Provention Bio Stock Craters After FDA Flags Deficiencies In PK Profiles From Teplizumab Trials For Diabetes - Macrogenics (NASDAQ:MGNX), Eli Lilly and Co (NYSE:LLY)

Provention Bio Inc 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 LLY and MacroGenics Inc 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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