Edgewise update in line with expectations, says Leerink

Edgewise Therapeutics (EWTX) announced that while the FDA deemed the CANYON data insufficient to support accelerated approval on its own, the agency provided a clear path to registration for sevasemten in Becker muscular dystrophy, Leerink analyst Joseph Schwartz tells investors in a research note. Additionally, the company’s LYNX and FOX studies in Duchenne muscular dystrophy suggest that a 10 mg dose could provide benefit to these patients, says Leerink. The firm points out that Edgewise believed its chances of having an accelerated approval path based on the CANYON data were 50/50. Leerink believes investor expectations were even lower, “so this outcome seems in line with expectations.” The firm has an Outperform rating on Edgewise Therapeutics. The stock in premarket trading is down 6% to $13.54.