Scholar Rock's Early FDA Approval on Spinal Muscular Atrophy Drug Seen as 'Positive Surprise,' UBS Says

12:17 PM EDT, 09/14/2026 (MT Newswires) -- Scholar Rock Holding (SRRK) won early regulatory approval of Isembyld to treat spinal muscular atrophy, a "positive surprise" that lifts a key regulatory hurdle, UBS Securities said Sunday in a report. Isembyld was approved with a broad label for patients aged 2 years and older ahead of its Prescription Drug User Fee Act date on Sept. 30, and the commercial rollout is expected to be gradual, generating $5 million in revenue this year, in line with market expectations, the report said. UBS expects uptake to accelerate as reimbursement pathways become more streamlined, generating peak sales of $1.5 billion to $2 billion, "particularly given the substantial unmet need" in spinal muscular atrophy. While Isembyld's label notes an imbalance in fracture rates between the treatment group and placebo group in the late-stage study, the overall benefits outweigh the risks, the report said. UBS maintained its buy rating on Scholar Rock's stock and its $60 price target. Price: 53.61, Change: -1.80, Percent Change: -3.25