Shares of Scholar Rock Holding Corp. reached a 52-week high of $58.52 on Monday, following the company’s decision to exclude a manufacturing facility from its Biologics License Application (BLA) for apitegromab, its lead drug candidate for spinal muscular atrophy.
The Cambridge, Massachusetts-based biotech said it removed the Catalent facility in Indiana from the BLA submission after the U.S. Food and Drug Administration classified the site’s inspection as Official Action Indicated (OAI). Scholar Rock plans to proceed with the application using a second fill-and-finish facility. The FDA has set a regulatory decision deadline of September 30.
Scholar Rock’s stock closed at $58.20 on Friday, August 24, before climbing to an intraday peak of $58.63 in early trading on Monday. The shares were last up 3.01% at $58.77 in after-hours trading. Over the past year, the stock has gained 74.02%, according to InvestingPro data, which also shows a one-year total return of 59%.
Analysts remain optimistic about the company’s prospects. BMO Capital maintained an Outperform rating and a price target of $76, citing the removal of the Catalent facility as unlikely to disrupt the FDA approval timeline. H.C. Wainwright reiterated a Buy rating with a $65 target, following the FDA’s OAI classification of the Indiana site.
Scholar Rock reported a narrower-than-expected loss in the second quarter, posting an adjusted net loss of $0.84 per share, beating the consensus estimate of a $0.85 loss. The company did not provide updated financial guidance in its latest update.
Despite the positive momentum, InvestingPro noted that Scholar Rock’s stock appeared overvalued relative to its Fair Value estimate, even as the company advances apitegromab toward a potential regulatory decision.
