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Investing.com -- Shares of Precigen Inc. (NASDAQ:PGEN) soared 18% after the biopharmaceutical company announced that the U.S. Food and Drug Administration (FDA) has granted priority review for its biologics license application (BLA) for PRGN-2012, a potential treatment for recurrent respiratory papillomatosis (RRP).
The FDA’s priority review status accelerates the review timeline to six months, highlighting the therapy’s potential to offer significant improvements in the treatment, diagnosis, or prevention of serious conditions. If approved, PRGN-2012 would be the first FDA-approved therapeutic option for adults with RRP, a rare and life-threatening disease currently managed by repeated surgeries that do not address the underlying cause.
The BLA submission is backed by data from a pivotal Phase 1/2 clinical study, which met its primary safety and efficacy endpoints. Findings presented at the 2024 American Society of Clinical Oncology (ASCO) annual meeting and published in The Lancet Respiratory Medicine showed that over 50% of patients achieved a Complete Response, with more than 85% experiencing a reduction in surgical interventions post-treatment compared to the year prior.
The company’s CEO, Helen Sabzevari, expressed optimism about the therapy’s potential, stating, "We have patients treated with PRGN-2012 who have been surgery-free for more than three years now, bringing hope for an alternative to the cycle of repeated surgeries."
The RRP patient population in the U.S. is estimated to be over 27,000 adults, underscoring the significant impact PRGN-2012 could have if it becomes available. The PDUFA target action date for the FDA’s decision is set for August 27, 2025. Investors will be closely monitoring the progress as Precigen works with the FDA during the review period.
The rise in Precigen’s stock reflects the market’s recognition of the company’s potential to address a high unmet medical need with PRGN-2012, as well as the FDA’s acknowledgment of the therapy’s promise through the priority review designation.
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