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.

Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers TOKYO , June 9, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the submission of a New Drug Application (NDA) on June 9, 2023 to Japan's Ministry of Health, Labour and Welfare (MHLW) 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 Japan for these patients.

Astellas Submits New Drug Application for Zolbetuximab in Japan

KT430 is a preclinical, next-generation investigational gene therapy to treat X-linked myotubular myopathy (XLMTM) TOKYO and SAN DIEGO , June 8, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas"), and Kate Therapeutics ("KateTx") today announced an exclusive license agreement to develop and commercialize KT430. KT430 is a preclinical next-generation investigational gene therapy that delivers a functional copy of the MTM1 gene via a novel MyoAAV capsid to treat X-linked myotubular myopathy (XLMTM), a serious, life-threatening, rare neuromuscular disease characterized by extreme muscle weakness, respiratory failure and early death.

Astellas and Kate Therapeutics Announce Exclusive License Agreement for KT430

TOKYO , May 25, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that it has committed to supporting the 3rd phase of the Global Health Innovative Technology Fund (GHIT Fund), together with a cross-sector group of funding partners. The cross-sector group has committed over US$200 million to the GHIT Fund.

Astellas Announces Commitments to 3rd Phase of GHIT Fund Replenishment

HDFC Bank Limited

Nintendo

You have probably seen coverage of a renewed interest in Japanese stocks among well-known investors, including Berkshire Hathaway BRK.B, -0.57% CEO Warren Buffett. But Krishna Mohanraj, who runs a highly rated international fund for Diamond Hill Capital Management, prefers a company-specific approach over a geographic focus.

You can't rely on indexes to pick international stocks, this 5-star fund manager says. Here are 3 of his top selections.

- Conduct collaborative research on Sony's unique polymeric materials to achieve high-DAR ADC - TOKYO , May 16, 2023 /PRNewswire/ -- Sony Corporation (President and CEO: Kimio Maki, "Sony") and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that they have entered into a collaborative research agreement to discover a novel Antibody-Drug Conjugate (ADC)*1 platform in oncology based on Sony's unique polymeric material, "KIRAVIA™*2 Backbone*3." ADC is expected to selectively deliver anti-cancer drugs to target cells, thereby increasing efficacy and reducing side effects caused by anti-cancer drugs attacking normal cells.

Sony and Astellas Enter into Collaborative Research Agreement to Discover a Novel ADC Platform for the Oncology Field

VEOZAH is first-in-class treatment option to reduce the frequency and severity of moderate to severe VMS due to menopause TOKYO, May 12, 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 approved VEOZAHTM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause1 on May 12. VEOZAH is the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat VMS due to menopause.

Astellas' VEOZAH™ (fezolinetant) Approved by U.S. FDA for Treatment of Vasomotor Symptoms Due to Menopause

Foreign investors and businesspeople with exposure to China are becoming increasingly unnerved. And for good reason.

Foreign businesses in China fear they're being targeted in a ‘campaign' of government crackdowns. It's probably not that simple.

IVERIC bio Inc

Iveric Bio Inc shares climbed 16% to $38.01 on Monday after the US drugmaker agreed to be acquired by Japan's Astellas Pharma for $40 per share in cash or total consideration of about $5.9 billion.   Iveric's primary asset is avacincaptad pegol (ACP) which is currently in trials for treating geographic atrophy, the advanced stage of macular degeneration, a common cause of vision loss in the elderly.

Iveric Bio stock surges on Astellas Pharma takeover deal

Astellas Pharma snapped up Iveric Bio for $5.9 billion in cash, the companies said Monday in an announcement that sent ISEE stock flying. The post Biotech Buying Bonanza: Iveric Bio Snags $5.9 Billion Deal From Astellas Pharma appeared first on Investor's Business Daily.

Biotech Buying Bonanza: Iveric Bio Snags $5.9 Billion Deal From Astellas Pharma

Japan's Astellas agrees to pay $40 a share for Iveric, citing the potential of the biopharmaceutical company's ophthalmology programs.

