Scholar Rock resubmits apitegromab BLA after CRL; Q1 loss up 41% on launch prep spending

Filed May 7, 2026 · Period ending March 31, 2026 · Compared to 10-Q May 14, 2025 · ~1 min read

Key Changes

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  FDA issued Complete Response Letter in Sept 2025 over third-party fill-finish facility issues (not drug efficacy/safety). BLA resubmitted March 2026 with two facilities; new PDUFA date Sept 30, 2026.

  MD&A: CRL and BLA resubmission verify on EDGAR →
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  Q1 2026 net loss jumped 41% to $105.5M as G&A expense surged 77% to $50.2M, driven by $11.5M in commercial team hiring and $7.2M in professional fees for launch readiness ahead of Sept approval target.

  MD&A: G&A expense increase verify on EDGAR →
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  Refinanced debt with $350M Blue Owl facility (up from $200M Oxford), drawing $200M by March 31. Recognized $3.3M loss on extinguishment. Also raised $111.8M via ATM sales, lifting cash to $479.9M.

  MD&A: debt refinancing verify on EDGAR →