Scholar Rock reaffirms 2026 BLA resubmission, U.S. launch, up to $550m Blue Owl Capital debt

 

Scholar Rock reaffirms 2026 apitegromab BLA resubmission and U.S. launch, secures up to $550m Blue Owl Capital debt facility

• FDA–Novo–Catalent remediation progressing after constructive FDA meeting; manufacturing resumed, reinspection expected, enabling 2026 BLA resubmission.
• Company reaffirms 2026 apitegromab BLA resubmission and U.S. launch timing despite prior CRL and manufacturing disruptions.
• Second U.S. fill/finish site advancing; engineering runs underway, with supplemental BLA planned for later 2026 approval.
• EMA review of apitegromab ongoing; European decision expected mid-2026, with Germany anticipated as first launch market.
• Commercial build-out advanced: U.S. field team active, payer discussions ongoing, and home-infusion network established ahead of launch.
• 2025 operating expenses $384.6m, including $75.6m stock-based compensation; year-end cash balance $368m supports planned development and launch.

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