June 17, 2025 10:44 AM EDT

Dyne pivots on primary endpoint, delays filing for DM1 drug

Lei Lei Wu

News Reporter

Dyne Therapeutics met with the FDA to discuss what’s needed for the accelerated approval of its myotonic dystrophy drug, and it settled on a different …

Sign up to read this article for free.

Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.

TRENDING NOW

Dyne pivots on primary endpoint, delays filing for DM1 drug

Lei Lei Wu

News Reporter

Sign up to read this article for free.

FDA unveils one-year pilot to speed some new drugs to market in just one month

Lyell’s lymphoma data for recently acquired CAR-T receive lukewarm reception on Wall Street

Lilly to bolster gene editing pipeline, buying Verve for up to $1.3B

After a quiet year, Xaira unwraps some of its AI research, eyeing a virtual cell

Prothena moves forward with layoffs; Aldeyra resubmits dry eye drug to FDA

This company has spent a decade innovating NGS-based companion diagnostics worldwide–what’s next?

Dyne piv­ots on pri­ma­ry end­point, de­lays fil­ing for DM1 drug

Lei Lei Wu

News Reporter

Sign up to read this article for free.

FDA un­veils one-year pi­lot to speed some new drugs to mar­ket in just one month

Lyell’s lym­phoma da­ta for re­cent­ly ac­quired CAR-T re­ceive luke­warm re­cep­tion on Wall Street

Lil­ly to bol­ster gene edit­ing pipeline, buy­ing Verve for up to $1.3B

Af­ter a qui­et year, Xaira un­wraps some of its AI re­search, eye­ing a vir­tu­al cell

Prothena moves for­ward with lay­offs; Aldeyra re­sub­mits dry eye drug to FDA

This com­pa­ny has spent a decade in­no­vat­ing NGS-based com­pan­ion di­ag­nos­tics world­wide–what’s next?

Dyne pivots on primary endpoint, delays filing for DM1 drug

FDA unveils one-year pilot to speed some new drugs to market in just one month

Lyell’s lymphoma data for recently acquired CAR-T receive lukewarm reception on Wall Street

Lilly to bolster gene editing pipeline, buying Verve for up to $1.3B

After a quiet year, Xaira unwraps some of its AI research, eyeing a virtual cell

Prothena moves forward with layoffs; Aldeyra resubmits dry eye drug to FDA

This company has spent a decade innovating NGS-based companion diagnostics worldwide–what’s next?