FDA Risk-Taking Bet... $700 Billion Surge in U.S. Biotech Stocks in One Day

Scholar Rock Holding Corporation (NASDAQ: SRRK) shares jumped 8.75% intraday on the 25th (U.S. time), closing at $46. This lifted its market capitalization by roughly $500 million to about $5.2 billion (approximately KRW 7 trillion). Trading volume topped 1.27 million shares, with aggressive buying evident from the opening bell.

In a recent SEC filing, the company reported holding about $365 million (KRW 490 billion) in cash, cash equivalents and marketable securities as of year-end 2025. It also reaffirmed plans to resubmit its Biologics License Application (BLA) for apitegromab—a treatment for spinal muscular atrophy—once manufacturing issues at Catalent’s Indiana facility, which prompted an FDA Complete Response Letter (CRL) last September, have been resolved. In Europe, the EMA review of the same therapy is ongoing, with both patient groups and the company expecting a decision around mid-2026.

Headquartered in Cambridge, Massachusetts, Scholar Rock is a late-stage biotech leveraging an antibody platform that targets myostatin, a key regulator of muscle growth. Its lead programs include apitegromab for spinal muscular atrophy and other muscle-metabolic diseases, as well as SRK-439, a candidate targeting obesity and cardiometabolic disorders.