PRVB - Provention Bio says FDA accepted marketing application for diabetes candidate

Clinical stage biopharmaceutical company, Provention Bio (NASDAQ:PRVB), announced on Monday that the U.S. Food and Drug Administration (FDA) accepted its resubmitted Biologics License Application (BLA) for experimental medication for diabetes, teplizumab. With the BLA, Provention (PRVB)seeks FDA clearance for teplizumab as a treatment to delay the clinical type 1 diabetes (T1D) in at-risk individuals. The federal agency has set a user fee goal date of August 17, 2022, for the BLA, which could potentially make teplizumab the first disease-modifying therapy for T1D. "We are delighted to have received the Agency's acceptance of our BLA resubmission as a complete response to the July 2021 CRL,” Chief Executive Ashleigh Palmer said. Despite the FDA’s previous rejection of teplizumab last year, Provention (PRVB) has added more than a quarter of value since then, as indicated in this graph.

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Provention Bio says FDA accepted marketing application for diabetes candidate