Dyne Therapeutics Reports First Quarter 2025 Financial Results and Recent Business Highlights |
- 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 - |
globenewswire.com |
2025-05-08 11:30:00 |
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Dyne Therapeutics Receives European Medicines Agency (EMA) Orphan Drug Designation for DYNE-251 in Duchenne Muscular Dystrophy |
- 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 orphan drug designation for DYNE-251 for the treatment of Duchenne muscular dystrophy (DMD). |
globenewswire.com |
2025-04-24 11:30:00 |
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Dyne Therapeutics Announces Chief Business Officer and Chief Scientific Officer Appointments |
- Vikram Ranade, PhD, appointed as chief business officer - - Ranjan Batra, PhD, appointed as chief scientific officer - - Oxana Beskrovnaya, PhD, transitioning to chief innovation officer - WALTHAM, Mass., April 15, 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 appointments of Vikram (Vik) Ranade, PhD, as chief business officer (CBO) and Ranjan (Ron) Batra, PhD, as chief scientific officer (CSO) of Dyne. |
globenewswire.com |
2025-04-15 11:30:00 |
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Dyne Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) |
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)(4). |
globenewswire.com |
2025-04-14 20:30:00 |
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Dyne Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) to Newly Appointed Chief Financial Officer |
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. |
globenewswire.com |
2025-03-20 18:30:00 |
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Dyne Therapeutics Announces Appointment of Erick J. Lucera as Chief Financial Officer |
- Proven financial leader brings decades of experience in capital allocation, business development and shareholder value creation - |
globenewswire.com |
2025-03-20 18:10:00 |
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Dyne Therapeutics Announces New Long-Term Clinical Data from Phase 1/2 DELIVER Trial of DYNE-251 in Duchenne Muscular Dystrophy Demonstrating Unprecedented and Sustained Functional Improvement Through 18 Months |
- Continued favorable safety profile for DYNE-251 - - DELIVER Registrational Expansion Cohort is fully enrolled; data from this cohort planned for late 2025 - - Potential for Biologics License Application submission for U.S. accelerated approval in early 2026 - WALTHAM, Mass., March 16, 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 new long-term clinical data from its ongoing Phase 1/2 DELIVER trial of DYNE-251 demonstrating unprecedented and sustained functional improvement at the selected registrational dose of 20 mg/kg Q4W (approximate PMO dose). |
globenewswire.com |
2025-03-16 21:00:00 |
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Dyne: Accelerated Approval Of DYNE-101 Might Be Possible With Surrogate Biomarker |
Positive biomarker and functional data released from phase 1/2 ACHIEVE study, using DYNE-101 to treat patients with Myotonic Dystrophy Type 1. Data from registration cohort phase 1/2 ACHIEVE study, using DYNE-101 to treat patients with Myotonic Dystrophy Type 1, expected in the 1st half of 2026. With positive data released from phase 1/2 ACHIEVE study, plus FDA allowing splicing correction as a surrogate biomarker, it sets up a possible Accelerated Approval filing of DYNE-101 in 2026. |
seekingalpha.com |
2025-03-13 11:09:38 |
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Dyne Therapeutics to Present at Stifel 2025 Virtual CNS Forum |
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. |
globenewswire.com |
2025-03-11 09:30:00 |
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Dyne Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights |
- Received FDA Fast Track Designation for DYNE-101 in DM1 - - Full enrollment of Registrational Expansion Cohort of ACHIEVE Trial of DYNE-101 in DM1 Planned for Mid-2025 to Support Submission for U.S. Accelerated Approval - - Full Enrollment of Registrational Expansion Cohort of DELIVER Trial of DYNE-251 in DMD Planned for Q1 2025 to Support Submission for U.S. Accelerated Approval - WALTHAM, Mass., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage neuromuscular disease company focused on advancing life-transforming therapeutics for people living with genetically driven diseases, today reported financial results for the fourth quarter and full year 2024 and recent business highlights. |
