12:45 PM EDT, 09/12/2025 (MT Newswires) -- Scholar Rock ( SRRK ) has a 50% to 60% chance of getting US approval with a broad label for its apitegromab drug candidate for spinal muscular atrophy by the target action date of Sept. 22, Truist Securities said in a note Friday.

A "modest" delay of about one quarter is also possible as the contract development and manufacturing organization feedback announcement is close to the Prescription Drug User Fee Act target action date, the brokerage said. CDMO inspections are standard during regulatory review.

Truist said an approval with a broad label by Sept. 22 could move the stock by 30% to 40% from present levels, while a delay in US Food and Drug Administration decision could result in a negative impact of less than 5% in the very near term.

Other potential scenarios include approval with a restricted label and the FDA issuing a complete response letter. The brokerage said these do not change its long-term outlook for the stock.

Truist maintained its buy rating and $54 price target on the stock.

Price: 31.69, Change: -0.15, Percent Change: -0.47