This biweekly Women’s Health video recap  covers a range of developments, including regulatory updates, clinical progress, data releases, and strategic partnerships. Key themes include advancements in treatment options and ongoing clinical trials for various conditions.

🎯 Watch Our Video Summary Capturing Top Women’s Health News from the Last Two Weeks

Dive deeper

📚 View the full Women’s health archive on our research hub page.

Top Stories Covered in This Video

Chapters

0:00 Introduction
0:08 Saphnelo (anifrolumab) SC Formulation Receives CRL from FDA
0:43 Lundbeck’s Bocunebart Shows Positive Results in Phase IIb Migraine Study
1:10 Fenebrutinib Reduces Disability Progression in PPMS
1:38 Bone-Viva Shows Potential for Improving Bone Mineral Density
2:09 Kisqali® Receives Positive Draft Recommendation in Canada
2:34 Datroway NDA Submitted in Japan for Metastatic TNBC
3:02 Merck’s KEYTRUDA® and KEYTRUDA QLEX™ Approved for Ovarian Cancer
3:27 Menstrual Blood Test Shows Promise for Cervical Cancer Screening
3:52 How to reach us

Transcript

Welcome to the latest edition of Women’s Health Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.

AstraZeneca’s Saphnelo (anifrolumab) subcutaneous formulation has received a complete response letter (CRL) from the FDA regarding its Biologics License Application (BLA) for systemic lupus erythematosus (SLE). While the intravenous formulation remains available, AstraZeneca plans to resubmit the application with additional information, although approval for the subcutaneous formulation has been delayed. The company continues to collaborate with the FDA to address the CRL and progress the application.

In migraine treatment, Lundbeck’s bocunebart (Lu AG09222), a novel anti-PACAP monoclonal antibody, showed positive results in a Phase IIb trial. The drug met its primary endpoint by significantly reducing monthly migraine days in patients with past treatment failures. These results suggest that bocunebart could offer a valuable treatment option for patients with severe, treatment-resistant migraines.

Roche’s fenebrutinib, an oral BTK inhibitor, has demonstrated a 12% reduction in disability progression in primary progressive multiple sclerosis (PPMS) compared to OCREVUS in a clinical trial. This positions fenebrutinib as a potential first-in-class oral treatment for PPMS, offering a promising new option for patients with this challenging form of multiple sclerosis.

Bone-Viva, a nutraceutical aimed at improving bone health, has shown potential in stabilizing and improving bone mineral density (BMD) in women with osteoporosis and osteopenia. The formulation demonstrated significant improvements in BMD, particularly when used in conjunction with established pharmaceutical therapies. Bone-Viva may offer a natural, adjunctive option for women at risk for fractures due to low bone mass.

In Canada, Kisqali® (ribociclib) has received a positive draft recommendation from the country’s drug agency for use in high-risk early breast cancer patients. This recommendation focuses on the treatment of HR-positive, HER2-negative breast cancer, and if approved, Kisqali® could become a key treatment to help prevent recurrence in this high-risk patient population.

In Japan, Daiichi Sankyo has submitted a supplemental New Drug Application (NDA) for Datroway (datopotamab deruxtecan) as a first-line treatment for metastatic triple-negative breast cancer (TNBC). The drug has shown improved survival outcomes compared to chemotherapy in Phase 3 trials, and its potential approval in Japan would provide a new treatment option for TNBC patients, particularly those who cannot undergo immunotherapy.

Merck has received FDA approval for both KEYTRUDA® and KEYTRUDA QLEX™ for the treatment of platinum-resistant ovarian cancer in patients with PD-L1-positive tumors. These approvals provide new treatment options for patients with limited choices in managing platinum-resistant ovarian cancer, potentially improving survival and disease progression.

A promising study suggests that menstrual blood collected via a sanitary pad could serve as a non-invasive alternative for cervical cancer screening. The test was found to be highly sensitive in detecting HPV, the virus responsible for cervical cancer, offering a potentially more accessible screening option, especially for women who may not regularly attend clinical screenings.

