-- Polaryx Therapeutics (PLYX) 周二宣布，美国食品药品监督管理局 (FDA) 已授予其药物 PLX-200 快速通道资格，用于治疗包括幼年型神经元蜡样脂褐质沉积症、克拉伯病和桑德霍夫病在内的多种神经退行性疾病。 该公司表示，该资格允许其与 FDA 进行更频繁的互动，并有可能在未来的上市申请中获得滚动审查。 Polaryx 表示，PLX-200 目前已获得 SOTERIA II 期篮子试验中所有四项潜在适应症的快速通道资格。该公司于今年 3 月获得了治疗晚期婴儿型神经元蜡样脂褐质沉积症的快速通道资格。 周二，该公司股价下跌超过 7%。
Price: $5.38, Change: $-0.32, Percent Change: -5.65%
Fadu (KOSDAQ:440110) posted first-quarter net income of 10.2 billion won, rebounding from a net loss of 12.1 billion won a year earlier, according to a Monday filing with the Korea Exchange.The South Korean chipmaker's sales revenue surged 210% year over year to 59.5 billion won from 19.2 billion won.Shares of Fadu jumped nearly 14% in recent trade.
Here are the 10 ASX-listed companies with the biggest losses on Monday.Wisetech (ASX:WTC): -3%, AU$42.79NexGen Energy (ASX:NXG): -3%, AU$17.26Telix Pharmaceuticals (ASX:TLX): -2%, AU$14.47Cochlear (ASX:COH): -2%, AU$94.76Paladin Energy (ASX:PDN): -2%, AU$12.28Origin Energy (ASX:ORG): -2%, AU$12.44EVT (ASX:EVT): -2%, AU$12.44Tuas (ASX:TUA): -2%, AU$5.97Ramsay Health Care (ASX:RHC): -2%, AU$39.15Southern Cross Gold (ASX:SX2): -2%, AU$11.07
Sun Pharmaceutical Industries (NSE:SUNPHARMA, BOM:524715) has agreed to acquire US-based Organon & Co in an all-cash deal at an enterprise valuation of $11.8 billion, according to a Monday filing to the Indian stock exchanges.Under the pact, Sun Pharmaceutical will buy all outstanding shares of Organon for $14.00 per share. It plans to fund the acquisition through a combination of available cash resources and committed financing from banks.The acquisition is estimated to boost Sun Pharmaceutical's revenues to $12.4 billion.Organon, which was spun off from Merck in 2021, specializes in women's health and biosimilars and has more than 70 products sold across 140 countries.The Organon buyout is part of Sun Pharmaceutical's strategy "of growing its Innovative Medicines business," according to Sun Pharma's statement.The transaction is subject to customary closing conditions, including receipt of required regulatory approvals andapproval by Organon stockholders.