Investors responded to the announcement by pushing Prime Medicine shares up 5.1% to $3.40 in Monday morning trading, extending the stock's recent rally to 15% over the past month. The RMAT status is specifically designed to accelerate the development of treatments for conditions where preliminary clinical evidence suggests the potential to fill a significant unmet medical need.
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Prime Medicine Gains FDA Boost for Gene-Edited CGD Therapy
The Food and Drug Administration has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Prime Medicine’s PM359, a move that provides a faster regulatory pathway for the company’s gene-edited cell therapy aimed at treating a rare and severe form of chronic granulomatous disease.
Prime Medicine based its application on Phase 1/2 clinical data, which recently appeared in The New England Journal of Medicine. The findings demonstrate rapid engraftment and durable restoration of immune cell function in patients. As the company continues its Phase 1/2 study, PM359 remains the only gene-editing candidate in development for this specific form of CGD, bolstered further by existing fast-track, orphan-drug, and rare-pediatric-disease designations.
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