Scholar Rock is trading 4.3% down at $54.98 after September 9, 2026 conference commentary highlighted manufacturing compliance as the FDA’s only remaining approvability issue for apitegromab.
- The company still targets the September 30 FDA decision, despite an alternate fill-finish site.
- The disclosure appears to have renewed regulatory-risk concerns.
- Broader risk-off trading, including declines in major U.S. indexes, is adding pressure.