SCHOLAR ROCK HLDG DL-,001

Weeks before the PDUFA date on September 30, 2026, Scholar Rock highlights late Phase III data on apitegromab as well as secured commercial production and go‑to‑market infrastructure. After an earlier Complete Response Letter over manufacturing issues, the company moved commercial fill‑finish production to an alternative site and says it has already produced commercial vials there. Management emphasizes statistically significant Phase III results, high treatment adherence, and prepared sales, nursing and patient‑support structures for the US, with plans for Europe and Japan. » More on de.investing.com

At the Cantor Fitzgerald Global Healthcare Conference, Scholar Rock said the FDA has identified compliance with manufacturing requirements as the only remaining approval hurdle and that the company has since established a contractually committed alternative fill-and-finish facility. The crucial PDUFA date is September 30, 2026; management is holding intensive talks with the FDA about labeling and safety data. Scholar Rock has roughly $500 million in cash, sees worldwide market potential in the billions, and expects initial but manageable reimbursement and market-access hurdles during the first three to five quarters after launch. » More on de.investing.com

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). » More on de.investing.com