Syndax Pharmaceuticals' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Syndax Pharmaceuticals (SNDX).
Over the past two years, Syndax Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Revumenib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Revumenib FDA Regulatory Timeline and Events
Revumenib is a drug developed by Syndax Pharmaceuticals for the following indication: Relapsed/Refractory KMT2Ar Acute Leukemia.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Revumenib
- Announced Date:
- June 11, 2026
- Indication:
- Relapsed/Refractory KMT2Ar Acute Leukemia
Announcement
Syndax Pharmaceuticals announced that data from the Phase 1/2 SAVE trial of an all-oral regimen of Revuforj® (revumenib), decitabine/cedazuridine, and venetoclax in relapsed or refractory (R/R) NPM1 mutated (NPM1m), KMT2A-rearranged (KMT2Ar), or NUP98-rearranged (NUP98r) acute myeloid leukemia (AML) were published in the Journal of Clinical Oncology and simultaneously presented at the European Hematology Association (EHA) 2026 Congress in Stockholm, Sweden.
AI Summary
Syndax Pharmaceuticals said new data from its Phase 1/2 SAVE trial were published in the Journal of Clinical Oncology and presented at the European Hematology Association 2026 Congress. The study tested an all-oral combination of Revuforj® (revumenib), decitabine/cedazuridine, and venetoclax in patients with relapsed or refractory AML tied to NPM1, KMT2A, or NUP98 changes. Among 42 heavily pretreated patients, the regimen showed strong activity, with an 88% overall response rate, 71% complete remission composite rate, and 60% complete remission or complete remission with partial hematologic recovery. Responses were seen across subgroups, including patients who had or had not received venetoclax before. Many patients also had deep disease clearance, with high measurable residual disease negativity rates. Nearly half of the patients later went on to transplant. The company said the combination was generally well-tolerated.
Read Announcement- Drug:
- Revumenib
- Announced Date:
- May 21, 2026
- Indication:
- Relapsed/Refractory KMT2Ar Acute Leukemia
Announcement
Syndax Pharmaceuticals announced the acceptance of four Revuforj® (revumenib) abstracts for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago.
AI Summary
Syndax Pharmaceuticals said four abstracts for Revuforj® (revumenib) were accepted for presentation at the 2026 ASCO Annual Meeting in Chicago from May 29 to June 2. The company said one oral presentation will show positive results in 21 adults and children with KMT2Ar, NPM1m, or NUP98r acute leukemia who received revumenib after a transplant. Other presentations will focus on revumenib’s pharmacokinetic, or PK, profile, including data showing it can be taken with gastric acid-reducing medicines and low-fat meals without losing effectiveness. Syndax will also present the design of ongoing pivotal trials testing revumenib with low- or high-intensity chemotherapy in newly diagnosed patients with NPM1m or KMT2Ar acute leukemia. The abstracts are now posted on the ASCO website, and the slides and posters will be shared later on Syndax’s website after the meeting.
Read Announcement- Drug:
- Revumenib
- Announced Date:
- October 24, 2025
- Indication:
- Relapsed/Refractory KMT2Ar Acute Leukemia
Announcement
Syndax Pharmaceuticals announced that the Food and Drug Administration approved revumenib a menin inhibitor, for relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options.
Read Announcement- Drug:
- Revumenib
- Announced Date:
- September 19, 2025
- Indication:
- Relapsed/Refractory KMT2Ar Acute Leukemia
Announcement
Syndax Pharmaceuticals announced that the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia were updated to include revumenib as a category 2A recommendation for relapsed or refractory (R/R) acute myeloid leukemia (AML) with an NPM1 mutation (mNPM1).1
AI Summary
Syndax Pharmaceuticals announced that the NCCN Clinical Practice Guidelines for Acute Myeloid Leukemia now include revumenib as a category 2A recommendation for patients with relapsed or refractory AML that has an NPM1 mutation. This change is based on positive results from the AUGMENT-101 trial, which were published in Blood in 2025.
The NCCN had already recommended revumenib as category 2A for acute leukemia with a KMT2A rearrangement. Adding the NPM1 mutation group reflects strong evidence that revumenib can target key drivers of this aggressive blood cancer. Patients with relapsed or refractory NPM1-mutated AML face limited treatment options and a high risk of relapse.
By including revumenib in these guidelines, clinicians, patients, and payers gain a clear pathway to access a first-in-class menin inhibitor backed by pivotal trial data. This milestone underscores revumenib’s growing role in treating acute leukemia.
