Dyne Therapeutics, Inc. Stock Price, News & Analysis

Satellos Bioscience (OTCQB: MSCLF) has appointed Dr. Wildon Farwell as Chief Medical Officer to advance their muscle disease therapeutic programs. Dr. Farwell joins from Dyne Therapeutics, where he served as CMO and brings significant expertise in neuromuscular disease drug development.

Dr. Farwell's notable achievements include building Dyne's development organization and leading their DMD and DM1 programs. At Biogen, he led the development of SPINRAZA®, the first approved treatment for spinal muscular atrophy, and initiated late-stage development of QALSODY® for ALS.

In his new role, Dr. Farwell will focus on advancing SAT-3247 into a global Phase 2 clinical trial for children with Duchenne muscular dystrophy (DMD). He succeeds Dr. Jordan Dubow, who will continue as a consultant and Clinical Advisory Board chair.

[ "Appointment of highly experienced CMO with proven track record in neuromuscular disease drug development", "New CMO has successful history of regulatory approvals, including SPINRAZA®", "Progress toward Phase 2 clinical trial for SAT-3247 in DMD treatment" ]

Dyne Therapeutics (NASDAQ:DYN), a clinical-stage biotech company focused on neuromuscular diseases, has successfully completed its previously announced public offering of common stock. The company sold 27,878,788 shares at $8.25 per share, including the full exercise of the underwriters' option to purchase additional shares.

The offering generated gross proceeds of approximately $230.0 million before deducting underwriting discounts, commissions, and offering expenses. Morgan Stanley, Jefferies, Stifel, and Guggenheim Securities served as joint book-running managers, with Jones acting as co-manager for the offering.

Dyne Therapeutics (NASDAQ: DYN), a clinical-stage company specializing in genetically driven neuromuscular diseases, has announced the pricing of a public offering of 24,242,425 shares of its common stock at $8.25 per share. The offering is expected to generate gross proceeds of $200.0 million before deducting underwriting discounts and commissions.

The company has granted underwriters a 30-day option to purchase up to an additional 3,636,363 shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close around July 2, 2025. Morgan Stanley, Jefferies, Stifel, and Guggenheim Securities are serving as joint book-running managers, with Jones acting as co-manager.

[ "Expected gross proceeds of $200.0 million to strengthen company's financial position", "Additional potential proceeds through 30-day option for underwriters to purchase extra shares", "Strong institutional backing with multiple prominent investment banks as joint book-running managers" ]

Dyne Therapeutics (NASDAQ: DYN), a clinical-stage company specializing in neuromuscular disease treatments, has announced a proposed public offering of $200 million of common stock shares. The company will also grant underwriters a 30-day option to purchase up to an additional $30 million in shares.

The offering will be managed by joint book-running managers Morgan Stanley, Jefferies, Stifel, and Guggenheim Securities, with Jones acting as co-manager. The offering will be made through a shelf registration statement on Form S-3 previously filed with the SEC on March 5, 2024.

The completion of the offering is subject to market and other conditions, with final terms to be disclosed in a final prospectus supplement to be filed with the SEC.

Dyne Therapeutics (Nasdaq: DYN) has secured a $275 million non-dilutive senior secured term loan facility from Hercules Capital (NYSE: HTGC). The financing includes $100 million funded upfront and additional tranches of up to $175 million tied to specific milestones.

The financing will support the advancement of Dyne's clinical programs: DYNE-101 for myotonic dystrophy type 1 (DM1) and DYNE-251 for Duchenne muscular dystrophy (DMD). The company plans potential U.S. Accelerated Approval submissions in 2026 and targets a potential U.S. launch in DMD by 2027.

The loan facility is structured in five tranches, including the initial $100 million, three milestone-dependent tranches totaling $115 million, and a final $60 million tranche subject to Hercules' approval. This structure provides Dyne with strategic flexibility through key inflection points in 2025 and 2026.

Dyne Therapeutics announced FDA Breakthrough Therapy Designation for DYNE-101 in treating myotonic dystrophy type 1 (DM1) and revealed plans for Accelerated Approval following positive clinical data. The company submitted a revised ACHIEVE trial protocol with video hand opening time (vHOT) as the primary endpoint for potential Accelerated Approval. The Registrational Expansion Cohort will enroll 60 participants with a 3:1 randomization to receive DYNE-101 6.8 mg/kg Q8W or placebo. New 12-month data showed sustained improvements in multiple endpoints, with vHOT improvement of 3.3 seconds vs placebo at 6 months and muscle strength improving from 10% at 6 months to 20% at 12 months. The company plans to complete enrollment in Q4 2025, with data expected mid-2026 to support U.S. Accelerated Approval submission in late 2026. DYNE-101 demonstrated a favorable safety profile with no serious treatment-related adverse events. Dyne's cash position of $677.5M is expected to fund operations into Q4 2026.

Dyne Therapeutics (Nasdaq: DYN), a clinical-stage neuromuscular disease company, has scheduled an investor conference call and webcast for June 17, 2025, at 8:00 a.m. ET to provide updates on DYNE-101, their therapeutic candidate for myotonic dystrophy type 1 (DM1). The company will release a press statement before the event. The webcast will be accessible through Dyne's website investor section, with presentation slides available and a replay option accessible for 90 days after the event. This announcement represents a standard corporate communication about an upcoming investor event focused on their DM1 program.

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.