Stay ahead in Women’s Health research! Like, share, and subscribe for our updates. Visit www.lqventures.com or email us at info@lqventures.com for expert healthcare consulting. See you next time!

Why It Matters

  • Saphnelo’s delay highlights regulatory challenges in lupus treatment, though resubmission offers hope for a quick resolution [1].
  • Bocunebart’s success in treating severe migraines could provide relief to patients who are unresponsive to existing therapies [2].
  • Fenebrutinib’s Phase III results could reshape PPMS treatment, providing an oral option for patients with limited current choices [3].
  • Bone-Viva’s promising data suggests a new nutraceutical option for improving bone health, addressing the needs of women with osteoporosis [4].
  • Kisqali’s draft recommendation in Canada underscores the growing importance of targeted therapies in early-stage breast cancer prevention [5].
  • Datroway’s NDA submission in Japan could lead to a new treatment for metastatic TNBC, particularly for those who cannot use immunotherapy [6].
  • Merck’s approval of KEYTRUDA marks a significant advancement for ovarian cancer treatment, particularly for those with platinum-resistant disease [7].
  • Menstrual blood test for cervical cancer provides a potential alternative that could make screening more convenient and accessible for women [8].

🚀 Accelerate your success. Contact us now

📂 Explore our case studies. See examples of our work.

💡 Read our insights. Learn from our latest reports and analysis

🎬 Watch on YouTube. Subscribe and never miss a video.

🧰 See our full range of servicesDiscover how we can help you.

📚 View the full Women’s health archive on our research hub page.

FAQ

What is the impact of Saphnelo’s FDA CRL?

The CRL for Saphnelo’s SC formulation delays its approval, but AstraZeneca plans to resubmit the necessary data [1].

What does Lundbeck’s bocunebart trial mean for migraine treatment?

Bocunebart’s success in reducing migraine frequency could offer a new solution for patients with severe, treatment-resistant migraines [2].

How does Fenebrutinib impact PPMS?

Fenebrutinib demonstrated a 12% reduction in disability progression compared to OCREVUS, offering an oral treatment option for PPMS patients [3].

What’s new with Bone-Viva in osteoporosis treatment?

Bone-Viva, a nutraceutical, showed positive results in improving bone mineral density, especially when combined with traditional therapies [4].

What is Kisqali’s role in breast cancer?

Kisqali has received a positive draft recommendation in Canada for use in high-risk early breast cancer patients, offering new hope for recurrence prevention [5].

What is Datroway’s significance in TNBC?

Datroway’s NDA submission in Japan could lead to a new treatment for metastatic TNBC, particularly for those who cannot use immunotherapy [6].

Entities / Keywords

Saphnelo, bocunebart, Fenebrutinib, Bone-Viva, Kisqali, Datroway, KEYTRUDA, cervical cancer, menstrual blood test, TNBC, lupus, migraine, PPMS, ovarian cancer, Japan, Canada.

References

https://www.astrazeneca.com/media-centre/press-releases/2026/update-on-saphnelo-subcutaneous-administration.html

https://news.cision.com/h–lundbeck-a-s/r/lundbeck-announces-positive-phase-iib-top-line-results-with-bocunebart–lu-ag09222–anti-pacap-mab–,c4307114

https://www.roche.com/media/releases/med-cor-2026-02-07

https://www.prnewswire.com/news-releases/new-research-published-in-the-european-journal-of-medicine-shows-promising-results-for-women-with-osteoporosis-and-osteopenia-302684652.html

https://www.newswire.ca/news-releases/kisqali-r-receives-positive-draft-recommendation-from-canada-s-drug-agency-for-all-eligible-early-breast-cancer-patients-at-high-risk-of-recurrence-887512966.html

https://www.daiichisankyo.com/files/news/pressrelease/pdf/202602/20260212_E.pdf

https://www.merck.com/news/keytruda-pembrolizumab-and-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-plus-paclitaxel-%C2%B1-bevacizumab-approved-for-certain-adults-with-pd-l1-cps-%E2%89%A51/

https://www.theguardian.com/society/2026/feb/06/menstrual-blood-test-alternative-cervical-screening-hpv

 

Privacy Preference Center