NVAX

The end of the earnings season is always a good time to take a step back and see who shined (and who didn’t). Let’s take a look at how therapeutics stocks fared in Q2, starting with Novavax (NASDAQ:NVAX). Over the next few years, therapeutic companies, which develop a wide variety of treatments for diseases and disorders, face strong tailwinds from advancements in precision medicine (including the use of AI to improve hit rates) and growing demand for treatments targeting rare diseases. However, headwinds such as rising scrutiny over drug pricing, regulatory unknowns, and competition from larger, more resourced pharmaceutical companies could weigh on growth. The 11 therapeutics stocks we track reported a very strong Q2. As a group, revenues beat analysts’ consensus estimates by 8%. Luckily, therapeutics stocks have performed well with share prices up 21.8% on average since the latest earnings results. Pioneering a nanoparticle technology that mimics the molecular structure of disease pathogens, Novavax (NASDAQ:NVAX) develops and commercializes protein-based vaccines for infectious diseases, with a primary focus on its COVID-19 vaccine and combination respiratory vaccine candidates. Novavax reported revenues of $56.7 million, down 76.3% year on year. This print exceeded analysts’ expectations by 1.5%. Overall, it was a very strong quarter for the company with a beat of analysts’ EPS estimates. "We're encouraged by the momentum we're seeing across our business as we continue to advance our strategy," said John C. Jacobs, President and Chief Executive Officer, Novavax. Novavax delivered the slowest revenue growth in the group. Interestingly, the stock is up 22.5% since reporting and currently trades at $9.44. Is now the time to buy Novavax? Access our full analysis of the earnings results here, it’s free. Founded in 1978 and pioneering treatments for some of medicine's most complex challenges, Biogen (NASDAQ:BIIB) develops and markets therapies for neurological conditions, including multiple sclerosis, Alzheimer's disease, spinal muscular atrophy, and rare diseases. Biogen reported revenues of $2.74 billion, up 3.4% year on year, outperforming analysts’ expectations by 12.1%. The business had an incredible quarter with a beat of analysts’ EPS estimates and a solid beat of analysts’ full-year EPS guidance estimates. The market seems happy with the results as the stock is up 7.9% since reporting. It currently trades at $221.76. Is now the time to buy Biogen? Access our full analysis of the earnings results here, it’s free. Founded in 1991 as one of the pioneers in translating genetic discoveries into clinical applications, Myriad Genetics (NASDAQ:MYGN) develops genetic tests that assess disease risk, guide treatment decisions, and provide insights across oncology, women's health, and mental health. Myriad Genetics reported revenues of $190.7 million, down 10.5% year on year, falling short of analysts’ expectations by 8.2%. It was a disappointing quarter as it posted full-year revenue guidance missing analysts’ expectations and a significant miss of analysts’ EPS estimates. Myriad Genetics delivered the weakest performance against analyst estimates and weakest full-year guidance update among its peers. As expected, the stock is down 40.2% since the results and currently trades at $3.21. Read our full analysis of Myriad Genetics’s results here. Known for transforming hours-long intravenous infusions into minutes-long subcutaneous injections, Halozyme Therapeutics (NASDAQ:HALO) develops and licenses its proprietary ENHANZE technology that enables subcutaneous delivery of injectable drugs that would otherwise require intravenous administration. Halozyme Therapeutics reported revenues of $481 million, up 47.7% year on year. This result beat analysts’ expectations by 19%. Overall, it was an incredible quarter as it also produced a solid beat of analysts’ full-year EPS guidance estimates. Halozyme Therapeutics scored the fastest revenue growth and highest full-year guidance raise of the whole group. The stock is up 26.2% since reporting and currently trades at $108.23. Read our full, actionable report on Halozyme Therapeutics here, it’s free. Born from a 2013 spinoff of Abbott Laboratories' pharmaceutical business, AbbVie (NYSE:ABBV) is a biopharmaceutical company that develops and markets medications for autoimmune diseases, cancer, neurological disorders, and other complex health conditions. AbbVie reported revenues of $16.99 billion, up 10.2% year on year. This number surpassed analysts’ expectations by 1.2%. Aside from that, it was a mixed quarter as it also recorded a narrow beat of analysts’ EPS estimates but a slight miss of analysts’ full-year EPS guidance estimates. The stock is up 3.3% since reporting and currently trades at $265.90. Read our full, actionable report on AbbVie here, it’s free. Over the past year, investors have been forced to repeatedly answer the same question: what is the market’s biggest risk? The answer has changed several times, and each shift has reshaped market leadership. Late in 2025 and early 2026, artificial intelligence became the market’s primary uncertainty. Investors questioned whether AI would erode software pricing power and weaken competitive moats as AI made it easier to replicate once-differentiated products. By the spring, technology took a back seat to geopolitics. The U.S. conflict with Iran briefly became the market’s dominant narrative, raising concerns about oil prices, inflation, and global growth. But as energy markets remained orderly and fears of a prolonged supply disruption faded, investors quickly turned their focus back to fundamentals. Want to invest in winners with rock-solid fundamentals? Check out our Strong Momentum Stocks and add them to your watchlist. These companies are poised for growth regardless of the political or macroeconomic climate.

