Scholar Rock Holding Corporation Q1 FY2026 earnings call

David Hillel announced that the FDA accepted the biologics license application for epidegromab for SMA treatment, with a PDUFA date of September 30th. Akshay Vashna updated on R&D progress, including the acceptance of the BLA, progress at fill-finish facilities, and pipeline updates like the Phase II OPAL trial for SMA and Phase II study for FSHD. Keith Woods discussed commercial launch preparations, including US and European efforts. Vikas Binha provided financial update with $480M in cash, etc.

FDA has a 90-day period to classify the Catalan Indiana facility; commercial epidegromab from the second facility expected in early Q3; MAA review in Europe progressing, expecting CHMP opinion near mid-year; Phase II study in FSHD to commence soon; subcutaneous epitigromab and SRK439 programs ongoing

Q: Questions on epitagromab approval timelines, confidence in Catalan facility classification, commercial supply split, use with other therapies, CHMP review, label broadness, payer discussions, sub-Q version timelines, FORGE trial vs Roche's effort, reimbursement strategies, Catalan site feedback, launch sequencing and pricing, investigator interest in FSHD trials.

A: Responses covering FDA engagement, facility progress, commercial preparations, regulatory dialogues, trial details, etc.