Scholar Rock Secures $550M Debt Facility, Prepares BLA Resubmission After FDA Clears Site
Scholar Rock resumed manufacturing at Catalent Indiana after the FDA raised no new remediation requests and will resubmit apitegromab BLA for a 2026 U.S. approval. The company ended 2025 with $368 million cash and a $550 million milestone–linked debt facility, and plans a second fill–finish site filing to bolster capacity.
1. FDA Interaction and BLA Resubmission
Following a Type A meeting in November, the FDA issued a warning letter to Catalent Indiana but raised no additional remediation requests after a reinspection, allowing Scholar Rock to resume routine manufacturing and prepare for apitegromab BLA resubmission targeting 2026 U.S. approval.
2. Financial Position and Funding
Scholar Rock closed 2025 with $368 million in cash, secured a $550 million milestone‐linked debt facility and plans to monetize a Priority Review Voucher, strengthening its balance sheet ahead of potential product launch.
3. Commercial Infrastructure and Launch Preparedness
The company has built commercial infrastructure including specialty pharmacy access, a home infusion network of over 10,000 nurses, patient services and payer engagement programs, positioning it for a smooth U.S. launch and addressing potential reimbursement challenges.
4. Second Fill-Finish Site and European Review
Engineering runs are underway at a second fill-finish site aimed at diversifying supply, with a supplemental BLA filing planned later in 2026, while the EMA review of apitegromab's marketing application is expected to conclude by mid-2026.