Sanofi has withdrawn and refiled its Premerger Notification and Report Form with the US Federal Trade Commission (FTC) for its pending $2.9-billion acquisition of Provention Bio, a Red Bank, New Jersey-based bio/pharmaceutical company, to provide the FTC additional time for review. Sanofi had announced the acquisition on March 13, 2023 and had filed its initial notification with the FTC on March 24, 2023. Following the refiling, the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, will expire on April 25, 2023. As originally announced, the acquisition is still expected to close in the second quarter of 2023. 

Provention Bio is focused on immune-mediated diseases. Its lead product, which was approved by the US Food and Drug Administration in 2022, is Tzield (teplizumab-mzwv) for delaying the onset of Stage 3 Type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D. Tzield is also in late-stage clinical development for the treatment of pediatric and adolescent patients that are newly diagnosed with clinical T1D (Stage 3). A Phase III trial is currently underway and top-line results are expected in the second half of 2023. Additional opportunities for the drug include re-dosing and formulation as well as new therapeutic indications. 

Source: Sanofi (refiling) and Sanofi (acquisition announcement)