Astellas Pharma Inc

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Astellas Pharma, Inc. engages in the research, development, manufacture, import, and export of pharmaceutical products. Its products focus on therapeutic fields that include transplantation, immunology, infectious diseases, urology, oncology, neuroscience, diabetic complications, and metabolic diseases. The firm's global brands include Prograf, Vesicare, Protopic, Harnal, and Funguard. The company was founded by Kenji Yamanouchi in April 1923 and is headquartered in Tokyo, Japan.

First-in-class treatment option reduces number and intensity of hot flashes and night sweats  TOKYO , Dec. 10, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the European Commission (EC) on December 7 approved VEOZATM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.  VMS, also known as hot flashes and/or night sweats, are common symptoms of menopause.1,2 Worldwide, more than half of women 40 to 64 years of age experience VMS, with rates in Europe ranging from 56% to 97%.3,4,5 The prevalence of moderate to severe VMS in postmenopausal women in Europe has been reported at 40%.6 VMS can have a disruptive impact on women's daily activities and overall quality of life.2 Prof.

Astellas' VEOZA™ (fezolinetant) Approved by European Commission for Treatment of Vasomotor Symptoms Associated with Menopause

TORONTO & WALTHAM, Mass.--(BUSINESS WIRE)--Phenomic AI Inc. (“Phenomic”), a biotech company developing therapies for stroma-rich tumors using its scTx® single cell transcriptomics platform, has entered into a strategic research collaboration with Astellas Pharma Inc., “Astellas” through Xyphos Biosciences, Inc. (a wholly owned subsidiary of Astellas). For this collaboration, Phenomic and Astellas will explore the ability of antibodies, developed by Phenomic and directed at a novel target of the.

Phenomic Enters into Strategic Research Collaboration with Astellas for Solid Tumor Cell Therapies

Phase 3b DAYLIGHT study being presented at ESG 2023 demonstrated fezolinetant 45 mg achieved statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms due to menopause and patient-reported sleep disturbance at 24 weeks Women considered unsuitable included those with contraindications, who are averse to taking, have stopped taking or have conditions that suggest caution in using hormone therapy Results will support health technology assessment and reimbursement dossiers throughout Europe TOKYO , Nov. 29, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will present 24-week results from the Phase 3b DAYLIGHT clinical trial examining the efficacy and safety of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause in women considered unsuitable for hormone therapy, in an oral presentation on November 30 at the 15th Congress of the European Society of Gynecology in Amsterdam, The Netherlands (Abstract #12497). VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.

Astellas' Fezolinetant Reduces Frequency and Severity of VMS Associated with Menopause in Women Considered Unsuitable for Hormone Therapy

- Accelerating the development of the life science ecosystem centered on Tsukuba - - Promoting innovative drug discovery research using AI and digital technologies and creating new drug discovery startups - TOKYO and IBARAKI, Japan , Nov. 16, 2023 /PRNewswire/ -- University of Tsukuba (President: Kyosuke Nagata) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that they have signed a letter of confirmation regarding a strategic partnership to accelerate the digitalization of the drug discovery research field, as well as the development of the life science ecosystem in Tsukuba and Kashiwa-no-ha, and to further accelerate innovative drug discovery research and development. Under this agreement, the two parties will exchange information on and discuss: Promotion of drug discovery and other research, and creation of new startups through industry-academia collaboration between the two parties Utilization of cutting-edge research equipment, drug discovery-related data and research seeds mutually owned by the two parties Implementation of discussions and seminars to accelerate and develop collaborative research already conducted by the two parties Promotion of drug discovery research and creation of new startups through exchange and communication with third-party venture company innovators in residence at SakuLab™-Tsukuba*1 Based on this agreement, the University of Tsukuba will establish an office in Astellas' SakuLab™-Tsukuba for the Tsukuba Digital-Bio International Center*2, where they are participating as a lead organization.

