Hot Japanese Stocks and Entertainment

  The FDA target action date (PDUFA date) is set for November 28, 2025 If approved, sibeprenlimab would offer patients a convenient single-dose prefilled syringe for subcutaneous injection every four weeks intended for at home self-administration Sibeprenlimab has Breakthrough Therapy designation based on favorable results from the Phase 2 (ENVISION) trial (NCT04287985) 26 May 2025 Monday -  Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) announce the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sibeprenlimab, an investigational monoclonal antibody that selectively inhibits the activity of APRIL ( A PR oliferation- I nducing L igand) in adults with immunoglobulin A nephropathy (IgAN). APRIL plays a key role in the pathogenesis of IgAN as explained by the 4-hit process, in which pathogenic galactose-deficient IgA (Gd-IgA1) is produced, lead...

DESTINY-Gastric05 Phase 3 Trial of ENHERTU® Initiated in Patients with Previously Untreated HER2 Positive Advanced Gastric Cancer Tokyo and Basking Ridge, NJ – (March 31, 2025) – The first patient has been dosed in the DESTINY-Gastric05 phase 3 trial evaluating ENHERTU® (trastuzumab deruxtecan) in combination with a fluoropyrimidine chemotherapy (5-FU or capecitabine) and Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) versus trastuzumab in combination with platinum-based chemotherapy (cisplatin plus 5-FU or oxaliplatin plus capecitabine) and pembrolizumab in previously untreated patients with unresectable, locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) cancer with PD-L1 CPS ≥1. An exploratory cohort of patients with PD-L1 CPS <1 will be randomized to either ENHERTU plus fluoropyrimidine or trastuzumab plus platinum-based chemotherapy. ENHERTU is a specifically engineered...

Company Profile Company Name: NPT CO.,LTD. Scheduled Listing Date: Thu Jan. 30, 2025 Market Section: TOKYO PRO Market Representative HARA Kenichiro, President Address of Main Office 3-5-7 Ariake, Koto-ku Tokyo, 135-0063 Tel. +81-3-6455-7150 Home Page: https://www.neopt.jp/ Date of Incorporation: Nov. 1, 2018 Description of Business: Clinical development of new drugs and treatments for personalized medicine Category of Industry: Pharmaceutical Ticker: 311A Income Statement (Profit & Loss   '000 yen)  

Company Profile Company Name: COSMOS CHOUZAI Pharmacy Co.,Ltd. Scheduled Listing Date: Wed Jan. 8, 2025 Market Section: TOKYO PRO Market Representative MATSUURA Hironori, President Address of Main Office 5-4-14 Meieki, Nakamura-ku, Nagoya-shi, Aichi, 450-0002 Tel. +81-52-561-2255 Home Page: https://www.cosmos-ph.co.jp/ Date of Incorporation: Dec. 3, 1999 Description of Business: Management of dispensing pharmacy, Wholesale of generic pharmaceuticals, Management of vocational school specialized in the national examination for pharmacists Category of Industry: Retail Trade Ticker: 309A  Income Statement (Profit & Loss   '000000 yen)  

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced that the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” has been launched in South Korea. LEQEMBI received the Ministry of Food and Drug Safety (MFDS) approval in May 2024 for treatment in adult patients with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD dementia (early AD). LEQEMBI selectively binds to soluble Aβ aggregates (protofibrils*), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques in AD, thereby reducing both Aβ protofibrils and Aβ plaques in the brain. LEQEMBI is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. It is estimated there were approximately 900,000 dementia patients in South Korea...

28 Oct 2024 - Olympus Corporation (“Olympus”) announces that Mr. Stefan Kaufmann, Director, Representative Executive Officer, President and CEO of Olympus has resigned from his positions as Director, Representative Executive Officer, President, and CEO, Executive Officer and Member of the Nominating Committee on October 28 as below. 1. Name and title of the resigned representative executive officer Stefan Kaufmann, Director, Representative Executive Officer, President and CEO 2. Reason for the change Upon receiving an allegation that Mr. Stefan Kaufmann had purchased illegal drugs, Olympus, in consultation with outside legal counsel, immediately investigated the facts, made a report to the investigative authorities, and cooperated fully with their investigation. Based on the results of the investigation, the Board of Directors unanimously determined that Mr. Stefan Kaufmann likely engaged in behaviors that were inconsistent with our Global Code of Conduct, Our Core Values, and our corp...