DYN

- Positive pre-BLA meeting completed with FDA for z-rostudirsen in exon 51 DMD; on track for BLA submission in Q2 2026 and potential launch in Q1 2027 - - Positive cardiopulmonary results and long-term dystrophin data from Phase 1/2 DELIVER trial of z-rostudirsen in exon 51 DMD presented at MDA conference - - Completion of enrollment in registrational expansion cohort of Phase 1/2 ACHIEVE trial of z-basivarsen in DM1 on track for Q2 2026; global confirmatory Phase 3 HARMONIA trial initiated - - New preclinical data to be presented at ASGCT underscore differentiated capability of clinically validated FORCETM platform to cross the blood-brain barrier - WALTHAM, Mass., May 11, 2026 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today reported financial results for the first quarter of 2026 and recent business highlights. “Following positive topline data late last year, we continue to ramp up activities to support a potential launch of z-rostudirsen in DMD in the first quarter of 2027,” said John Cox, president and chief executive officer of Dyne. “We are grateful to the FDA for a collaborative pre-BLA meeting, where we aligned on the contents of our planned BLA submission for U.S. Accelerated Approval of z-rostudirsen, which is on track for this quarter.” “In DM1, we have reached our target of 60 participants in the registrational expansion cohort of the ACHIEVE trial of z-basivarsen. Based on a recent acceleration in the number of participants in screening, we currently expect to exceed this target when we complete enrollment later this quarter. As we look toward the important expected readout in the first quarter of 2027, we continue to be driven by our goal to deliver functional improvement for individuals living with DM1. We remain committed to disciplined execution as we advance our two lead programs and broader pipeline and aim to maximize returns for our shareholders,” concluded Mr. Cox. Zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251) in DMD (Duchenne muscular dystrophy) Positive cardiopulmonary results and long-term dystrophin data from the DELIVER trial In March 2026, at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, Dyne presented positive results of new anal...

- New analyses out to 24-months showed improvement in heart and lung function compared to expected declines in DMD natural history - - Data expand on previously reported results demonstrating that z-rostudirsen treatment led to sustained functional improvement across multiple clinical measures - WALTHAM, Mass., March 08, 2026 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today announced additional positive data from the ongoing Phase 1/2 DELIVER clinical trial of zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251), in individuals with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. These data are being presented in a late-breaking poster presentation at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference being held March 8-11, 2026, in Orlando, FL, which is available in the Scientific Publications & Presentations section of Dyne’s website along with all of Dyne’s other posters being presented at the conference. “This week we are presenting additional analyses of 24-month data from the DELIVER trial showing the breadth of potential benefits z-rostudirsen may bring to individuals with exon 51 skip amenable DMD beyond the previously reported unprecedented improvements in muscle function,” said Doug Kerr, M.D., Ph.D., chief medical officer of Dyne. “Cardiopulmonary issues are a key area of concern in DMD, so we are particularly encouraged by new analyses showing improvement in both heart and lung function out to 24 months. We attribute these results to the differentiated capabilities of our FORCE platform to deliver therapeutics to a broad range of muscles, including the heart, trunk and diaphragm, as well as the CNS.” Dyne announced the results of new analyses of cardiac and pulmonary function amongst all DELIVER participants who were randomized to z-rostudirsen treatment at baseline (any dose1) and for whom cardiac magnetic resonance imaging and/or pulmonary function data were available. Improvement from baseline in lung function, as measured by Forced Vital Capacity Percent Predicted (FVC%p), was observed through 24 months, as compared to the expected decline estimated in published natural history data2-4. Improvement from baseline was observed through 24 mont...

Never miss an important update on your stock portfolio and cut through the noise. Over 7 million investors trust Simply Wall St to stay informed where it matters for FREE. Dyne Therapeutics (DYN) is back in focus after Q4 2025 results showed a loss per share that came in ahead of expectations, alongside continued net losses and detailed progress in its late stage pipeline. See our latest analysis for Dyne Therapeutics. Despite Q4 earnings beating expectations, Dyne Therapeutics' recent share price has eased. The 30 day share price return is 19.83% and the 90 day share price return is 25.05%, while the 1 year total shareholder return of 24.18% indicates that longer term holders have still seen gains. This suggests some momentum has cooled as investors weigh clinical progress against ongoing losses and recent financing steps such as the shelf registration. If this earnings update has you thinking about other neuromuscular and biotech names, it could be a good moment to scan through 32 healthcare AI stocks as potential ideas to research next. With shares giving back some of their recent gains and the stock trading at a discount to analyst targets, investors now face a simple question: is this weakness a genuine opening, or is the market already pricing in Dyne’s future growth? On the numbers provided, Dyne Therapeutics trades on a P/B of 2.6x, which sits slightly below the US biotechs industry average of 2.7x and well below the peer group average of 8.7x. At a last close of $15.20 and with the shares described as trading at an 88.2% discount to an internal fair value estimate, the market is clearly pricing Dyne as a higher risk, loss making clinical stage name, but not at the premium levels seen across many peers. P/B looks at what investors are paying relative to the company’s net assets on the balance sheet. This tends to be a common yardstick for pre revenue and unprofitable biotechs where traditional earnings based metrics are less useful. For Dyne, this metric is being applied to a business that reports no meaningful revenue, a net loss of $446.214m and a negative return on equity of 45.9%, alongside forecasts that it will remain unprofitable over the next three years. The combination of a modest P/B versus the broader biotech industry and a much lower P/B than the 8.7x peer average suggests the market is putting a materially lower price on Dyne’s balance...

