Market frets over 'deficiencies' in teplizumab submission

9 April 2021

Stock in Provention Bio (Nasdaq: PRVB) fell 35% ahead of trading on Friday, after the firm reported a regulatory setback related to its novel diabetes med teplizumab.

In a statement, the firm said the US Food and Drug Administration had "identified deficiencies" in an ongoing review of the firm’s Biologic License Application (BLA) for teplizumab.

While these deficiencies would “preclude discussion of labeling and post-marketing requirements/commitments at this time,” they do not indicate a final negative decision from the US regulator.

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