SCHOLAR ROCK HLDG DL-,001

Shares of Scholar Rock climbed to a 52-week high of $58.52 and posted a total return of about 59% over the past year. In the second quarter the company reported an adjusted loss of $0.84 per share, slightly beating consensus expectations. Lead drug Apitegromab remains on track for a U.S. approval decision by September 30 after Scholar Rock removed a Catalent production site from the BLA and continued the filing with a second fill‑finish facility. BMO reaffirmed its “Outperform” rating (price target $76.00) and H.C. Wainwright stated “Buy” (price target $65.00). » Más en de.investing.com

Scholar Rock has removed Catalent Indiana as the commercial fill-and-finish and manufacturing site from the US biologics license application (BLA) for apitegromab and is asking the FDA to review the filing with an alternative US-based manufacturer. The company is simultaneously withdrawing its EMA submission and plans to refile it with the new manufacturing site after Catalent’s FDA inspection was classified as "Official Action Indicated." Scholar Rock expects the FDA decision by September 30, 2026, plans a Japan submission by the end of 2026, and notes that commercial vials would already be available from the alternative manufacturer. » Más en de.investing.com

The FDA has classified an inspection at Catalent Indiana as OAI, effectively removing that site from the approval pathway for apitegromab and making an alternative fill‑finish facility the primary route for the decision expected by Sept. 30, 2026. Scholar Rock says all required data milestones were met early, is still negotiating the label with the FDA, and has advanced commercial preparations including a launch team and patient program. The approval path in Europe is more uncertain, as the EMA is waiting to reassess the fill‑finish situation. The stock rose after the statements, and management emphasized the second facility has sufficient inventory for a possible market launch. » Más en de.investing.com