Investing.com - BofA Securities raised its price target on Scholar Rock (NASDAQ:SRRK) to $58 from $51 while maintaining a Buy rating on the stock. The new target implies roughly 21% upside from the current stock price of $48.07, which is trading near its 52-week high of $49.82. The biotech stock has delivered a 34% return over the past year, with analyst consensus showing a Strong Buy rating. According to InvestingPro Tips, 5 analysts have recently revised their earnings upwards for the upcoming period, with additional insights available in the comprehensive Pro Research Report.
The company announced it resubmitted its biologics license application for apitegromab in spinal muscular atrophy following a positive Type C meeting with the FDA on March 3. The resubmission includes two fill-finish partners in the filing.
Scholar Rock expects a late-September PDUFA goal date for the Class II refiling. The original complete response letter in 2025 cited manufacturing as the sole approvability issue for apitegromab.
BofA Securities said the inclusion of two manufacturing options for U.S. approval reduces risk related to the previous manufacturing concerns. The firm moved its U.S. launch timeline estimate to the fourth quarter of 2026 from mid-2027.
The analyst noted the FDA alignment achieved through the Type C meeting process. BofA Securities maintained its Buy rating on the biotechnology company.
In other recent news, Scholar Rock has resubmitted its Biologics License Application to the FDA for apitegromab, a treatment for spinal muscular atrophy. This resubmission includes Catalent Indiana LLC, now part of Novo Nordisk, and an additional U.S.-based fill-finish facility. The company initially received a Complete Response Letter in September 2025 due to FDA inspection observations at Catalent Indiana, which were not specific to apitegromab. Additionally, several analyst firms have reiterated their positive outlook on Scholar Rock. Truist Securities maintained a Buy rating and set a $55.00 price target after Roche halted the development of a competing drug, emugrobart. Similarly, BMO Capital reiterated an Outperform rating with a $70.00 price target, highlighting the setback for the rival drug. Cantor Fitzgerald also reaffirmed an Overweight rating on Scholar Rock, following the discontinuation of Genentech/Roche's emugrobart. These recent developments reflect significant interest and confidence in Scholar Rock's potential within the SMA treatment landscape.