Dyne Therapeutics, INC 8-K filings

Dyne Therapeutics announced its second quarter 2026 financial results, highlighting significant progress in its clinical pipeline for rare neuromuscular diseases and a strong cash position extending runway into Q2 2028.

Dyne Therapeutics announced the pricing of an upsized public offering of common stock, raising substantial capital to fund its operations and development programs.

Dyne Therapeutics announced its biologics license application for zeleciment rostudirsen (DYNE-251) for Duchenne muscular dystrophy has been accepted for FDA Priority Review, with a target action date of January 21, 2027.

Dyne Therapeutics amended its loan agreement with Hercules Capital, increasing the total debt facility to $400 million and borrowing an initial $50 million tranche.

Dyne Therapeutics, Inc. announced the results of its 2026 Annual Meeting of Stockholders, including director elections, executive compensation approval, and amendments to its charter.

Dyne Therapeutics announced full enrollment in the registrational expansion cohort of its Phase 1/2 ACHIEVE trial for zeleciment basivarsen in myotonic dystrophy type 1 patients.

Dyne Therapeutics announced first quarter 2026 financial results, highlighting progress in its Duchenne Muscular Dystrophy (DMD) and Myotonic Dystrophy Type 1 (DM1) programs, with key regulatory milestones and clinical trial updates.

Dyne Therapeutics announced positive full-year 2025 financial results and significant clinical progress for its Duchenne muscular dystrophy and myotonic dystrophy type 1 programs, including planned accelerated approval submissions.

Dyne Therapeutics announced preliminary cash of $1.1 billion as of year-end 2025 and presented positive clinical data for its Duchenne muscular dystrophy and myotonic dystrophy type 1 programs, targeting potential commercial launches in 2027 and 2028.

Dyne Therapeutics, Inc. announced the election of Vikram Karnani as an independent Class II director to its Board of Directors.

Dyne Therapeutics announced the pricing of an upsized underwritten public offering of 18,980,478 shares of common stock at $18.44 per share, expecting to raise $350.0 million in gross proceeds.

Dyne Therapeutics, Inc. amended its loan agreement with Hercules Capital, Inc. to borrow an additional $50.0 million, with potential for further funding.

Dyne Therapeutics announced positive topline results from its Phase 1/2 DELIVER trial for z-rostudirsen in Duchenne muscular dystrophy, meeting its primary endpoint and showing sustained functional improvement.

Dyne Therapeutics reported Q3 2025 financial results, received Breakthrough Therapy Designation for two programs, and updated clinical trial timelines, including a delay for DM1 enrollment.

Dyne Therapeutics, Inc. announced the election of Brian Posner as an independent Class III director to its Board of Directors, effective October 1, 2025.

Dyne Therapeutics announced that its investigational therapy DYNE-251 received FDA Breakthrough Therapy Designation for Duchenne muscular dystrophy amenable to exon 51 skipping.

Dyne Therapeutics reported second quarter 2025 financial results, highlighting an extended cash runway into Q3 2027 and significant clinical progress for its DM1 and DMD investigational therapies.

Dyne Therapeutics, Inc. announced the pricing of an underwritten public offering of 24,242,425 shares of common stock, expected to generate approximately $187.0 million in net proceeds, significantly extending its cash runway.

Dyne Therapeutics, a clinical-stage biotechnology company, has entered into a new loan and security agreement with Hercules Capital for up to $275 million, providing significant capital for its ongoing operations and strategic initiatives.

Dyne Therapeutics announced today that the FDA granted Breakthrough Therapy Designation for DYNE-101 for myotonic dystrophy type 1 (DM1) and outlined an updated plan for U.S. Accelerated Approval based on new long-term clinical data.

Dyne Therapeutics, Inc. announced the results of its 2025 Annual Meeting of Stockholders, where all management-backed proposals passed, including the election of two Class II directors, the approval of executive compensation on an advisory basis, and the ratification of Deloitte & Touche LLP as the independent auditor.

Dyne Therapeutics reports its Q1 2025 financial results, highlights progress in its DM1 and DMD programs, and announces new leadership appointments.

Dyne Therapeutics announces the appointment of Erick Lucera as Chief Financial Officer and Treasurer, effective March 31, 2025, while Richard Scalzo departs from his role as Senior Vice President, Head of Finance & Administration and Treasurer.

Dyne Therapeutics reports promising clinical data for DYNE-101 and DYNE-251, plans for accelerated approval submissions, and a strong cash position to fund operations into the second half of 2026.

Dyne Therapeutics reported promising clinical trial results for its DYNE-101 and DYNE-251 programs, with plans to pursue accelerated regulatory approvals in the U.S.

Dyne Therapeutics has filed a prospectus supplement to offer up to $300 million of its common stock through an open market sale agreement.

Dyne Therapeutics reported positive clinical trial updates for their DYNE-101 and DYNE-251 programs, along with their third quarter 2024 financial results.

Dyne Therapeutics reported promising clinical trial results for its DYNE-251 drug in Duchenne muscular dystrophy, showing unprecedented dystrophin expression and functional improvements, while also announcing key leadership changes.

Dyne Therapeutics reported positive clinical data from their ACHIEVE and DELIVER trials, along with a strengthened balance sheet following a $374 million public offering.

Dyne Therapeutics held its annual meeting on May 22, 2024, electing three Class I directors and ratifying Deloitte & Touche LLP as its independent auditor for the fiscal year ending December 31, 2024.