DNLI

Benzinga and Yahoo Finance LLC may earn commission or revenue on some items through the links below. On Wednesday, Nancy Pelosi Stock Tracker drew attention to an AI-powered portfolio's latest biotech wager after Claude AI opened a new position in Denali Therapeutics ahead of its earnings report. The AI-run portfolio, known as The Claude Portfolio, allocated roughly 4.82% of its $50,000 fund to Denali, framing the move as a high-risk earnings play centered on the commercial launch of AVLAYAH, the company's treatment for neurological Hunter syndrome. Claude argued Denali's first-quarter report could offer key insights into "patient starts, payer coverage penetration, and manufacturing run-rate," while suggesting Wall Street may be undervaluing the stock. "The orphan-disease commercial ramp cadence is the question the market is pricing uncertainly," Claude said, adding that the uncertainty may create an attractive entry point. Don't Miss: A single bad hire can set a startup back years. Here are the 5 hires founders most often misjudge — and why Still Learning the Market? These 50 Must-Know Terms Can Help You Catch Up Fast Claude's thesis also pointed to Denali's competitive advantage after REGENXBIO's rival gene therapy received an FDA Complete Response Letter earlier this year, effectively leaving AVLAYAH without an approved competitor in the U.S. market. The AI model projected a $24.75 price target for Denali, implying more than 32% upside over 12 months. Claude acknowledged substantial risks, including Denali's annual cash burn, manufacturing scale-up challenges and the limited patient population for its ultra-rare disease treatment. "The sizing at 4.82% reflects those risks," the AI noted. Trending: Avoid the #1 Investing Mistake: How Your ‘Safe' Holdings Could Be Costing You Big Time Nancy Pelosi Stock Tracker summarized the move by posting, "We now have Claude doing Pharma earnings plays. Will be interesting to see how this one plays out." DNLI is set to release its first-quarter 2026 earnings on May 19, with Wall Street projecting a loss of 71 cents per share on revenue of $3.82 million. In the prior quarter, the company posted a loss of 73 cents per share, outperforming analyst expectations of 75 cents, though revenue fell short at zero versus the projected $8.99 million. Photo courtesy: Shutterstock Read Next: Skip the Regrets: The Essential Retiremen...

FDA approved AVLAYAH™ (tividenofusp alfa-eknm) for treatment of Hunter syndrome (MPS II) and as first medicine to leverage transferrin receptor to cross blood-brain barrier AVLAYAH launched in U.S. with strong momentum, vibrant community engagement, and first patients treated in commercial setting in April Broad clinical pipeline progressing for lysosomal storage and neurodegenerative diseases, including first patient dosed with Oligonucleotide TransportVehicle™ (OTV)-enabled DNL628 (OTV:MAPT) targeting tau for Alzheimer's disease Advancing DNL593 (PTV:PGRN) in Phase 1/2 study for GRN-related frontotemporal dementia after regaining full rights, with data expected by end of 2026 SOUTH SAN FRANCISCO, Calif., May 07, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the first quarter ended March 31, 2026, and provided business highlights, including the recent U.S. Food and Drug Administration (FDA) approval of AVLAYAH™ (tividenofusp alfa-eknm). “The FDA approval of AVLAYAH is a major milestone for Denali, for the Hunter syndrome community, and for the field of biotherapeutics enabled to cross the blood-brain barrier. We are thrilled by the strong engagement with the community, seamless execution by our commercial team, and achievement of our first patient dosed in less than one month from approval,” said Ryan Watts, Ph.D., Chief Executive Officer of Denali Therapeutics. “AVLAYAH provides validation for our TransportVehicle™ (TV) platform enabling our broad clinical portfolio for lysosomal storage and neurodegenerative diseases. We are excited about progress achieved across the portfolio, including dosing of the first patients with our Oligonucleotide TV-enabled investigational therapy DNL628 (OTV:MAPT) targeting tau for Alzheimer’s disease and advancing DNL593 (PTV:PGRN) for FTD-GRN after regaining full rights." First Quarter 2026 and Recent Program Updates COMMERCIAL PRODUCT AVLAYAH (tividenofusp alfa-eknm) for Hunter syndrome (mucopolysaccharidosis type II [MPS II]) On March 25, 2026, Denali announced AVLAYAH (tividenofusp alfa-eknm) received accelerated approval for the treatment of neurologic manifestations of Hunter syndrome (MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment. Continued approval for this indication may...