University of Tsukuba and Astellas Confirm a Strategic Partnership

- Acquire PRL-02, prostate cancer treatment program being developed by Propella Therapeutics - TOKYO and PITTSBORO, N.C. , Nov. 15, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Propella Therapeutics, Inc. (President and CEO: William Moore, "Propella") today announced that Astellas, through a U.S. subsidiary, and Propella have entered into a merger agreement pursuant to which Astellas will acquire Propella.

Astellas to Acquire Propella Therapeutics

Preliminary data analysis on ventilator dependence and motor improvement are reported alongside overall safety findings TOKYO , Nov. 15, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that The Lancet Neurology published a preliminary data analysis from the ASPIRO trial, evaluating the safety and efficacy of investigational AT132 (resamirigene bilparvovec), an adeno-associated viral vector (AAV) gene replacement therapy designed to deliver a functional human MTM1 gene for the treatment of pediatric patients with X-linked myotubular myopathy (XLMTM). The AT132 IND and ASPIRO trial are currently on clinical hold.

Astellas Announces Data from ASPIRO Study in X-linked Myotubular Myopathy Published in The Lancet Neurology

Astellas Pharma Inc. (OTCPK:ALPMF) Q2 2023 Earnings Conference Call November 1, 2023 3:00 AM ET Company Participants Hiromitsu Ikeda - Corporate Head, Advocacy & Relations Atsushi Kitamura - Chief Financial Officer Naoki Okamura - Representative Director, President & Chief Executive Officer Yoshitsugu Shitaka - Chief Scientific Officer Tadaaki Taniguchi - Chief Medical Officer Claus Zieler - Chief Commercial Officer Conference Call Participants Hidemaru Yamaguchi - Citigroup Securities Kazuaki Hashiguchi - Daiwa Securities Shinichiro Muraoka - Morgan Stanley MUFJ Securities Seiji Wakao - JPMorgan Securities Akinori Ueda - Goldman Sachs Securities Shinya Tsuzuki - Mizuho Securities Hiromitsu Ikeda Thank you very much for joining Astellas Pharma Inc.'s FY 2023 Second Quarter Financial Results Announcement meeting out of a very busy schedule. I'm delighted to serve us as moderator today.

Astellas Pharma Inc. (ALPMF) Q2 2023 Earnings Call Transcript

Fezolinetant is an investigational nonhormonal treatment for vasomotor symptoms (VMS) associated with menopause More than half of women ages 40 to 64 worldwide experience VMS, with rates in Europe ranging from 56% to 97% 1 ,2,3 TOKYO , Oct. 13, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on October 12 adopted a positive opinion relating to the use of VEOZA™ (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.4 VMS, also known as hot flashes and/or night sweats, are common symptoms of menopause. 5 ,6   If approved by the European Commission (EC), fezolinetant will be a first-in-class, nonhormonal treatment option to reduce moderate to severe VMS associated with menopause.

Astellas Receives Positive CHMP Opinion for VEOZA™ (fezolinetant)

- Open Innovation Hub Named SakuLabTM-Tsukuba will open at the Astellas Tsukuba Research Center - TOKYO and BOSTON , Oct. 10, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and BioLabs Global, Inc. (Founder and CEO: Johannes Fruehauf, "BioLabs") and Mitsui Fudosan (TSE: 8801, President and CEO: Takashi Ueda, "Mitsui Fudosan") today announced that they have agreed on a tri-party memorandum of understanding to enhance the life science ecosystem in Tsukuba and Kashiwa-no-ha, Japan, world-renowned science hubs. With this agreement, the three companies will partner to advance SakuLabTM-Tsukuba, an open innovation hub launched by Astellas in October 2023, and embark on an exciting journey to accelerate open innovation and enhance the life science ecosystem in Tsukuba, Kashiwa-no-ha and the surrounding areas.

