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Provention Bio Stock Craters After FDA Flags Deficiencies In PK Profiles From Teplizumab Trials For Diabetes

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·1 min read
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  • Provention Bio Inc (NASDAQ: PRVB) revealed it had received a notification on April 2 from the FDA stating that the agency has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.

  • Notably, the FDA expressed concerns over teplizumab pharmacokinetics data and comparability when Lilly first put teplizumab into clinical trials.

  • Regulators assert the PK profiles from Provention’s studies and Lilly’s trials are not the same and asked for more data on April 2.

  • According to the regulators, such concerns mean that the candidate cannot start post-marketing and label discussions.

  • Investors responded sourly to the news after Thursday’s bell, with the stock crashing almost 40%.

  • Provention responded, noting it is “willing to discuss these issues.” Regulators had scheduled a May 27 AdCom to discuss the experimental drug, which will continue as planned.

  • The drug has a long history. In 2007, Eli Lilly And Co’s (NYSE: LLY) and MacroGenics Inc (NASDAQ: MGNX) partnered to develop and commercialize teplizumab.

  • In 2010, teplizumab failed a pivotal late-stage diabetes study undertaken by Eli Lilly, and it handed the rights back to MacroGenics.

  • In 2018, Provention Bio stepped in and in-licensed the drug from MacroGenics, hoping to bring the experimental drug back from the dead.

  • PRVB used teplizumab as their lead drug for a $56 million IPO filing.

  • Teplizumab is an investigational anti-CD3 monoclonal antibody for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals.

  • Price Action: PRVB shares plunged 40.7% at $5.77 in the premarket session on the last check Friday.

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