Scholar Rock Holding (SRRK) news

Scholar Rock Holding Corporation - withdraws Apitegromab MAA in Europe; to resubmit with alternate fill-finish facility

Scholar Rock Holding Corporation (NASDAQ: SRRK) has announced its decision to withdraw the Marketing Authorisation Application (MAA) for apitegromab in Europe to facilitate resubmission with an alternate fill-finish facility. The withdrawal is part of the company’s strategy to address regulatory…

Scholar Rock Holding Corporation - prepared for U.S. apitegromab launch upon FDA approval by Sept 30, 2026 PDUFA date

Scholar Rock Holding Corporation (NASDAQ: SRRK) has announced that the U.S. Food and Drug Administration (FDA) is currently reviewing its Biologics License Application (BLA) for apitegromab, a potential treatment for spinal muscular atrophy (SMA). The FDA has set a Prescription Drug User Fee Act…

Scholar Rock's BLA on track for potential FDA approval by Sept. 30

Scholar Rock's apitegromab BLA review shifts to second facility

Scholar Rock (NASDAQ: SRRK) has shifted its focus to a second U.S.-based fill-finish facility for the FDA review of its Biologics License Application (BLA) for apitegromab, a potential treatment for spinal muscular atrophy (SMA), following delays related to the FDA’s inspection of the primary…

Scholar Rock Holding Corporation: BMO raises target price to $76 from $70

BMO Capital has raised its target price for Scholar Rock Holding Corporation (SRCK) to $76 from $70, reflecting a positive outlook on the company’s growth prospects and operational performance. The updated price target indicates increased confidence in the firm’s ability to deliver value to…