Dyne Therapeutics Q2 Net Loss $178.6M; FDA Accepts DMD BLA with Priority Review
Dyne Therapeutics reported a net loss of $178.6 million, or $1.08 per share, for the second quarter of 2026, an increase from $110.9 million in the prior year. The company announced significant clinical and regulatory progress, including the FDA's acceptance of its Biologics License Application for z-rostudirsen in Duchenne muscular dystrophy with Priority Review, setting a PDUFA target action date of January 21, 2027. Dyne also completed enrollment for the registrational expansion cohort of its ACHIEVE trial for z-basivarsen in DM1 and received FDA clearance for its IND application for DYNE-302 in FSHD. With recent financing activities, including a $405.0 million public offering, the company expects its cash runway to extend into the second quarter of 2028.
Key Highlights
- FDA accepted BLA for z-rostudirsen (DMD) with Priority Review; PDUFA target date January 21, 2027.
- Completed enrollment of 71 participants in registrational expansion cohort of ACHIEVE trial for z-basivarsen (DM1).
- FDA cleared IND Application for DYNE-302 in FSHD.
- Reported Q2 2026 net loss of $178.6 million, or $1.08 per share, compared to $110.9 million in Q2 2025.
- R&D expenses increased to $152.2 million in Q2 2026 from $99.2 million in Q2 2025.
- Cash, cash equivalents, and marketable securities were $898.5 million as of June 30, 2026.
- Completed a public offering in July 2026, raising approximately $405.0 million net proceeds.
- Expected cash runway into Q2 2028.
Price Impact
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