Astellas, BioLabs and Mitsui Fudosan Announce a Collaboration to Enhance the Life Science Ecosystems in Tsukuba and Kashiwa-no-ha, Japan

Awardees win a year of access to a prestigious life-science incubator in San Francisco, CA and to Astellas expertise to further their research Award helps biotech start-ups accelerate early drug discovery and research efforts TOKYO and SAN FRANCISCO , Sept. 18, 2023 /PRNewswire/ -- Astellas Venture Management LLC (President: William Watt, Ph.D.

Astellas Venture Management and MBC BioLabs Announce the 5th Annual Astellas Future Innovator Prize

CBRE Group

Farmers & Merchants Bancorp

ALPMY, CBRE and FMAO have been added to the Zacks Rank #5 (Strong Sell) List on September 18, 2023.

New Strong Sell Stocks for September18th

Pooled analyses from pivotal Phase 3 SKYLIGHT™ studies provide new insights into fezolinetant for the treatment of moderate to severe VMS due to menopause Additional presentations highlight real-world data on the prevalence and impact of VMS TOKYO , Sept. 18, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will share new pooled efficacy and safety analyses from the pivotal Phase 3 SKYLIGHT™ studies for VEOZAH™ (fezolinetant), its first-in-class treatment for moderate to severe vasomotor symptoms (VMS) due to menopause, during the 2023 Annual Meeting of The Menopause Society from September 27-30.

Astellas Highlights VEOZAH™ (fezolinetant) Data at the 2023 Annual Meeting of The Menopause Society

- Investment will build capabilities to supply the Astellas global market and accelerate the development and commercialisation of innovative medicines - TOKYO , Sept. 14, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced its intention to submit a planning application to build a new state-of-the-art facility, at an approximate cost of €330 million in Tralee, Co. Kerry.

Astellas to Invest more than €330 Million in a New State-of-the-Art Facility in Tralee, Co. Kerry. Ireland

Japan-based Astellas Pharma on Wednesday withdrew a lawsuit filed against the U.S. government, days after its prostate cancer drug was spared from the first list of drugs that will be subject to Medicare price negotiations.

Astellas withdraws lawsuit challenging Medicare drug price negotiation plans

Amgen

Bristol-Myers

Horizon Pharma

Johnson & Johnson

Eli Lilly

Merck

Novo Nordisk

Novartis

Major pharmaceutical companies including Johnson & Johnson NYSE: JNJ, Novartis AG NYSE: NVS, Bristol-Myers Squibb (NYSE: BMY), Merck & Co., Inc. NYSE: MRK, Eli Lilly & Co. NYSE: LLY and Amgen Inc. NASDAQ: AMGN were trading normally following news that their drugs would be subject to next year's Medicare price negotiations.

How Much Pain Will Lower Medicare Prices Cause for Pharma Stocks?

Basel, August 28, 2023 – Sandoz, a global leader in generic and biosimilar medicines, has successfully completed the acquisition of worldwide brand rights for leading systemic antifungal agent Mycamine ® (micafungin sodium, Funguard® in Japan) from Astellas.

Sandoz completes acquisition of leading antifungal agent Mycamine® from Astellas, reinforcing leading global anti-infectives portfolio

TOKYO and SAN FRANCISCO, Aug. 9, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and DivcoWest, a DivCore Capital Company, announced today plans for Astellas to open a new state-of-the-art life sciences facility at 441 Morgan Avenue, in the Cambridge Crossing (CX) neighborhood in Cambridge, Mass. This investment establishes a significant presence for Astellas in one of the world's premier life science innovation hubs, showcasing the company's commitment to expanding its R&D footprint in order to accelerate innovation and deliver VALUE to patients.

