Dyne Therapeutics, Inc. — News

- Biologics License Application (BLA) for z-rostudirsen in exon 51 DMD accepted for review by FDA; Priority Review granted; PDUFA target action date set for January 21, 2027 -

globenewswire.com - 2026-07-29 16:30:00

- Company's third program to enter clinical development leveraging FORCE platform with the goal of delivering functional improvement in rare neuromuscular disease -

globenewswire.com - 2026-07-28 07:30:00

Fifth Third Bancorp purchased a new stake in Dyne Therapeutics, Inc. (NASDAQ: DYN) during the undefined quarter, according to its most recent filing with the Securities and Exchange Commission. The fund purchased 54,229 shares of the company's stock, valued at approximately $983,000. Several other institutional investors and hedge funds have also recently added

defenseworld.net - 2026-07-27 04:03:46

WALTHAM, Mass., July 24, 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 that it has granted inducement equity awards to 12 newly hired employees. The awards were made as an inducement material to the newly hired employees' acceptance of employment with Dyne in accordance with Nasdaq Listing Rule 5635(c)(4).

globenewswire.com - 2026-07-24 16:05:00

WALTHAM, Mass., July 23, 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 the closing of its previously announced upsized underwritten public offering of 21,045,000 shares of its common stock at a public offering price of $20.50 per share, which includes 2,745,000 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares of common stock in the offering.

globenewswire.com - 2026-07-23 16:05:00

WALTHAM, Mass. , July 21, 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 the pricing of an upsized underwritten public offering of 18,300,000 shares of its common stock at a public offering price of $20.

globenewswire.com - 2026-07-21 22:46:14

WALTHAM, Mass., July 21, 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 the pricing of an upsized underwritten public offering of 18,300,000 shares of its common stock at a public offering price of $20.50 per share. The gross proceeds to Dyne from the offering, before deducting underwriting discounts and commissions and offering expenses payable by Dyne, are expected to be $375,150,000. All shares in the offering are being sold by Dyne. The offering is expected to close on or about July 23, 2026, subject to customary closing conditions. In addition, Dyne has granted the underwriters a 30-day option to purchase up to an additional 2,745,000 shares of its common stock at the public offering price, less the underwriting discounts and commissions.

globenewswire.com - 2026-07-21 22:46:00

WALTHAM, Mass., July 21, 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 that it has commenced an underwritten public offering of $300,000,000 of shares of its common stock. Dyne also intends to grant the underwriters a 30-day option to purchase up to an additional $45,000,000 of shares of its common stock. All of the shares in the proposed offering are to be sold by Dyne.

globenewswire.com - 2026-07-21 16:46:00

Dyne gains momentum as FDA priority review for its lead DMD therapy and progress in its DM1 program strengthen confidence in its pipeline.

zacks.com - 2026-07-21 11:20:21

Dyne Therapeutics receives FDA Priority Review for z-rostudirsen in DMD, with a potential U.S. launch in Q1 2027. DYN demonstrates best-in-class dystrophin expression in registrational trials, targeting a $3.5bn market for exon 51 skipping DMD patients. Robust pipeline includes z-basivarsen for DM1, with pivotal data expected Q1 2027 and potential accelerated approval/launch in 2028.

seekingalpha.com - 2026-07-20 14:35:56

- Priority Review granted; PDUFA target action date set for January 21, 2027 - - Submission for Accelerated Approval based on dystrophin as a surrogate endpoint - - In the registrational expansion cohort of the DELIVER trial, treatment with z-rostudirsen once every 4 weeks resulted in a robust and statistically significant increase in dystrophin production with functional improvement observed across multiple clinical endpoints and a favorable safety profile 1  - WALTHAM, Mass., July 20, 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 that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251) for the treatment of individuals with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.

globenewswire.com - 2026-07-20 07:30:00

Dyne Therapeutics is advancing a clinical-stage platform specifically targeting genetically driven neuromuscular diseases. Recursion Pharmaceuticals utilizes an artificial intelligence OS to accelerate drug discovery across several therapeutic areas.

fool.com - 2026-07-04 09:21:09

Dyne Therapeutics focuses on high-potential therapies for rare neuromuscular diseases using its proprietary FORCE platform. Vertex Pharmaceuticals maintains a dominant market share in cystic fibrosis while expanding its reach into gene editing and pain management.

fool.com - 2026-07-01 11:38:42

Dyne is advancing therapies for rare muscle diseases while Viking targets the booming weight-loss market. See how their financials and risk profiles compare.

