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FDA fast-tracks ovarian cancer drug

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The US Food and Drug Administration (FDA) has granted fast track status to stenoparib, an ovarian cancer drug for patients who cannot tolerate platinum-based treatments.

The designation, given to medicines addressing serious medical needs, allows more frequent FDA communication and may enable accelerated approval if criteria are met.

Allarity Therapeutics is developing stenoparib as an option for women with advanced ovarian cancer who have hypersensitivity to platinum drugs such as cisplatin and carboplatin, or whose tumours no longer respond to these therapies.

Ovarian cancer begins in the reproductive organs that produce eggs.

While platinum drugs can shrink tumours and slow their growth, some patients cannot take them due to health complications or allergic reactions to the metal.

Thomas Jensen, chief executive officer of Allarit, said: “We are very pleased that the FDA has granted fast track designation to stenoparib.

“We look forward to engaging closely with the FDA as we advance this program.”

Jensen added that the designation “underscores the significant unmet need facing women with advanced ovarian cancer and reflects the potential of stenoparib to meaningfully improve treatment outcomes.”

Stenoparib, first developed by Eisai as E7449 and later called 2X-121, is an oral small molecule that blocks PARP1/2 and tankyrase 1/2 enzymes – proteins involved in cancer cell growth.

Blocking these enzymes is expected to slow tumour progression.

A Phase 1 clinical trial (NCT01618136) showed stenoparib as an add-on treatment was well tolerated and prolonged survival in patients with solid cancers, including five with ovarian cancer.

Phase 1 trials test safety and dosing in small groups.

Allarity is now enrolling patients in a Phase 2 study to determine the best dose – 600mg or 800mg daily as hard gelatin capsules – for women with advanced, recurrent ovarian cancer who cannot take platinum drugs or whose tumours are resistant.

Phase 2 trials test effectiveness in larger patient groups.

Several patients have been receiving treatment since June. The study will measure clinical benefit, progression-free and overall survival, disease control, and response rates over about two years.

The company is using its Drug Response Predictor (DRP) platform to identify patients whose tumour genetics suggest they are likely to respond to stenoparib.

DRP also helps identify biomarkers of response or resistance to treatment.

Fast track designation may also give access to accelerated approval, priority review, or rolling review, potentially bringing the drug to patients more quickly than standard processes.

Wellness

Women’s HealthX unveils Northwell Health, Corewell Health, Biogen & more to headline Chronic Disease stage

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Women’s HealthX has announced its lineup of healthcare trailblazers speaking on Chronic Disease Management, alongside other specialisations including Fertility, Sexual Health, Maternity, Menopause and Cognitive Health, taking a holistic approach to women’s health.

It will bring together 750+ leaders across pharma, health systems, and innovation to address one of the most urgent and underexamined challenges in healthcare; the sex difference gap in data and evidence.

Since cardiovascular disease remains the leading cause of death among women globally, and autoimmune and neurological conditions affect women at significantly higher rates, Women’s HealthX will home in on chronic disease management with 17+ sessions spotlighting case studies and lessons learned.

The Chronic Disease Management Stage at Women’s HealthX responds directly to this gap, convening senior decision makers and innovators to explore how sex specific science, digital health, and new care models can reshape outcomes for women.

Attending pharma & healthcare organisations include:

  • Tracy Sims, Executive Director, Cardiometabolic Health, Eli Lilly
  • Adrian Kielhorn, Senior Director, Global Head HEOR Neurology, Alexion Pharmaceuticals
  • Lauren Powell, Head of Health Equity and Clinical Innovation, Biogen
  • Amy Kao, SVP, Head of Neuroscience and Immunology Research, EMD Serono
  • Stella Vnook, Executive Chair and CEO, Kaida Biopharma
  • Amanda Borsky, Director, Clinical Research, Northwell Health
  • Lacey McIntosh, Division Chief, Oncologic and Molecular Imaging, UMass Memorial Medical Center
  • Nicole Turck, Vice President Operations, Women’s Health, Corewell Health
  • Mette Dyhrberg, CEO, Autoimmune Registry
  • Lyn Agostinelli, Principal Consultant, Halloran Consulting Group

Sessions addressing the real gaps in women’s chronic care

The agenda features a series of high impact sessions tackling the structural and scientific gaps in women’s health:

  • Improving outcomes in obesity through evidence based person centered care: Eli Lilly
  • Tackling sex based health inequities by breaking down barriers and bias: Alexion Pharmaceuticals
  • Close the health equity gap in women’s health by improving how autoimmune diseases are diagnosed, treated and managed: Autoimmune Registry
  • How a GYN only care model is driving faster access to gynecological care: Corewell Health
  • Transforming early detection in ovarian cancer: new pathways to accuracy, safety, and better outcomes: UMass Memorial Medical Center

Panel discussions include:

  • Why chronic disease looks different in women and why health systems haven’t adapted: Biogen, Kaida Biopharma, EMD Serono
  • How can we better engage with our customers: Northwell Health, Halloran Consulting Group

Health equity starts here. REGISTER YOUR PLACE

Why This Matters Now

Women’s HealthX positions chronic disease not just as a clinical challenge, but as a critical frontier for innovation, investment, and system redesign.

From AI powered monitoring and digital therapeutics to real world data and integrated care pathways, the stage highlights where meaningful progress is already being made and where the biggest opportunities lie.

For the FemTech ecosystem, this represents a pivotal moment: aligning technology, clinical insight, and commercial strategy to finally close the long standing data and care gaps in women’s health.

About Women’s HealthX

Women’s HealthX is where the transformation of women’s health begins at its true foundation: data, science, and evidence.