Iveric Bio Stock Surges. It's Being Bought by Astellas for $5.9 Billion.

Astellas Pharma Inc. said Monday that it agreed to acquire Iveric bio Inc. for about $5.9 billion to strengthen its capabilities in the ophthalmology field.

Japan's Astellas Pharma to buy Iveric Bio in deal worth $5.9 billion

TOKYO & PARSIPPANY, N.J.--(BUSINESS WIRE)--Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and IVERIC Bio, Inc. (NASDAQ: ISEE, CEO: Glenn P. Sblendorio, “Iveric Bio”) today announced that on April 29, 2023 (Japan time), the Companies have entered into a definitive agreement under which Astellas through Berry Merger Sub, Inc., a wholly-owned subsidiary of Astellas US Holding, Inc., has agreed to acquire 100% of the outstanding shares of Iveric Bio for US$40.00 per.

Astellas Enters Into Definitive Agreement to Acquire Iveric Bio

TOKYO and PARSIPPANY, N.J., April 30, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Iveric bio, Inc. (NASDAQ: ISEE, CEO: Glenn P. Sblendorio, "Iveric Bio") today announced that on April 29, 2023 (Japan time), the Companies have entered into a definitive agreement under which Astellas through Berry Merger Sub, Inc., a wholly-owned subsidiary of Astellas US Holding, Inc., has agreed to acquire 100% of the outstanding shares of Iveric Bio for US$40.00 per share in cash for a total equity value of approximately US$5.9 billion (the "Acquisition"). In the Acquisition, Iveric Bio will become an indirectly wholly-owned subsidiary of Astellas.

Astellas Enters into Definitive Agreement to Acquire Iveric Bio

Astellas Pharma Inc. (OTCPK:ALPMF) Q4 2022 Results Conference Call April 27, 2023 3:00 AM ET Company Participants Hiromitsu Ikeda - Corporate Head, Advocacy and Relations Naoki Okamura - Representative Director, President and CEO Yoshitsugu Shitaka - Chief Scientific Officer Tadaaki Taniguchi - Chief Medical Officer Claus Zieler - Chief Commercial Officer Conference Call Participants Hidemaru Yamaguchi - Citi Group Kazuaki Hashiguchi - Daiwa Securities Shinichiro Muraoka - Morgan Stanley MUFG Securities Akinori Ueda - Goldman Sachs Securities Naomi Kumagai - Mitsubishi UFJ, Morgan Stanley Securities Seiji Wakao - JPMorgan Securities Kasumi Haruta - Credit Suisse Securities Motoya Kohtani - Nomura Securities Hiromitsu Ikeda Thank you very much for your participation on Astellas Earning Call for FY'22 Financial Results Ended March 31. I'm Ikeda, Corporate Advocacy & Relations.

Astellas Pharma Inc. (ALPMF) Q4 2022 Earnings Call Transcript

Zoetis

Investors interested in Medical - Drugs stocks are likely familiar with Astellas Pharma Inc. (ALPMY) and Zoetis (ZTS). But which of these two stocks presents investors with the better value opportunity right now?

ALPMY or ZTS: Which Is the Better Value Stock Right Now?

TOKYO, April 14, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that The Lancet published detailed data from the Phase 3 SPOTLIGHT trial evaluating first-line treatment with zolbetuximab, an investigational first-in-class Claudin 18.2 (CLDN18.2) targeted monoclonal antibody, plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) versus placebo plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study data was first published online on April 14 in The Lancet.[1] Initial results from SPOTLIGHT, which met its primary endpoint of progression-free survival (PFS) and a key secondary endpoint of overall survival (OS), were presented at the 2023 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium.

Results from Astellas' Phase 3 SPOTLIGHT Trial of Investigational Zolbetuximab Published in The Lancet

KYOTO, Japan and TOKYO , April 11, 2023 /PRNewswire/ -- The Center for iPS Cell Research and Application, Kyoto University (Director: Dr. Jun Takahashi; "CiRA") and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") entered into the second phase of a joint research agreement to further promote the utilization of differentiated cells and tissues derived from human induced pluripotent stem cells (iPS cells)*1 and to create innovative medical solutions.

