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

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