MedPath

Syndax's Revumenib Shows Positive Phase II Results in AML

• Syndax Pharmaceuticals announced positive top-line results from the pivotal Phase II portion of the Augment-101 study, evaluating revumenib in acute myeloid leukemia (AML). • The Augment-101 study is designed to assess the safety and efficacy of oral small-molecule revumenib in patients with relapsed or refractory AML. • Despite the positive results, Syndax's shares experienced a significant drop, closing down 26% after the data release, reflecting market caution. • Revumenib is part of the competitive menin-inhibitor space, with these results adding to the growing body of data in this therapeutic area.

Syndax Pharmaceuticals Inc. has released positive top-line results from the pivotal phase II portion of the Augment-101 study, which is evaluating the oral small-molecule revumenib for safety and efficacy in relapsed or refractory acute myeloid leukemia (AML). The announcement was made public, however, shares of Syndax (NASDAQ:SNDX) closed at $16.21, a 26% decrease.
The Augment-101 study is specifically designed to test the effectiveness and safety of revumenib, an oral small-molecule drug. Revumenib is a menin inhibitor. The competitive landscape for menin inhibitors is evolving, and Syndax's data contributes to the growing body of evidence in this therapeutic area.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

FDA Approves Syndax's Revuforj, a First-in-Class Menin Inhibitor for Acute Leukemia

The FDA has approved Syndax Pharmaceuticals' Revuforj (revumenib) for adults and children with relapsed or refractory acute leukemia with KMT2A rearrangement.
Revuforj, a menin inhibitor, showed a complete remission or complete remission with partial hematologic recovery in 21.2% of study participants, with a median response duration of 6.4 months.

FDA Approves Syndax's Revuforj as First Menin Inhibitor for KMT2A-Rearranged Leukemia

The FDA has granted priority review and approval to Syndax Pharmaceuticals' Revuforj (revumenib) for relapsed or refractory acute leukemia with KMT2A translocations.
Revuforj is the first FDA-approved menin inhibitor, marking a significant advancement in treating this aggressive form of leukemia in patients aged one year and older.

Revumenib Shows Promise in Relapsed/Refractory NPM1-Mutated AML

Revumenib demonstrated a 23% complete remission rate with or without partial hematological recovery (CR/CRh) in relapsed/refractory NPM1-mutated AML patients.
A significant 64% of evaluable patients achieving CR/CRh with revumenib had negative minimal residual disease (MRD) status.

AC Immune's ACI-7104 Shows Promise in Phase II Parkinson's Disease Trial

AC Immune's stock surged by over 20% following positive interim data from its Phase II VacSYn trial of ACI-7104.056 for Parkinson's disease.
The immunotherapy ACI-7104.056 induced a 16-fold increase in anti-alpha-synuclein antibodies compared to placebo after three immunizations.

Syndax's Revumenib Meets Primary Endpoint in AML Trial Despite Stock Drop

Syndax Pharmaceuticals' Phase II trial of revumenib met its primary endpoint in patients with relapsed or refractory acute myeloid leukemia (AML).
The AUGMENT-101 trial demonstrated a 23% complete remission rate in efficacy-evaluable patients with mutant NPM1 AML.

Revumenib Shows Promise in Phase 2 Trial for Relapsed/Refractory AML

Syndax Pharmaceuticals' revumenib demonstrated a 23% complete remission rate in patients with relapsed or refractory mutant NPM1 acute myeloid leukemia (AML).
The AUGMENT-101 trial also showed a 47% overall response rate in heavily pre-treated AML patients, including those who had prior venetoclax exposure.

Revuforj (Revumenib) Shows Promising Results in Acute Leukemia Trials

Syndax Pharmaceuticals presented data from multiple trials of Revuforj (revumenib) at the ASH Annual Meeting, showcasing its efficacy in acute leukemias.
The SAVE trial showed an 82% overall response rate (ORR) and 48% complete remission rate (CR/CRh) when revumenib was combined with venetoclax and decitabine/cedazuridine in R/R AML.

Moleculin Reports First Quarter 2024 Financial Results and Corporate Update

Moleculin Biotech, Inc. announced its first quarter 2024 financial results, highlighting significant progress in its clinical trials for AML treatment, including promising interim data from the MB-106 study. The company also discussed its financial health and upcoming milestones.

FDA Grants Priority Review to Revumenib for Relapsed/Refractory KMT2Ar Acute Leukemia

The FDA has granted Priority Review to Syndax Pharmaceuticals' NDA for revumenib, a menin inhibitor, for relapsed/refractory KMT2Ar acute leukemia.
The NDA is supported by positive data from the AUGMENT-101 trial, which showed a 23% complete remission rate in KMT2Ar acute leukemia patients.

Syndax Pharmaceuticals Announces Key Updates and 2024 Milestones

Syndax Pharmaceuticals has shared significant updates, including the submission of a BLA for axatilimab in chronic graft-versus-host disease and an NDA for revumenib in R/R KMT2Ar acute leukemia. The company also anticipates completing enrollment in the AUGMENT-101 trial and reporting topline data in 2024. With a recent $230 million follow-on offering, Syndax is well-positioned to fund its operations through 2026.

Reference News

[1]
Menin suits? Syndax's revumenib phase II win in AML measured - BioWorld
bioworld.com · Nov 13, 2024

Syndax Pharmaceuticals disclosed positive top-line results from the phase II Augment-101 study for revumenib in AML, but...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy