On Friday, Shares of Zafgen Inc (NASDAQ:ZFGN), lost -50.71% to $10.36.
Zafgen, declared that it received verbal notice late yesterday from the U.S. Food and Drug Administration (FDA) that beloranib has been placed on partial clinical hold. This partial clinical hold impacts ongoing or planned clinical trials, counting ZAF-311 and ZAF-312. A partial clinical hold is an order that the FDA issues to delay or suspend part of a sponsor’s clinical work requested under its investigational new drug (IND) application.
As formerly stated, Zafgen learned of a death in the ongoing Phase 3 bestPWS study (ZAF-311) of beloranib in Prader-Willi Syndrome (PWS). While the cause of death remains unknown, the patient’s treatment assignment has been unblinded and it is now known that the patient was receiving beloranib. Due to formerly stated thromboembolic events in ongoing and preceding clinical trials of beloranib and the unknown nature of the death, the FDA gave verbal notice of a partial clinical hold to institute measures to ensure patient safety. Patients presently participating in the ZAF-311 study will be screened for existing thrombotic disease preceding to receiving further study drug and regularly monitored through the completion of the study. Given that the study is near complete, at this time, the Company anticipates to report top-line results in the first quarter of 2016. Similar screening and monitoring is being considered for the ongoing Phase 2b study (ZAF-203) in patients with severe obesity complicated by type 2 diabetes. The Company now anticipates that the PWS Phase 3 clinical trial, ZAF-312, will be initiated after ZAF-311 is accomplished and a full assessment of the safety and efficacy of beloranib is performed by the FDA.
Patient safety is our top precedingity, and we will work closely with the FDA to implement these measures to support the further development of beloranib, said Dr. Thomas Hughes, Chief Executive Officer of Zafgen.
Zafgen, Inc., a biopharmaceutical company, focuses on the development of therapeutics for patients suffering from obesity and obesity-related disorders. Its lead product candidate comprises Beloranib, an injection, which is in Phase III clinical trials for the treatment of obesity and hyperphagia in Prader-Willi Syndrome patients; that has accomplished Phase II clinical trials for the treatment of hypothalamic injury-associated obesity, counting craniopharyngioma-associated obesity; and which is in Phase IIb clinical trials for the treatment of severe obesity in the general population.
Shares of Express Scripts Holding Company (NASDAQ:ESRX), inclined 1.88% to $86.22, during its last trading session.
Express Scripts Holding Company, declared its intention to release its third quarter earnings on Tuesday, October 27, 2015 after the market closes and will hold its quarterly conference call to discuss third quarter results on Wednesday, October 28, 2015, at 8:30 a.m. Eastern Time (7:30 a.m. Central Time).
Express Scripts Holding Company operates as a pharmacy benefit administration (PBM) company in the United States and Canada. The company operates through two segments, PBM and Other Business Operations. The company’s PBM segment’s services comprise clinical solutions to enhance health outcomes, such as adherence, case coordination, and personalized medicine; specialized pharmacy care; home delivery pharmacy; specialty pharmacy, counting the distribution of fertility pharmaceuticals that require special handling or packaging; and retail network pharmacy administration.
Finally, Shares of JetBlue Airways Corporation (NASDAQ:JBLU), ended its last trade with -1.15% loss, and closed at $24.10.
JetBlue, declared it has passed two major milestones on its path to becoming the only U.S. carrier to offer free high-speed Wi-Fi Internet on every aircraft.
JetBlue has accomplished installation of Fly-Fion its fleet of more than 150 Airbus A320 and A321 aircraft, and its first Fly-Fi-enabled E190 made its official inaugural flight this week. The airline anticipates it will complete the installation of Fly-Fi on all 60 of its E190s by fall 2016, at which point it will have accomplished installation of Fly-Fi on the entire JetBlue fleet.
Fly-Fi uses Ka-band satellite technology to offer a broadband Internet experience similar to what customers have at home, counting the ability to stream video and use multiple devices at once.
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