Business
Syndax Pharmaceuticals Reports Fourth Quarter 2019 Financial Results and Provides Clinical and Business Update
- Final OS analysis for Phase 3 E2112 trial in HR+, HER2- metastatic breast cancer expected in 2Q20; potential NDA filing later this year - - Phase 1 data
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 in 2Q20; potential NDA filing later this year -\n - Phase 1 data presentation from AUGMENT-101 trial of SNDX-5613 in acute leukemias expected 4Q20; potential for interim results throughout 2020 -\n - SNDX-6352 granted generic name axatilamab; presentation of additional cGVHD results expected 4Q20 -\n - 1Q 2020 financings of $55 million extend cash runway into 2021, through all key milestones -\n - Company to host conference call today at 4:30 p.m. ET -\n\n\nWALTHAM, Mass., March 3, 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 fourth quarter ended December 31, 2019. In addition, the Company provided a clinical and business update. As of December 31, 2019, Syndax had $59.8 million in cash, cash equivalents and short-term investments.\n\"With meaningful data readouts expected for each of our innovative pipeline candidates aimed at addressing unmet need in some of the most underserved patient populations, 2020 is poised to be an exciting and transformative year for the Company,\" said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. \"Of note, this includes the final overall survival readout from E2112, our Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, in the second quarter of this year. 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. We remain on track to file for the regulatory approval of entinostat in HR+ breast cancer by year end, with a potential launch expected in 2021, positioning us as a fully-integrated oncology company.\"\nDr. Morrison added, \"In 2020, we also expect to present the first clinical data from the AUGMENT-101 trial of SNDX-5613, our oral Menin inhibitor, in adults with relapsed/refractory acute leukemias. Supported by a robust body of preclinical data, including two recently published articles in Cancer Cell and Science magazine, we believe SNDX-5613 has t...