Precigen Reports FDA Confirmation That Ongoing Phase 1/2 Study Of PRGN-2012 AdenoVerse Immunotherapy Will Serve As Pivotal Study To Support Accelerated Approval
Portfolio Pulse from Benzinga Newsdesk
Precigen has received confirmation from the FDA that its ongoing Phase 1/2 study of PRGN-2012 AdenoVerse Immunotherapy will serve as a pivotal study to support accelerated approval. The FDA also confirmed that no additional randomized, placebo-controlled trial will be required to support the submission of a biologics license application (BLA). Precigen plans to initiate a confirmatory study prior to the BLA submission.
August 09, 2023 | 11:06 am
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POSITIVE IMPACT
The FDA's confirmation of Precigen's ongoing Phase 1/2 study for accelerated approval and no need for an additional trial for BLA submission is positive news for the company. This could potentially expedite the process of getting PRGN-2012 to market.
The FDA's confirmation is a significant regulatory milestone for Precigen, potentially reducing the time and resources needed to bring PRGN-2012 to market. This could have a positive impact on the company's stock in the short term as it reduces uncertainty and demonstrates progress in their pipeline.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100