Core Insights - Scholar Rock is preparing to resubmit the biologics license application (BLA) for apitegromab following a successful FDA reinspection of the Catalent Indiana facility, with a targeted U.S. launch in 2026 [2][6][12] Regulatory Updates - The FDA issued a warning letter to the Catalent Indiana facility after a Type A meeting in November, but subsequent meetings indicated no additional requests for the remediation plan [1] - The FDA plans to conduct a site reinspection after routine manufacturing activities resumed in late February [1] - The compliance status of the Catalent Indiana site is the sole issue affecting the approval of the BLA [2][6] Financial Position - Scholar Rock ended 2025 with $368 million in cash and secured a new debt facility of up to $550 million, with staged draws tied to milestones [4][20] - The company plans to monetize a Priority Review Voucher to strengthen its balance sheet further [4][20] Commercial Infrastructure - The company has developed a commercial infrastructure, including specialty pharmacy access and a home-infusion network with over 10,000 affiliated nurses [5][12] - Initial access and reimbursement challenges are anticipated, particularly related to J-codes and Medicaid processes [5][12] Pipeline Developments - Scholar Rock is advancing a second fill-finish facility to support future commercial demand, with engineering runs underway [8][9] - The company is also progressing in its anti-myostatin pipeline, including ongoing studies for apitegromab in infants and toddlers [15][19] European Market Strategy - The marketing authorization application (MAA) review for apitegromab is ongoing with the European Medicines Agency (EMA), and a decision is expected in mid-2026 [11][12] - Preparations for a European launch include establishing local leadership and progressing reimbursement planning [14]