earnings
confidence high
sentiment neutral
materiality 0.70
Scholar Rock Q2 net loss $109.9M; apitegromab BLA on track for FDA decision by Sept 30, 2026
Scholar Rock Holding Corp
- Net loss of $109.9M ($0.84 per share) vs $110.0M ($0.98) in Q2 2025; no revenue recorded.
- Cash, equivalents, and marketable securities of $492.1M as of June 30, 2026, including $62.8M net from ATM.
- Apitegromab BLA for SMA under FDA review with two fill-finish facilities; PDUFA date Sept 30, 2026; ample supply for launch.
- Initiated Phase 2 FORGE trial in FSHD (approx 60 patients, primary endpoint LMV at 12 months).
- Engaging with EMA on apitegromab MAA; FDA inspection classification of Catalent Indiana pending.