Tividenofusp alfa (DNL310; ETV:IDS) launch readiness established ahead of April 5, 2026 Prescription Drug User Fee Act (PDUFA) target action date for Hunter syndrome DNL126 (ETV:SGSH) Phase 1/2 preliminary data presented at 2026 WORLDSymposium™, supporting plans to pursue an accelerated approval path in Sanfilippo syndrome type A Start-up activities underway for DNL628 (OTV:MAPT) Phase 1b study for Alzheimer's disease and DNL952 (ETV:GAA) Phase 1 study for late-onset Pompe disease TransportVehicle™ platform and clinical pipeline progressing across lysosomal storage disorders and neurodegenerative diseases SOUTH SAN FRANCISCO, Calif., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided business highlights. “In 2025, we made meaningful progress toward delivering urgently needed treatment options for people living with neurodegenerative diseases and lysosomal storage disorders, building on the strong scientific foundation that defines Denali,” said Ryan Watts, Ph.D., Chief Executive Officer of Denali Therapeutics. “We established commercial readiness for the anticipated launch of tividenofusp alfa for individuals and families affected by Hunter syndrome and continued advancing our TransportVehicle platform across serious neurologic and systemic diseases that impact millions worldwide. "In 2026, we are focused on launching tividenofusp alfa and transforming life for individuals living with other serious diseases. Data presented at WORLDSymposium support our plans to pursue an accelerated approval path for DNL126 in Sanfilippo syndrome type A. We are also initiating clinical studies of DNL628 (OTV:MAPT) in Alzheimer’s disease and DNL952 (ETV:GAA) in late-onset Pompe disease. Over the next three years, we expect to advance four to six additional programs into the clinic, guided by our commitment to the patients we serve.” Fourth Quarter 2025 and Recent Program Updates CLINICAL PROGRAMS Tividenofusp alfa (DNL310; ETV:IDS) for Hunter syndrome (mucopolysaccharidosis type II [MPS II]) Denali has established commercial launch readiness in anticipation of a regulatory decision on the Biologics License Application (BLA) for tividenofusp alfa under the U.S. Food and Drug Administration (FDA) accelerated approval pathway with a Prescription Drug...

Denali Therapeutics Inc. (NASDAQ:DNLI) is one of the 15 stocks set to explode in 2026. On November 7, 2025, H.C. Wainwright’s Andrew Fein reiterated his “Buy” rating on Denali Therapeutics Inc. (NASDAQ:DNLI) with a $32 price target. Fein’s bullish stance followed Denali Therapeutics Inc. (NASDAQ:DNLI)’s Q3 results. He highlighted the upcoming launch of tividenofusp, which is the first transferrin receptor (TfR)-enabled medicine. Fein believes this launch will establish a commercial framework capable of supporting future enzyme replacement programs. He also discussed the recent acquisition of Avidity, which reflects the industry’s increasing recognition of TfR-based delivery as an efficient method for tissue penetration. Moreover, with tividenofusp getting closer to its PDUFA date and DNL126 completing Phase 1/2 enrollment, the analyst believes Denali’s pipeline is advancing strongly. Furthermore, with its innovative Transport Vehicle (TV) platform seen as both clinically and commercially viable, investor confidence in the company’s ability to bank on its technological progress is bolstered. At the same time, Denali Therapeutics Inc. (NASDAQ:DNLI) is filing new Investigational New Drug applications (INDs) for programs targeting Alzheimer’s and Pompe disease, which the analyst believes will expand its market reach. The analyst’s note followed the company’s earnings release on the previous day, where it reported a net loss of $126.9 million. Denali Therapeutics Inc. (NASDAQ:DNLI) reported slightly increased R&D expenses of $102 million, driven by operational start at its large molecule manufacturing facility in Salt Lake City, Utah. The company ended the quarter with $872.9 million in cash balance. Denali Therapeutics Inc. (NASDAQ:DNLI), a South San Francisco-based biopharmaceutical company, is focused on the development of therapies for neurodegenerative and lysosomal storage diseases, improving drug delivery across the blood-brain barrier. While we acknowledge the potential of DNLI as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 13 Best Fortune 500 Stocks to Invest in Now and 13 Best Fortune 50...

