ANIP - 2023 A Big Year For Testosterone: AbbVie And ANI Pharmaceuticals Best Positioned To Benefit
Summary
- Results from three major testosterone trials expected in 2023, including the largest testosterone cardiovascular safety/efficacy trials for men and women.
- AbbVie led Androgel 1.62% 5,246-participant cardiovascular safety trial is also measuring efficacy for dysthymia, clinical fractures, anemia, and progression from pre-diabetes to diabetes, results could lead to sNDA submissions.
- ANI Pharmaceuticals' 3,656-participant LibiGel testosterone trial appears headed for NDA submission, likely to be the first approved testosterone drug for women. Expect reduction in cardiovascular and breast cancer events.
- Results from M.D. Anderson Cancer Center's 700,000-participant study association between decreasing testosterone levels and risk of dementia and adverse mental health outcomes to guide future studies.
- ANI Pharmaceuticals and AbbVie are currently undervalued. AbbVie is best suited to take global lead on female testosterone, including future dementia and mental health studies for men and women.
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2023 A Big Year For Testosterone: AbbVie And ANI Pharmaceuticals Best Positioned To Benefit