Syndax Pharmaceuticals Inc Stock News

The U.S. Food and Drug Administration on Friday approved Syndax Pharmaceuticals' drug for the treatment of adult and pediatric patients with a type of blood cancer, sending the company's shares up 3% in after-hours trading.

– Approval based on positive data from the AUGMENT-101 clinical trial, in which Revuforj delivered robust and durable rates of remission in R/R acute leukemia patients with a KMT2A translocation – – Syndax to host conference call today at 6:00 p.m. ET – WALTHAM, Mass.

Primary endpoint of pivotal phase 2 study met with statistical significance in using Revumenib for the treatment of relapsed/refractory mNPM1 AML patients; sNDA expected 1st half 2025. PDUFA action date of December 26th of 2024 deployed for FDA to decide if Revumenib should be approved for the treatment of relapsed/refractory KMT2Ar Acute leukemia patients. The global acute myeloid leukemia mar...

–      Primary endpoint met with CR/CRh rate of 23% in pivotal Ph 2 cohort of R/R mNPM1 AML patients (p-value = 0.0014) – –      47% (30/64) ORR in a heavily pre-treated population, including 75% with prior venetoclax exposure in the efficacy population – –      Favorable safety and tolerability profile; only 5% of patients discontinued due to treatment-related adverse events – –      Results h...

Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX ) Q3 2024 Earnings Conference Call November 5, 2024 4:30 PM ET Company Participants Sharon Klahre - Head, Investor Relations Michael Metzger - Chief Executive Officer Neil Gallagher - President & Head, R&D Steve Closter - Chief Commercial Officer Keith Goldan - Chief Financial Officer Anjali Ganguli - Chief Strategy Officer Conference Call Participants ...

–  New revumenib and Niktimvo ™  clinical data will be highlighted at 66th ASH Annual Meeting – – mNPM1 AML topline data from AUGMENT-101 expected in 4Q24; potential sNDA filing in 1H25 – – Revumenib NDA in R/R KMT2Ar acute leukemia is being reviewed under RTOR; PDUFA action date of December 26, 2024 – – Niktimvo approved by U.S. FDA for treatment of chronic GVHD after failure of at least two p...

WALTHAM, Mass. , Nov. 5, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the Company will host an in-person investor event, along with a live webcast, on Monday, December 9, 2024, at 7:00 a.m.

– Rapid responses and symptom improvement observed in inflammatory and fibrotic manifestations of chronic GVHD in heavily pretreated patients – WALTHAM, Mass. , Nov. 5, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq:SNDX), today announced that multiple abstracts evaluating Niktimvo™ (axatilimab-csfr), an anti-CSF-1R antibody for the treatment of chronic graft-versus-host disease (GVHD), ha...