USFDAAug 6, 2026, 07:26 AM
Scholar Rock Apitegromab BLA Resubmitted, PDUFA Date Set for Sep 30, 2026
AI Summary
Scholar Rock Holding Corp. announced the resubmission of its Biologics License Application (BLA) for apitegromab to the FDA in March 2026, with a PDUFA action date of September 30, 2026. This follows a Complete Response Letter in September 2025 related to third-party manufacturing facilities. For the first six months of 2026, the company reported a net loss of $(215.4) million, an increase from the prior year, with total operating expenses rising to $210.9 million. The company strengthened its financial position through financing activities, including $160.8 million from an at-the-market offering, ending the period with $492.1 million in cash, cash equivalents, and marketable securities.
Key Highlights
- Apitegromab BLA resubmitted to FDA in March 2026 with a PDUFA action date of September 30, 2026.
- FDA previously issued a Complete Response Letter in September 2025 due to third-party fill-finish facility observations.
- Net loss for the six months ended June 30, 2026, was $(215.4) million, compared to $(184.8) million YoY.
- Total operating expenses for the six months ended June 30, 2026, increased to $210.9 million from $189.2 million YoY.
- Cash, cash equivalents, and marketable securities totaled $492.1 million as of June 30, 2026.
- Net cash provided by financing activities was $276.9 million for H1 2026, including $160.8 million from an ATM offering.
- Phase 2 FORGE trial for apitegromab in FSHD initiated in Q2 2026.
- Phase 1 study for SRK-439 is underway, with topline data anticipated in H2 2026.
Price Impact
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