Scholar Rock has announced that its management team will participate in a fireside chat at the Jefferies Global Healthcare Conference in New York on June 3, 2026, at 11:40 AM ET. This event coincides with a critical period for the company's lead drug candidate, apitegromab, which is under review by the FDA, drawing significant investor attention.
According to the company's announcement, Chairman and CEO David Hallal will represent Scholar Rock at the conference. The event will be held in New York, and a live webcast will be accessible via the "Events & Presentations" section of the company's investor relations website. A replay will be available on the site for approximately 90 days. Additionally, the company is scheduled to participate in the Jefferies conference session on June 6 and the Goldman Sachs Global Healthcare Conference on June 13.
Scholar Rock's lead asset, apitegromab, is a first-in-class, muscle-targeting monoclonal antibody for the treatment of spinal muscular atrophy (SMA). The FDA accepted the resubmitted Biologics License Application for the drug in May 2026 and set a Prescription Drug User Fee Act action date of September 30, 2026. The resubmitted BLA includes two manufacturing facilities: the Catalent Indiana site and a second U.S. facility. The FDA has completed a re-inspection of the Catalent Indiana site, with a classification decision for the facility expected within 90 days.
The company has prepared for the potential launch of apitegromab in the U.S. and Europe. Commercial supply from the second facility is anticipated to be available early in the third quarter of 2026, and the U.S. commercial team is ready to launch immediately upon potential FDA approval. As of March 31, 2026, Scholar Rock held approximately $480 million in cash, cash equivalents, and marketable securities, which is expected to fund operations into 2027. The company reported a net loss of $105.5 million for the first quarter, primarily due to increased research and development and general and administrative expenses.
Scholar Rock is expanding the development of apitegromab to include SMA patients under two years of age, with its Phase 2 OPAL trial continuing to enroll and dose patients. The company plans to initiate the Phase 2 FORGE trial in facioscapulohumeral muscular dystrophy around mid-2026. Furthermore, a Phase 1 study of its next-generation, subcutaneous myostatin inhibitor, SRK-439, in healthy volunteers is ongoing, with topline data expected in the second half of 2026.