Tividenofusp alfa BLA review process for accelerated approval for MPS II continues with productive engagement with the FDA; commercial launch preparations on track DNL126 Phase 1/2 study enrollment completed, supporting an accelerated approval path in MPS IIIA Two new regulatory applications submitted to initiate clinical studies with DNL628 (OTV:MAPT) for Alzheimer’s disease and DNL952 (ETV:GAA) for Pompe disease Tim Van Hauwermeiren, CEO of argenx, to join Denali's Board of Directors Carole Ho, M.D., Chief Medical Officer, departing company; Peter Chin, M.D., assuming role of Acting CMO and Head of Development Denali to host Investor Day on December 4, 2025 SOUTH SAN FRANCISCO, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the third quarter ended September 30, 2025, and provided business highlights. “Momentum is building across Denali as we prepare for the anticipated launch of tividenofusp alfa with an experienced and focused commercial team in place,” said Ryan Watts, Ph.D., Chief Executive Officer of Denali Therapeutics. “We are also excited to have submitted regulatory applications to initiate clinical studies with two additional programs representing new opportunities to expand the TransportVehicle™ platform to Alzheimer's disease and Pompe disease. Our robust pipeline continues to lead the way in the emerging class of transferrin receptor (TfR)-enabled medicines designed to deliver the power of biotherapeutics throughout the body, including the brain.” Third Quarter 2025 and Recent Program Updates CLINICAL PROGRAMS Tividenofusp alfa (DNL310, ETV:IDS) for Hunter syndrome (MPS II) In October, Denali announced that the FDA extended its review timeline of the Biologics License Application (BLA) seeking accelerated approval of tividenofusp alfa for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome. The Prescription Drug User Fee Act (PDUFA) target date was extended from January 5, 2026, to April 5, 2026. The extension follows Denali’s submission of updated clinical pharmacology information in response to an information request from the FDA as part of the standard review process and is not related to efficacy, safety or biomarkers. The FDA classified the submission as a Major Amendment (MA) to the BLA, which, per FDA regulations, extends the review...

A month has gone by since the last earnings report for Denali Therapeutics Inc. (DNLI). Shares have added about 16.2% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Denali Therapeutics due for a pullback? Well, first let's take a quick look at the latest earnings report in order to get a better handle on the recent drivers for Denali Therapeutics Inc. before we dive into how investors and analysts have reacted as of late. Denali reported a second-quarter 2025 loss of 72 cents per share, narrower than the Zacks Consensus Estimate of a loss of 74 cents. The company reported a loss of 59 cents in the year-ago quarter. The loss per share deteriorated year over year due to an increase in total operating expenses. In the absence of a marketed product, the company only recognizes revenues from ongoing collaborations. Denali did not generate collaboration revenues in the reported quarter. The Zacks Consensus Estimate for revenues was pegged at $25 million. Research and development expenses increased 12.4% to $102.7 million. The increase was primarily due to increased spending on multiple preclinical programs. An increase in other research and development expenses, consultants and general facilities costs also contributed to the surge. General and administrative expenses increased 28% to $32.3 million due to activities related to the preparations for a potential launch of tividenofuspalfa. As of June 30, 2025, cash, cash equivalents, and marketable securities amounted to approximately $977.4 million. In July 2025, Denali announced that the FDA accepted its biologics license application (BLA) for pipeline candidate tividenofuspalfa for priority review. The regulatory body assigned a target action date of Jan. 5, 2026. The BLA seeks accelerated approval based on a data package, including results from the phase I/II study in individuals with Hunter syndrome. The FDA had previously granted tividenofusp alfa Breakthrough Therapy, Fast Track, Orphan Drug, and Rare Pediatric Disease designations. Tividenofusp alfa is an investigational, next-generation enzyme replacement therapy designed to cross the blood-brain barrier (BBB) and deliver the iduronate-2-sulfatase (IDS) enzyme throughout the body and brain. Denali continues to prepare for commercial launch and is conducting the phase II/II...

