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Stock impact report

Scholar Rock outlines 2026 apitegromab launch plan and accelerates supply chain redundancy amid regulatory review [Seeking Alpha]

Scholar Rock Holding Corporation (SRRK) 
Last scholar rock holding corporation earnings: 11/12 07:30 am Check Earnings Report
Company Research Source: Seeking Alpha
CEO David Hallal described the company's transition following his appointment in April, highlighting confidence in Scholar Rock's potential as a "global biotech powerhouse" with apitegromab in SMA and an expanding focus Quick Insights The primary regulatory risk relates to FDA approval delays caused by compliance issues at a third-party fill/finish facility, with additional risks tied to regulatory unpredictability and inspection outcomes. Scholar Rock is accelerating supply chain redundancy, securing capacity at a second U.S. fill/finish facility, and preparing a supplemental BLA to minimize operational risk and ensure seamless distribution post-approval. Scholar Rock reported $369.6 million in cash, expects cash to fund operations into 2027, and is employing disciplined financial management by deferring some investments and prioritizing non-dilutive financing options. More Trending News Show less Read more
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