclusive rights to develop and market the drug in their respective territories. Both companies are liable to pay royalties to Ironwood on net Linzess revenues earned in their regions. Ironwood's royalties and other revenues were $3 million in the second quarter of 2026. In the year-ago quarter, the company recorded royalties and other revenues of negative $0.5 million. Total cost and expenses (including research and development expenses, selling, general and administrative expenses and restructuring expenses) in the second quarter were $33.7 million, down 15.5% from the year-ago quarter. Ironwood recorded adjusted EBITDA of $83 million in the reported quarter, up 65.7% year over year. As of June 30, 2026, Ironwood had cash and cash equivalents worth $79.1 million compared with $220.5 million as of March 31, 2026. Ironwood raised its full-year 2026 revenue guidance, reflecting higher demand for Linzess. The company now expects total revenues to be in the range of $460 to $485 million in 2026 compared with the previous expectation of $450 to $475 million. U.S. sales of Linzess (to be recorded by AbbVie) are now expected to be in the range of $1.15-$1.20 billion versus the earlier projection of $1.13-$1.18 billion in 2026. Ironwood now expects to deliver an adjusted EBITDA of more than $310 million in 2026, indicating effective cost management. Previously, the company expected to deliver an adjusted EBITDA of more than $300 million. In May 2026, the FDA approved the expanded use of Linzess for the treatment of functional constipation (FC) in pediatric patients aged two years and older. The therapy was previously approved for FC in children and adolescents aged six to 17 years. Linzess is the only FDA-approved daily treatment for pediatric FC. Linzess is already approved for the treatment of irritable bowel syndrome with constipation in adults and pediatric patients aged seven years and above. The drug is also approved for chronic idiopathic constipation in adults. Ironwood is developing its next-generation GLP-2 analog, apraglutide, for treating patients with short bowel syndrome (“SBS”) with intestinal failure (“IF”) who are dependent on parenteral support (“PS”). The confirmatory phase III STARS-2 study evaluating apraglutide in short bowel syndrome with intestinal failure (SBS-IF) is now actively recruiting patients. The primary endpoint of the STARS-2 study will check the relative change from baseline in actual weekly PS volume at week 24 in the given patient population. Ironwood acquired the rights to develop and commercialize apraglutide following the acquisition of VectivBio in June 2023. Ironwood Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Ironwood Pharmaceuticals, Inc. Quote Ironwood currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Liquidia Corporation LQDA, currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $5.31 during the same time. LQDA shares have surged 159.3% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Ironwood Pharmaceuticals, Inc. (IRWD) : Free Stock Analysis Report AstraZeneca PLC (AZN) : Free Stock Analysis Report AbbVie Inc. (ABBV) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

This article first appeared on GuruFocus. Cash Position: Ended Q2 2026 with cash, equivalents, and marketable securities of $106 million. Pro Forma Cash: More than $310 million after receiving a $100 million milestone payment from AbbVie and approximately $108 million in net proceeds from a follow-on public offering. Cash Runway: Extended into Q4 2027, excluding potential proceeds from healthcare royalty agreements, partner program milestones, or the sale of the RGX-121 PRV. Operating Expenses: R&D and G&A expenses were generally consistent with the same period in 2025. Warning! GuruFocus has detected 6 Warning Signs with RGNX. Is RGNX fairly valued? Test your thesis with our free DCF calculator. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Completed enrollment in the confirmatory study for RGX-202 ahead of schedule, with over 60 patients in pivotal and confirmatory trials supporting a robust safety data set. Received $100 million milestone payment from AbbVie and raised approximately $108 million in a follow-on offering, extending cash runway into Q4 2027. FDA confirmed that available data for RGX-121 is sufficient for review under accelerated approval, with no additional studies required for BLA resubmission. Long-term data for sura-vec in wet AMD and diabetic retinopathy showed durable efficacy and safety, with over 500 surgeons trained for the procedure. Initiated the Phase 2B/3 NAVIGATE study for diabetic retinopathy, expanding the retinal franchise and potential market opportunity. US patent on Zolgensma has expired, reducing future royalty revenue from that product in the US. Cash runway guidance does not include potential proceeds from additional non-dilutive sources, indicating reliance on future financing events. The ex-US AFFINITY RISE study for RGX-202 is not yet initiated, with details on design and regions still undisclosed. Top-line data for sura-vec in wet AMD is not expected until Q4 2026, leaving uncertainty in the near term. The BLA submission for RGX-202 is a multi-module process, with the clinical module not expected to be complete until Q1 2027, delaying potential approval. Q: Can you provide more color on the enrollment for the Affinity Confirmatory study and feedback from ASRS on gene therapy versus alternative modalities, particularly regarding subretinal and suprachoroidal delivery versus intravitreal gene therapies? A: Curran Simpson (President and