Abeona Therapeutics Provides Progress Update On Pz-cel Biologics License Application; Says On Track For PDUFA Target Action Date Of May 25, 2024
Portfolio Pulse from Benzinga Newsdesk
Abeona Therapeutics announced progress on its Pz-cel Biologics License Application, stating it remains on track for the PDUFA target action date of May 25, 2024. A BIMO inspection at Abeona's headquarters found no issues, and the FDA does not plan to convene an Advisory Committee for pz-cel.
February 01, 2024 | 12:35 pm
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Abeona Therapeutics' Pz-cel remains on track for its PDUFA target action date with a successful BIMO inspection and no FDA Advisory Committee planned.
The successful BIMO inspection and the FDA's decision not to convene an Advisory Committee for Pz-cel are positive indicators for Abeona Therapeutics. These developments suggest a smooth regulatory path ahead for Pz-cel, potentially leading to a positive impact on ABEO's stock price in the short term.
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