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Investing.com -- Dyne Therapeutics, Inc. (NASDAQ:DYN) reported a second quarter loss that slightly missed analyst expectations as the clinical-stage biotech company continues to advance its neuromuscular disease therapies toward potential regulatory approvals.
The company reported a second quarter loss of $0.97 per share, $0.03 worse than analyst estimates of $0.94 per share. Research and development expenses increased to $99.2 million from $62.3 million in the same quarter last year, reflecting the company’s expanded clinical programs. Shares of Dyne rose 1.4% following the announcement.
Dyne highlighted significant progress in its clinical programs for DM1 (myotonic dystrophy type 1) and DMD (Duchenne muscular dystrophy), with both therapies on track for potential U.S. Accelerated Approval submissions in 2026. The company has strengthened its financial position through a $275 million non-dilutive loan facility with Hercules Capital (NYSE:HTGC) and a $230 million public offering completed in July.
"This quarter we made significant progress on our clinical and regulatory plans for our DM1 and DMD investigational therapies, as we advance both programs toward potential U.S. Accelerated Approval submissions in 2026 and possible commercial launches in 2027," said John Cox, president and chief executive officer of Dyne.
The company reported that its cash, cash equivalents and marketable securities stood at $683.9 million as of June 30, 2025. With the additional funds raised in July, Dyne expects its cash runway to extend into the third quarter of 2027, which would cover key milestones including data readouts from registrational trials, regulatory submissions, and the potential U.S. launch of DYNE-251 for DMD if approved.
Dyne has completed enrollment for its DMD therapy trial with data expected in late 2025, while its DM1 program received Breakthrough Therapy Designation from the FDA in June. The company plans to complete enrollment for its DM1 registrational cohort in the fourth quarter of 2025, with data expected by mid-2026.
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