"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 o ...

- 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 NEWSWIR ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to ________________ Commission File Number: 001-39509 Dyne Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 3 ...

- Recently presented data demonstrated sustained functional improvement with DYNE-251 treatment through 18 months - - Data from the fully enrolled DELIVER registrational expansion cohort is planned for late 2025 - WALTHAM, Mass., April 24, 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 announced that the European Commission (EC) has granted orph ...

WALTHAM, Mass., April 14, 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 announced that it has granted inducement equity awards to three new employees. The awards were approved by Dyne's Compensation Committee and made as an inducement material to the new employees' acceptance of employment with Dyne in accordance with Nasdaq Listing Rule 5635(c ...

WALTHAM, Mass., March 20, 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 announced it has granted inducement equity awards to its newly appointed Chief Financial Officer, Erick J. Lucera. The awards were approved by the Compensation Committee of Dyne and made as an inducement material to Mr. Lucera's acceptance of employment with Dyne under Dyne ...

Erick J. Lucera Erick J. Lucera, Chief Financial Officer (CFO) of Dyne Therapeutics - Proven financial leader brings decades of experience in capital allocation, business development and shareholder value creation - WALTHAM, Mass., March 20, 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 announced the appointment of Erick J. Lucera, as chi ...

Core Insights - Dyne Therapeutics is advancing DYNE-251, a therapeutic for Duchenne muscular dystrophy (DMD), showing significant functional improvements in clinical trials [2][3][4] - The DELIVER trial has fully enrolled its registrational expansion cohort, with data expected in late 2025 and a potential Biologics License Application submission for U.S. accelerated approval anticipated in early 2026 [2][13] Group 1: Clinical Trial Results - The DELIVER trial demonstrated unprecedented and sustained functional improvement at the registrational dose of 20 mg/kg Q4W, with meaningful improvements observed in multiple functional endpoints [2][4] - At the 6-month mark, patients receiving 20 mg/kg of DYNE-251 exhibited a mean absolute dystrophin expression of 8.72% of normal, indicating significant clinical efficacy [4][10] - Safety data as of February 7, 2025, continues to show a favorable profile for DYNE-251, with no new treatment-related serious adverse events reported [13] Group 2: Regulatory Pathway and Future Plans - The company is leveraging dystrophin expression as a surrogate endpoint for regulatory submissions, with the FDA's precedent for using dystrophin as a biomarker for accelerated approval still available [5][13] - Dyne Therapeutics has fully enrolled a registrational expansion cohort of 32 patients in the DELIVER trial, with plans for data release in late 2025 [13] - The potential for rapid adoption of DYNE-251 by physicians and patients is anticipated if the therapy receives approval [3][13] Group 3: Industry Context - DMD is a rare genetic disorder affecting approximately 12,000 to 15,000 individuals in the U.S. and 25,000 in Europe, characterized by progressive muscle degeneration due to lack of dystrophin [14] - Current therapies for DMD provide limited benefits, highlighting the urgent need for effective treatments like DYNE-251 [14][15] - Dyne Therapeutics is building a global DMD franchise, with ongoing preclinical programs targeting other exons beyond exon 51 [11][15]

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WALTHAM, Mass., March 11, 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 announced that management is scheduled to participate in a fireside chat at the Stifel 2025 Virtual CNS Forum on Tuesday, March 18, 2025 at 4:00 p.m. ET. A live webcast will be available in the Investors & Media section of Dyne’s website at https://investors.dyne-tx.com/ne ...