PRVB - Provention Bio stock tanks 22% after receiving CRL for teplizumab application

Provention Bio (PRVB) plummets 21.6% premarket in reaction to the announcement that the FDA has issued a Complete Response Letter ((CRL)) for its Biologics License Application ((BLA)) for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.In the CRL, the FDA stated that a single, low-dose pharmacokinetic/pharmacodynamic (PK/PD) bridging study in healthy volunteers to compare planned commercial product with product originating from drug substance had failed to show PK comparability.The Company expects relevant additional PK/PD data being, or to be, collected from a substudy in patients receiving 12-days of therapy in the ongoing Phase 3 PROTECT trial in newly diagnosed T1D patients later this quarter.In the CRL, the FDA cited several additional considerations related to product quality, which the Company believes have either been addressed or can be addressed in the short-term.The CRL did not cite any clinical deficiencies related to the efficacy and safety data packages submitted to the BLA

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Provention Bio stock tanks 22% after receiving CRL for teplizumab application