Scholar Rock Holding Corp. shares reached a 52-week high of $58.52 on Wednesday, extending a recent rally driven by progress in its lead drug candidate apitegromab. The stock last traded at $58.63, roughly 1% below the intraday peak, according to market data. Over the past year, the biotech’s shares have delivered a total return of 59%, with a 12-month gain of 74.02%, InvestingPro data show.
The advance follows a narrower-than-expected second-quarter loss. Adjusted earnings came in at negative $0.84 per share, beating the consensus estimate of negative $0.85 per share. Revenue, however, fell short of analyst projections, contributing to concerns over the stock’s valuation relative to its Fair Value estimate.
Apitegromab, Scholar Rock’s experimental therapy for spinal muscular atrophy, remains on track for a U.S. regulatory decision by September 30. The company recently adjusted its Biologics License Application (BLA) submission after the FDA classified the Catalent Indiana fill-finish facility as having an Official Action Indicated (OAI) status. Scholar Rock will proceed with the BLA using an alternative manufacturing site, a move analysts said is unlikely to disrupt approval timelines.
BMO Capital maintained an Outperform rating on Scholar Rock with a $76 price target, citing the FDA’s site inspection classification as a manageable risk. H.C. Wainwright also reiterated a Buy rating with a $65 price target, underscoring confidence in the drug’s regulatory pathway.
