Scholar Rock Holding Corporation - Common Stock (SRRK)

The biotech suffered a regulatory setback last month, and this new development might be another blow to its prospects.

Scholar Rock stock falls as FDA issues Form 483 to Catalent; company to meet FDA, while apitegromab shows lean mass preservation in trial.

Regeneron and Scholar Rock’s submissions have been delayed or denied following an FDA inspection at the third-party fill-finish facility Catalent Indiana, owned by Novo Nordisk.

A pundit at an influential U.S. bank is quite bullish on the company's future.

U.S. stocks were higher, with the Dow Jones index gaining more than 200 points on Friday. Shares of Crinetics Pharmaceuticals, Inc. (NASDAQ: CRNX) rose sharply during Friday's session after the FDA approved PALSONIFY.

FDA cites Catalent Indiana issues in Scholar Rock's SMA drug review; European approval decision expected in 2026, with Germany as the launch market.

Shares tumbled Tuesday after the FDA rejected the company's spinal muscular atrophy drug.

As the regular session of the US market concludes on Monday, let's get an insight into the after-hours session and identify the stocks leading the pack in terms of gains and losses.

One pundit believes the share price could rise in excess of 50%.

The market was hoping the company could better contain its losses.

Scholar Rock reports Q2 2025 loss of $0.98 per share but gains investor optimism ahead of FDA decision for apitegromab in SMA. Cash runway extends to 2027.