Edgewise Therapeutics falls after mid-stage study data found insufficient for accelerated approval

Edgewise Therapeutics

26/06/2025 20:29

** Shares of biopharma company Edgewise Therapeutics EWTX.O fall as much as 9.7% to a near two-month low of $12.15

** EWTX says its experimental drug showed sustained disease stabilization, up to three years, in a mid-stage study to treat two types of rare genetic disorders

** Becker and Duchenne muscular dystrophies are genetic disorders that affect muscles, causing progressive muscle wasting over time

** FDA found the mid-stage study data insufficient for accelerated approval, but said the measure of physical abilities in Becker muscular dystrophy is a valid main goal for a traditional approval - EWTX

** J.P.Morgan says FDA findings data insufficient for accelerated approval is in line with its expectations

** "We continue to remain positive on EWTX but for the most part still see the cardiovascular assets driving the most value for the stock in the mid-term" - J.P.Morgan

** Company says it plans to meet the FDA in Q4 of 2025 to discuss late stage study design

** Including session moves, stock down 51.6% YTD

(Reporting by Siddhi Mahatole)

((siddhi.mahatole@thomsonreuters.com))