GlycoMimetics’ stock $GLYC tanked over 60% in premarket trading Monday morning after the biotech announced a Phase 3 trial failure for its lead drug, uproleselan, in relapsed/refractory acute myeloid leukemia.
In the 388-patient trial, those treated with uproleselan and chemotherapy had a median overall survival of 13 months compared to 12.3 months for those on a placebo and chemotherapy, meaning the company’s drug combo did not achieve a statistically significant improvement in the primary endpoint of overall survival in the intent-to-treat population.
Harout Semerjian“We are thoroughly analyzing the data in collaboration with medical, statistical and regulatory experts and are committed to submitting a comprehensive data analysis for presentation at an upcoming medical meeting,” GlycoMimetics CEO Harout Semerjian said in a statement.
In its full-year financial report in March, GlycoMimetics wrote that it would submit an NDA by the end of the year if the trial was positive.
The drug is still being tested in a Phase 2/3 study in adults with newly diagnosed AML who are 60 years or older and fit for intensive chemotherapy. GlycoMimetics wrote in Monday’s release that the data will be revealed from that study “when available.”
According to GlycoMimetics’ website, uproleselan is also in a Phase 1 study for relapsed/refractory AML in pediatric patients. The company has two other early-stage drugs, one dubbed GMI-1687 and being tested for sickle cell disease vaso-occlusive crisis and inflammatory disease, and an undeclared drug in fibrosis and oncology. GMI-1687 hit the primary and secondary endpoints in a Phase 1a trial for SCD vaso-occlusive crisis and inflammatory disease, the company wrote in March.
The Maryland-based company also released “preliminary” first-quarter earnings Monday: The company has cash and cash equivalents of $31.3 million, compared to $41.8 million as of Dec. 31, 2023.
GlycoMimetics also once partnered up with Pfizer for nearly a decade, though that partnership ended in 2020 after an older sickle cell disease drug failed the primary and secondary goals in a pivotal late-stage study.