Mayne Pharma’s BIJUVA and IMVEXXY Set to Benefit from FDA Label Change

Regulatory Shift in Women’s Health

In a landmark decision announced on 12 November 2025, the U.S. Food & Drug Administration (FDA) declared it will remove the longstanding "black box" warnings from a broad class of hormone replacement therapies (HRTs) used to manage menopausal symptoms. This move reflects evolving clinical evidence that challenges previous risk assessments and signals a new era for women’s health treatments.

For Mayne Pharma Group Limited (ASX – MYX), a specialty pharmaceutical company with a strong presence in women’s health, this regulatory update is particularly significant. The company’s flagship menopause therapies, BIJUVA and IMVEXXY, have historically carried these warnings, which have contributed to stigma and hesitation among prescribers and patients alike.

Implications for Prescribing and Market Dynamics

Mayne Pharma’s CEO, Shawn Patrick O’Brien, welcomed the FDA’s decision, emphasizing that removing these outdated regulatory barriers could meaningfully increase the utilisation of their HRT products. The black box warnings, which highlighted risks such as cardiovascular disorders, breast and endometrial cancers, and probable dementia, have long been a source of caution, limiting broader adoption despite the therapies’ benefits.

With the FDA’s directive, Mayne Pharma anticipates updating the product labels for BIJUVA and IMVEXXY to reflect the removal of these warnings. This is expected to enhance physician confidence, reduce stigma, and potentially unlock new patient segments who may have previously avoided HRT due to safety concerns.

Broader Industry and Patient Impact

The FDA commissioner, Dr Martin A. Makary, underscored the significance of this change by highlighting that millions of women have been denied the long-term health benefits of hormone replacement therapy due to what he described as "a medical dogma rooted in a distortion of risk." This regulatory update could therefore reshape prescribing practices across the U.S., encouraging more clinicians to consider HRT as a viable and safe option for managing menopausal symptoms.

For Mayne Pharma, which has a 40-year track record of innovation and leadership in women’s health, this development aligns with its strategic focus on expanding access to effective and safe therapies. The company’s commitment to commercial execution and patient value suggests it will actively leverage this regulatory tailwind to strengthen its market position.

Looking Ahead

While the FDA’s announcement is a clear positive signal, the timing and final approval of updated product labeling remain to be seen. Market uptake will depend on how quickly physicians and patients respond to the new guidance and whether Mayne Pharma can capitalize on the opportunity to grow its women’s health portfolio in a competitive landscape.