On Thursday, GlycoMimetics (Nasdaq: GLYC) surged as high 100% after the company announced that it had received FDA breakthrough therapy designation. The drug that got the designation is the one that is known as GMI-1271. This drug was developed to treat patients with Acute Myeloid Leukemia — AML — which is a cancer of the blood/bone marrow. This was an impressive designation by the FDA, which is why the stock traded as high as it did. This drug has shown some strong efficacy, which is why breakthrough therapy designation is not all this drug has received by the FDA.
The FDA has also already granted the drug to treat AML patients with Orphan Drug Designation, and Fast Track Status. There are two factors according to the FDA breakthrough therapy designation website for obtaining the indication. First, the single arm treatment or combination therapy must treat a serious of life threatening condition. Secondly, it must show that it is better than the current treatment option available. With that in mind, it comes down to the results seen to date.
On Friday, GlycoMimetics surged another 19%, after the company gave an update on clinical data in relation to its AML drug GMI-1271. The combination of GMI-1271 alongside with chemotherapy showed improved efficacy in 42 patients in the trial. Of those 42 patients treated, they achieved an overall response rate of 50%. The 30 day mortality rate stood at 0% and the 60 day mortality rate concluded with 7%.
The medial overall survival in the first part of the study was 7.6 months. With this good data on hand traders bid up the stock to where it is now at $12.76 per share. Before the breakthrough therapy designation, and newly released data the stock traded around $5 per share. There is more opportunity though, because GlycoMimetics will post the rest of the data at the upcoming ASCO meeting in June. That meeting is a place where prominent biotechnology companies report encouraging results for cancer treatments. If the additional data proves to be solid then the stock should continue to trade higher.