Interested in Valneva SE Sponsored ADR? Here are five stocks we like better. First-half performance weakened: Revenue fell to €65.8 million from €97.6 million, while the operating loss widened to €49.9 million, partly due to IXCHIQ-related provisions and inventory impairments. Valneva maintained its 2026 outlook for product sales of €135 million–€150 million and total revenue of €145 million–€160 million, supported by €121.5 million in cash and restructuring measures expected to improve second-half cash flow. Lyme vaccine regulatory progress remains pivotal: Pfizer has filed with the European Medicines Agency and expects regulatory decisions within 12 months, with potential financial self-sustainability beginning in 2027 if the vaccine is approved and commercialized. Novavax’s dispute resolution and upcoming earnings call Valneva (NASDAQ:VALN) reported lower first-half revenue and wider losses for 2026, while maintaining its full-year sales outlook and emphasizing its cash position, restructuring measures and expectations for regulatory progress on its Lyme disease vaccine candidate with Pfizer. CEO Thomas Lingelbach said the company ended the period with more than €120 million in cash following disciplined cash management, a recent offering and a restructuring program that included workforce reductions, project reprioritization and a focus on core operations. Cash at June 30 was €121.5 million, compared with €109.6 million at the end of 2025. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be Product sales totaled €64 million in the first half, down from €91 million a year earlier. Total revenue fell to €65.8 million from €97.6 million, largely reflecting lower product sales and the absence of a prior-year upfront payment tied to a licensing agreement with the Serum Institute of India for Valneva’s single-shot chikungunya vaccine. CFO Peter Bühler said IXIARO sales declined to €44 million from €54.7 million. The decrease reflected a transition to a new German distributor in January, the timing of deliveries to the U.S. Department of Defense and a €1.5 million adverse foreign-exchange effect. The company expects to sign a new U.S. Department of Defense supply contract in the coming months and begin recognizing sales under that agreement in the second half. → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand DUKORAL sales declined to €14.7 million from €17.4 million. The prior-year period benefited from one-time doses supplied to Mayotte during a cholera outbreak, while 2026 sales were affected by the German distributor transition and some weakening in travel markets due to geopolitical factors. IXCHIQ sales were €4.4 million, compared with €7.5 million in the first half of 2025. While the current period included the first shipment of drug substance to Brazilian partner Instituto Butantan, the prior-year period included 40,000 doses sold to La Réunion during a chikungunya outbreak and U.S. travel sales. Bühler said Valneva is evaluating IXCHIQ’s future commercial strategy, including a potential greater focus on endemic markets because of slow travel-market uptake. → On Holding's Price Stumble May Be an Opening for a Company Built to Run Third-party product revenue fell to €1 million from €11.4 million after distribution agreements ended in December 2025 without renewal. Valneva reported an operating loss of €49.9 million for the first half, compared with a €16.8 million loss a year earlier. Adjusted EBITDA loss widened to €40.1 million from €6 million. Cost of goods and services rose to €59.5 million from €47.2 million. Bühler attributed the increase partly to exceptional IXCHIQ-related charges, including a €9.7 million provision for cancellation fees on external manufacturing commitments and a €4.5 million non-cash impairment on excess inventory following lower-than-expected sales. Research and development spending declined to €30.2 million from €32.4 million due to reprioritization and rescheduling of activities. Marketing and distribution expense fell to €13.5 million from €20.3 million, while general and administrative expense declined to €15.4 million from €19 million. The first-half figures included €3.2 million in one-time restructuring costs. The company expects its restructuring actions to produce favorable profit-and-loss and cash-flow effects in the second half and beyond. Bühler said Valneva expects gross margin to improve in the second half as first-half nonrecurring items do not repeat, though full-year gross margin may remain below the prior year’s level. Lingelbach said Pfizer continues to be positive about the outlook for the Lyme disease vaccine candidate, referred to during the call as LB6V. Pfizer has said it expects regulatory decisions within the next 12 months, according to Valneva. Valneva said the vaccine showed point efficacy above 70% and a favorable safety profile, though the lower bound of the 95% confidence interval missed the targeted threshold in one analysis. Lingelbach noted that the lower confidence-interval bound exceeded 20% in a second prespecified analysis and said the company believes the totality of evidence, disease burden and potential health-economic benefit support the program. During the question-and-answer session, Lingelbach confirmed Pfizer has filed with the European Medicines Agency and said European and U.S. regulatory activities are independent processes. He said he expects Europe could move first, while Pfizer continues to work with the FDA in support of a planned biologics license application submission. Valneva shares development costs with Pfizer through licensure under the existing agreement. Lingelbach said any further investment in the program after licensure, including potential post-marketing work, would be addressed later and is not currently covered by the contract. For IXCHIQ, Valneva is supporting a Brazilian pilot vaccination campaign in adults ages 18 to 59, where more than 50,000 people have been vaccinated. Lingelbach said Brazil’s government aims to vaccinate at least 100,000 people as part of active pharmacovigilance before broader public-health deployment. Butantan’s locally manufactured version of the vaccine has been approved and is expected to be incorporated into Brazil’s public health system. The company also expects results in coming months from two studies of its in-licensed tetravalent Shigella vaccine candidate: an adult controlled human infection study and an infant immunogenicity and safety study. Lingelbach said Valneva plans to determine next development steps based on the data, including whether potential optimization of dose, schedule or formulation is needed. Valneva reaffirmed 2026 guidance for product sales of €135 million to €150 million and total revenue of €145 million to €160 million. Management said the commercial business is expected to continue generating positive cash flow. Lingelbach corrected an earlier statement on timing for potential financial self-sustainability, saying the company sees potential to reach that position beginning in 2027, subject to Lyme vaccine approval and subsequent commercialization by Pfizer. Valneva SE is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases. Headquartered in Saint-Herblain, France, the company applies inactivated whole-cell and recombinant technology platforms to address public health needs. Valneva's research and development efforts span a range of viral and bacterial pathogens, with an emphasis on travel-related and emerging infectious diseases. Among its marketed products, Valneva offers IXIARO®/JESPECT® for the prevention of Japanese encephalitis and DUKORAL® for the prevention of cholera and diarrhea caused by enterotoxigenic Escherichia coli. 