It’s the leading event dedicated to closing the sex difference data gap and accelerating breakthroughs through science driven, real world case studies.

Taking place on December 3 to 4, 2026 in Boston, USA, the exhibition will bring together more than 750 healthcare leaders, including clinicians, payers, employers, investors, and policymakers.

Seven different stages with 150+ expert speakers taking an holistic approach to women’s health. From fertility, maternity, sexual health, cognitive health, menopause and chronic disease, we address care at every stage of a woman’s life.

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Menopause

AI maps how reproductive organs age differently during menopause

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An AI atlas has mapped how reproductive organs age through menopause, with the ovaries, vagina and uterus changing on different timelines.

To better understand how this process affects health, researchers at the Barcelona Supercomputing Center developed what they describe as the first large-scale atlas of female reproductive system ageing, using artificial intelligence.

The team combined 1,112 tissue images from 659 samples, covering 304 women aged 20 to 70, with gene expression data from thousands of genes.

This allowed them to reconstruct how seven key reproductive organs, including the uterus, ovary, vagina, cervix, breast and fallopian tubes, age over time.

The study used the supercomputing power of MareNostrum 5 together with advanced image-recognition methods to process the data.

Using deep learning techniques, the researchers detected visible tissue changes as well as the underlying molecular processes linked to ageing in each organ.

The result was a detailed, organ-by-organ map of the reproductive system’s ageing process.

The researchers found that not all organs age in the same way or at the same speed. The ovaries and vagina showed a more gradual ageing process that begins even before menopause officially starts.

By contrast, the uterus appeared to undergo more sudden changes around the time of menopause.

Even within a single organ, different tissues aged at different rates. In the uterus, for example, the mucosa, its inner lining, and the muscular layer did not change in sync. These tissues also appeared to be particularly sensitive to the hormonal and biological shifts associated with menopause.

Marta Melé, leader of the transcriptomics and functional genomics group at BSC and director of the study, said: “Our results show that it acts as a turning point that profoundly reorganises other organs and tissues of the reproductive system, and allows us to identify the genes and molecular processes that could be behind these changes.”

Building on the finding that organs age according to different patterns, co-first author Laura Ventura said the research “paves the way for personalised medicine where treatments are tailored to a woman’s specific molecular profile and the specific tissues showing the most age-related distress.”

The study also identified molecular signals linked to reproductive ageing that can be detected in blood samples from more than 21,441 women.

These biomarkers could allow doctors to monitor the condition of reproductive organs in a non-invasive way, potentially helping to anticipate risks such as pelvic floor complications without the need for biopsies.

According to the researchers, this could lead to simpler and more accessible clinical tools for tracking women’s health over time.

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Cancer

Ovarian cancer cases rising among younger adults, study finds

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Ovarian cancer cases are rising among younger adults in England, with bowel cancer showing a similar pattern, a new study suggests.

Researchers said excess weight is a key contributor, but is unlikely on its own to explain the pattern.

The authors wrote: “These patterns suggest that while similar risk factors across ages are likely, some cancers may have age-specific exposures, susceptibilities, or differences in screening and detection practices.”

They added: “Although overweight and obesity are linked to 10 of the 11 cancers evaluated and account for a substantial proportion of cancer cases, both BMI-attributable and BMI-non-attributable incidence rates have increased, though the latter more slowly, suggesting other contributors.”

The study analysed cancer incidence, meaning new diagnoses, in England between 2001 and 2019 across more than 20 cancer types, comparing adults aged 20 to 49 with those aged 50 and over.

Among younger women, cases of 16 out of 22 cancers increased significantly over the period, while among younger men, 11 out of 21 cancers increased significantly.

In particular, there was a significant rise in 11 cancers with known behavioural risk factors among adults under 50. These were thyroid, multiple myeloma, liver, kidney, gallbladder, bowel, pancreatic, endometrial, mouth, breast and ovarian cancers.

Rates of all 11 also rose significantly among adults aged 50 and over, with the notable exceptions of bowel and ovarian cancer.

Five cancers, endometrial, kidney, pancreatic, multiple myeloma and thyroid cancer, increased significantly faster in younger than in older women, while multiple myeloma increased faster in younger than in older men.

The researchers looked at established risk factors including smoking, alcohol intake, diet, physical inactivity and body mass index, a measure used to assess whether someone is underweight, a healthy weight, overweight or obese.

With the exception of mouth cancer, all 11 cancers were associated with obesity. Six, liver, bowel, mouth, pancreatic, kidney and ovarian, were also linked to smoking.

Four, liver, bowel, mouth and breast, were associated with alcohol intake. Three, bowel, breast and endometrial, were linked to physical inactivity, and one, bowel, was associated with dietary factors.

But apart from excess weight, trends in those risk factors over the past one to two decades were stable or improving among younger adults.

That suggests other factors may also play a part, including reproductive history, early-life or prenatal exposures, and changes in diagnosis and detection.

The study noted that red meat consumption fell among younger adults, while fibre intake remained stable or slightly improved in both sexes between 2009 and 2019, although more than 90 per cent of younger adults were still not eating enough fibre in 2018.

Established behavioural risk factors accounted for a substantial share of cancer cases.

Excess weight was the risk factor associated with most cancers in 2019, ranging from 5 per cent for ovarian cancer to 37 per cent for endometrial cancer.

The researchers said the findings were based on observational data, meaning the study could identify patterns but could not prove cause and effect.

They also noted there were no consistent long-term national data for several risk factors, that the analysis was limited to England rather than the UK, and that cancer remains far more common overall in older adults despite the rise in cases among younger people.

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