01/23/23 6:30 PMOTC : ALPMY Astellas Transfers MYCAMINE® Product WorldwideAstellas Pharma Inc. today announced that Astellas and Sandoz AG have entered into an Asset Purchase Agreement, under which Astellas will transfer the world wide product rights for antifungal agent MYCAMINE ®. The financial terms of asset purchase agreement will be recorded as a gain on divestiture of intangible assets. Schedule of Asset Purchase...RHEA-AIneutral
01/20/23 1:00 AMOTC : ALPMY clinical trialAstellas Announces Hold Lifted by FDA on FORTIS Clinical Trial of AT845 Investigational Treatment for Adult Patients with Late-Onset Pompe DiseaseAstellas Pharma Inc. today announced that the U.S. Food and Drug Administration has lifted the clinical hold on January 19 th for the FORTIS Ph1/2 clinical trial evaluating the safety, tolerability and efficacy of investigational AT845 in adults with late-onset Pompe disease. "With that same spirit and focus on patient safety, we look forward to resuming the...RHEA-AIneutral
01/19/23 10:00 AMOTC : ALPMY conferencesclinical trialAstellas to Present Positive Findings from Phase 3 SPOTLIGHT Trial of Zolbetuximab during 2023 ASCO GI Cancers SymposiumAstellas Pharma Inc. today will present detailed results from the Phase 3 SPOTLIGHT trial evaluating first-line treatment with zolbetuximab, an investigational first-in-class Claudin 18.2 targeted monoclonal antibody, plus mFOLFOX6 versus placebo plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or...RHEA-AIneutral
01/19/23 12:00 AMOTC : ALPMY Astellas Receives SBTi Approval for Revised Science-Based Climate Goals to Reduce Greenhouse Gas EmissionsAstellas Pharma Inc. today announced that the Science Based Targets initiative* 1 has validated and approved its greenhouse gas emissions reduction targets. The targets, as a science-based initiative, have been approved towards achieving the 1.5 degrees Celsius and well-below 2 degrees Celsius targets of the Paris Climate Agreement.RHEA-AIvery positive
01/09/23 7:30 AMOTC, Nasdaq : ALPMY, SELB Selecta Biosciences and Astellas Announce Exclusive Licensing and Development Agreement for Xork IgG ProteaseNext-generation IgG protease candidate Xork to be licensed for development with AT845, an investigational Astellas Gene Therapies' product, for the treatment of Pompe DiseaseSelecta to receive a $10M upfront payment and eligible to receive up to $340M for certain additional development andRHEA-AIneutral
01/09/23 7:00 AMNasdaq, OTC : TWST, ALPMY Twist Bioscience and Astellas Enter into Multitarget Antibody Discovery Research CollaborationTwist Bioscience Corporation, a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, today announced a research collaboration with Astellas Pharma Inc. to discover antibodies against multiple targets of interest to develop curative therapies for patients suffering from diseases that...RHEA-AIneutral
12/20/22 6:45 AMOTC, Nasdaq, NYSE : ALPMY, SGEN, MRK Astellas, Seagen and Merck Announce FDA Acceptance of Supplemental Biologics License Applications for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for the First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer– This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting –– FDA granted the applications Priority Review with a PDUFA date of April 21, 2023 –TOKYO, BOTHELL, Wash. and RAHWAY, N.J. , Dec. 20, 2022RHEA-AIneutral
12/20/22 6:45 AMNasdaq, NYSE, OTC : SGEN, MRK, ALPMY Seagen, Astellas and Merck Announce FDA Acceptance of sBLAs for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for the First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer. Seagen Inc., Astellas Pharma Inc. and Merck, known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration has accepted for Priority Review supplemental Biologics License Applications for PADCEV ® and...RHEA-AIneutral
12/15/22 6:30 PMOTC : ALPMY clinical trialAstellas Announces Zolbetuximab Meets Primary Endpoint in Phase 3 GLOW Trial as First-Line Treatment in Claudin 18.2 Positive, HER2-negative Locally Advanced Unresectable or Metastatic Gastric and Gastroesophageal Junction (GEJ) CancersAstellas' GLOW trial, the second Phase 3 trial in CLDN18.2 positive, HER2-negative locally advanced unresectable or metastatic gastric and GEJ cancers, meets primary endpoint for progression-free survival (PFS) and key secondary endpoint for overall survival (OS)GLOW results, along with SPOTLIGHTRHEA-AIneutral
12/13/22 6:00 PMOTC : ALPMY Astellas and MBC BioLabs Announce 2022 Future Innovator Prize Awarded to Bespoke Biotherapeutics and Cellinfinity BioAstellas Venture ManagementRHEA-AIvery positive