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 "Valneva Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Novavax NVAX incurred a loss of 32 cents per share in the second quarter of 2026, narrower than the Zacks Consensus Estimate of a loss of 36 cents. In the year-ago quarter, the company had recorded earnings per share (EPS) of 62 cents, driven by milestone-related payments. Quarterly revenues totaled $56.7 million, down 76% year over year. Yet, this metric beat the Zacks Consensus Estimate of $50 million. Shares of Novavax have increased 14% so far this year compared with the industry’s 4% growth. Image Source: Zacks Investment Research As the company’s partner, Sanofi SNY, has assumed commercial responsibility for marketing its COVID-19 vaccine Nuvaxovid, it did not record any direct product sales. Novavax recorded supply sales worth $19 million, up 47% year over year, supported by higher demand for the Matrix-M adjuvant from partners as well as COVID-19 supply to its license partners. Licensing, royalties and other revenues fell 83% to $37.8 million, almost entirely generated from Sanofi. The prior-year quarter benefited from a $175 million milestone payment from SNY and $27 million received from Takeda. Research and development (R&D) expenses declined 11% year over year to $70.7 million. This figure does not include the $22.6 million of R&D reimbursement from Sanofi. Selling, general and administrative (SG&A) expenses fell 39% to $26.7 million, primarily due to the transition of lead commercial activities to Sanofi and the elimination of Novavax’s commercial infrastructure. As of June 30, 2026, Novavax had $724 million in cash and cash equivalents compared with $795 million in the previous quarter. With Sanofi leading commercialization in key COVID-19 markets, NVAX continues to emphasize an adjusted revenue framework rather than total revenue guidance. For 2026, the company raised its adjusted total revenue outlook to $235-$275 million from $230-$270 million. The framework excludes Sanofi supply sales, royalties and milestones. NVAX lowered its 2026 combined R&D and SG&A expense guidance to $370-$410 million from $380-$420 million. Expected R&D reimbursements from Sanofi were revised to $60-$70 million from $70-$80 million. The company reiterated that adjusted combined R&D and SG&A expenses, net of partner reimbursements, are expected in the $150-$200 million range in 2028. Sanofi is in advanced discussions with regulators regarding the timing of a phase III study on its COVID-19-influenza combination vaccine. Initiation of the study in the United States or the European Union would trigger a $125 million milestone payment to Novavax. The Nuvaxovid manufacturing technology transfer to Sanofi is expected to be completed in mid-2027, triggering another $75 million milestone. Management expects that payment to extend the company's cash runway from 2028 into 2029. The company emphasized that four of the top 10 pharmaceutical companies now have licensing agreements or material transfer agreements involving Matrix-M. This includes a non-exclusive agreement signed with Pfizer PFE earlier this year. Multiple partner-led experiments are underway across infectious disease and oncology, including a recent oncology MTA with a leading global pharmaceutical company. The company also advanced its multivalent Clostridium difficile colitis (C. Diff.) vaccine candidate into pre-IND interactions with the FDA and initiated GMP manufacturing. The program remains on track for potential clinical entry as early as 2027, while the next tranche of Matrix-M data from evaluations with commercial vaccines is expected by early 2027. Novavax, Inc. price | Novavax, Inc. Quote Novavax currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. 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 Novavax, Inc. (NVAX) : Free Stock Analysis Report Sanofi (SNY) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Interested in Novavax, Inc.? Here are five stocks we like better. Q2 revenue fell to $57 million from $239 million a year earlier, largely because the prior-year quarter included a $202 million milestone benefit. Novavax ended the quarter with $743 million in cash and receivables and cut combined non-GAAP R&D and SG&A costs by 36% year over year. Novavax highlighted potential near-term Sanofi payments totaling $200 million, including a $125 million milestone tied to starting a Phase III COVID-19/influenza vaccine trial and a $75 million manufacturing technology-transfer payment expected around mid-2027. The company raised its 2026 adjusted revenue outlook to $235 million-$275 million and lowered its GAAP R&D and SG&A expense midpoint to $390 million. It also reported expanding Matrix-M partnerships into oncology, advanced its C. difficile vaccine toward potential clinical entry in 2027, and maintained targets for non-GAAP profitability as early as 2028. Analysts Think These Stocks Could More Than Double in Value Novavax (NASDAQ:NVAX) reported second-quarter 2026 revenue of $57 million and a net loss of $53 million, while highlighting progress in its Sanofi partnership, expanding use of its Matrix-M adjuvant platform and continued cost reductions. Revenue declined from $239 million a year earlier, primarily because the second quarter of 2025 included a $202 million benefit from a biologics license application approval milestone and a Takeda amendment, Chief Financial Officer Jim Kelly said. The latest quarter included $19 million in product sales, up 76% year over year, driven by demand for Matrix-M from Takeda and Serum Institute. Novavax also recorded $36 million in Sanofi-related revenue, largely from research-and-development reimbursements and amortization. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Is Biotech’s Bull Run Over? Examining Election Impacts The company ended the quarter with $743 million in cash and accounts receivable. Kelly said Novavax reduced combined non-GAAP R&D and selling, general and administrative expenses by 36% year over year during the quarter. Chief Executive Officer John Jacobs said Sanofi has confirmed its intention to be among the first companies to enter the COVID-19/influenza combination-vaccine market. Sanofi is in advanced discussions with regulators on the timing of a Phase III study for a program combining Nuvaxovid with Sanofi’s influenza vaccines, according to Novavax. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High Moderna Dips on Q2 Earnings But Can It Rip on a Short Squeeze? Initiation of that Phase III study in either the U.S. or European Union would trigger a $125 million milestone payment to Novavax. Separately, Novavax expects to earn a $75 million manufacturing technology-transfer milestone from Sanofi around mid-2027. Kelly said the anticipated payment would extend the company’s cash runway from 2028 into 2029. Jacobs said the two potential milestones provide visibility to an additional $200 million in near-term payments, on top of more than $1 billion in upfront payments, milestones, royalties and cost savings that Novavax has already realized through its Sanofi relationship. → Ulta's Growth Is Real, But So Are the Risks Sanofi is preparing a broader commercial campaign for Nuvaxovid in the U.S., including pharmacy activation and direct-to-consumer outreach, Chief Strategy Officer Elaine O’Hara said. The partner also plans to expand availability to markets including the United Kingdom, Germany and Canada during the coming season. Kelly described the U.S. COVID-19 vaccine market as primarily consumer- and retail-driven, saying more than 85% of vaccinations are administered through retail channels. He said Novavax expects Sanofi’s direct-to-consumer campaign and retail presence to support a multi-year effort to establish the protein-based vaccine option in the market. Novavax said the vaccine Sanofi plans to distribute matches the strain selections of U.S. and other regulators, and Jacobs said the company remains on track to deliver doses to Sanofi. Management emphasized expanding interest in Matrix-M, the company’s saponin-based adjuvant. Jacobs said four of the world’s 10 largest pharmaceutical companies now have licensing or material transfer agreements involving Matrix-M. Licensed partners and material transfer agreement holders collectively have rights to more than 30 areas of experimentation in infectious disease and oncology, according to the company. O’Hara said Novavax executed a material transfer agreement during the second quarter with a leading global pharmaceutical company active in immuno-oncology for therapeutic cancer-vaccine applications. She said cancer-vaccine programs may generate meaningful clinical data and development milestones more quickly than infectious-disease vaccines because trials typically enroll patients with active disease. Head of R&D Bob Walker said Novavax is increasingly focused on Matrix-M’s