On Thursday, shares of biotech company GlycoMimetics Inc. (NASDAQ:GLYC) are skyrocketing, up over 100% to 410.92 per share in afternoon trading after the company announced that the FDA designated one of its drugs as a “Breakthrough Therapy.”
GlycoMimetic’s drug candidate, GMI-1271, treats adult relapsed/refractory acute myeloid leukemia (AML), which is a cancer of the blood and bone marrow; AML is most common type of acute leukemia in adults. The cancer is known for rapid growth of abnormal white blood cells that gather in the bone marrow, preventing normal blood cell production. About 19,900 people are diagnosed every year in the U.S., and roughly 10,400 die from all forms of the disease.
GMI-1271 is an E-selectin antagonist currently in Phase 2 of a Phase 1/2 clinical trial. In the trial, the treatment is being administered in addition to chemotherapy; patients treated with the drug achieved higher than expected remission rates, as well as lower than expected 30- and 60-day mortality rates in early evaluations.
The FDA’s Breakthrough Therapy designation helps companies accelerate the development and review of drug candidates, 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,” she continued.
Currently, GLYC is a #3 (Hold) on the Zacks Rank, with a VGM score of ‘F.’
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