It’s a very rewarding trading day for investors in GlycoMimetics Inc (NASDAQ:GLYC) with shares up over 70%, making the stock Wall Street’s bull of the day. The reason? The drug maker’s GMI-1271 has been granted FDA breakthrough therapy designation for treatment of adult relapsed/refractory AML, adding to the existing orphan designation and fast track status.
In the ongoing clinical trial, GMI-1271 is being administered, along with chemotherapy, to patients with relapsed or refractory AML as well as those 60 years of age and older with newly diagnosed disease. Data from this trial were presented in 2016 at meetings of the European Hematology Association (EHA) and the American Society of Hematology (ASH). In the trial, patients treated with GMI-1271 achieved higher than expected remission rates and lower than expected 30- and 60-day mortality rates in early evaluations of patients with relapsed/refractory AML as well as in newly diagnosed patients. In March 2017, the Company announced that the first of two patient cohorts in the Phase 2 portion of the trial of GMI-1271 had completed enrollment. In April 2017, the Company announced plans to present further data updates on both patient populations in the ongoing AML trial at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in June.
The FDA grants Breakthrough Therapy designation to companies to help accelerate development and review of drug candidates when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies. The designation is designed to expedite the development and review of designated therapies, without changing FDA standards for new drug approval.
“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,” said Helen Thackray, MD, Chief Medical Officer of GlycoMimetics. “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.”
On the ratings front, GlycoMimetics has been the subject of a number of recent research reports. In a report issued on May 9, Cowen analyst Ritu Baral reiterated a Buy rating on GLYC. Separately, on April 4, Jefferies’ Biren Amin reiterated a Buy rating on the stock and has a price target of $9.00.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ritu Baral and Biren Amin have a yearly average return of 10.2% and 2.4% respectively. Baral has a success rate of 45% and is ranked #341 out of 4561 analysts, while Amin has a success rate of 49% and is ranked #1459.
GlycoMimetics, Inc. operates as a clinical stage biotechnology company, which focuses on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. It develops proprietary glycomimetics that inhibit disease-related functions of carbohydrates.