By Colin Kellaher


Avidity Biosciences has won Food and Drug Administration breakthrough-therapy designation for delpacibart etedesiran, the biopharmaceutical company's lead clinical development program, for the treatment of myotonic dystrophy type 1.

Avidity on Wednesday said there are currently no approved therapies for myotonic dystrophy type 1, a progressive and often fatal neuromuscular disease.

The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.

San Diego-based Avidity said it is initiating a pivotal Phase 3 study of delpacibart etedesiran during the current quarter.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

05-08-24 0640ET