Bayer AG, BYR.L, BAYRY.PK, BAYZF.PK, BAY.MI, BAYN.DE, FDA Calendar, PDUFA Date

Company Name	Bayer AG BYR.L, BAYRY.PK, BAYZF.PK, BAY.MI, BAYN.DE
Drug Name	Elinzanetant (NDA)
Event Name	FDA decision on Elinzanetant for moderate-to-severe vasomotor symptoms (VMS) associated with menopause
Event Date	10/26/2025
Outcome Date	10/24/2025
Outcome	FDA approved Elinzanetant for moderate-to-severe vasomotor symptoms (VMS) associated with menopause, under the brand name Lynkuet, on Oct.24, 2025
Drug Status
Rival Drugs	Elinzanetant, non-hormonal menopause drug, if approvd, will have to compete with Astellas Pharma's VEOZAH, the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat VMS due to menopause
Market Potential	Bayer expects Elinzanetant to generate sales of at least $1 billion at its peak
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