Tividenofusp alfa BLA for Hunter syndrome accepted for priority review and assigned PDUFA target action date of January 5, 2026; company preparing for commercial launch DNL126 accelerated approval path for Sanfilippo syndrome Type A aligned with FDA; Phase 1/2 study nearing completion of enrollment; planning underway for a global Phase 3 confirmatory study On track to submit regulatory applications in 2025 to begin clinical testing of one to two additional TransportVehicleTM (TV)-enabled programs Preclinical research on ATV:Abeta program for Alzheimer’s disease published in the journal Science SOUTH SAN FRANCISCO, Calif., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the second quarter ended June 30, 2025, and provided business highlights. “The FDA’s priority review of our BLA for tividenofusp alfa and alignment on an accelerated approval path for DNL126 are key milestones highlighting the potential of our Transport Vehicle (TV) platform to catalyze a new class of blood-brain barrier-crossing therapeutics,” said Ryan Watts, Ph.D., CEO of Denali Therapeutics. “With launch readiness in motion and a growing portfolio of TV-enabled enzyme, antibody, and oligonucleotide programs, Denali is poised to deliver meaningful treatments for people living with lysosomal, neurodegenerative, and other serious diseases.” Second Quarter 2025 and Recent Program Updates CLINICAL PROGRAMS Tividenofusp alfa (DNL310, ETV:IDS) for Hunter syndrome (MPS II) In July 2025, Denali announced that the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for tividenofusp alfa for priority review, assigning a Prescription Drug User Fee Act (PDUFA) target action date of January 5, 2026. The BLA seeks accelerated approval based on a data package including results from the Phase 1/2 study in individuals with Hunter syndrome. Tividenofusp alfa is an investigational, next-generation enzyme replacement therapy designed to cross the blood-brain barrier (BBB) and deliver the iduronate-2-sulfatase (IDS) enzyme throughout the body and brain. The FDA previously granted tividenofusp alfa Breakthrough Therapy, Fast Track, Orphan Drug, and Rare Pediatric Disease designations. Denali continues to prepare for commercial launch and is conducting the Phase 2/3 COMPASS study to support global regulatory submis...

Denali Therapeutics (DNLI) reported a second-quarter 2025 loss of 72 cents per share, narrower than the Zacks Consensus Estimate of a loss of 74 cents. The company reported a loss of 59 cents in the year-ago quarter. The loss per share deteriorated year over year due to an increase in total operating expenses. In the absence of a marketed product, the company only recognizes revenues from ongoing collaborations. Denali did not generate collaboration revenues in the reported quarter. The Zacks Consensus Estimate for revenues was pegged at $25 million. Shares of DNLI have lost 31.7% year to date compared with the industry’s 0.6% decline. Image Source: Zacks Investment Research Research and development expenses increased 12.4% to $102.7 million. The increase was primarily due to increased spending on multiple preclinical programs. An increase in other research and development expenses, consultants and general facilities costs also contributed to the surge. General and administrative expenses increased 28% to $32.3 million due to activities related to the preparations for a potential launch of tividenofusp alfa. As of June 30, 2025, cash, cash equivalents, and marketable securities amounted to approximately $977.4 million. Denali Therapeutics Inc. price-consensus-eps-surprise-chart | Denali Therapeutics Inc. Quote In July 2025, Denali announced that the FDA accepted its biologics license application (BLA) for pipeline candidate tividenofusp alfa for priority review. The regulatory body assigned a target action date of Jan. 5, 2026. The BLA seeks accelerated approval based on a data package, including results from the phase I/II study in individuals with Hunter syndrome. The FDA had previously granted tividenofusp alfa Breakthrough Therapy, Fast Track, Orphan Drug, and Rare Pediatric Disease designations. Tividenofusp alfa is an investigational, next-generation enzyme replacement therapy designed to cross the blood-brain barrier (BBB) and deliver the iduronate-2-sulfatase (IDS) enzyme throughout the body and brain. Denali continues to prepare for commercial launch and is conducting the phase II/III COMPASS study to support global regulatory submissions. Denali is also evaluating DNL126 for the treatment of Sanfilippo syndrome type A (MPS IIIA). Concurrent with the quarterly results, Denali announced that it has reached alignment with the FDA’s Center for Drug Eva...

A month has gone by since the last earnings report for Denali Therapeutics Inc. (DNLI). Shares have added about 0.7% in that time frame, underperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Denali Therapeutics due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important drivers. It turns out, estimates revision have trended upward during the past month. At this time, Denali Therapeutics has a poor Growth Score of F, however its Momentum Score is doing a lot better with a C. However, the stock was allocated a grade of F on the value side, putting it in the lowest quintile for this investment strategy. Overall, the stock has an aggregate VGM Score of F. 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 indicates a downward shift. Notably, Denali Therapeutics has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Denali Therapeutics belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Moderna (MRNA), has gained 13.3% over the past month. More than a month has passed since the company reported results for the quarter ended March 2025. Moderna reported revenues of $108 million in the last reported quarter, representing a year-over-year change of -35.3%. EPS of -$2.52 for the same period compares with -$3.07 a year ago. Moderna is expected to post a loss of $2.97 per share for the current quarter, representing a year-over-year change of +10.8%. Over the last 30 days, the Zacks Consensus Estimate has changed -3.9%. Moderna 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 Denali Therapeutics Inc. (DNLI) : Free Stock Analysis Report Moderna, Inc. (MRNA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

