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Syndax Pharmaceuticals Reports Second Quarter 2019 Financial Results and Provides Clinical and Business Update
WALTHAM, Mass., Aug. 7, 2019 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"WALTHAM, Mass., Aug. 7, 2019 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today reported its financial results for the second quarter ended June 30, 2019. In addition, the Company provided a clinical and business update. As of June 30, 2019, Syndax had $80.5 million in cash, cash equivalents and short-term investments. \n\"The FDA's recent clearance of our IND application for SNDX-5613, a potent, highly selective, oral Menin inhibitor, marks an important milestone not only for Syndax, but also for patients suffering with acute leukemias,\" said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. \"The Menin-MLL interaction has been strongly implicated in the development of MLL-r and NPM1 mutant leukemias. We look forward to initiating the clinical program and anticipate establishing a safe dose that provides appropriate target coverage in patients.\"\nDr. Morrison added, \"We look forward to the near-term completion of E2112, the Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, which we anticipate will occur either in the fourth quarter of 2019 or the first half of 2020. A positive survival benefit at either assessment will enable us to file an NDA with the FDA and take us one step closer to improving outcomes for patients with this difficult to treat disease.\" \nPipeline Updates\nEntinostat\nIn May 2019, Syndax announced that the E2112 trial passed its fourth interim overall survival (OS) analysis and will continue as planned until either an OS benefit is observed, or the final target number of events occur. E2112 is Syndax's NCI-sponsored, ECOG-ACRIN led Phase 3 registration trial of entinostat, a Class I selective HDAC inhibitor, plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer. \nThe Company continues to anticipate the final E2112 interim OS analysis in 4Q19. If necessary, the final OS assessment, which will be triggered when the trial reaches a total of 410 death events, is expected to be conducted in 2Q20. A positive OS assessment at any point would enable the Company to file for full regulatory approval. The E2112 trial design was informed by the Phase 2b ENCORE 301 trial, the resul...