Mayne Pharma to present major IMVEXXY® safety data at 2026 ISPE Annual Meeting
Mayne Pharma Group (ASX:MYX) will present a poster on IMVEXXY® endometrial cancer safety data at the International Society for Pharmacoepidemiology (ISPE) 42nd Annual Meeting in Milan, Italy, held from 29 August to 2 September 2026.
The headline finding is notable. Across a total study cohort of 9.5 million women, comparative analyses and meta-analysis showed no effect of very-low-dose vaginal estrogen (VLDVE) exposure on the risk of endometrial cancer.
In a second development, the Company’s menopause product BIJUVA® has been named a finalist in three categories at the 2026 PM360 Trailblazer Awards.
When big ASX news breaks, our subscribers know first
What the endometrial cancer study found
The observation-based clinical study was a post-marketing requirement by the US Food and Drug Administration (FDA), with the safety analysis concluded in April 2026. Its primary objective was to determine whether the use of VLDVE, including IMVEXXY® 4 µg and 10 µg, carried an increased risk of endometrial cancer compared to patients who were not exposed.
The study is titled “Risk of Endometrial Cancer in Postmenopausal Women Prescribed Very-Low-Dose Vaginal Estrogen Products in the US.” According to Mayne Pharma, it represents one of the largest real-world analyses of very low-dose vaginal estrogen undertaken to date.
Key study details include:
-
Study cohort: more than nine million women (9.5 million)
-
Products studied: IMVEXXY® 4 µg and 10 µg (VLDVE)
-
Analysis concluded: April 2026
-
Presentation: ISPE 42nd Annual Meeting, Milan, 29 August – 2 September 2026
The study authors concluded that comparative analyses and meta-analysis show no effect of VLDVE exposure on the risk of endometrial cancer. This conclusion is consistent with the US FDA’s recent request to remove the box warnings from the prescribing information for certain hormone replacement therapy drug products, including IMVEXXY® and BIJUVA®.
Dr Frank Casty, Global Head of R&D and Chief Medical Officer
“This is one of the largest real-world analyses of very low-dose vaginal estrogen undertaken to date, drawing on US data from more than nine million women. In this study, very low-dose vaginal estrogen use was not associated with an increased risk of endometrial cancer. Rigorous real-world evidence of this scale makes an important contribution to the scientific understanding of a class of therapies that many postmenopausal women rely on.”
Understanding VLDVE and menopause care — why the data matters
IMVEXXY® (estradiol) is a vaginal insert indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy (VVA) in postmenopausal women.
The study’s conclusion is consistent with the US FDA’s recent request to remove the box warnings from the prescribing information for certain hormone replacement therapy drug products, including IMVEXXY® and BIJUVA®.
BIJUVA® recognition and the US Women’s Health growth story
BIJUVA® has been named a finalist in three categories at the 2026 PM360 Trailblazer Awards, a long-established US life-sciences marketing programme, with winners to be announced on 29 September 2026. The nominations span Professional Campaign, Sales Aid, and Relaunch/Revitalisation of the Year.
The recognition reflects the commercial and marketing execution behind BIJUVA® as the Company continues to build momentum in its US Women’s Health portfolio. BIJUVA® (estradiol and progesterone) is a combination of an estrogen and progesterone indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause.
The Women’s Health portfolio momentum extends beyond clinical data, with Mayne Pharma’s direct-to-patient fulfilment strategy taking shape through DistributeRx, a wholly owned subsidiary launched in March 2026 to improve margin capture across Women’s Health and Dermatology product lines.
| Product | Active Ingredient(s) | FDA-Approved Indication | Recent Milestone |
|---|---|---|---|
| IMVEXXY® | estradiol | Moderate–severe dyspareunia (VVA symptom) | ISPE safety data presentation |
| BIJUVA® | estradiol + progesterone | Moderate–severe vasomotor symptoms | PM360 Trailblazer finalist (3 categories) |
Aaron Gray, CEO
“Menopause care is one of the largest and most under-served markets in women’s health in the United States, and demand for therapies continues to grow. Mayne Pharma’s Women’s Health portfolio, which includes IMVEXXY® positions the Company to play a meaningful and growing role in that market, where the macro tailwinds are strong. In addition, being named a finalist for BIJUVA® across three categories is a credit to our commercial, marketing and medical teams and reflects the momentum we are building in Women’s Health. It speaks to the growing role BIJUVA® plays in menopause care and the strength of the brand we are building in that market.”
What’s next for Mayne Pharma investors
Two near-term catalysts are on the calendar for the US Women’s Health portfolio:
-
ISPE 42nd Annual Meeting poster presentation — 29 August to 2 September 2026
-
PM360 Trailblazer Awards winners announced — 29 September 2026
According to CEO Aaron Gray, menopause care remains one of the largest and most under-served markets in women’s health in the United States, with strong macro tailwinds supporting continued demand. The upcoming safety data presentation and award recognition together underline the Company’s growing focus on this market as it continues to build its US Women’s Health portfolio.
Investors exploring the infrastructure behind Mayne Pharma’s US Women’s Health growth can find our detailed coverage of the Adelaide Apothecary expansion, which outlines the Lexington facility build-out targeting 2.5 million annual prescriptions and the capital investment underpinning the company’s direct-to-patient scaling strategy.
Don’t Miss the Next Healthcare Breakthrough on ASX
Big News Blast delivers FREE breaking ASX healthcare news directly to your inbox within minutes of release, complete with in-depth analysis already done for you. Join 20,000+ investors who stay ahead of the market the moment announcements drop. Click the “Free Alerts” button at StockWire X to start receiving alerts today.