possible oncology applications. A study published by Novavax in npj Vaccines showed that Matrix-M supports antigen cross-presentation and downstream CD8 T-cell activation, he said. Walker also cited Stanford research published in Science Advances on saponin adjuvants used alone or with innate immune stimulators. Novavax is conducting internal oncology research across multiple target types and expects partner work to add independent data sets. Jacobs said the company believes Matrix-M “as it stands today” may have potential in oncology, while Novavax is also evaluating other approaches that could expand its use across both oncology and infectious disease. Novavax said it initiated good manufacturing practice production and pre-investigational new drug interactions with the FDA for its multivalent C. difficile vaccine candidate. Walker said the company remains on track for potential clinical entry as early as 2027. The candidate is intended to cover most circulating C. difficile clades and ribotypes, according to Walker. In response to analyst questions, he said Novavax is generally pursuing preventive vaccines and that Phase I plans are not being disclosed in detail, beyond describing the study as a standard dose-escalation effort focused on safety. Walker also said preclinical models have shown evidence that the candidate could induce mucosal immunity, although the company will discuss the finding further if it is observed in human studies. Novavax raised its 2026 adjusted total revenue framework to $235 million to $275 million, from a prior midpoint that was $5 million lower. The midpoint of $255 million reflects a $5 million increase in adjusted supply sales, a $10 million increase in other partner-related revenue, and a $10 million reduction in partner R&D reimbursements as Novavax completes obligations more efficiently. The company expects most remaining 2026 revenue to arrive in the fourth quarter, driven by the COVID-19 vaccine season. Its adjusted revenue framework excludes Sanofi supply sales, royalties and milestones. Novavax also reduced its midpoint guidance for combined 2026 GAAP R&D and SG&A expenses by $10 million to $390 million. It reiterated expected non-GAAP R&D and SG&A expenses, net of partner reimbursements, of $325 million at the midpoint. Looking to 2028, the company continues to target combined non-GAAP R&D and SG&A expenses of $150 million to $200 million, non-GAAP profitability as early as 2028, and repayment of pandemic-era advance purchase agreement liabilities by the first quarter of 2029. Kelly said Novavax anticipates reducing headcount to less than half of its first-quarter 2026 level and is exploring a reduction of more than 50% in its operating footprint. Novavax, Inc is a clinical-stage biotechnology company headquartered in Gaithersburg, Maryland, that specializes in the discovery, development and commercialization of next-generation vaccines to prevent serious infectious diseases. Founded in 1987, the company has built a platform based on recombinant nanoparticle technology and its proprietary Matrix-M™ adjuvant to enhance immune responses. The company's lead product is NVX-CoV2373, a protein-based vaccine designed to elicit a robust immune response against the SARS-CoV-2 virus. 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 "Novavax Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

ADMA Biologics, Inc. ADMA reported second-quarter 2026 earnings of 16 cents per share, which matched the Zacks Consensus Estimate and rose from 14 cents in the year-ago quarter. Revenues grew 2.0% year over year to $124.4 million but missed the Zacks Consensus Estimate of $126.0 million. ADMA Biologics markets plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases. The company’s top line currently comprises sales of three FDA-approved products — Bivigam (an Intravenous Immune Globulin [“IVIG”] product to treat primary humoral immunodeficiency), Asceniv (to treat primary immunodeficiency disease or PIDD) and Nabi-HB (to treat and provide enhanced immunity against the hepatitis B virus). Strong Asceniv growth and margin expansion were partly offset by a sharp year-over-year decline in Bivigam sales. ADMA Biologics Inc price-consensus-eps-surprise-chart | ADMA Biologics Inc Quote Asceniv revenues increased 23.5% year over year to $102.9 million. The product accounted for most of ADMA’s quarterly revenues and remained the company’s principal growth driver amid competitive pressure across the broader U.S. immune globulin market. Management stated that Asceniv utilization strengthened progressively during the quarter. June produced the strongest sequential month-over-month utilization growth since the first half of 2024, supported by new patient starts, broader prescriber engagement and higher patient utilization. Bivigam revenues plunged 48.5% year over year to $19.4 million. Increased supply, aggressive discounting and competitive pricing continued to pressure the standard immune globulin market. However, Bivigam revenues improved sequentially. Management said demand stabilized during the second quarter and expects the product’s current run rate to remain sustainable, though the company is not incorporating a meaningful recovery into its guidance. Gross profit increased to $86.3 million from $67.2 million in the prior-year period. Gross margin expanded to 69% from 55%, reflecting a greater contribution from the higher-margin Asceniv product and benefits from the yield-enhanced manufacturing process approved in 2025. The shift in revenue mix supported substantial earnings leverage despite modest top-line growth. Research and development expenses climbed to $6.0 million from $1.0 million a year earlier, primarily due to investments in the SG-001 development program. Management expects quarterly R&D spending to remain near the second-quarter level, with another increase anticipated in the fourth quarter. Selling, general and administrative expenses rose to $26.7 million from $22.2 million recorded a year earlier, mainly due to higher employee-related expenses, increased software maintenance costs, greater legal and consulting fees, and investments in strategic growth initiatives. ADMA reiterated its 2026 revenue guidance of $530-$560 million. The company continues to expect adjusted net income in the band of $170-$200 million and adjusted EBITDA in the $265-$300 million range. The outlook assumes persistent competitive dynamics and pricing pressure in the standard immune globulin market. Asceniv is expected to remain the main driver of revenue growth, profitability and cash generation, with management forecasting upper-20% to low-30% revenue growth for the product in 2026. ADMA ended the quarter with $136.0 million in cash and cash equivalents. The company repurchased approximately 7.1 million shares during the quarter. Year-to-date repurchases totaled about 13.8 million shares, representing 5.3% of outstanding common stock as of June 30, 2026. ADMA remains on track to complete at least $200 million of share repurchases during 2026. ADMA continued progressing SG-001, its hyperimmune globulin program targeting S. pneumoniae. ADMA expects to submit a pre-investigational new drug meeting package to the FDA by the end of 2026 and believes the candidate could address a $300-$500 million annual revenue opportunity if approved. ADMA’s performance in the second quarter was mixed, with earnings matching expectations but revenues missing the same as the company grapples with challenges in the IG market. The stock is down in pre-market trading. Year to date, shares of ADMA have plunged 49.2% against the industry’s growth of 2.6%. Image Source: Zacks Investment Research Per management, increased supply and pricing competition continues to weigh on the standard IG market. Nonetheless, demand for Asceniv remains strong. Management believes Asceniv remains in the early stages of penetrating the later-line refractory primary immunodeficiency market and represents a key long-term growth driver for ADMA (supported by a differentiated, patented supply and manufacturing platform). ADMA currently has a Zacks Rank #5 (Strong Sell). Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY, Liquidia Corporation LQDA and Novavax NVAX, each 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 Harmony Biosciences’ 2026 earnings per share (EPS) have risen from $3.20 to $3.33, while those for 2027 EPS have increased from $3.64 to $3.87 during the same time. Harmony Biosciences’ earnings missed estimates in three of the trailing four quarters and beat on the remaining occasion, delivering an average negative surprise of 13.97%. Over the past 60 days, estimates for Liquidia’s 2026 EPS have increased from $2.97 to $3.02, while those for 2027 EPS have improved from $4.81 to $5.31. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%. Over the past 60 days, estimates for Novavax’s 2026 loss per share have remained unchanged at 20 cents. Over the same period, loss per share estimates for 2027 have narrowed from 26 cents to 25 cents. Novavax’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 305.24%. 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 ADMA Biologics Inc (ADMA) : Free Stock Analysis Report Novavax, Inc. (NVAX) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Reported total revenue of $57 million for the second quarter of 2026 and raised full-year 2026 Revenue Framework Improved GAAP Combined R&D and SG&A expense guidance by $10 million at mid-point Sanofi confirmed with Novavax that they are in advanced discussions with regulators regarding their Phase 3 COVID-19-Influenza Combination trial timing and intend to be among the first movers in the combination vaccine segment Completion of manufacturing technology transfer to Sanofi expected in mid-2027 and would trigger a $75 million milestone payment to Novavax Multiple partner-led experiments with Matrix-M are currently underway in a wide array of infectious disease and oncology targets On track to advance C. difficile vaccine program into the clinic as early as 2027 GAITHERSBURG, Md., Aug. 6, 2026 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced its financial results and operational highlights for the second quarter ended June 30, 2026. "We're encouraged by the momentum we're seeing across our business as we continue to advance our strategy," said John C. Jacobs, President and Chief Executive Officer, Novavax. "As we enter the second half of 2026 and prepare for next year, we believe we are well positioned to deliver several important partner milestones while we advance our internal R&D programs and progress our MTA collaborations. This continued progress reinforces our confidence in our strategy and the potential to drive vaccine innovation to create meaningful value for our shareholders." Second Quarter 2026 and Recent Highlights Key Business Highlights Sanofi partnership continues to advance, supporting significant potential near- and long-term value creation. A growing body of scientific evidence supports Matrix-M's utility in oncology and infectious disease. Multiple scientific evaluations by partners and potential partners are underway, enabling future licensing opportunities. Advanced Novavax's differentiated C. difficile vaccine candidate into pre-IND interactions with the FDA and initiated GMP manufacturing process, supporting potential clinical entry as early as 2027. Second Quarter 2026 Total Revenue Second Quarter 2026 Financial Results Total revenue for the second quarter of 2026 was $57 million, a 76% decrease compared to $239 million in the same period in 2025. The prior year's second quarter 2025 total revenue included the benefit of $202 million from the combination of a $175 million milestone earned for the Nuvaxovid U.S. Biologics License Application (BLA) approval and a $27 million Takeda amendment. Product sales of $19 million in the second quarter of 2026 were 76% higher than the same period in 2025 due to higher Matrix-M adjuvant demand and sales to license partners. Cost of sales for the second quarter of 2026 were $14 million, compared to $15 million in the same period in 2025. Research and development (R&D) expenses for the second quarter of 2026 were $71 million, compared to $79 million in the same period in 2025. R&D expenses reimbursed by partners in the second quarter of 2026 were $23 million. Non-GAAP R&D expenses, net of partner reimbursement, were $48 million in the second quarter of 2026, a 34% decrease when compared to $73 million in the same period in 2025. The lower Non-GAAP R&D expenses were driven by the ongoing Novavax cost reduction program as it streamlines operations and makes targeted R&D investments. Selling, general and administrative expenses (SG&A) expenses for the second quarter of 2026 were $27 million, a 39% decrease compared to $44 million for the same period in 2025. The decrease was primarily due to the transition of lead commercial activities to Sanofi and the elimination of commercial infrastructure plus the ongoing general administrative cost reduction program. Net loss for the second quarter of 2026 was $53 million, compared to net income of $107 million in the same period in 2025. The prior years, second quarter of 2025 net income benefited from $202 million from a combination of a $175 million milestone earned for the Nuvaxovid U.S. BLA approval and a $27 million Takeda amendment. Cash, cash equivalents, marketable securities and restricted cash (Cash) were $724 million as of June 30, 2026, compared to $751 million as of December 31, 2025. Financial Framework Improves Full Year 2026 Financial Guidance Novavax improved its Full Year 2026 Financial Guidance by reducing Combined R&D and SG&A Expense guidance while maintaining Non-GAAP Combined R&D and SG&A Expense guidance and expects to achieve the following results: Non-GAAP Combined R&D and SG&A Expenses exclude R&D Reimbursements, which are amounts reimbursed by Novavax's license partners. See "Non-GAAP Financial Measures" below. R&D Reimbursements are recorded as revenue under Licensing, Royalties and Other Revenue. Raises Full Year 2026 Revenue Framework For 2026, Novavax raised its 2026 Revenue Framework and expects to achieve Adjusted Total Revenue4 to between $235 million and $275 million. Novavax transitioned lead commercial responsibility of Nuvaxovid beginning with the 2025-2026 COVID-19 vaccination season to Sanofi for select markets. Since Novavax is reliant on Sanofi's sales forecasts for certain revenue components, these are not included in the Full Year 2026 Revenue Framework. Revenue Framework Footnotes Components of Revenue excluded from the Full Year 2026 Revenue Framework are described below. Sanofi Supply Sales Novavax will sell Nuvaxovid commercial supply to Sanofi for the 2026-2027 COVID-19 vaccination season and the reimbursement for this supply will be recorded as product sales. Sanofi Royalties Sanofi will lead commercial activities for the 2026-2027 COVID-19 vaccination season in select markets, including the U.S. Novavax is eligible to receive royalties in the high teens to low twenties percent on Sanofi global net sales. Sanofi Milestones Novavax is eligible to receive up to $350 million in Phase 3 development and commercial launch milestone payments associated with Sanofi CIC products. For each new vaccine using Matrix-M, Novavax is eligible to receive up to $200 million in launch and sales milestones and mid-single digit sales royalties for 20 years. Conference CallNovavax will discuss second quarter 2026 financial results and operational highlights at 8:30 a.m. Eastern Time on Thursday, August 6, 2026. Dial-in information can be found here. A webcast of the conference call can also be accessed on the Novavax website at ir.novavax.com/events. About NovavaxNovavax, Inc. (Nasdaq: NVAX) tackles some of the world's most pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including its Matrix-M adjuvant and protein-based nanoparticles. The Company's corporate growth strategy is designed to deliver value via three key strategic pillars: partnering its technology, targeted and capital-efficient R&D innovation and a lean and efficient operating model. This includes maximizing impact through partnerships for its marketed products (Nuvaxovid, R21/Matrix-M), Matrix technology and R&D assets. Please visit novavax.com and LinkedIn for more information. Non-GAAP Financial MeasuresThe Company presents the following non-GAAP financial measures in this press release: Non-GAAP Combined R&D and SG&A Expenses, Adjusted Total Revenue and Adjusted Licensing, Royalties and Other Revenue. Non-GAAP financial