Scholar Rock to sell PRV to BioNTech for $205M; Q3 EPS loss $0.81, first ISEMBYLD revenue $0.6M

Scholar Rock Holding Corp

Definitive PRV asset purchase agreement signed Nov 9, 2026 with BioNTech US Inc.; $205M in cash payable at closing, subject to HSR waiting-period expiration.
Q3 2026 net loss $107.2M ($0.81 per share) vs $102.2M ($0.90 per share) a year earlier; net product revenue of $0.6M from ISEMBYLD after Sept 11 FDA approval.
Cash, cash equivalents and marketable securities of $413.6M at Sept 30, 2026; R&D $54.1M, SG&A $52.5M, stock-based compensation $17.9M.
EMA validated the apitegromab MAA resubmission in October 2026, with CHMP opinion expected H1 2027; Japanese JNDA accepted under priority review (~9-month cycle).
SRK-439 Phase 1 topline data expected by year-end 2026; FSHD FORGE Phase 2 enrolling ~60 patients; FDA granted Fast Track and Orphan Drug designations in September 2026.

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