Scholar Rock Holding Corp’s shares hit a 52-week high of $58.52 on Monday, extending a 74% gain over the past year as investors focus on the company’s regulatory pathway for its lead drug apitegromab.
The biotech firm’s stock, listed under ticker SRRK, last traded at $58.63, just 1% below its peak, according to market data. The advance follows a 59% total return over the past 12 months, as tracked by InvestingPro. Analysts at BMO Capital and H.C. Wainwright have maintained optimistic outlooks, with price targets of $76 and $65, respectively.
Scholar Rock’s progress hinges on a U.S. regulatory decision for apitegromab, its experimental therapy for spinal muscular atrophy, with a Prescription Drug User Fee Act (PDUFA) target date set for September 30. The company recently removed the Catalent facility from its Biologics License Application (BLA) after the U.S. Food and Drug Administration (FDA) classified the Catalent Indiana site inspection as Official Action Indicated (OAI). Scholar Rock plans to proceed with the BLA using an alternative fill-finish facility.
BMO Capital noted that the removal of the Catalent facility is unlikely to disrupt the FDA’s review timeline, keeping approval prospects on track. The drugmaker reported adjusted losses of $0.84 per share in the second quarter, narrower than the consensus estimate of $0.85 per share.
Despite the strong performance, InvestingPro data suggests the stock may be trading above its fair value estimate, though analysts remain bullish on its long-term prospects.
