- Astellas Pharma Inc (OTC:ALPMF) announced topline results from the Phase 3 SKYLIGHT 4 trial investigating the long-term safety of fezolinetant in vasomotor symptoms associated with menopause (VMS).
- The data will support future regulatory filing submissions.
- The study has met its primary objectives, including safety and tolerability and improvements in endometrial health at week 52.
- The most common adverse events were headache and COVID-19, which matched the placebo arm.
- The topline results come from the phase 3 trial called Skylight 4, which examined the long-term safety of nonhormonal menopause treatment fezolinetant.
- The study featured 1,800 women with moderate-to-severe vasomotor symptoms of menopause, such as hot flashes and night sweats.
- The readout will be used to inform future regulatory filings in the U.S. and EU, Astellas said.
- Also included in the future data package will be results from two other late-stage pivotal trials, Skylight 1 and Skylight 2, the latter of which previously found that fezolinetant reduced the frequency and severity of menopause symptoms.
- Fezolinetant is an investigational selective neurokinin-3 (NK3) receptor antagonist.
- Price Action: ALPMF shares are trading $16.25 during the market session on the last check Monday.