measures refer to financial information adjusted from financial measures prepared in accordance with accounting principles generally accepted in the United States (GAAP). The Company believes that the presentation of these adjusted financial measures is useful to investors as they provide additional information on comparisons between periods by including certain items that affect overall comparability. The Company uses these non-GAAP financial measures for business planning purposes and to consider underlying trends of its business. Non-GAAP financial measures should be considered in addition to, and not as an alternative for, the Company's reported results prepared in accordance with GAAP. Our use of non-GAAP financial measures may differ from similar measures reported by other companies and may not be comparable to other similarly titled measures. The Company is unable to reconcile these revenue forward-looking non-GAAP financial measures to the most directly comparable GAAP measures without unreasonable effort because the Company is reliant on Sanofi sales forecasts for certain revenue categories, which are not available. Forward-Looking StatementsThis press release contains forward-looking statements relating to the future of Novavax, its mission; its corporate strategy and operating plans, objectives and prospects; its value drivers and strategic priorities; its partnerships, including expectations with respect to potential partner product sales and royalties, milestones and other commercial objectives, and cost reimbursement, Matrix-M's potential utility in partners' vaccine portfolios and plans for additional potential partnering activities; the development of Novavax's clinical and preclinical product candidates and pipeline advancement opportunities the conduct, timing and potential results from clinical trials, conducted by Novavax or its partners, ; expectations as to the timing and outcome of future and pending regulatory filings and actions; full year 2026 financial guidance and revenue framework; and Novavax's future financial or business performance. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, Novavax's ability to successfully and timely obtain and maintain full U.S. FDA licensure or foreign regulatory approvals necessary to manufacture, market, distribute, or deliver its COVID-19 vaccine; the impact of delays in obtaining regulatory approval, including regulatory decisions impacting labeling, approval or authorization, including the scope of the indicated population, product dosage, manufacturing processes, shelf life, safety, for our product candidates; challenges in conducting the PMC study, our ability to obtain adequate additional funding to maintain our current level of operations and fund the further development of our vaccine candidates; challenges related to Novavax's partnership with Sanofi, including collaboration on the Nuvaxovid PMC, and in pursuing additional partnership opportunities; challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification, assay validation and stability testing, necessary to satisfy applicable regulatory authorities; challenges or delays in conducting clinical trials or studies for its product candidates; manufacturing, distribution or export delays or challenges; Novavax's substantial dependence on Serum Institute of India Pvt. Ltd. and Serum Life Sciences Limited for co-formulation and filling Novavax's COVID-19 vaccine and the impact of any delays or disruptions in their operations; the impact of potential legislative, regulatory, or policy changes under the current presidential administration, including any adverse impact funding for vaccine research and development, reimbursement for vaccines and their administration, vaccine mandates and recommendations, and public perception of vaccine importance; uncertainty with respect to pricing, third-party reimbursement and healthcare reform; uncertainty in the regulatory pathway for Novavax's COVID -19 Vaccine; the impact of any new or changes in interpretations of existing trade measures, including tariffs, embargoes, sanctions, import restrictions, and export licensing requirements; difficulty obtaining scarce raw materials and supplies including for its proprietary adjuvant; resource constraints, including human capital and manufacturing capacity; constraints on Novavax's ability to pursue planned regulatory pathways, alone or with partners, in multiple jurisdictions simultaneously, leading to staggering of regulatory filings, and potential regulatory actions; Novavax's ability to timely deliver doses; challenges in obtaining commercial adoption and market acceptance of its COVID-19 vaccine or any COVID-19 variant strain containing formulation, or for its CIC vaccine candidates, stand-alone influenza vaccine candidates or other candidates; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities, including requirements to deliver doses that may require Novavax to refund portions of upfront and other payments previously received or result in reduced future payments pursuant to such agreements; challenges related to the seasonality of vaccinations against COVID-19; challenges related to the demand for vaccinations against COVID-19 or influenza; challenges in identifying and successfully pursuing innovation expansion opportunities; Novavax's expectations as to expenses and cash needs may prove not to be correct for reasons such as changes in plans or actual events being different than its assumptions; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Contacts: InvestorsNaina Zaman240-410-5353 [email protected] Media Yvonne [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/novavax-reports-second-quarter-2026-financial-results-and-operational-highlights-302844473.html

This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Novavax Inc (NASDAQ:NVAX) has secured licensing or material transfer agreements with 4 of the TOP10 global pharmaceutical companies, including Pfizer, for its Matrix-M adjuvant, covering over 30 areas of exploration in infectious disease and oncology. The Sanofi partnership is progressing well, with Sanofi confirming its intent to be a first mover in the combination COVID-19/influenza vaccine market and entering advanced regulatory discussions for a Phase 3 study, which would trigger a $125 million milestone payment. The company is seeing strong momentum in oncology, executing an MTA with a leading global pharma company in immuno-oncology and generating encouraging preclinical data supporting Matrix-M's potential in therapeutic cancer vaccines. Novavax Inc (NASDAQ:NVAX) is on track to achieve an approximately 90% reduction in operating expenses from peak, with a 36% decrease in combined R&D and SG&A expenses in Q2 2026, and is reiterating its goal of reaching non-GAAP profitability as early as 2028. The company increased its full-year 2026 revenue guidance to between $235 million and $275 million, driven by strong demand for Matrix-M from commercial partners like Takeda and Serum Institute, and expects to extend its cash runway into 2029 with the anticipated $75 million manufacturing tech transfer milestone from Sanofi. Novavax Inc (NASDAQ:NVAX) reported a net loss of $53 million in Q2 2026, with total revenue of $57 million, a significant decline from $239 million in the prior year, largely due to the absence of one-time milestone payments. The company's future profitability is heavily dependent on the timing of Sanofi's combination vaccine launch, which remains uncertain and outside of Novavax's direct control. Novavax Inc (NASDAQ:NVAX) faces potential non-cash fixed asset write-offs of up to $35 million in 2027 as part of its plan to reduce its operating footprint by over 50%. The company is reducing its partner R&D reimbursements guidance by $10 million for 2026, reflecting lower expected reimbursements as it delivers efficiently on partner-related obligations. Novavax Inc (NASDAQ:NVAX) remains reliant on a few key partners, particularly Sanofi, for significant milestone payments and commercial success, and the company cannot provide guidance on partner activities, creating uncertainty for investors. Warning! GuruFocus has detected 7 Warning Signs with NVAX. Is NVAX fairly valued? Test your thesis with our free DCF calculator. Q: Can you provide