Astellas Pharma - ALPMY STOCK NEWS

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.

Seagen, Astellas Pharma, and Merck announced the FDA's acceptance of supplemental Biologics License Applications for their combination therapy of PADCEV and KEYTRUDA, targeting locally advanced or metastatic urothelial cancer patients ineligible for cisplatin-based chemotherapy. The FDA granted the applications Priority Review, setting a PDUFA date of April 21, 2023. The combination therapy, previously designated as Breakthrough Therapy, is supported by clinical trial data. Continued research includes a phase 3 study to assess the treatment's efficacy and facilitate potential accelerated approval.

Astellas Pharma, Seagen, and Merck announced that the FDA has accepted their applications for Priority Review of PADCEV® and KEYTRUDA® in combination for treating locally advanced or metastatic urothelial cancer. This therapy aims to provide a new treatment option for patients who cannot receive cisplatin-based chemotherapy. The FDA set a PDUFA date of April 21, 2023, for potential accelerated approval. Supported by data from the EV-103 trial, the combination has shown promise, with additional studies ongoing to further evaluate its effectiveness.

Astellas Pharma's Phase 3 GLOW trial for zolbetuximab has successfully met its primary endpoint for progression-free survival (PFS) and secondary endpoint for overall survival (OS) in patients with CLDN18.2-positive, HER2-negative gastric and gastroesophageal junction (GEJ) cancers. The study, involving 507 patients, compared zolbetuximab plus CAPOX to placebo plus CAPOX. Treatment-emergent adverse events included nausea and vomiting. The results will be presented at a scientific congress and are expected to advance the development of zolbetuximab as a first-line treatment option.