CiRA, Kyoto University and Astellas Second Phase Joint Research Agreement Signed for Medical Applications of iPS Cells

TOKYO and COLUMBIA, Md., March 28, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that it has entered into an agreement ("the Agreement") with Roche Diabetes Care Japan Co., Ltd. (Country Manager: Noriko Hattori, "Roche Diabetes Care Japan") for the development and commercialization of Roche Diabetes Care's world-renowned Accu-Chek® Guide Me blood glucose monitoring system with advanced accuracy as a combined medical product with BlueStar®*1. BlueStar is an FDA-cleared digital health solution for diabetes patients, developed by Welldoc, Inc. (President, CEO: Kevin McRaith, "Welldoc") and is currently marketed in the U.S. and Canada. Astellas and Welldoc are jointly developing BlueStar in Japan. In the future, Astellas will aim to obtain regulatory approval and reimbursement as a combined medical product.

Astellas and Roche Diabetes Care Japan ink partnership agreement to develop and commercialize integrated diabetes self-management solution with BlueStar®

The arrest on suspicion of spying comes as Beijing seeks to reassure foreign executives that it is open for business, and follows a raid on Mintz Group.

China Detains Japanese Employee From Drugmaker Astellas

Treatment with fezolinetant resulted in statistically significant reductions in the frequency and severity of VMS and improvements in quality of life TOKYO , March 13, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced The Lancet published detailed results from the pivotal Phase 3 SKYLIGHT 1™ study of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause.

Results from Astellas' Pivotal Phase 3 SKYLIGHT 1™ Study of Fezolinetant for Vasomotor Symptoms Due to Menopause Published in The Lancet

XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) significantly delays time to PSA progression compared to placebo plus ADT Study enrolled 180 men with metastatic hormone-sensitive prostate cancer in mainland China TOKYO , March 13, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced positive topline results from the Phase 3 China ARCHES study of XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC) versus placebo plus ADT.

Astellas Announces Phase 3 China ARCHES Study of XTANDI® Meets Primary Endpoint

TOKYO and ROCKVILLE, Md. , March 9, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D.

Astellas and BMT CTN Announce Topline Results from Phase 3 MORPHO Trial of Gilteritinib

TOKYO , Feb. 19, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced the U.S. Food and Drug Administration (FDA) notified the company that it is extending the original priority review Prescription Drug User Fee Act (PDUFA) goal date for fezolinetant, an investigational agent for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause.

Astellas Provides Update on Fezolinetant New Drug Application in U.S.

TOKYO , Feb. 9, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced its commitment to achieve net zero greenhouse gas (GHG) emissions by 2050.

Astellas Commits to Achieve Net Zero Greenhouse Gas Emissions by 2050

Astellas Pharma Inc. (OTCPK:ALPMF) Q3 2022 Earnings Conference Call February 6, 2023 1:30 AM ET Company Participants Hiromitsu Ikeda - Corporate Head, Advocacy and Relations Kenji Yasukawa - President and Chief Executive Officer ( Naoki Okamura - Representative Director, Executive Vice President, Chief Strategy Officer Minoru Kikuoka - Chief Financial Officer Yukio Matsui - Chief Commercial Officer Yoshitsugu Shitaka - Chief Scientific Officer ( Tadaaki Taniguchi - Chief Medical Officer Conference Call Participants Fumiyoshi Sakai - Credit Suisse Hidemaru Yamaguchi - Citigroup Securities Kazuaki Hashiguchi - Daiwa Securities Motoya Koutani - Nomura Securities Shinichiro Muraoka - Morgan Stanley MUFG Securities Akinori Ueda - Goldman Sachs Securities Seiji Wakao - JPMorgan Hiromitsu Ikeda Everyone, thank you very much for your participation of this announcement of the Financial Result in the FY '22, Third Quarter. I'm Ikeda from Corporate, Advocacy and Relations, serving as the moderator for today.

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