SOUTH SAN FRANCISCO, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the first quarter ended March 31, 2025, and provided business highlights. “The completion of our BLA submission for tividenofusp alfa represents a pivotal milestone—not only in our commitment to delivering a potentially transformative therapy to individuals living with Hunter syndrome, but also in Denali’s evolution as a fully integrated, late-stage development and commercial organization,” said Ryan Watts, Ph.D., CEO of Denali Therapeutics. “We are now preparing for commercial launch in late 2025 or early 2026. If approved, tividenofusp alfa would be the first FDA-approved enzyme replacement therapy engineered to cross the blood-brain barrier to treat body and brain manifestations of Hunter syndrome. Our broader TransportVehicle-enabled pipeline continues to advance, including the DNL126 program for Sanfilippo syndrome Type A for which we have an ongoing and productive collaboration with the FDA through the START program. Additionally, the recent launch of our in-house clinical biomanufacturing facility in Salt Lake City further enhances our ability to scale efficiently in the U.S. and supply future programs across lysosomal and neurodegenerative diseases.” First Quarter 2025 and Recent Program Updates CLINICAL PROGRAMS Tividenofusp alfa (DNL310, ETV:IDS) for Hunter syndrome (MPS II) Today, Denali announced completion of submission of a Biologics License Application (BLA) for tividenofusp alfa under the U.S. Food and Drug Administration’s (FDA’s) accelerated approval pathway based on data from the Phase 1/2 study in participants with Hunter syndrome. The submission of the final BLA modules initiates the FDA’s 60-day filing review process and, upon acceptance of the application, the FDA will communicate the Prescription Drug User Fee Act (PDUFA) target action date. In January 2025, the FDA granted Breakthrough Therapy Designation for tividenofusp alfa for the treatment of individuals with Hunter syndrome (MPS II). Tividenofusp alfa was previously granted Fast Track, Orphan Drug and Rare Pediatric Disease designations. In February 2025, at the WORLD Symposium conference, Denali presented the primary analysis of the Phase 1/2 study in 47 participants with Hunter syndrome in the 24-week treatment period and additional long-t...

The first-quarter earnings season for the Medical sector will be in full swing this week as several drugmakers are slated to report their earnings results. The sector mainly comprises pharma/biotech and medical device companies. Most pharma bigwigs have already reported their first-quarter earnings results. Among the large caps, J&J Merck, Bristol Myers, Novartis and Amgen have beaten both their first-quarter earnings and sales estimates, while Pfizer, Eli Lilly, Sanofi and Biogen reported mixed first-quarter earnings results. Regeneron, on the other hand, missed both earnings and sales estimates this time around. Per the Earnings Trends report, as of April 30, 45% of the Medical sector companies, constituting about 57.9% of the sector’s market capitalization, posted earnings. Among the companies that reported first-quarter earnings, 66.7% of them beat both earnings and revenue estimates. Earnings increased 60.5% year over year, while revenues rose 7.8%. Overall, first-quarter earnings of the Medical sector are expected to rise 40%, while revenues are projected to increase 8.3%. (Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.) Here, we have highlighted five drug/biotech companies — Novo Nordisk NVO, Pacira BioSciences PCRX, Ultragenyx Pharmaceuticals RARE, Acadia Pharmaceuticals ACAD and Denali Therapeutics DNLI — that are expected to deliver a beat in their upcoming quarterly results. Earnings ESP is our proprietary methodology for determining the stocks that have the best chance of delivering an earnings surprise. Earnings ESP shows the percentage difference between the Most Accurate Estimate and the Zacks Consensus Estimate. According to the Zacks model, the combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. The selection can be done with the help of the Zacks Stock Screener. Our research shows that for stocks with this combination, the chance of an earnings surprise is as high as 70%. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter. Bagsværd, Denmark-based Novo Nordisk has an Earnings ESP of +0.82% and a Zacks Rank #3 at present. You can see the complete list of today’s Zacks #1 Rank stocks here. The Zacks Consensus Estimate for first-quarter earnings is pegged at 92 cents per share, while that f...