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FDA Grants Priority Review for Biologics License Application (BLA) and EMA Accepts Marketing Authorisation Application (MAA) for Apitegromab as a Treatment for Spinal Muscular Atrophy

1. Scholar Rock's apitegromab BLA accepted by FDA, advancing its neuromuscular treatments. 2. This acceptance boosts potential market entry for SRRK's innovative therapies.

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Why Bullish?

FDA acceptance of BLA is a critical milestone for SRRK, possibly leading to increased market confidence and investment interest, similar to past instances where such approvals have positively influenced a company's stock value.

How important is it?

The announcement is pivotal as it signals potential revenue streams from FDA-approved therapies, increasing investor interest and stock performance in the long run.

Why Long Term?

Successful commercialization post-FDA approval could solidify SRRK's position and profitability over time, as seen with other biotech firms like Biogen after similar FDA approvals.

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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for neuromuscular diseases, cardiometabolic disorders, and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for apitegromab, an investigational muscle-targeted treatment that is being developed to provide clinically meaningful improvement in motor function for.

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