earnings
confidence high
sentiment positive
materiality 0.85
Scholar Rock reports Q1 net loss $105.5M; FDA accepts apitegromab BLA with Sep 30 PDUFA
Scholar Rock Holding Corp
2026-Q1 EPS reported
-$0.83
- FDA accepted apitegromab BLA for SMA; PDUFA action date Sep 30, 2026; two fill-finish facilities included.
- Cash of $479.9M as of Mar 31, 2026, includes $100M debt draw and $98M ATM proceeds.
- Q1 2026 net loss $105.5M ($0.83 per share) vs $74.7M ($0.67) in Q1 2025; no revenue.
- R&D expense $51.8M, G&A $50.2M; stock-based compensation $18.2M.
- Pipeline: Phase 2 OPAL trial enrolling; FORGE FSHD trial on track for mid-2026; SRK-439 Phase 1 data H2 2026.