Scholar Rock reports FY2025 net loss $378M; BLA resubmission expected in 2026 after FDA reinspection

Scholar Rock Holding Corp

Net loss $377.9M for 2025 ($3.29 per share) vs $246.3M in 2024; no revenue; cash $367.6M at Dec 31.
Apitegromab BLA resubmission planned for 2026 after successful FDA reinspection of Catalent Indiana facility.
Secured up to $550M non-dilutive debt facility with Blue Owl Capital; $100M drawn to retire prior debt.
EMA decision on apitegromab MAA expected mid-2026; European launch (starting Germany) in H2 2026.
Phase 2 FORGE trial for FSHD on track for mid-2026; SRK-439 Phase 1 topline data expected H2 2026.

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