Edgewise Therapeutics' (EWTX) skeletal myosin inhibitor sevasemten is poised to succeed in Becker muscular dystrophy, or BMD, with optionality in Duchenne muscular dystrophy, or DMD, due to "clean safety, signals of efficacy" and management's development strategy, RBC Capital said in a Thursday note.
There is a "clear" registrational path to be the "first-ever" approved therapy for BMD but "no accelerated approval" is in sight, analysts led by Leonid Timashev said.
Edgewise needs to wait for the full Grand Canyon data next year before filing for sevasemten's approval, while topline results are expected in Q4 2026, the analysts said.
There was a "positive patient experience" across the 99% of the eligible participants with BMD enrolled in the MESA open label extension trial, according to RBC. The analysts also said that a DMD trial is "worth running" because of mechanistic rationale although its dataset was "complex."
RBC maintained an outperform rating on the stock with a $48 price target.
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