NEW YORK, Jan 2, 2026, 3:19 PM ET — Regular session
- Dyne Therapeutics shares fell about 6% in afternoon trading after a sharp intraday swing.
- The stock drifted toward the $18.44 price of Dyne’s December equity offering.
- Investors are looking ahead to a planned 2026 FDA submission and trial start for its lead Duchenne program.
Dyne Therapeutics shares fell about 6% on Friday, giving back earlier gains in a volatile first session of 2026 for some biotech names. The Nasdaq-listed stock was down 6.1% at $18.36 in afternoon trading, after touching $20.90 at the high and $18.13 at the low.
The move matters because it pulls Dyne back toward the $18.44 price of its December share sale, a reference point traders often watch after a dilutive financing. Dyne said that offering raised about $402.5 million in gross proceeds.
The broader tape offered little help. U.S. stocks were mixed in the first session of the new year, with the S&P 500 and Nasdaq slipping after early gains, and Bank of America strategist Savita Subramanian warned that “stocks trade expensive” across most valuation measures, Reuters reported. Reuters
Biotech stocks were also soft at the margin, with the Nasdaq Biotechnology Index down 0.22% on the day. Nasdaq Global Index Watch
Dyne, a clinical-stage biotech, has drawn attention for late-stage work in Duchenne muscular dystrophy, a rare genetic disease that causes progressive muscle weakness. Its lead Duchenne candidate, zeleciment rostudirsen (also known as DYNE-251), is designed to boost dystrophin, a protein that is missing or defective in patients.
A Dec. 8 company presentation filed with the U.S. Securities and Exchange Commission said Dyne plans to submit a biologics license application (BLA) in the second quarter of 2026 for U.S. accelerated approval and start a Phase 3 study in the same quarter. The presentation also laid out a potential U.S. launch in the first quarter of 2027, assuming priority review.
Accelerated approval is an FDA pathway that can clear drugs based on a surrogate measure — such as a biomarker — that is “reasonably likely” to predict clinical benefit, while requiring confirmatory testing after approval.
Dyne is developing its therapy for a subset of Duchenne patients whose mutations are amenable to “exon 51 skipping,” a genetic approach intended to restore the dystrophin reading frame. Sarepta Therapeutics’ Exondys 51 is already approved in that niche, and Dyne is working to differentiate on delivery and effect size, industry analysts have said. Fierce Biotech
Evercore ISI analyst Gavin Clark-Gartner said the December Duchenne readout met the bar for an accelerated-approval filing and modeled roughly 75% to 80% odds of approval, Fierce Biotech reported. Fierce Biotech
For traders, the near-term watch list is less about quarterly revenue and more about regulatory steps: any change in the timing or contents of the planned FDA submission, details on longer-term functional measures, and the pace of Phase 3 startup.
Macro data could also matter for high-beta biotech. Reuters flagged next week’s U.S. labor-market data as a key January focus as investors recalibrate expectations for the Federal Reserve’s rate path. Reuters
On the chart, Friday’s slide left $18.13 — the session low — as the first level traders were eyeing, with the $18.44 offering price nearby as another marker. A rebound would need to reclaim the $20.90 intraday high to shift the short-term tone.
