Business
Syndax Pharmaceuticals Reports First Quarter 2020 Financial Results and Provides Clinical and Business Update
- Final OS analysis for Phase 3 E2112 trial in HR+, HER2- metastatic breast cancer expected this quarter; potential NDA filing later this year - - Preliminary
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"- Final OS analysis for Phase 3 E2112 trial in HR+, HER2- metastatic breast cancer expected this quarter; potential NDA filing later this year -\n - Preliminary Phase 1 results from AUGME-T-101 trial of menin inhibitor SNDX-5613 represent first clinical evidence that inhibition of the menin-MLL1 interaction can induce response in patients with MLL-r acute leukemias -\n - Recently completed a follow-on offering with net proceeds of $93.7M -\n - Company to host conference call today at 4:30 p.m. ET -\n\n\nWALTHAM, Mass., May 7, 2020 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (\"Syndax,\" the \"Company\" or \"we\") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today reported its financial results for the first quarter ended March 31, 2020. In addition, the Company provided a clinical and business update. \n\"During the first quarter, we generated significant momentum that we believe will take us through what we expect will be a transformational year for Syndax, with key data readouts expected across the entirety of our portfolio,\" said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. \"We continue to anticipate the final overall survival readout from E2112, our Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer later this quarter, with a potential regulatory filing for entinostat in HR+ breast cancer by year end. Supported by the compelling overall survival benefit observed in the Phase 2b ENCORE 301 trial, we believe the combination of entinostat and exemestane has strong potential to serve as a much-needed option in a setting for which existing therapies are inadequate. While we await this final readout, we remain focused on preparations to establish ourselves as a fully integrated oncology company, with a potential launch expected in 2021.\"\nDr. Morrison added, \"Beyond entinostat, we were pleased to recently announce initial Phase 1 data from the AUGMENT-101 trial of SNDX-5613, our oral menin inhibitor, in adults with relapsed/refractory acute leukemias. These data provide the first clinical evidence that inhibition of the menin-MLL1 interaction can induce response in patients with MLL-r acute leukemias. We believe that SNDX-5613 has great potential to serve as an effective intervention for both MLL-r acute leuk...