Astellas' Menopause Drug Suffers Setback After Failed Asian Trial

After acing a pair of phase 3 trials, Astellas Pharma Inc ALPMF has reported the failure of fezolinetant to beat placebo in a late-stage study of patients in Asia.
The study randomized 302 women in China, Korea, and Taiwan.
After 12 weeks, Astellas saw numerical improvements in the rate of hot flashes from baseline in the fezolinetant arm, but the difference from placebo fell short of statistical significance.
Fezolinetant is yet to share 24-week data from the study. The one positive is that the 12-week safety data are in line with the results of earlier trials.
Related: Astellas Touts Safety Data For Phase 3 Menopause Drug, Sets Up US Filing.
As previously reported, the results from two Phase 3 trials, SKYLIGHT 1 and SKYLIGHT 2, along with the findings from the long-term safety study, SKYLIGHT 4, will provide the foundational data for regulatory submissions in the U.S. and Europe.
Also See: Astellas Pharma's Fezolinetant Topped Placebo For Reducing Severity Of Menopausal Hot Flash In Phase 3 Studies.
Price Action: ALPMF shares are trading at $15.81 during the market session on the last check Tuesday.