NEW YORK, NY / ACCESSWIRE / May 19, 2017 / GlycoMimetics' shares saw a huge breakout as investors digested the big FDA news the company received. The FDA has granted the company’s GMI-1271 therapy "breakthrough therapy" status. Endologix shares weren't so lucky in yesterday's trading as shares hit a multi-year low after the company announced it may be longer than expected to get U.S. approval for its Nellix Endovascular Aneurysm Sealing System.
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GlycoMimetics was one of the biggest gainers on the NASDAQ and closed up 98.70% yesterday on staggering volume. The stock even hit a new high of $11.58 during intra-day trading. So what was all the fuss yesterday? GlycoMimetic's drug candidate GMI-1271 was just granted Breakthrough Therapy designation for treatment of adult relapsed/refractory acute myeloid leukemia (AML) by the FDA. It is currently being evaluated in the Phase 2 portion of a Phase 1/2 clinical trial in patients that have AML and is being administered, along with chemotherapy. Considering that the FDA already has granted the company's drug Orphan Drug designation and Fast Track Status, traders felt very confident about the company's future.
Chief Medical Officer of the company Helen Thackray commented, "The FDA's granting to GMI-1271 of Breakthrough Therapy designation will further help GlycoMimetics to accelerate the development of GMI-1271 as a treatment for this very difficult-to-treat patient population. We believe GMI-1271 when combined with chemotherapy has the potential to address an unmet therapeutic need for individuals living with AML. We are encouraged by our clinical results to date, and look forward to working closely with the FDA to bring this novel therapy to patients as quickly as possible."
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Endologix's shares were brutalized in Thursday trading and even hit a multi-year low after investors were discouraged by a meeting the company had with the FDA. Endologix released an update for its shareholders announcing that the timeline for the Nellix Endovascular Aneurysm Sealing System, which treats infrarenal abdominal aortic aneurysms, could be longer than they anticipated. Endologix is currently seeking U.S. approval of the Nellix EVAS. The Gen2 device design is already sold in Europe and other international markets. The FDA and Endologix will be collaborating together on the confirmatory clinical study protocol and expect to start patient enrollment in the fourth quarter. It won't be until 2020 that PMA approval is expected to occur.
CEO John McDermott commented, "While the timeline has shifted from our projections, we appreciate the FDA's collaboration as Nellix EVAS proceeds in the regulatory process. We have evidence that our previously updated Nellix IFU provides excellent patient outcomes and look forward to starting the confirmatory clinical study with our Gen2 device. We appreciate the support of our physicians worldwide and their continued collaboration in developing new technologies and conducting clinical studies to provide the best outcomes for patients with abdominal aortic aneurysms." Shares closed down 36.70% yesterday and hit as low as $4.20.
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