Syndax Pharmaceuticals (NASDAQ: SNDX) reported Q3 EPS of ($0.41), $0.06 better than the analyst estimate of ($0.47).

"We are pleased to have passed the final interim futility analysis of overall survival for E2112, our Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, and anticipate the final overall survival readout in the second quarter of 2020," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "Supported by highly compelling survival data from the Phase 2b ENCORE 301 trial, leading to Breakthrough Therapy designation for entinostat in HR+ breast cancer, we believe the combination of entinostat and exemestane has the potential to improve outcomes for patients with this difficult to treat disease."

Pending a positive overall survival (OS) assessment in E2112, Syndax intends to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for entinostat plus exemestane for the treatment of HR+, HER2- breast cancer.

Dr. Morrison added, "Beyond entinostat, patient dosing is now underway in the Phase 1/2 open-label AUGMENT-101 trial of SNDX-5613, our potent, highly selective, oral Menin inhibitor, in adults with relapsed/refractory acute leukemias. We look forward to establishing a safe dose that provides the appropriate target coverage to advance into the Phase 2 portion of the trial. We are committed to bringing this promising therapeutic option to patients, and expect to report initial data from this trial in 2020."

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