Shares of Scholar Rock Holding Corp (SRRK) soared 10.59% in intraday trading on Thursday, as investors reacted positively to the company’s narrower second-quarter loss and promising updates on the regulatory pathway for its lead drug candidate, apitegromab.

The biopharmaceutical firm reported a Q2 net loss of $0.84 per share, a significant improvement from the $0.98 per share loss recorded a year earlier, and slightly better than the consensus analyst estimate of a $0.85 loss. The results were bolstered by a decrease in research and development expenses. More importantly, Scholar Rock provided an encouraging update on the U.S. Food and Drug Administration (FDA) review of apitegromab, a treatment for spinal muscular atrophy. The company confirmed that the review is progressing with two qualified fill-finish facilities, offering two independent paths to a potential approval decision by the Prescription Drug User Fee Act (PDUFA) date of September 30, 2026.

CEO David L. Hallal emphasized that Scholar Rock is fully prepared for an immediate U.S. commercial launch of apitegromab upon receiving FDA approval. The company also ended the quarter with a strong cash position of $492.1 million, which is expected to adequately fund operations and the anticipated product launch. The combination of the earnings beat, the de-risked regulatory outlook, and the company’s commercial readiness fueled a strong rally in the stock.