Scholar Rock (SRRK) Q1 FY26 earnings call

Scholar Rock announced the FDA's acceptance of its apitegromab BLA for SMA, featuring two fill-finish facilities and a PDUFA date of September 30. This significantly de-risks the regulatory path, with commercial supply expected ahead of approval. The company is also advancing its pipeline, including a Phase II study for FSHD and a subcutaneous formulation of apitegromab, while maintaining a strong cash position.