Precigen Completes Submission of BLA with Request for Priority Review to the FDA for PRGN-2012 for the Treatment of Adults with Recurrent Respiratory Papillomatosis
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Precigen has completed the submission of a Biologics License Application (BLA) to the FDA for PRGN-2012, a potential first FDA-approved treatment for recurrent respiratory papillomatosis (RRP). The drug has received Breakthrough Therapy and Orphan Drug Designations, and the BLA is supported by promising Phase 1/2 study results.
December 30, 2024 | 12:15 pm
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Precigen has submitted a BLA for PRGN-2012 to the FDA, seeking priority review. The drug could become the first approved treatment for RRP, supported by strong Phase 1/2 results. This development could significantly impact Precigen's market position.
The submission of a BLA with a request for priority review indicates a potential for accelerated approval, which could lead to a significant market opportunity for Precigen. The strong clinical trial results and designations from the FDA and European Commission further enhance the drug's prospects, likely leading to a positive short-term impact on PGEN's stock price.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100