more color on Sanofi's advanced discussions with regulators regarding the Phase 3 study for the combined COVID-19/influenza vaccine, and what needs to be aligned for that trial to start?A: John Jacobs (President and CEO) confirmed that Sanofi has explicitly stated their intent to be among the first movers in the combination vaccine market and are in advanced discussions with regulators regarding Phase 3 study timing. He emphasized that these statements are directly from Sanofi and have been signed off by them, reflecting their strong commitment despite recent leadership changes. The initiation of a Phase 3 study in either the US or EU would trigger a $125 million milestone payment to Novavax. Q: What is the updated 2026 financial outlook, and how does the expected $75 million manufacturing tech transfer milestone from Sanofi impact the cash runway?A: Jim Kelly (Chief Financial Officer) announced an increased full-year 2026 revenue framework of $235 million to $275 million in adjusted total revenues, a $5 million increase at midpoint. He also confirmed the expectation to earn a $75 million manufacturing tech transfer milestone from Sanofi by mid-2027, which would extend the current cash runway from 2028 into 2029. The company reiterated its 2028 non-GAAP R&D and SG&A expense guidance of $150 million to $200 million and the goal of reaching non-GAAP profitability as early as 2028. Q: How much of the 2026 COVID-19 vaccine uptake assumptions depend on contract wins versus physician/patient-driven uptake, including Sanofi's DTC outreach?A: Jim Kelly (CFO) explained that the US market is consumer and retail-driven, with over 85% of shots coming through the retail market. Sanofi has contracted with all major US retailers and is rolling out a direct-to-consumer advertising campaign emphasizing the favorable tolerability profile of Nuvaxovid. John Jacobs added that Sanofi is also launching in additional international markets this year, including the UK, Germany, and Canada, positioning for a robust season and a multi-year long-term market-building strategy. Q: Can you provide details on the Phase 1 trial design for the C. difficile vaccine candidate, and are potential Phase 2/3 costs embedded in the 2028 operating expense framework?A: Bob Walker (Head of R&D) stated that the Phase 1 trial design is a standard dose escalation study focused on characterizing safety and demonstrating an adequate safety profile for further development. Jim Kelly (CFO) confirmed that the company has contemplated the ability to fund advanced development programs like C. diff, potentially as early as 2028, within the provided forward-looking expense guidance range. The company is on track for potential clinical entry as early as 2027, having initiated GMP manufacturing and pre-IND interactions with the FDA. Q: Given the recent leadership changes at Sanofi and their portfolio review, what tangible steps give you confidence that the combo vaccine remains a strategic priority for them?A: John Jacobs (CEO) emphasized that despite internal changes at Sanofi, they are seeing more engagement behind the scenes, not less. He stressed that the statements about Sanofi's intent to be a first mover in the combination vaccine market and their advanced regulatory discussions are directly provided by Sanofi and signed off by them. The company is "leaning in" with stronger commitment, and Novavax is more encouraged than ever about the partnership's potential. Q: What is the biggest need in the COVID-flu combination vaccine market, and what level of engagement will Novavax have with Sanofi as they take their combination program into Phase 3?A: Jim Kelly (CFO) highlighted the continued burden of disease, especially in the over-65 population, citing recent data on deaths and hospitalizations. Elaine O'Hara (Chief Strategy Officer) clarified that Novavax does not provide guidance or advice to Sanofi on their combo program, as they are technically competitors in that arena with their own combination influenza/COVID program. The company views the advancement to Phase 3 as a critical value-unlocking catalyst. Q: Can you provide an update on the Pfizer partnership and the progress of the 30+ areas of exploration under MTA agreements?A: Elaine O'Hara (Chief Strategy Officer) stated that Novavax continues to collaborate with Pfizer and uphold commitments under the license agreement, expressing excitement about the progress being made, though contractually restricted from discussing specific fields. Regarding the 30+ areas of exploration, she noted that each MTA is different, with partners evaluating different indications and moving on different timelines, making it difficult to predict when they might progress into full licensing agreements. The company is encouraged by the quality and diversity of organizations evaluating Matrix-M. Q: Is the C. diff vaccine candidate being developed as a prophylactic or therapeutic vaccine, and who would be the target population?A: Bob Walker (Head of R&D) indicated that while it is early days, the general philosophy is to develop a preventive vaccine, but the company is considering all options as they build the database. He noted that the candidate has the potential to cover the vast majority of circulating C. diff clades and ribotypes, and the company is exploring the possibility of inducing mucosal immunity, though preclinical models are limited and they will discuss this further if observed in human studies. Q: Do your oncology partners want Matrix-M as it currently exists, or are they licensing the components to experiment with different formulations?A: Bob Walker (Head of R&D) confirmed that Novavax believes the final version of Matrix-M as it stands today has potential in oncology and is exploring its potential deeply. The company is also looking at other approaches to expand its utility, including combining it with innate immune stimulators like TLR agonists. He noted that early data generated internally and shared under NDA with a recent partnera top-10 pharma and global leader in oncologyencouraged them to evaluate Matrix-M across a variety of oncology targets. Q: Has the strain selection for the fall COVID-19 vaccine season been completed, and is Novavax prepared to scale manufacturing for this season's strain?A: Bob Walker (Head of R&D) confirmed that the vaccine Sanofi will distribute in the US matches the strain selection of US and other regulators, and Novavax is on track for delivering doses to Sanofi. Jim Kelly (CFO) added that this is the final year of Novavax offering commercial support directly to Sanofi, and Sanofi is well-prepared to For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Harmony Biosciences Holdings, Inc. HRMY reported second-quarter 2026 earnings of $1.28 per share, up from 68 cents in the year-ago quarter. The figure surpassed the Zacks Consensus Estimate of 97 cents. Quarterly revenues rose 30% year over year to $261.28 million and surpassed the Zacks Consensus Estimate of $253 million. Growth was driven by sustained demand for lead drug, Wakix (pitolisant), with the estimated average patient count increasing by 450 sequentially to 8,950. Shares gained 8.9% following the results. Year to date, shares of HRMY have risen 3.6% compared with the industry’s 0.8% gain. Image Source: Zacks Investment Research Cost of products sold represented 24.2% of product revenues compared with 19% in the prior-year quarter, primarily due to new royalties tied to the Novitium license agreement. Research and development expenses declined 7.1% to $46.6 million, reflecting the absence of a $15-million CiRC upfront payment recorded a year ago. Sales and marketing expenses increased 13.5% to $34.1 million due to the expansion of field-based teams. General and administrative expenses decreased 17.3% to $28.1 million due to a charge related to an ANDA settlement in the second quarter of 2025. Cash, cash equivalents and investments totaled $962.5 million as of June 30, 2026, up from $882.5 million as of 2025-end. In April 2024, the company expanded into orexin-based therapies through a sublicense agreement with Bioprojet for BP-205, an investigational orexin-2 receptor agonist being developed for narcolepsy and other central nervous system (CNS) disorders. The agreement grants exclusive rights to