Syndax Pharmaceuticals Reports Second Quarter 2021 Financial Results and Provides Clinical and Business Update prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.
FDA grants fast track designation to SNDX-5613 for acute leukemia healio.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from healio.com Daily Mail and Mail on Sunday newspapers.
Syndax Pharmaceuticals Reports First Quarter 2021 Financial Results and Provides Clinical and Business Update
- Today announced two of the prior responders from ongoing Phase 1 portion of AUGMENT-101 trial of SNDX-5613 achieved full count recovery bringing CR/CRh rate up to 23% -
- Company on track to initiate pivotal Phase 2 portion of AUGMENT-101 trial in 2Q21 -
- Enrollment of 23 cGVHD patients in Phase 2 expansion cohort testing axatilimab at 1 mg/kg complete; enrollment ongoing in pivotal AGAVE-201 trial of axatilimab in cGVHD -
- Company to host conference call today at 4:30 p.m. ET -
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WALTHAM, Mass., April 20, 2021 /PRNewswire/ Syndax Pharmaceuticals, Inc. ( Syndax, the Company or we ) (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced updated positive data from the Phase 1 dose escalation portion of the ongoing Phase 1/2 AUGMENT-101 trial of SNDX-5613 in patients with mixed lineage leukemia rearranged (MLLr) and nucleophosmin (NPM1c) mutant relapsed/refractory (R/R) acute leukemias. SNDX-5613 is the Company s highly selective, oral menin inhibitor. Information on how to access the live video webcast and accompanying slide presentation can be found below. Data reported today further support the potential for SNDX-5613 to induce clinically meaningful responses in patients with genetically-defined acute leukemias, said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. Notably, robust clinical activity, including multiple complet
Syndax Announces Orphan Drug Designation Granted to Axatilimab for Treatment of Idiopathic Pulmonary Fibrosis
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WALTHAM, Mass., April 8, 2021 /PRNewswire/ Syndax Pharmaceuticals, Inc. ( Syndax, the Company or we ) (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to axatilimab, its anti-CSF-1R monoclonal antibody, for the treatment of patients with idiopathic pulmonary fibrosis (IPF). IPF is a serious, life-limiting orphan disease, and today s Orphan Drug Designation validates axatilimab s potential to serve as an effective therapeutic option for the currently-underserved patients living with this rare disease, said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. Building on promising data demonstrating meaningful multiorgan clinical benefit i