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.

Astellas' investigational nonhormonal treatment meets all primary endpoints, significantly reducing the frequency and severity of vasomotor symptoms associated with menopause TOKYO , May 5, 2022 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") will present 12-week results from the pivotal Phase 3 SKYLIGHT 1™ 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 associated with menopause (VMS), on Sunday, May 8, 2022 at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting in San Diego.

Astellas to Present 12-Week Data from Pivotal Phase 3 SKYLIGHT 1™ Trial of Fezolinetant in Oral Session at the American College of Obstetricians and Gynecologists Annual Meeting

Astellas Pharma, Inc. (OTCPK:ALPMF) Q4 2022 Results Conference Call April 27, 2022 1:00 AM ET Company Participants Hiromitsu Ikeda - Corporate Head, Advocacy and Relations Kenji Yasukawa - President and CEO Bernie Zeiher - Chief Medical Officer Yukio Matsui - Chief Commercial Officer Minoru Kikuoka - CFO Conference Call Participants Hidemaru Yamaguchi - Citigroup Securities Kazuaki Hashiguchi - Daiwa Securities Shinichiro Muraoka - Morgan Stanley Securities Fumiyoshi Sakai - Credit Suisse Securities Motoya Kohtani - Nomura Securities Akinori Ueda - Goldman Sachs Securities Kenji Yasukawa Hello, everyone. I'm Kenji Yasukawa from Astellas Pharma, Inc. Thank you very much for joining our FY 2021 financial results announcement meeting out of your very busy schedule today.

Astellas Pharma, Inc. (ALPMF) CEO Kenji Yasukawa on Q4 2022 Results - Earnings Call Transcript

Astellas' MOONLIGHT 1TM clinical trial evaluating investigational fezolinetant 30 mg administered once daily TOKYO, March 14, 2022 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced topline results from the ongoing Phase 3 MOONLIGHT 1™ clinical trial investigating the efficacy and safety of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms associated with menopause (VMS), in women in Asia.

Astellas Announces Topline 12-week Results from Phase 3 Study of Fezolinetant for the Nonhormonal Treatment of Vasomotor Symptoms in Women in Asia

Astellas looks posed to exit a period of prolonged weak revenue growth and see acceleration into the mid-to-high single-digits on multiple product/indication approvals.

Astellas Worth A Look On Revenue Re-Acceleration Potential

Seagen

Seagen Inc (NASDAQ: SGEN) and Astellas Pharma Inc (OTC: ALPMF) announced the initial results from Cohort H of the EV-103 trial investigating PADCEV (enfortumab vedotin-ejfv) in muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy.  Data will be presented at the 2022 ASCO Genitourinary Cancers Symposium (ASCO GU).

Astellas Pharma - Seagen's Enfortumab Shows 36% Pathologic Complete Response In Bladder Cancer Patients

Japan's Ministry of Health, Labor, and Welfare (MHLW) has approved Astellas Pharma Inc's (OTC: ALPMF) Padcev (enfortumab vedotin) for radically unresectable urothelial carcinoma that has progressed after anti-cancer chemotherapy. Enfortumab vedotin is the first and only antibody-drug conjugate approved in Japan for patients with advanced urothelial cancer.

Astellas Pharma's Bladder Cancer Treatment Scores Approval In Japan

Astellas Pharma, Inc. (ALPMF) Q1 2022 Results - Earnings Call Transcript

Cytokinetics

Cytokinetics Inc (NASDAQ: CYTK) revealed in an SEC filing that Astellas Pharma Inc (OTCMKTS: ALPMY) is walking away from a pact to research and develop skeletal sarcomere activators for diseases associated with muscle weakness. Astellas had extended the research pact initially set to expire on December 31 last year, through March of this year.

Astellas Walks Away From $450M Research & Discovery Partnership With Cytokinetics

Astellas Pharma, Inc. (ALPMF) CEO Kenji Yasukawa on Q4 2021 Results - Earnings Call Transcript

In a financial notice posted earlier today, Astellas Pharma Inc (OTCMKTS: ALPMY) said it was taking an impairment loss of ¥58.8 billion ($540 million) because of last year's FDA clinical hold on Audentes' AT132, gene therapy X-linked myotubular myopathy (XLMTM), a rare muscle-wasting disorder that is usually evident at birth. Last year, Audentes told patient groups that an XLMTM patient had died after receiving AT132.

Astellas Takes $540M Impairment Charge Of $3B Audentes Buy­out On Gene Therapy Trial Hold

Astellas Pharma Plc (OTCMKTS: ALPMY) has reported positive topline results from two Phase 3 trials, SKYLIGHT 1 and SKYLIGHT 2, evaluating an oral non-hormonal compound, fezolinetant, for treating moderate to severe vasomotor symptoms (VMS), specifically hot flashes associated with menopause. Results showed that both trials met all four co-primary endpoints.

Astellas Pharma's Fezolinetant Topped Placebo For Reducing Severity Of Menopausal Hot Flash In Phase 3 Studies

SAN FRANCISCO--(BUSINESS WIRE)--Audentes Therapeutics, an Astellas genetic medicines company, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold for the ASPIRO clinical trial evaluating AT132 in patients with X-linked myotubular myopathy (XLMTM). XLMTM is a serious, life-threatening neuromuscular disease characterized by extreme muscle weakness, respiratory failure, and early death. “We are grateful for the efforts of our team and investigators who hav

Audentes Therapeutics Announces FDA Lifts Hold on ASPIRO Clinical Trial of AT132 for Treatment of X-Linked Myotubular Myopathy (XLMTM)

Shares more than doubled after the gene therapy company announced that it has accepted a buyout offer. Here are the key details.

Why Audentes Therapeutics Stock Is Skyrocketing Today

Gene therapy company Audentes Therapeutics Inc (NASDAQ: BOLD) announced a deal late Monday to be acquired by Japanese pharma company ASTELLAS PHARMA/ADR (OTC: ALPMY) for $60 per share, representing a 110% premium over Audentes' Monday closing price.

The Gene Therapy Names Moving On The Audentes Buyout Deal

Shares of Astellas Pharma Inc. rose about 1% in premarket trading after the Japanese drugmaker said Monday evening that it plans to acquire Audentes Therapeutics for $3 billion in cash.

Astellas bets $3 billion in gene therapy deal

Japanese company Astellas Pharma is acquiring gene therapy biotech company Audentes Therapeutics for $3 billion, the companies said late Monday.

This Gene Therapy Player Just Grabbed A $3 Billion Takeover Bid

Audentes Therapeutics, Inc. (BOLD) CEO Matt Patterson on Q3 2019 Results - Earnings Call Transcript

4 newborns diagnosed with XLMTM no longer require a ventilator after being treated with BOLD's AT-132.

Why Audentes' rAAV Gene Therapy Can Be A Game Changer

Audentes Therapeutics, Inc. (BOLD) CEO Matt Patterson on Q2 2019 Results - Earnings Call Transcript

Shares have risen by over 130% since my initial recommendation.

Audentes Therapeutics: Encouraging Progress In XLMTM, Pipeline Continues To Evolve

Audentes Therapeutics' (BOLD) CEO Matt Patterson on Q1 2019 Results - Earnings Call Transcript

News for Astellas Pharma Inc Stock (ALPMY)