DYNE-302 FSHD IND Clearance Sets Up Third FORCE Clinical Program

研报英文原文证据摘录

DYNE-302 FSHD IND Clearance Sets Up Third FORCE Clinical Program

Update

July 28, 2026 12:36 PM GMT

Morgan Stanley & Co. LLCMDyne Therapeutics Inc | North America Michael E Ulz

Equity Analyst

DYNE-302 FSHD IND Clearance Mike.Ulz@morganstanley.comRohit Bhasin +1 212 761-4650

Research Associate

Rohit.Bhasin@morganstanley.com +1 212 761-0534

Sets Up Third FORCE Clinical Avraham Novick

Avi.Novick@morganstanley.com +1 212 761-2231

Program

Dyne Therapeutics Inc (DYN.O, DYN US)

Biotechnology | United States of America

Key Takeaways Stock Rating Overweight

Industry View Attractive

FDA clearance enables initiation of the Ph1 DYNE-302 trial, marking Dyne’s third Price target $47.00

clinical program and targeting a disease with no approved therapies. Shr price, close (Jul 27, 2026) $25.63

Mkt cap, curr (mm) $4,230

Recall, preclinical data support potential differentiation with encouraging DUX4 52-Week Range $26.12-8.88

suppression, reversal of muscle damage, and functional improvements.

We are encouraged by continued pipeline advancement and expect momentum

to build ahead of multiple key catalysts in 1Q27; Reiterate Overweight.

FDA clearance of DYNE-302 enables initiation of Ph1 trial. Earlier today, Dyne

announced FDA clearance of its IND for DYNE-302, enabling initiation of a Ph1 trial

in facioscapulohumeral muscular dystrophy (FSHD) and marking the third clinical

program built on the FORCE platform (press release). The randomized, placebo-

controlled, multiple-ascending-dose (MAD) study will initially enroll nine

ambulatory adults receiving three intravenous doses of DYNE-302 at 1.5 mg/kg

every four weeks or placebo in the first cohort, with subsequent cohorts expected

to evaluate higher doses and less frequent administration. In addition to safety and