Bayer (BAYRY.US) filed an IPO for its research drug, elinzanetant.

On August 2, Bayer (BAYRY.US) announced that it has submitted a new drug application (NDA) to the US FDA seeking approval for the treatment of moderate to severe vasomotor symptoms associated with menopause (VMS, also known as hot flashes) with elinzanetant in a Phase 3 clinical trial.

The application is based on positive efficacy and safety data from the OASIS 1, 2 and 3 trials. Previous data from the OASIS 1 and 2 trials showed that elinzanetant successfully met all four primary endpoints.

Full results from the OASIS 1 and 2 trials were recently presented at the 2024 ACOG Annual Meeting. Positive top-line results from the OASIS 3 trial were published in March 2024, providing additional supportive efficacy data and safety data for elinzanetant for 52 weeks, with detailed information to be presented at an upcoming scientific meeting.