OTC Markets OTCPK - Delayed Quote ? USD Astellas Pharma Inc. (ALPMY) Follow Compare 11.47 -0.01 (-0.09%) At close: October 15 at 4:00 PM EDT All News Press Releases SEC Filings All SEC Filings Corporate Changes & Voting Matters Periodic Financial Reports Proxy Statements Tender Offer/Acquisition Reports Offering Registrations Astella’s iota receives FDA go-ahead for bladder implant trial Iota Biosciences's early feasibility study will test the device in patients with underactive bladder. Clinical Trials Arena ? yesterday ALPMY -0.09% GLDAF FDA Grants iota Biosciences IDE Approval for First-In-Human Early Feasibility Study with Implantable Bladder Device iota Biosciences, Inc., a wholly-owned subsidiary of Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) for an Early Feasibility Study (EFS). The EFS will evaluate the safety and feasibility of an investigational implantable device designed to deliver electrical stimulation directly to the bladder wall, inducing contractions that facilitate bladder PR Newswire ? 5 days ago ALPMF 0.00% ALPMY -0.09% Astellas to Present VEOZA? (fezolinetant) Data at IMS World Congress on Menopause Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") announced that VEOZA? (fezolinetant)*, its first-in-class treatment for moderate to severe vasomotor symptoms (VMS) associated with menopause, will be featured in four oral and two poster presentations during the International Menopause Society (IMS) 19th World Congress on Menopause in Melbourne, Australia, October 19-22. VMS, also known as hot flashes and/or night sweats, are common symptoms of menopause.1,2 PR Newswire ? 6 days ago ALPMF 0.00% ALPMY -0.09% Protein prediction wins chemistry Nobel; Alnylam submits an all-important drug application AlphaFold’s developers were awarded science’s top prize. Elsewhere, J&J is shuttering an intriguing cancer study and Alnylam is asking for approval of a drug that could rival a Pfizer blockbuster. BioPharma Dive ? 6 days ago ALNY JNJ ALPMY -0.09% Astellas and AviadoBio Announce Exclusive Option and License Agreement for Gene Therapy AVB-101 Targeting Frontotemporal Dementia and Other Indications AviadoBio Ltd. ("AviadoBio") and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced an exclusive option and license agreement for AVB-101, an investigational, AAV-based gene therapy in Phase 1/2 development for patients with frontotemporal dementia with progranulin mutations (FTD-GRN). PR Newswire ? 7 days ago ALPMF 0.00% ALPMY -0.09% Are Investors Undervaluing Astellas Pharma (ALPMY) Right Now? Here at Zacks, our focus is on the proven Zacks Rank system, which emphasizes earnings estimates and estimate revisions to find great stocks. Nevertheless, we are always paying attention to the latest value, growth, and momentum trends to underscore strong picks. Zacks ? 13 days ago ALPMY -0.09% Japan's Ministry of Health, Labour and Welfare Approves PADCEV? (enfortumab vedotin) with KEYTRUDA? (pembrolizumab) for First-Line Treatment of Radically Unresectable Urothelial Carcinoma Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved PADCEV? (enfortumab vedotin [genetical recombination]) with MSD's KEYTRUDA? (pembrolizumab [genetical recombination]) as a combination therapy for the first-line treatment of adult patients with radically unresectable urothelial carcinoma. This is the first approved combination treatment for radically unresectable urothelial cancer PR Newswire ? 22 days ago ALPMF 0.00% ALPMY -0.09% Astellas Receives Approval from the European Commission for VYLOY? (zolbetuximab) in Combination with Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the European Commission (EC) has approved VYLOY? (zolbetuximab) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive. The PR Newswire ? 25 days ago ALPMF 0.00% ALPMY -0.09% FDA lists Astellas’ digital health solution for heart failure management DIGITIVA combines a digital stethoscope with a smartphone app and is designed for heart failure patients. Medical Device Network ? 27 days ago ALPMY -0.09% Astellas Announces FDA Listing of DIGITIVA? for the Management of Heart Failure Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that DIGITIVA?, a non-invasive digital health solution for heart failure management, has been listed with the U.S. Food and Drug Administration (FDA). DIGITIVA is classified as a Class I Software as a Medical Device (SaMD) and is exempt from 510(k) premarket submission. DIGITIVA is the first digital health offering from Astellas in the U.S. PR Newswire ? 