Astellas Pharma Inc. - ALPMY STOCK NEWS

Astellas Pharma Inc. (TSE: 4503) has received a positive opinion from the CHMP recommending approval of PADCEV™ (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) for first-line treatment of advanced bladder cancer. This recommendation is based on the Phase 3 EV-302 clinical trial results, which showed the combination nearly doubled median overall survival compared to platinum-containing chemotherapy. The trial demonstrated a median OS of 31.5 months for the combination versus 16.1 months for chemotherapy, representing a 53% reduction in risk of death. If approved, this combination will be the first alternative to platinum-containing chemotherapy for unresectable or metastatic urothelial cancer. The European Commission will now review the positive opinion for potential approval in the EU and associated countries.

Astellas Pharma Inc. (TSE: 4503) and Osaka University have announced a research collaboration to develop an innovative pluripotent stem cell-derived cartilage organoid cell therapy for treating intervertebral disc degenerative disease. The partnership combines:

• Osaka University's cartilage tissue creation protocol
• Universal Cells' Universal Donor Cell (UDC) technology
• Astellas Institute for Regenerative Medicine's R&D expertise in cell therapy

This collaboration aims to create a cell therapy with reduced risk of immune rejection by genetically modifying Human Leukocyte Antigen (HLA) using gene editing technology. The partnership represents a significant step in open innovation using UDC technology to develop regenerative therapies for intervertebral disc degenerative disease.

Astellas Pharma announced that the FDA has acknowledged the resubmission of their Biologics License Application (BLA) for zolbetuximab, a CLDN18.2-targeted monoclonal antibody.

If approved, it will be the first therapy for patients with advanced gastric and gastroesophageal junction cancers in the U.S. The FDA has set a target action date of November 9, 2024. A previous FDA review in January 2024 highlighted third-party manufacturing issues, not clinical concerns.

The BLA is based on Phase 3 trials (SPOTLIGHT and GLOW), which showed that 38% of patients had CLDN18.2 positive tumors. Zolbetuximab was recently approved in Japan for similar indications. Financial expectations related to this acknowledgment have already been factored into Astellas' forecasts for the fiscal year ending March 31, 2025.

Astellas Pharma has signed a non-binding memorandum of understanding with YASKAWA Electric to explore creating an advanced cell therapy ecosystem by integrating pharmaceutical and robotics technologies. The collaboration aims to digitize cell manufacturing processes using YASKAWA's humanoid robot, Maholo. This technology could streamline research to commercialization, potentially offering a platform for startups and academia. Astellas will provide cell manufacturing technology and regulatory insights, while YASKAWA will contribute cutting-edge robotics. The financial impact on Astellas for the fiscal year ending March 31, 2025, is expected to be minor.

Astellas Pharma Inc. will present new research at the 2024 ASCO Annual Meeting showcasing scientific advancements in its oncology portfolio. The company will share data from pivotal trials across various hard-to-treat cancers like prostate, urothelial, and gastric/gastroesophageal junction cancers. Key highlights include Phase 3 trial data supporting enfortumab vedotin, final overall survival results from the SPOTLIGHT study on zolbetuximab, and post-hoc analyses of the EMBARK trial on enzalutamide. Astellas continues to focus on innovative therapies for cancer patients.

Astellas Pharma Inc. unveiled a new $90 million West Coast Innovation Center in the South San Francisco Biotech Corridor. The 154,000 square-foot lab and office facility serves as a central location for Astellas' West Coast cell and gene therapy research and business development operations. The center aims to enhance collaboration, productivity, and innovation to deliver innovative treatments and value to patients worldwide.

Astellas Pharma's XTANDI (Enzalutamide) receives European Commission approval for use in additional recurrent early prostate cancer treatment setting, making it the first novel hormone therapy available for high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer in the EU. The approval is based on positive Phase 3 EMBARK study results, showing XTANDI alone or in combination with leuprolide reduces the risk of metastasis or death. The European Association of Urology updated their treatment guidelines to include enzalutamide for men with high-risk BCR nmHSPC, filling a treatment gap in this patient population.

Takeda, Astellas, and Sumitomo Mitsui Banking have announced a master agreement to establish a joint venture company dedicated to the incubation of early drug discovery programs in Japan. The new company aims to advance innovative drug discovery programs, foster entrepreneurship, and create start-up companies to unleash the potential of the drug discovery ecosystem in Japan.

Astellas Pharma Inc. announces the acceptance of the sBLA for enfortumab vedotin with KEYTRUDA as a combination therapy for first-line treatment of urothelial cancer in China, potentially offering an alternative to platinum-containing chemotherapy. The pivotal trial results show significant improvements in overall and progression-free survival, potentially changing the treatment paradigm for this life-threatening condition.