earnings
confidence high
sentiment positive
materiality 0.80
Scholar Rock Q3 net loss $102.2M; Type A FDA meeting positive for apitegromab BLA resubmission in 2026
Scholar Rock Holding Corp
2025-Q3 EPS reported
-$2.54
- Net loss $102.2M (EPS -$0.90) vs $64.5M (EPS -$0.66) YoY; no revenue.
- Cash $369.6M; plus ~$60M from warrants expiring Dec 31, 2025, expected to fund into 2027.
- Type A meeting with FDA completed Nov 12; BLA resubmission and U.S. launch for apitegromab in SMA anticipated in 2026.
- Second U.S. fill-finish facility secured; commercial capacity reserved starting Q1 2026.
- FDA cleared IND for SRK-439; dosing in healthy volunteers to begin Q4 2025.