Scholar Rock Holding Corp. Stock News

Scholar Rock Holding Corporation remains a Strong Buy despite a recent FDA Complete Response Letter for apitegromab in spinal muscular atrophy. The CRL was due to manufacturing site issues with Catalent Indiana LLC, not safety or efficacy, and a quick BLA resubmission is expected once resolved. Company has catalysts ahead, including EMA review for apitegromab in mid-2026 and promising phase 2 d...

Shares of Scholar Rock tumbled Tuesday after the FDA rejected the company's spinal muscular atrophy drug, citing concerns at a plant.

The U.S. Food and Drug Administration has declined to approve Scholar Rock's drug for a rare neuromuscular disease, citing issues at a third party manufacturing facility, the company said on Tuesday.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to dramatically improving the lives of children and adults with spinal muscular atrophy (SMA) and additional rare, severe and debilitating neuromuscular diseases by applying its leading platform in myostatin biology to advance musculoskeletal health, today announced that the U.S. Food an...

Monday was a good day to be invested in Scholar Rock (SRRK 6.31%) stock. The clinical-stage biotech received a nod from an analyst initiating coverage on its shares, a move that sent its price more than 6% higher across the day.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK; the “Company”), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases, today announced that the company granted inducement equity awards covering an aggregate of 120,800 shares of...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK; the “Company”), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases, today announced that the company granted inducement equity awards covering an aggregate of 426,250 shares of...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases, announced today that positive study results from the pivotal Phase 3 SAPPHIRE trial (NCT05156320) were published in the pee...