Dyne's DYNE-101 Shows 12-Month Functional Gains in DM1; REC Topline Set for Q1 2027
DYN sits 32% above its 52-week low of $11.92.
Summary
Dyne reported 12-month pooled MAD data for z-basivarsen (DYNE-101) in DM1 showing functional improvement versus baseline, placebo, and a matched natural history cohort. The REC's primary endpoint is 6-month vHOT, with topline expected in Q1 2027 and an Accelerated Approval submission targeted for Q3 2027. The REC has a mean baseline vHOT of 8.3 seconds (SD 6.0) for 71 participants. Pooled dose group improvements at 12 months include vHOT -3.2s at 6 months, 5xSTS -1.2s, 10MWR -0.3s, QMT +4.8%, and MDHI +25.2%. This is the first disclosure of these durability data and the specific regulatory timeline, building on earlier DYNE-101 signals. The improvement versus natural history strengthens the clinical relevance and de-risks the registrational program. The Q1 2027 REC readout is the key upcoming event for the stock.
Updated with an SEC 8-K filing · What changed
Updates
· SEC 8-K — The 8-K adds REC mean baseline vHOT of 8.3 seconds (SD 6.0) for 71 participants and details pooled dose group improvements: vHOT -3.2s at 6 months, 5xSTS -1.2s, 10MWR -0.3s, QMT +4.8%, MDHI +25.2% at 12 months.
At the time of this announcement, DYN was trading at $15.78 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $3B. The 52-week trading range was $11.92 to $27.31. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: Wiseek News.