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Dyne Therapeutics, Inc. (DYN) Presents at TD Cowen 46th Annual Health Care Conference Prepared Remarks Transcript
Dyne Therapeutics maintains a strong $1.1B cash position, funding operations into mid-2028 despite heavy R&D and operating expenses in 2025. Encouraging long-term cardiopulmonary data from the DELIVER trial of z-rostudirsen (DYNE-251) strengthens the bull case for DMD therapy. Initiation of the pivotal Phase 3 HARMONIA trial for DYNE-101 in DM1 marks a critical regulatory and value inflection point.
- HARMONIA trial will assess multi-system efficacy, safety and tolerability of z-basivarsen in DM1 - - 48-week trial will enroll approximately 150 individuals, and first sites are now open for enrollment - - Primary endpoint is the five times sit to stand (5xSTS) test; secondary and exploratory endpoints will assess muscle function, CNS manifestations, and patient- and clinician-reported outcomes - - HARMONIA 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., 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 the initiation of the Phase 3 HARMONIA trial of zeleciment basivarsen (z-basivarsen, also known as DYNE-101), in individuals with myotonic dystrophy type 1 (DM1).
- 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.
Dyne Therapeutics, Inc. (NASDAQ: DYN - Get Free Report)'s stock price dropped 6.6% during trading on Monday following a weaker than expected earnings announcement. The company traded as low as $14.00 and last traded at $14.5960. Approximately 316,576 shares traded hands during mid-day trading, a decline of 84% from the average daily volume of 1,972,522 shares.
209,523-share increase in Dyne Therapeutics; estimated transaction value $3.97 million (based on quarterly average pricing) Quarter-end position in Dyne Therapeutics rose $12.82 million in value, reflecting both trading and stock price movement Transaction represented a 0.55% change relative to Palo Alto Investors' 13F AUM Fund now holds 1,472,197 shares in the company, worth $28.80 million as of December 31, 2025 Stake is 4.01% of reported AUM, which places it outside the fund's top five holdings
- Planned submission for U.S. Accelerated Approval of z-rostudirsen on track for Q2 2026; potential launch in Q1 2027 -
WALTHAM, Mass., Feb. 25, 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:
- Late-breaking poster to feature new positive cardiopulmonary function results from the DELIVER trial of z-rostudirsen in DMD -
BOSTON, Feb. 02, 2026 (GLOBE NEWSWIRE) -- Sparrow Pharmaceuticals, a targeted cardiometabolic therapeutics company, today announced the appointment of Carlo Incerti, M.D., to its Board of Directors, effective January 1, 2026. Dr. Incerti is a highly accomplished executive with a strong background in medicine and over 35 years of strategic experience in the biopharmaceutical industry.
Keros Therapeutics KROS is a clinical-stage biopharmaceutical company developing innovative therapies for patients with disorders caused by abnormal signaling within the transforming growth factor-beta (TGF-β) protein family.
Dyne Therapeutics leverages its FORCE platform to target genetically driven muscle diseases with two lead clinical programs approaching pivotal milestones. DYNE-101 shows strong safety and functional improvement in DM1, with a potential BLA submission in Q3 2027 but faces competition and a lengthy timeline. DYNE-251's efficacy in DMD lags behind Avidity on a numerical basis, with a narrow therapeutic window and safety concerns at higher doses.
- Zeleciment basivarsen (z-basivarsen) demonstrated sustained functional improvement across multiple clinical measures in the ongoing ACHIEVE clinical trial - - Expect to complete enrollment in ACHIEVE Registrational Expansion Cohort in early Q2 2026 - WALTHAM, Mass., Jan. 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 Ministry of Health, Labour and Welfare (MHLW) in Japan has granted Orphan Drug designation for zeleciment basivarsen (z-basivarsen), for the treatment of myotonic muscular dystrophy type 1 (DM1).
Campbell and CO Investment Adviser LLC bought a new stake in Dyne Therapeutics, Inc. (NASDAQ: DYN) in the undefined quarter, according to its most recent filing with the Securities and Exchange Commission. The firm bought 64,517 shares of the company's stock, valued at approximately $816,000. Other institutional investors have also recently bought and
Dyne Therapeutics, Inc. (DYN) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
WALTHAM, Mass., Jan. 07, 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 John Cox, president and chief executive officer, is scheduled to present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 14, 2026 at 5:15 p.m. PT (8:15 p.m. ET).
WALTHAM, Mass., Dec. 23, 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 announced the appointment of Vikram Karnani to its Board of Directors. Mr. Karnani brings extensive commercial and executive leadership experience in rare disease and biopharmaceuticals, serving as the current chief executive officer of Collegium Pharmaceutical and having spent nearly a decade leading several lines of business and functions at Horizon Therapeutics.
Dyne Therapeutics, Inc. (NASDAQ: DYN - Get Free Report) has been assigned an average rating of "Moderate Buy" from the nineteen analysts that are covering the company, Marketbeat.com reports. One equities research analyst has rated the stock with a sell rating, two have given a hold rating, thirteen have assigned a buy rating and three have
WALTHAM, Mass., Dec. 11, 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 announced the closing of its previously announced upsized underwritten public offering of 21,827,549 shares of its common stock at a public offering price of $18.44 per share, which includes 2,847,071 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares of common stock in the offering. The gross proceeds to Dyne from the offering were approximately $402.5 million, before deducting underwriting discounts and commissions and offering expenses payable by Dyne. All of the shares in the offering were sold by Dyne.
An analyst upgraded his recommendation on the biotech. He now feels it's worthy of a buy, and what's more, he almost quadrupled his price target.