27 days ago ALPMF 0.00% ALPMY -0.09% Astellas Presents Scientific Progress in Advanced and Hard-to-Treat Cancers at ESMO 2024 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will highlight new data from across its approved and investigational cancer therapies during the 2024 European Society for Medical Oncology (ESMO) Congress being held in Barcelona, Spain on 13-17 September. Eight abstracts across a broad range of cancer types will be presented, reinforcing Astellas' commitment to making a meaningful difference to people living with advanced and hard-to-treat cancers. Six abstracts inc PR Newswire ? last month ALPMF 0.00% ALPMY -0.09% Astellas Unveils New Life Sciences Center in Cambridge, Massachusetts to Accelerate the Discovery of Breakthrough Therapies Today, Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") officially opened its new Astellas Life Sciences Center (ALSC) in Cambridge, Mass., which will accelerate the company's efforts to create an innovation network across the state, connecting leading incubators, ambitious biotechnology start-ups and academia to foster the discovery and development of potential breakthrough therapies in areas of significant medical need. PR Newswire ? last month ALPMF 0.00% ALPMY -0.09% Astellas to Present VEOZAH? (fezolinetant) Data at 2024 Annual Meeting of The Menopause Society Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") announced that VEOZAH? (fezolinetant), its first-in-class treatment for moderate to severe vasomotor symptoms (VMS) due to menopause, will be featured in four oral presentations during the 2024 Annual Meeting of The Menopause Society (TMS) September 10-14 in Chicago. VMS, also known as hot flashes and/or night sweats, are common symptoms of menopause.1,2 PR Newswire ? last month ALPMF 0.00% ALPMY -0.09% EC approves Astellas’ PADCEV for urothelial cancer The regimen is intended for adults with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy. Pharmaceutical Technology ? last month ALPMY -0.09% European Commission Approves Astellas' PADCEV? (enfortumab vedotin) in Combination with KEYTRUDA? (pembrolizumab) for First-Line Treatment of Advanced Urothelial Cancer Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the European Commission has granted Marketing Authorization for PADCEV? (enfortumab vedotin, an antibody-drug conjugate [ADC]) in combination with KEYTRUDA? (pembrolizumab, a PD-1 inhibitor) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy. PR Newswire ? last month ALPMF 0.00% ALPMY -0.09% Astellas Initiates Phase 3 Clinical Study of Fezolinetant for VMS in Women with Breast Cancer Receiving Adjuvant Endocrine Therapy Astellas Pharma Inc. (TSE: 4503), President and CEO: Naoki Okamura, "Astellas"), the parent company of Astellas Pharma Canada, Inc., today announced dosing of the first patient in the HIGHLIGHT 1? Phase 3 pivotal study for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) in women with breast cancer receiving adjuvant endocrine therapy. CNW Group ? last month ALPMF 0.00% ALPMY -0.09% NMPA approves Astellas’ PADCEV for advanced urothelial cancer The drug binds to cancer cells, internalising and then releasing a cytotoxic agent, leading to cell death. Pharmaceutical Technology ? last month ALPMY -0.09% China's National Medical Products Administration (NMPA) Approves PADCEV? (enfortumab vedotin) for Treatment of Locally Advanced or Metastatic Urothelial Cancer Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") today announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved PADCEV? (enfortumab vedotin) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) after prior treatment with platinum-containing chemotherapy and programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors. PR Newswire ? last month ALPMF 0.00% ALPMY -0.09% Astellas Pharma and Frequency Therapeutics collaborate on hearing loss therapy Astellas Pharma recently announced that it had entered into an agreement with Frequency Therapeutics to co-develop and commercialise FX-322, a regenerative therapy to treat hearing loss. Medical Device Network ? 2 months ago ALPMY -0.09% Astellas Receives Positive CHMP Opinion for Zolbetuximab in Combination with Chemotherapy for Treatment of Advanced Gastric and Gastroesophageal Junction Cancer Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that on July 26, 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of zolbetuximab in the European Union. Zolbetuximab, a first-in-class claudin (CLDN) 18.2-targeted monoclonal antibody, is recommended in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line tre PR Newswire ? 2 months ago ALPMF 0.00% ALPMY -0.09% Performance Overview Trailing total returns as of 10/16/2024, which may include dividends or other distributions. Benchmark is Nikkei 225 Return ALPMY Nikkei 225 YTD -3.61% +17.08% 1-Year -12.04% +23.76% 3-Year -34.64% +34.79%
