Dyne Therapeutics, Inc. Stock Price, News & Analysis

Dyne Therapeutics (Nasdaq: DYN), a clinical-stage company developing therapeutics for genetically driven neuromuscular diseases, has granted inducement equity awards to its new Chief Financial Officer, Erick J. Lucera. The awards include:

• A non-statutory stock option to purchase 214,500 shares at the March 31, 2025 closing price
• A restricted stock unit (RSU) award for 66,100 shares

The stock option has a 10-year term with a 4-year vesting schedule: 25% vesting on March 31, 2026, and the remainder in quarterly installments over three years. The RSU award vests in equal annual installments over four years, starting March 31, 2026. Both awards are contingent on Mr. Lucera's continued service and were granted under Dyne's 2024 Inducement Stock Incentive Plan, complying with Nasdaq Listing Rule 5635(c)(4).

Dyne Therapeutics (Nasdaq: DYN) has appointed Erick J. Lucera as Chief Financial Officer, effective March 31, 2025. Lucera brings over 30 years of life science industry experience in finance, operations, and investment. He joins from Editas Medicine, where he served as CFO managing financial strategy and infrastructure scaling.

The appointment comes as Dyne prepares for potential expedited approvals and commercialization of its DM1 and DMD programs. Lucera's previous experience includes CFO roles at AVEO Pharmaceuticals, where he led the company's transition to commercialization, and positions at Valeritas and Viventia Bio. He holds a Certificate in Public Health from Harvard University, an MS in Finance from Boston College, an MBA from Indiana University, and a BS in Accounting from the University of Delaware.

Dyne Therapeutics (Nasdaq: DYN) has announced promising long-term clinical data from its Phase 1/2 DELIVER trial of DYNE-251 for Duchenne muscular dystrophy (DMD) patients amenable to exon 51 skipping. The trial demonstrated unprecedented and sustained functional improvement at the 20 mg/kg Q4W registrational dose.

Key findings include:

• Meaningful functional improvements observed through 12 months in the 20 mg/kg cohort and 18 months in the 10 mg/kg cohort
• Mean absolute dystrophin expression of 8.72% of normal at 6 months with 20 mg/kg dose
• Favorable safety profile across 54 participants with 970 doses administered over 77.1 patient-years

The Registrational Expansion Cohort of 32 patients is fully enrolled, with data expected in late 2025. Dyne anticipates submitting a Biologics License Application for U.S. accelerated approval in early 2026.

Dyne Therapeutics (Nasdaq: DYN), a clinical-stage company developing therapeutics for genetically driven neuromuscular diseases, has announced its upcoming participation in the Stifel 2025 Virtual CNS Forum. The company's management will engage in a fireside chat scheduled for Tuesday, March 18, 2025 at 4:00 p.m. ET.

Investors and interested parties can access the live webcast through the Investors & Media section of Dyne's website. The presentation recording will remain available for replay on the company's platform for 90 days following the event.

Dyne Therapeutics (DYN) reported its Q4 and full year 2024 financial results, highlighting significant progress in its clinical programs. The company received FDA Fast Track Designation for DYNE-101 in DM1 treatment, with plans to complete enrollment of the Registrational Expansion Cohort by mid-2025.

Financial highlights include:

• Cash position of $642.3 million as of December 31, 2024
• Additional $140.6 million raised in Q1 2025 through ATM offering
• Q4 2024 net loss of $89.5 million ($0.88 per share)
• Full year 2024 net loss of $317.4 million ($3.37 per share)

The company expects its current cash position to fund operations into H2 2026. Both DYNE-101 and DYNE-251 programs are advancing toward potential U.S. Accelerated Approval submissions in H1 2026 and early 2026, respectively.

Dyne Therapeutics (Nasdaq: DYN) has announced multiple presentations scheduled for the 2025 MDA Clinical & Scientific Conference in Dallas, TX, from March 16-19, 2025. The company will present two oral and five poster presentations, highlighting data from their ongoing clinical trials.

Key presentations include results from the DELIVER trial for Duchenne muscular dystrophy (DMD) and the ACHIEVE trial for myotonic dystrophy type 1 (DM1). Dr. Kevin Flanigan will present DELIVER trial data on March 19 at 8:30 AM CT, while Dr. James Lilleker will present ACHIEVE trial results at 12:30 PM CT.

The company will also host a symposium titled 'Harnessing the FORCE™ Platform to Advance Targeted Therapies for Neuromuscular Diseases' on March 18 at 12:00 PM CT, featuring data on splicing correction as a prognostic biomarker for DM1 outcomes. Poster sessions will run from March 16-18, showcasing additional research on the FORCE™ Platform's capabilities in treating various muscular dystrophies.

Dyne Therapeutics (Nasdaq: DYN), a clinical-stage neuromuscular disease company, has announced its upcoming participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference. The company's management will engage in a virtual fireside chat scheduled for Tuesday, February 11, 2025, at 4:00 p.m. ET.

Interested parties can access a live webcast of the presentation through the Investors & Media section of Dyne's website. The presentation recording will remain available for 90 days following the event on the company's investor relations platform at https://investors.dyne-tx.com/news-and-events/events-and-presentations.

Dyne Therapeutics (Nasdaq: DYN) has received FDA Fast Track designation for DYNE-101, their treatment candidate for myotonic dystrophy type 1 (DM1). The designation follows positive clinical data from their ongoing Phase 1/2 ACHIEVE global trial, which showed substantial functional benefits and splicing correction in patients.

The company plans to submit for U.S. Accelerated Approval in H1 2026. The Fast Track status enables more frequent FDA communications, rolling review of marketing applications, and potential eligibility for Accelerated Approval and Priority Review. This development pathway aims to expedite the delivery of DYNE-101 to DM1 patients, for whom there are currently no approved therapies.

Dyne Therapeutics (DYN) has announced significant progress in its Phase 1/2 ACHIEVE trial of DYNE-101 for myotonic dystrophy type 1 (DM1). The company plans to initiate a global Registrational Expansion Cohort with a 6.8 mg/kg Q8W dose, targeting a potential U.S. Accelerated Approval submission in H1 2026.

The clinical data showed substantial functional benefits across multiple measures, including DMPK knockdown, splicing correction, and improvements in myotonia, strength, and mobility. The trial demonstrated a favorable safety profile across 56 patients, with most adverse events being mild or moderate.

The company will proceed with a placebo-controlled Registrational Expansion Cohort including approximately 32 patients. Additionally, Dyne reported progress on DYNE-251 for Duchenne muscular dystrophy, pursuing U.S. Accelerated Approval with dystrophin as surrogate endpoint, with data expected in late 2025.