CEO) noted that enrollment in the confirmatory study (30 patients) was completed ahead of schedule, indicating strong patient demand and momentum for the upcoming AFFINITY RISE study. Stephen Pakola (Chief Medical Officer) added that the key message from ASRS was "durability," with five-year follow-up data in wet AMD and 2.5-year data in DR showing excellent safety and efficacy. He emphasized that the unmet need is clearer in DR due to its asymptomatic nature, where a one-time treatment is preferable to repeated injections. Q: Regarding the wet AMD readouts in Q4, what is the expected non-inferiority margin for ATMOSPHERE and ASCENT, and can you comment on the powering of the studies? A: Stephen Pakola (Chief Medical Officer) confirmed that the non-inferiority margin is 4.5 letters, which has been standard and reiterated by the FDA. He noted that the studies have very large sample sizes, making them the largest gene therapy programs ever executed, and are powered at 90%. Q: For the AFFINITY RISE study, how long is the placebo-controlled period, what are the primary and key secondary endpoints, and what ex-US regions will be included? A: Stephen Pakola (Chief Medical Officer) stated that the high-level design includes a 2:1 randomization (active to placebo) to meet ex-US requirements, including Europe. He did not disclose specific details on the placebo-controlled period, endpoints, or regions, noting that more information will be shared closer to trial initiation in the first half of 2027. Q: On the RGX-121 resubmission, what specific question is the longer-term follow-up and imaging data answering, and will this meaningfully shift the known clinical profile? A: Curran Simpson (President and CEO) explained that the initial data provided was six-month biomarker data, which has been expanded to two-year biomarker and imaging data. The Type A meeting reset the review process, and the FDA confirmed no additional studies, including an RCT, are required. The resubmission will consolidate all data for an evaluation of the benefit-risk profile, with no requirement for additional patient dosing beyond the two-year horizon. Q: How should we think about the potential impact of patent expiry on the Zolgensma royalty stream and the potential revenue stream from the royalty rate compared to Zolgensma? A: Patrick Christmas (Chief Legal Officer) noted that the US patent on Zolgensma has expired, but coverage remains in about 20 countries outside the US. Additionally, coverage on Invisma exists both in the US and worldwide, with Novartis potentially reaching up to $2 billion in sales, which should result in continued significant royalties. Q: For the DMD program, will the FDA wait for the biomarker outcome of the AFFINITY RISE study to make decisions on the RGX-202 program? A: Curran Simpson (President and CEO) clarified that the goal is to have AFFINITY RISE up and enrolling during the review period, but data from that study is not expected to play into the active review for accelerated approval. He noted that over 60 patients will be dosed at the time of filing, with roughly half of the pivotal cohort through 12 months of functional assessment, providing a strong data package. Q: Can you quantify how many patients will have 12-month functional data at the time of BLA initiation this quarter versus completion in Q1 2027, and does the FDA require a pre-specified minimum for accelerated approval? A: Curran Simpson (President and CEO) stated there is no pre-specified level of functional data required for submission. At the time of the clinical module submission, estimated to be around 14-15 patients out of the 30 treated in the pivotal portion will have 12-month data, depending on visit timing and data QC. The critical path is defined by the CMC module, which allows time to add additional patient data to the clinical module. Q: For RGX-314, what is the latest perspective on the commercial outlook in the evolving landscape, and can you characterize site qualification efforts for launch? A: Curran Simpson (President and CEO) noted that AbbVie will lead commercialization for subretinal wet AMD, with many of the 100+ clinical sites likely to be involved in commercial launch. Joint development of the commercial plan is just beginning, given the expected 12-month review cycle. He highlighted the potential for a meaningful market, with wet AMD potentially reaching $10 billion, and noted that experienced physicians can easily identify 2-3 out of 10 patients as obvious candidates for subretinal administration. Q: Will you disclose ATMOSPHERE and ASCENT top-line data together with full non-inferiority margin and injection burden data, and is there a milestone tied to the top-line versus the 2027 submissions? A: Curran Simpson (President and CEO) confirmed the studies will be disclosed together, with primary endpoint disclosure expected for both. There is no milestone associated with top-line data, but undisclosed milestones exist for BLA acceptance and approval, which could further extend the cash runway. Q: For the AFFINITY RISE study, how should we think about crossover from placebo, and will the study enroll any US patients? A: Stephen Pakola (Chief Medical Officer) indicated that a crossover is reasonable to expect for patients on placebo, providing them access to treatment while allowing the trial to gather more exposure data. He did not specify whether US patients would be enrolled, deferring details until closer to trial initiation. For the complete transcript of the earnings call, please refer to the full earnings call transcript.