fool.com - 2026-06-26 11:05:48

After a sweeping semi-annual rebalance, the biotech index underlying the ALPS Medical Breakthroughs ETF (SBIO) gained over 10% in just six trading days beginning June 18. Key Takeaways: SBIO's underlying index gained 10.01% in six trading days following its June 18 semi-annual rebalance.

etftrends.com - 2026-06-25 11:31:47

WALTHAM, Mass., June 22, 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 the appointment of Barry Greene to its Board of Directors. Mr. Greene brings more than three decades of biopharmaceutical industry experience and a track record of building and scaling innovative companies from development through commercialization across rare diseases, neuroscience, and oncology.

globenewswire.com - 2026-06-22 16:10:00

WALTHAM, Mass., June 18, 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 that it has granted inducement equity awards to 6 newly hired employees. The awards were made as an inducement material to the newly hired employees' acceptance of employment with Dyne in accordance with Nasdaq Listing Rule 5635(c)(4).

globenewswire.com - 2026-06-18 16:05:00

- Up to $125 million in additional borrowing capacity provides further strategic flexibility - - $50 million of additional capacity funded at amendment closing - WALTHAM, Mass., June 17, 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 that it has entered into an amendment to its non-dilutive senior secured term loan facility with Hercules Capital, Inc. (NYSE: HTGC), a leader in customized debt financing for companies in the life sciences and technology-related markets.

globenewswire.com - 2026-06-17 07:30:00

- Registrational expansion cohort enrolled 71 participants; topline data planned for Q1 2027 -  WALTHAM, Mass., June 03, 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 the completion of enrollment in the registrational expansion cohort (REC) of the Phase 1/2 ACHIEVE trial of zeleciment basivarsen (z-basivarsen, also known as DYNE-101) in individuals with DM1.

globenewswire.com - 2026-06-03 07:30:00

DYN shares jump after the company files a BLA with the FDA for z-rostudirsen in Duchenne muscular dystrophy.

zacks.com - 2026-05-27 11:21:05

- Submission for Accelerated Approval based on dystrophin as a surrogate endpoint - - In the registrational expansion cohort of the DELIVER trial, treatment with z-rostudirsen resulted in a robust and statistically significant increase in dystrophin production with functional improvement observed across multiple clinical endpoints and a favorable safety profile 1 - - Proposed dosing regimen of 20 mg/kg administered intravenously once every 4 weeks (Q4W) - WALTHAM, Mass., May 26, 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 the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251) 20 mg/kg Q4W for the treatment of individuals with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.

globenewswire.com - 2026-05-26 07:30:00

Dyne Therapeutics, Inc. retains a Strong Buy rating, driven by clinical progress in DM1 and DMD programs targeting significant unmet needs. DYN expects to file a BLA for z-rostudirsen in DMD exon 51 skipping patients in Q2 2026, with potential commercialization by Q1 2027. Top-line data from the phase 1/2 ACHIEVE REC study in DM1 is anticipated in Q1 2027, supporting future accelerated approval filings.

seekingalpha.com - 2026-05-21 14:37:15

DYN shares jump 10% after launching a phase III study of z-rostudirsen in Duchenne muscular dystrophy patients amenable to exon 51 skipping.

zacks.com - 2026-05-21 12:36:13

WALTHAM, Mass., May 20, 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 that it has granted inducement equity awards to 17 newly hired employees.

globenewswire.com - 2026-05-20 17:30:00

- 72-week trial will enroll approximately 90 participants; first site now open for enrollment - - Primary endpoint is rise from floor (RFF) velocity with multiple secondary endpoints to assess muscle and pulmonary function - - FORZETTO trial design and protocol aligned with FDA; trial intended to serve as confirmatory trial for traditional approval in the U.S. and support ex-U.S. marketing applications - WALTHAM, Mass., May 20, 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 the initiation of the Phase 3 FORZETTO trial of zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251), in individuals with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.

globenewswire.com - 2026-05-20 07:46:00

This clinical-stage biotech develops therapies for rare muscle diseases, leveraging its FORCE platform to target significant unmet needs.

fool.com - 2026-05-19 13:17:19

WALTHAM, Mass., May 13, 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 that management is scheduled to participate in the following upcoming investor conferences:

globenewswire.com - 2026-05-13 07:30:00

Dyne Therapeutics (DYN) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

zacks.com - 2026-05-11 13:01:15

- 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 -

globenewswire.com - 2026-05-11 07:30:00

- 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.

globenewswire.com - 2026-05-11 07:30:00