Scholar Rock Q2 loss $110M; apitegromab PDUFA Sept 22, 2025; positive EMBRAZE lean mass data

Scholar Rock Holding Corp

2025-Q2 EPS reported -$1.65

FDA accepted apitegromab BLA under priority review; PDUFA target action date September 22, 2025.
Phase 2 EMBRAZE trial: apitegromab + tirzepatide preserved 54.9% more lean mass vs tirzepatide alone (p=0.001).
Q2 net loss $110M ($0.98/shr) vs $58.5M ($0.60/shr) in prior year; no revenue.
Cash $295M as of June 30, 2025; expected to fund operations into 2027.
Preparing for U.S. commercial launch upon potential approval; EMA MAA validated, EU launch anticipated 2026.

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