develop, manufacture and commercialize BP-205 in the United States and Latin America. Harmony reported favorable phase I single-ascending-dose data for BP-205, its orexin-2 receptor agonist. The candidate demonstrated a short time to maximum plasma concentration (30-75 minutes) and a mean half-life of approximately 25 hours, supporting the potential for rapid onset and once-daily dosing. Exposure increased proportionally across the tested doses. BP-205 was generally safe and well tolerated, with no serious or severe treatment-emergent adverse events. Multiple-ascending-dose data in healthy volunteers are expected in the fourth quarter of 2026. Harmony also plans to begin a phase Ib study in sleep-deprived healthy volunteers during the third quarter, with data expected in early 2027. Phase II studies across multiple central nervous system indications are scheduled to begin in mid-2027. The FDA accepted the new drug application for pitolisant GR, assigning a target action date of April 1, 2027. The gastro-resistant formulation is designed to reduce gastrointestinal side effects and allow patients to begin treatment at a therapeutic dose without titration. Harmony is pursuing label expansion opportunities for pitolisant beyond narcolepsy, targeting rare neurological disorders such as Prader-Willi syndrome (PWS) and myotonic dystrophy type 1 (DM1). Phase III ONSTRIDE studies of high-dose pitolisant in narcolepsy and idiopathic hypersomnia remain underway, with top-line data expected in 2027. Top-line results are expected in mid-2027. The company is conducting the phase III TEMPO study in PWS, supported by FDA alignment, which has the potential to serve as the registrational trial and support the company’s efforts to seek pediatric exclusivity for pitolisant. The FDA granted Orphan Drug designation to pitolisant for the treatment of PWS in 2024. The company also strengthened its rare epilepsy pipeline by acquiring Epygenix Therapeutics, gaining exclusive rights to develop EPX-100 (clemizole hydrochloride) for Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). EPX-100 is being evaluated in the phase III LIGHTHOUSE study for LGS and the ARGUS study for DS. Top-line results from both rare-epilepsy programs are expected in the first half of 2027, with potential regulatory action targeted for 2028. Harmony reaffirmed its 2026 Wakix net revenue guidance of $1 billion to $1.04 billion. Wakix net product revenues rose 21% sequentially in the second quarter, reflecting a rebound from the seasonal market-access headwinds that affected patient starts during the first quarter. Management expects patient growth to continue steadily through the second half of the year, supported by the expanded commercial infrastructure. The average patient increase was the second highest in the product’s seven-year commercial history. Four of the past five quarters generated more than 400 patient additions, indicating steady demand within the narcolepsy market. Management attributed the strong performance to Wakix’s0020position as the only nonscheduled treatment option for narcolepsy. The product has payer coverage for more than 80% of covered lives and is used both as a standalone therapy and in combination with other narcolepsy therapies. HRMY delivered a strong second quarter, beating earnings and revenue estimates on robust demand for Wakix, while reaffirming its full-year revenue outlook. The company continues to generate healthy cash flows, providing ample resources to advance its pipeline. Harmony Biosciences Holdings, Inc. price-consensus-eps-surprise-chart | Harmony Biosciences Holdings, Inc. Quote Wakix remains the key growth driver, supported by rising patient additions, broad payer coverage and its differentiated profile as the only non-scheduled treatment for narcolepsy. While Harmony remains heavily dependent on Wakix, its expanding pipeline, strong balance sheet and multiple near-term regulatory and clinical catalysts strengthen its long-term growth outlook. HRMY currently sports a Zacks Rank #1 (Strong Buy). A couple of other top-ranked stocks from the sector are Liquidia Corporation LQDA and Novavax NVAX, each sporting a Zacks Rank #1 at present. 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 (EPS) have increased from $2.97 to $3.02. Over the same period, EPS estimates for 2027 have increased from $4.81 to $5.31. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%. Over the past 60 days, estimates for Novavax’s 2026 loss per share is unchanged at 20 cents. Over the same period, loss per share estimates for 2027 have narrowed from 26 cents to 25 cents. Novavax’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 305.24%. 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 Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report Novavax, Inc. (NVAX) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Novavax has moved away from trying to sell COVID vaccines on a large scale by itself. Instead, it is running a leaner operation that mainly licenses its proprietary Matrix-M adjuvant to larger drugmakers. Certain retail investors on Stocktwits voiced optimism for the Cyclospora outbreak, creating another opportunity for Novavax. Shares of Novavax (NVAX) rose about 1% on Monday as investors awaited the company's second-quarter earnings later this week, with the biotech continuing its shift away from COVID-19 vaccine sales. Novavax is scheduled to release its second-quarter 2026 financial results before the U.S. market opens on Thursday. According to data from Fiscal AI, the company is expected to report quarterly revenue of $52.06 million, down from $239.24 in the corresponding quarter of 2025. Loss per share is expected to come in at $0.38, compared to the profit of $0.62 recorded in Q2 2025. See what 10M+ investors are talking about. Get the Stocktwits Daily Rip for what retail is watching right now, free to your inbox Novavax has moved away from trying to sell COVID vaccines on a large scale by itself. Instead, it is running a leaner operation that mainly licenses its proprietary Matrix-M adjuvant — a technology that helps vaccines work better — to larger drugmakers. A key example is the January 2026 non-exclusive deal with Pfizer. Novavax received $30-million upfront and could earn up to $500 million more in milestones plus royalties if Pfizer uses Matrix-M in up to two vaccine programs. The company has also signed material-transfer agreements with other firms and continues work on combination vaccines through partnerships, including with Sanofi. In the first quarter, Novavax reported total revenue of about $140 million, with product sales declining sharply year-over-year while licensing and royalty revenue grew. The company has guided for full-year 2026 adjusted total revenue of $230–$270 million. On Thursday, investors will look for updates on cash position, progress with Matrix-M deals, and how the leaner model is performing. On Stocktwits, retail sentiment around NVAX stock stayed within the ‘bullish’ territory over the past 24 hours, while retail chatter remained at ‘normal’ levels. A Stocktwits user applauded Novavax’s strategy of licensing Matrix-M, noting that other drug companies can easily use it in their own vaccine development efforts. “Matrix M will be used simultaneously by the most ardent and embittered rivals. Business schools will study this coup d'état by Novavax in the future,” they wrote. Another user voiced optimism for the Cyclospora outbreak, creating an opportunity for Novavax after two deaths were confirmed in Michigan earlier on Monday. NVAX stock has gained 10% year-to-date. Read More: OMER Stock Gains 4% — CMS Green-Lights $287K Add-On Payments For Transplant Drug For updates and corrections, email newsroom[at]stocktwits[dot]com. Anan Ashraf has no position in any of the stocks mentioned in this article. StockTwits' news team content is for informational purposes only and is not intended as investment advice. For more, see our editorial policy. This article was originally published on StockTwits. Related: Snap CEO Bets Big On Subscription Revenue Runway After Q2 Beat Sends Stock Soaring: ‘Substantial Room To Grow’ Why Did AMZN, SNOW, BMY Stocks Surge To 52-Week Highs Today? SLS Stock Logs Best Day In Over 2 Weeks: Citigroup Builds Nearly $5M Stake Ahead Of Key AML Trial Trigger