globenewswire.com |
2025-02-27 09:30:00 |
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Dyne Therapeutics Announces Upcoming Presentations at the 2025 MDA Clinical & Scientific Conference |
- Data from DELIVER and ACHIEVE Clinicals Trial to be Presented - - Presentation on ACHIEVE Trial in DM1 and Company Symposium to Feature Data on the Use of Splicing Correction as a Prognostic Biomarker of Functional Outcomes in DM1 - - Presentations Add Insights into the FORCE™ Platform's Ability to Deliver Targeted Therapeutics to Muscle and the CNS - WALTHAM, Mass., Feb. 14, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. |
globenewswire.com |
2025-02-14 18:05:00 |
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After Plunging -10.43% in 4 Weeks, Here's Why the Trend Might Reverse for Dyne Therapeutics (DYN) |
Dyne Therapeutics (DYN) has become technically an oversold stock now, which implies exhaustion of the heavy selling pressure on it. This, combined with strong agreement among Wall Street analysts in revising earnings estimates higher, indicates a potential trend reversal for the stock in the near term. |
zacks.com |
2025-02-13 12:36:11 |
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Dyne Therapeutics to Present at Oppenheimer 35th Annual Healthcare Life Sciences Conference |
WALTHAM, Mass., Feb. 03, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage neuromuscular disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced that management is scheduled to present during a virtual fireside chat at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on Tuesday, February 11, 2025 at 4:00 p.m. ET. |
globenewswire.com |
2025-02-03 09:30:00 |
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5 Small Drug Stocks to Add to Your Kitty in the Trump 2.0 Era |
Innovation is at its peak for the Zacks Medical-Drugs industry. CORT, AMRX, DYN, NKTR and CRDL may prove to be good additions to one's portfolio. |
zacks.com |
2025-01-31 11:05:28 |
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Down -42.2% in 4 Weeks, Here's Why Dyne Therapeutics (DYN) Looks Ripe for a Turnaround |
Dyne Therapeutics (DYN) has become technically an oversold stock now, which implies exhaustion of the heavy selling pressure on it. This, combined with strong agreement among Wall Street analysts in revising earnings estimates higher, indicates a potential trend reversal for the stock in the near term. |
zacks.com |
2025-01-28 12:36:29 |
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Dyne Therapeutics Receives FDA Fast Track Designation for DYNE-101 for the Treatment of Myotonic Dystrophy Type 1 |
- Company Anticipates Submitting for U.S. Accelerated Approval in H1 2026 - WALTHAM, Mass., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. |
globenewswire.com |
2025-01-21 09:30:00 |
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Why Is Neuromuscular-Focused Dyne Therapeutics Stock Trading Lower On Friday? |
On Friday, Dyne Therapeutics, Inc. DYN revealed new data from its ongoing Phase 1/2 ACHIEVE trial of DYNE-101 in patients with myotonic dystrophy type 1 (DM1). |
benzinga.com |
2025-01-10 15:40:11 |
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Dyne Therapeutics Reports New Clinical Data Showing Compelling Impact on Multiple Measures of Myotonic Dystrophy Type 1 (DM1); Dyne Plans to Initiate Registrational Expansion Cohort to Support Potential Submission for U.S. Accelerated Approval for DYNE-101 in DM1 in H1 2026 |
- DYNE-101 in DM1: Dyne plans to initiate global Registrational Expansion Cohort of ACHIEVE trial with registrational dose of 6.8 mg/kg Q8W following study data showing splicing correction and robust and sustained functional improvements; potential to support H1 2026 submission for U.S. Accelerated Approval - |
globenewswire.com |
2025-01-10 08:30:00 |
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Dyne Therapeutics to Present at 43rd Annual J.P. Morgan Healthcare Conference |
WALTHAM, Mass., Jan. 09, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc . (Nasdaq: DYN), a clinical-stage neuromuscular disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced that John Cox, president and chief executive officer, is scheduled to present at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 15, 2025 at 10:30 a.m. PT (1:30 p.m. ET). |
globenewswire.com |
2025-01-09 09:30:00 |
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