Astellas to Open New Life Sciences Facility in DivcoWest's Cambridge Crossing Neighborhood

Poseida Therapeutics

Poseida is a clinical-stage biotechnology company dedicated to advancing a new class of cancer cell therapy and gene therapy products using genetic engineering technologies Astellas to invest a total of $50 million to acquire approximately 8.8 % of Poseida and to receive a right of exclusive negotiation and first refusal for any potential partnering of P-MUC1C-ALLO1, an allogeneic CAR-T cell therapy product candidate for solid tumors Astellas will have the right to designate an observer on the Poseida Board of Directors and Poseida's scientific advisory board TOKYO and SAN DIEGO , Aug. 7, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Poseida Therapeutics, Inc. (NASDAQ: PSTX, CEO: Mark Gergen, "Poseida") today announced a strategic investment to support the advancement of Poseida's commitment to redefining cancer cell therapy. Under the terms of the transaction agreements, Astellas will invest a total of $50 million, including $25 million to acquire 8,333,333 shares of common stock of Poseida (approximately 8.8% of the outstanding common stock of Poseida) at $3.00 per share in a private placement and a one-time $25 million payment for a right of exclusive negotiation and first refusal to license one of Poseida's clinical stage programs: P-MUC1C-ALLO1, an allogeneic CAR-T cell therapy in development for multiple solid tumor indications.

Astellas and Poseida Therapeutics Announce Strategic Investment to Support Poseida's Commitment to Redefining Cancer Cell Therapy

TOKYO , July 31, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in China for these patients.

China's National Medical Products Administration Accepts Astellas' Biologics License Application for Zolbetuximab

TOKYO & KAWASAKI, Japan--(BUSINESS WIRE)-- #proteindegrader--PeptiDream and Astellas plan to combine PeptiDream's peptide discovery technology with Astellas' capabilities to discover next-gen protein degraders.

Astellas and PeptiDream Enter into Research Collaboration and License Agreement to Discover Novel Targeted Protein Degraders

TOKYO, EMERYVILLE, Calif. and COLUMBIA, Md.

Astellas and Eko Health Announce Agreement to Incorporate Next Generation Eko CORE 500™ Digital Stethoscope into Z1608, an Innovative Solution Under Development for Heart Failure Patients Built on Welldoc's Proven Digital Therapeutic Platform

TOKYO , July 13, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the European Medicines Agency (EMA) has accepted for regulatory review the company's marketing authorization application (MAA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Europe for these patients.

European Medicines Agency Accepts Astellas' Marketing Authorization Application for Zolbetuximab

IVERIC bio Inc

TOKYO and PARSIPPANY, N.J. , July 11, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that it has successfully completed the acquisition of IVERIC bio, Inc. (NASDAQ: ISEE, CEO: Glenn P. Sblendorio, "Iveric Bio") with respect to the announcement on April 30, 2023, through its indirect wholly-owned subsidiary Berry Merger Sub, Inc. (the "Acquisition"). The Acquisition was completed on July 11, 2023, US Eastern Time, as follows, and Iveric Bio has become Astellas' wholly-owned subsidiary.

Astellas Completes Acquisition of Iveric Bio

If approved, the investigational therapy would offer a new treatment option for patients with advanced gastric and gastroesophageal cancers TOKYO , July 6, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company's Biologics License Application (BLA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in the U.S. for these patients.

Astellas Announces U.S. FDA Grants Priority Review for Zolbetuximab Biologics License Application

TOKYO, June 29, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Mitsui Fudosan Co., Ltd. (TSE: 8801, President and CEO: Takashi Ueda, "Mitsui Fudosan") announced today that Astellas will establish a "TME imaging and interactive research for innovation (TME iLab)" open innovation hub in October, 2023 in "MITSUI LINK-Lab KASHIWA-NO-HA 1" (Kashiwa City, Chiba Prefecture, "the Lab") operated by Mitsui Fudosan.

Astellas Establishes Open Innovation Hub for Tumor Microenvironment Research with Cutting-Edge Spatial Biology, in Mitsui Fudosan's "MITSUI LINK-Lab KASHIWA-NO-HA 1"

News for Astellas Pharma Inc Stock (ALPMY)