Scholar Rock

SRRK

Market cap $2.83B

A potential delay in an important submission was the news item driving Scholar Rock's (SRRK -13.14%) share price down as the trading week kicked off. On Monday, the biotech's shares fell by more than 13% as a result, contrasting unfavorably with the 1.6% gain of the S&P 500 (^GSPC 1.56%).

An analyst's initiation of coverage was the spark that lit the fire underneath Scholar Rock's (SRRK 5.95%) equity on Thursday. The clinical-stage biotech's share price ballooned by 6% in response, on a trading day when the benchmark S&P 500 (^GSPC -0.28%) sagged by 0.3%.

People don't like to throw money into a sinking ship , and by that logic, insider buys in Wall Street can be an easy way to gauge how well a company might do in the coming quarters.

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 data in obesity showing preserved lean muscle mass.

The U.S. Food and Drug Administration (FDA) on Tuesday issued a Complete Response Letter (CRL) for Scholar Rock's SRRK apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA).

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

U.S. stock futures were mixed this morning, with the Dow futures gaining around 0.1% on Tuesday.

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 and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the apitegromab Biologics.

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.