Scholar Rock Holding Corp

Scholar Rock Holding Corp. reported a net loss of $105.5 million for the first quarter of 2026, an increase from $74.7 million in Q1 2025, primarily due to higher operating expenses. The company significantly bolstered its cash position to $430.5 million, driven by $98.0 million from common share sales and $196.7 million from a new debt facility. The Biologics License Application (BLA) for apitegromab was resubmitted in March 2026, with a Prescription Drug User Fee Act (PDUFA) action date set for September 30, 2026. Scholar Rock anticipates its current cash resources will fund operations for at least one year.

Scholar Rock announced its Q1 2026 financial results and significant business updates. The FDA accepted the Biologics License Application (BLA) for apitegromab for spinal muscular atrophy (SMA), setting a PDUFA action date of September 30, 2026. The company reported a net loss of $105.5 million for the quarter, with cash, cash equivalents, and marketable securities totaling $479.9 million as of March 31, 2026. Preparations for a U.S. commercial launch are underway, with European regulatory review also progressing.