Dyne Therapeutics, Inc. Stock Price, News & Analysis

Dyne Therapeutics announced new preclinical data for DYNE-302 in treating facioscapulohumeral muscular dystrophy (FSHD), to be presented at the FSHD Society's International Research Congress in Amsterdam. The study showed promising results in a severe FSHD mouse model, where a single intravenous dose of DYNE-302 restored treadmill running ability and corrected muscle damage and inflammation markers. DYNE-302 uses TfR1-targeting technology to deliver siRNA specifically targeting DUX4 mRNA, a key factor in FSHD disease progression. The data suggests potential reversibility of severe skeletal muscle disease through DUX4 mRNA targeting. The presentation by Dr. Stefano Zanotti will take place on June 13, 2025, focusing on functional improvements and muscle transcriptomic changes in mouse models.

Dyne Therapeutics (DYN) reported Q1 2025 financial results and key developments for its lead programs. The company held an FDA Type C meeting for DYNE-101 in DM1 and initiated a Registrational Expansion Cohort of the ACHIEVE trial, targeting potential U.S. Accelerated Approval submission in H1 2026. The DELIVER trial's Registrational Expansion Cohort for DYNE-251 in DMD is fully enrolled, with potential BLA submission planned for early 2026. Financially, Dyne reported cash position of $677.5M, expected to fund operations into H2 2026. Q1 2025 showed R&D expenses of $106.4M (up from $44.5M in Q1 2024) and net loss of $115.4M ($1.05 per share). The company strengthened its leadership team with key appointments including a new CFO, CBO, CSO, and CIO to support upcoming regulatory filings and potential commercial launches in 2027.

Dyne Therapeutics (Nasdaq: DYN) has received European Commission orphan drug designation for DYNE-251, its investigational therapy for Duchenne muscular dystrophy (DMD). The designation follows promising long-term clinical data presented in March 2025, showing sustained functional improvement through 18 months in the Phase 1/2 DELIVER trial.

The trial evaluates DYNE-251 in DMD patients amenable to exon 51 skipping. The company has completed enrollment of 32 patients in the registrational expansion cohort, with data expected in late 2025. Dyne plans to submit a Biologics License Application for US accelerated approval in early 2026.

The EU orphan designation provides benefits including reduced regulatory fees, clinical protocol assistance, and potential 10-year market exclusivity. DYNE-251 previously received FDA orphan drug and rare pediatric disease designations in March 2023.

Dyne Therapeutics (Nasdaq: DYN) has announced key leadership appointments to strengthen its executive team ahead of potential product launches in 2027. Vikram Ranade, PhD, has been appointed as Chief Business Officer to lead business development and strategic partnerships, bringing experience from Tessera Therapeutics where he helped secure over $600 million in equity financing.

Ranjan Batra, PhD, will join as Chief Scientific Officer on April 28, 2025, bringing expertise in RNA biology and therapeutics from Lexeo Therapeutics. Additionally, Oxana Beskrovnaya, PhD, will transition to Chief Innovation Officer to drive the company's FORCE™ platform development.

These appointments align with Dyne's preparation for launching two medicines in myotonic dystrophy type 1 and Duchenne muscular dystrophy in 2027, focusing on delivering therapies for genetically driven neuromuscular diseases.

Dyne Therapeutics (DYN), a clinical-stage company developing therapeutics for genetically driven neuromuscular diseases, has granted inducement equity awards to three new employees. The awards include:

• Non-statutory stock options to purchase 330,200 shares at the closing price on April 14, 2025
• 101,900 restricted stock units

The stock options have a 10-year term with a 4-year vesting schedule: 25% vesting after one year, followed by quarterly installments. The restricted stock units vest annually over four years in equal installments. These awards were approved under Nasdaq Listing Rule 5635(c)(4) and are subject to Dyne's 2024 Inducement Stock Incentive Plan.

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.