ASTELLAS PHARMA UNSP/ADR - ALPMY STOCK NEWS

Astellas Pharma announced that the FDA is extending the PDUFA goal date for its investigational therapy, fezolinetant, by three months to May 22, 2023. This extension is intended to provide the FDA with additional time to complete its review of the drug, which targets moderate to severe vasomotor symptoms caused by menopause. Despite the extension, Astellas remains confident in the drug's clinical profile and potential benefits. The impact on the company's financial results for the current fiscal year, ending March 31, 2023, is expected to be minor. Fezolinetant is still under investigation, and regulatory approval is not guaranteed.

Astellas Pharma, based in Tokyo, has announced a commitment to achieve net zero greenhouse gas emissions by 2050. The company aims to reduce emissions in Scopes 1, 2, and 3 by 90% from 2015 levels and neutralize the remaining 10% emissions. This initiative has been accredited by the Science Based Targets initiative (SBTi) for its 2030 GHG emission reduction targets. CEO Kenji Yasukawa emphasized this commitment as part of their Corporate Strategic Plan, which focuses on sustainability and reducing environmental impact.

Astellas Pharma Inc. (TSE: 4503) announced leadership changes, appointing Naoki Okamura as the new President and CEO, effective April 1, 2023. This transition is part of the company’s strategic plans, aiming to accelerate growth following a revenue recovery since fiscal year 2020. The change comes as Astellas shifts from a specific disease focus to a broader Focus Area approach in drug development. Other management changes include Claus Zieler as Chief Commercial Officer and Adam Pearson as Chief Strategy Officer. The company emphasizes the need for adaptable leadership amid increasing geopolitical risks.

Astellas Pharma Inc. has entered an Asset Purchase Agreement with Sandoz AG to transfer worldwide rights for the antifungal agent MYCAMINE® (micafungin sodium). The agreement, signed on Jan. 23, 2023, aims to optimize Astellas' resource allocation for sustainable growth. The financial terms include an upfront payment ranging from US$ 62.5 million to 75 million and potential milestone payments based on sales. The transaction is expected to close in the first half of 2023, with MYCAMINE® generating sales of JPY 18.9 billion for the fiscal year ending March 31, 2022. Astellas will review the financial impacts of this transaction for the fiscal year ending March 31, 2023.

Astellas Pharma announced that the FDA lifted the clinical hold on the FORTIS Ph1/2 trial for AT845, an investigational treatment for late-onset Pompe disease (LOPD), as of January 19, 2023. This development allows the company to resume dosing in the trial, which aims to assess AT845's safety and efficacy. The trial's primary focus is on safety alongside the evaluation of muscle GAA protein expression. Astellas confirmed that the clinical hold lift will not affect its financial forecasts for the fiscal year ending March 31, 2023. The company remains committed to innovating therapies for patients with unmet medical needs.

Astellas Pharma Inc. (TSE: 4503) announced promising results from the Phase 3 SPOTLIGHT trial for zolbetuximab, a monoclonal antibody targeting Claudin 18.2 in patients with advanced gastric or gastroesophageal junction adenocarcinoma. The study showed a 24.9% risk reduction in progression or death with zolbetuximab plus mFOLFOX6 compared to placebo. Median progression-free survival was 10.61 months for the treatment group versus 8.67 months for placebo, while overall survival was significantly improved at 18.23 months versus 15.54 months. The findings were presented at the 2023 ASCO GI Cancers Symposium.

Astellas Pharma has announced that its greenhouse gas (GHG) emissions reduction targets have been validated by the Science Based Targets initiative (SBTi), aligning with the Paris Climate Agreement's 1.5°C target. The company aims to reduce absolute scope 1 and 2 GHG emissions by 63% and scope 3 emissions by 37.5% by FY2030, based on FY2015 levels. This initiative supports Astellas' commitment to sustainability outlined in its Corporate Strategic Plan 2021. CEO Kenji Yasukawa emphasized the importance of addressing climate change for sustainable growth.

Selecta Biosciences and Astellas Pharma have signed a licensing agreement for Xork, a next-generation IgG protease candidate aimed at enhancing the efficacy of Astellas’ AT845 gene therapy for Late-Onset Pompe Disease (LOPD). Selecta will receive a $10 million upfront payment and can earn up to $340 million in additional milestone payments, plus royalties on commercial sales. This collaboration aims to overcome patient eligibility issues in gene therapy trials due to pre-existing antibodies against AAV.

Twist Bioscience (NASDAQ: TWST) has announced a research collaboration with Astellas Pharma Inc to discover antibodies targeting diseases with high unmet medical needs. This partnership, following a successful initial collaboration, highlights Twist's antibody discovery capabilities through its Library of Libraries. Under the agreement, Twist will receive an upfront payment, project-specific research fees, and earn up to $11 million USD per product for clinical milestones, along with royalties on product sales. Astellas will handle product development and commercialization.