- Planned submission for U.S. Accelerated Approval of z-rostudirsen on track for Q2 2026; potential launch in Q1 2027 - - Positive topline results reported from Phase 1/2 DELIVER trial of z-rostudirsen in exon 51 skip amenable Duchenne muscular dystrophy (DMD); additional long-term data to be presented at MDA - - Completion of enrollment in registrational expansion cohort of Phase 1/2 ACHIEVE trial of z-basivarsen in myotonic dystrophy type 1 (DM1) expected in Q2 2026; Phase 3 trial design to be presented at MDA - - Advancing four development candidates for the potential treatment of DMD amenable to skipping of exons 53, 45, 44, and 55 - - Year-end cash of $1.1 billion; reaffirming expected cash runway into Q1 2028 - WALTHAM, Mass., March 02, 2026 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today reported financial results for the fourth quarter and full year 2025 and recent business highlights. “Dyne is entering a critical period of transformation as we advance programs from our clinically validated FORCE platform toward commercialization, with our first potential launch in DMD in less than 12 months, if Priority Review is granted and approval is received. The positive topline results we reported in December for z-rostudirsen further demonstrate the potential of the FORCE platform to safely and effectively deliver drug payloads broadly and deeply into targeted tissues, all with the goal of providing functional improvement to patients in urgent need of new therapies,” said John Cox, president and chief executive officer of Dyne. “In 2026, we are focused on disciplined execution across our two lead programs with the goal of delivering potential best-in-class therapies to patients as quickly as possible. We are actively preparing a submission for U.S. Accelerated Approval of z-rostudirsen, positioning us for a potential launch planned for the first quarter of next year. We have added seven new sites since September to the ACHIEVE trial of z-basivarsen in DM1, and we continue to accelerate patient screening and enrollment, which we believe will enable completion of enrollment in the second quarter. At the same time, we expect to initiate two field-defining Phase 3 trials in DMD and DM1, as we continue to advance...

Dyne Therapeutics Inc. (NASDAQ:DYN) is one of the high short interest stocks to buy right now. On December 8, Dyne Therapeutics announced positive topline results from the Registrational Expansion Cohort of its Phase 1/2 DELIVER trial. The trial is evaluating zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251) in individuals with Duchenne muscular dystrophy/DMD amenable to exon 51 skipping. The DELIVER trial also provided new positive long-term clinical data from its ongoing open-label extension and long-term extension portions. Z-rostudirsen is an investigational therapeutic using Dyne’s FORCE platform, designed to enable the production of near full-length dystrophin by conjugating a phosphorodiamidate morpholino oligomer to an antigen-binding fragment that binds to the transferrin receptor 1. The drug has received Breakthrough Therapy, Fast Track, and Rare Pediatric Disease designations from the US FDA, as well as Orphan Drug designation from the FDA, EMA, and MHLW in Japan. The REC met its primary endpoint and showed a statistically significant increase in muscle content-adjusted dystrophin expression to 5.46% of normal relative to baseline at 6 months. Functional improvement was observed across all 6 prespecified clinical endpoints at 6 months relative to baseline and declines in the pooled placebo group. Dyne is on track to submit a Biologics License Application/BLA for US Accelerated Approval in Q2 2026. Dyne Therapeutics Inc. (NASDAQ:DYN) is a clinical-stage neuromuscular disease company that discovers and develops therapeutics for neuromuscular diseases in the US. While we acknowledge the potential of DYN 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: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey.

- Topline data from Registrational Expansion Cohort of DELIVER trial of zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251) in DMD on track for December 2025 to support potential submission for U.S. Accelerated Approval in Q2 2026 - - FDA recently granted Breakthrough Therapy Designation to z-rostudirsen for the treatment of patients with DMD amenable to exon 51 skipping - - U.S. sites activated in ACHIEVE trial of zeleciment basivarsen (z-basivarsen, also known as DYNE-101) in DM1; completion of enrollment now expected in early Q2 2026 - - Additional one-year clinical data from ACHIEVE trial demonstrating sustained functional improvement across multiple clinical measures recently presented at WMS - - Reaffirming expected cash runway into Q3 2027, beyond Dyne’s first planned commercial launch of z-rostudirsen in DMD and potential z-basivarsen BLA submission in DM1 - WALTHAM, Mass., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today reported financial results for the third quarter of 2025 and recent business highlights. “Our lead programs in DMD and DM1 have now each been granted Breakthrough Therapy Designation by the FDA and are advancing toward anticipated U.S. Accelerated Approval submissions, as we aim to further validate the potential of our FORCE platform to safely and effectively deliver multiple drug payloads broadly and deeply into muscle and the CNS. We believe z-rostudirsen has the potential to transform the lives of individuals living with DMD amenable to exon 51 skipping, and we are excited to share topline data in December,” said John Cox, president and chief executive officer of Dyne. “We continue to advance z-basivarsen toward a U.S. Accelerated Approval submission in DM1 and now anticipate full enrollment in the ongoing Registrational Expansion Cohort of our ACHIEVE trial in early Q2 2026. This is a change from previous guidance of Q4 2025, but, starting in September, we initiated a significant expansion of clinical trial sites for ACHIEVE, including the recent activation of the first sites in the U.S. We expect that the additional sites will enable full enrollment of the planned 60 participants on this timeline. Importantly, we believe that the progress we have made ac...

