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Astellas Pharma Inc. - ALPMY STOCK NEWS

Welcome to our dedicated news page for Astellas Pharma (Ticker: ALPMY), a resource for investors and traders seeking the latest updates and insights on Astellas Pharma.

Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect Astellas Pharma's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.

Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of Astellas Pharma's position in the market.

News
Astellas Submits Supplemental New Drug Application in Japan for PADCEV™ (enfortumab vedotin (genetical recombination)) with KEYTRUDA® (pembrolizumab (genetical recombination)) for First-Line Treatment of Advanced Bladder Cancer
Rhea-AI Summary
Astellas Pharma Inc. submits a Supplemental New Drug Application for PADCEV with KEYTRUDA as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer in Japan. The pivotal Phase 3 trial found that the combination significantly extended overall and progression-free survival compared to platinum-containing chemotherapy. If approved, this combination would offer an alternative to the current standard of care in first-line urothelial cancer treatment. The submission is based on results from the EV-302 clinical trial, showing improved survival and disease progression compared to chemotherapy. The safety results were consistent with previous reports, and the combination therapy is under review by the European Medicines Agency and has been approved by the U.S. FDA.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
0.26%
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Astellas Announces Strategic Collaboration with Mass General Brigham
Rhea-AI Summary
Astellas Pharma Inc. announces a strategic collaboration with Mass General Brigham to advance translational medicine and early development of novel therapies in oncology, rare disease, and cell and gene therapy. The alliance aims to accelerate innovation, translate research into clinical trials, leverage scientific and clinical expertise, and enhance patient care. Mass General Brigham is a leading academic medical center in the US with extensive research in oncology, rare disease, and cell and gene therapy.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
0.26%
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none
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News
Astellas Provides Update on Zolbetuximab Biologics License Application in U.S.
Rhea-AI Summary
Astellas Pharma Inc. (TSE: 4503) receives a complete response letter from the FDA regarding the Biologics License Application for zolbetuximab, an investigational agent for the treatment of patients with advanced gastric or GEJ cancer. The FDA cannot approve the BLA due to unresolved deficiencies in a third-party manufacturing facility. No concerns were raised about the clinical data, and Astellas is working to resolve the feedback. The impact on financial results is expected to be limited.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-1.93%
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none
News
Elpiscience and Astellas Enter into Research Collaboration and License Agreement for Novel Bispecific Macrophage Engager
Rhea-AI Summary
Elpiscience Biopharma, Ltd. (Ticker: -) and Astellas Pharma Inc. (Ticker: 4503) have announced a research collaboration and license agreement for novel bi-specific macrophage engagers, ES019 and another program. Elpiscience will receive up to US $37 million, including the upfront payment and license option fees, and is eligible to potentially receive more than US $1.7 billion in payments for the achievement of future development, regulatory, and commercial milestones. The collaboration aims to develop next-generation immuno-oncology therapies utilizing Elpiscience's Bispecific Macrophage Engager Platform (BiME®) to modulate tumor-associated macrophages and reprogram the tumor microenvironment status, offering new options for cancer patients who do not respond to existing cancer immunotherapies.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
2.81%
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News
Astellas Completes Acquisition of Propella Therapeutics
Rhea-AI Summary
Astellas Pharma Inc. (TSE: 4503) has completed the acquisition of Propella Therapeutics, Inc., making it a wholly owned subsidiary. The acquisition gives Astellas access to PRL-02, a next-generation androgen biosynthesis inhibitor for prostate cancer. The company paid approximately US $175 million for the acquisition, with limited financial impact expected for the fiscal year ending March 31, 2024.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
0.86%
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acquisition
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News
EMA Recommends Arpraziquantel for Treatment of Schistosomiasis in Preschool-Aged Children
Rhea-AI Summary
Astellas Pharma Inc. (TSE: 4503) contributed to the development of a pediatric formulation to treat schistosomiasis as a member of the Pediatric Praziquantel Consortium. The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive scientific opinion for arpraziquantel to treat schistosomiasis in preschool-aged children. Astellas provided its innovative formulation technology to co-develop arpraziquantel as a member of the Consortium. The new pediatric formulation of arpraziquantel is palatable for very young children and is administered via a 150 mg dispersible tablet. Astellas has set a Strategic Goal to deepen its engagement in sustainability, and the positive CHMP scientific opinion represents a significant milestone in alignment with Astellas' Access to Health focus.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
0.53%
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Astellas and MBC BioLabs Announce 2023 Future Innovator Prize Awarded to TippingPoint Biosciences and Altay Therapeutics
Rhea-AI Summary
Astellas Pharma Inc. (TSE: 4503) and Mission BioCapital BioLabs announced TippingPoint Biosciences and Altay Therapeutics as winners of the Astellas-sponsored 'Future Innovator Prize' at MBC BioLabs. The award provides one-year priority usage of MBC BioLabs' lab facility, access to Astellas' research capabilities, and business leaders' expertise to accelerate early research efforts.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
0.69%
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News
Astellas' VEOZA™ (fezolinetant) Approved by European Commission for Treatment of Vasomotor Symptoms Associated with Menopause
Rhea-AI Summary
Astellas Pharma Inc. (TSE: 4503) has announced the approval of VEOZATM (fezolinetant) 45 mg once daily by the European Commission for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS, also known as hot flashes and/or night sweats, affect more than half of women aged 40 to 64 years, with rates in Europe ranging from 56% to 97%. The prevalence of moderate to severe VMS in postmenopausal women in Europe has been reported at 40%. The approval follows positive clinical trial results from the BRIGHT SKY™ program, with fezolinetant demonstrating efficacy and safety for the treatment of VMS. Astellas has already reflected the impact from this matter in its financial forecast of the current fiscal year ending March 31, 2024.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-0.67%
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News
Astellas' Fezolinetant Reduces Frequency and Severity of VMS Associated with Menopause in Women Considered Unsuitable for Hormone Therapy
Rhea-AI Summary
Astellas Pharma Inc. (TSE: 4503) will present 24-week results from the Phase 3b DAYLIGHT clinical trial examining the efficacy and safety of fezolinetant, an investigational oral, nonhormonal compound for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause in women unsuitable for hormone therapy. The study of over 450 women met all primary and secondary endpoints at 24 weeks, demonstrating statistically significant reductions in the frequency and severity of VMS, as well as patient-reported sleep disturbance. Treatment-emergent adverse events were reported by 65% of patients in the fezolinetant group compared to 61% in the placebo group.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
0.5%
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none
News
Pfizer and Astellas' XTANDI® Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting
Rhea-AI Summary
PFE and Astellas Pharma Inc. (4503) announced that the FDA approved a supplemental New Drug Application for XTANDI, making it the first and only androgen receptor signaling inhibitor approved for nonmetastatic castration-sensitive prostate cancer treatment with or without a GnRH analog therapy. This approval follows expedited development and review programs based on results from the Phase 3 EMBARK trial.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
3.2%
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Medicinal and Botanical Manufacturing
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Chuo Ku