- Expected cash runway extended into Q3 2027, beyond multiple potential inflection points including Dyne’s first planned commercial launch in early 2027 - - Registrational Expansion Cohort of DELIVER Trial of DYNE-251 in DMD fully enrolled to support potential submission for U.S. Accelerated Approval in early 2026 - - Registrational Expansion Cohort of ACHIEVE Trial of DYNE-101 in DM1 ongoing to support potential submission for U.S. Accelerated Approval in late 2026 - WALTHAM, Mass., July 28, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today reported financial results for the second quarter of 2025 and recent business highlights. “This quarter we made significant progress on our clinical and regulatory plans for our DM1 and DMD investigational therapies, as we advance both programs toward potential U.S. Accelerated Approval submissions in 2026 and possible commercial launches in 2027,” said John Cox, president and chief executive officer of Dyne. “We also strengthened our balance sheet, extending our cash runway into the third quarter of 2027 and believe we are well funded to achieve multiple value-creating milestones including two data readouts in DM1 and DMD, two potential U.S. Accelerated Approval submissions in those indications, and the potential launch of DYNE-251 in DMD in the U.S.” DYNE-101 in Myotonic Dystrophy Type 1 (DM1) In June 2025, Dyne announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to DYNE-101 for the treatment of DM1. Additionally, Dyne submitted a revised protocol to the FDA for the Registrational Expansion Cohort of the ACHIEVE trial with video hand opening time (vHOT) as the primary endpoint, to serve as an intermediate clinical endpoint for U.S. Accelerated Approval. Dyne also reported new positive long-term data from adult DM1 patients enrolled in the randomized, placebo-controlled multiple ascending dose (MAD) portion of the DYNE-101 ACHIEVE trial, including data from the 6.8 mg/kg Q8W cohort (n=6) at up to 12 months. Dyne plans to complete enrollment of 60 patients in the Registrational Expansion Cohort of the ACHIEVE trial in Q4 2025. Data from this cohort are planned for mid-2026 to support a potential U.S. Accelerated Appr...

- FDA (CDER) Type C meeting held in May 2025 for DYNE-101 in DM1 and Dyne plans to provide a regulatory update following receipt of meeting minutes - - Registrational Expansion Cohort of ACHIEVE Trial of DYNE-101 in DM1 initiated to support potential submission for U.S. Accelerated Approval in H1 2026 - - Registrational Expansion Cohort of DELIVER Trial of DYNE-251 in DMD fully enrolled to support potential submission for U.S. Accelerated Approval in early 2026 - WALTHAM, Mass., May 08, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on advancing life-transforming therapeutics for people living with genetically driven neuromuscular diseases, today reported financial results for the first quarter of 2025 and recent business highlights. “Our two lead programs continue to demonstrate compelling and favorable data, including evidence of functional improvement across multiple measures in DM1 and DMD. We are urgently advancing both programs toward potential U.S. Accelerated Approval submissions in 2026 and possible commercial launches in 2027,” said John Cox, president and chief executive officer of Dyne. “I am also thrilled to welcome Erick, Vik and Ron to the Dyne leadership team, which now includes a new role for Oxana as chief innovation officer. Together, our team has the proven experience and capabilities to efficiently drive the business, deliver therapies that bring functional improvement and create significant shareholder value.” DYNE-101 in DM1 Dyne participated in a Type C meeting with the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) in May 2025 and discussed the path to regulatory approval, including U.S. Accelerated Approval, for DYNE-101 in DM1. Dyne participated in a Type C meeting with the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) in May 2025 and discussed the path to regulatory approval, including U.S. Accelerated Approval, for DYNE-101 in DM1. Dyne has initiated a global placebo-controlled Registrational Expansion Cohort in the ACHIEVE trial that will include up to 48 participants with full enrollment planned for mid-2025. Data from this cohort is planned for H1 2026 to support a potential U.S. Accelerated Approval Biologics License Application (BLA) submission in H1 2026. Dyne has initiated a global placebo-...

Dyne Therapeutics (DYN) said Sunday that long-term clinical data from an ongoing phase 1/2 clinical