Read Announcement- Drug:
- Revumenib
- Announced Date:
- June 24, 2025
- Target Action Date:
- October 25, 2025
- Indication:
- Relapsed/Refractory KMT2Ar Acute Leukemia
Announcement
Syndax Pharmaceuticals announced that PDUFA action date set for October 25, 2025
AI Summary
Syndax Pharmaceuticals recently announced that the U.S. FDA has granted Priority Review for its supplemental New Drug Application (sNDA) for Revuforj® (revumenib). The review, conducted under the Real-Time Oncology Review (RTOR) program, carries a Prescription Drug User Fee Act (PDUFA) target action date of October 25, 2025. This decision marks a significant step as revumenib, an oral menin inhibitor, could become the first and only treatment approved for both relapsed or refractory (R/R) mutant NPM1 acute myeloid leukemia (AML) and R/R KMT2A-rearranged acute leukemia.
The RTOR program allows the FDA to work closely with Syndax to enhance review efficiency and provide early feedback. If approved, revumenib could offer a new treatment option for patients with limited alternatives, reinforcing Syndax’s leadership in developing innovative cancer therapies.
Read Announcement- Drug:
- Revumenib
- Announced Date:
- June 24, 2025
- Indication:
- Relapsed/Refractory KMT2Ar Acute Leukemia
Announcement
Syndax Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its supplemental New Drug Application (sNDA) for Revuforj® (revumenib) for the treatment of relapsed or refractory (R/R) mutant NPM1 (mNPM1) acute myeloid leukemia (AML).
AI Summary
Syndax Pharmaceuticals announced that the FDA has granted Priority Review for its supplemental New Drug Application (sNDA) for Revuforj® (revumenib) for treating relapsed or refractory (R/R) mutant NPM1 acute myeloid leukemia (AML). The sNDA is under review via the FDA’s Real-Time Oncology Review (RTOR) program, and the agency has set a Prescription Drug User Fee Act (PDUFA) target action date of October 25, 2025. Revuforj, an oral, first-in-class menin inhibitor, is supported by compelling data from the AUGMENT-101 trial, which demonstrated its potential to effectively treat patients with mNPM1 AML. If approved, Revuforj would offer a new and targeted treatment option for a patient group with limited alternatives, potentially becoming the first and only menin inhibitor approved for this indication.
Read Announcement- Drug:
- Revumenib
- Announced Date:
- June 12, 2025
- Indication:
- Relapsed/Refractory KMT2Ar Acute Leukemia
Announcement
Syndax Pharmaceuticals announced new data from the pivotal AUGMENT-101 trial of Revuforj® (revumenib), the Company's first-in-class menin inhibitor, in patients with relapsed or refractory (R/R) mutant NPM1 (mNPM1) and NUP98-rearranged (NUP98r) acute myeloid leukemia (AML).
AI Summary
Syndax Pharmaceuticals announced promising new data from the pivotal AUGMENT-101 trial for Revuforj® (revumenib), their first-in-class menin inhibitor, in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) harboring mutant NPM1 and NUP98 rearrangements. In the Phase 2 cohort of R/R mNPM1 AML patients, the trial showed a 26% complete remission plus partial recovery (CR+CRh) rate and a 48% overall response rate, with robust responses observed regardless of co-mutations, previous therapies, or prior venetoclax exposure. Additionally, a sub-analysis revealed a promising median overall survival of 23 months among responders. In the Phase 1 arm for patients with R/R NUP98r AML, a 60% overall response rate was reported. These results underscore revumenib’s potential to become a standard treatment option for AML patients with these specific genetic alterations.
Read Announcement- Drug:
- Revumenib
- Announced Date:
- December 9, 2024
- Indication:
- Relapsed/Refractory KMT2Ar Acute Leukemia
Announcement
Syndax Pharmaceuticals announced additional positive data from the AUGMENT-101 trial of Revuforj® (revumenib) in relapsed or refractory (R/R) mutant NPM1 (mNPM1) acute myeloid leukemia (AML) and the BEAT AML trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed AML patients.
AI Summary
Syndax Pharmaceuticals announced promising results from two key AML studies evaluating Revuforj® (revumenib). In the AUGMENT-101 trial for relapsed or refractory mutant NPM1 AML, data from a Phase 2 cohort showed a 26% rate of complete remission (including partial hematologic recovery) and a 48% overall response rate among evaluable patients. These responses were seen across major subgroups, including those with multiple prior therapies, suggesting that revumenib may offer new hope for difficult-to-treat patients.
Additionally, the BEAT AML trial evaluated revumenib in combination with venetoclax and azacitidine in newly diagnosed AML patients. In this study, all 37 efficacy-evaluable patients achieved an overall response, with a composite complete remission rate of 95%. The high response rates and safety profile of the combination support the potential for revumenib to improve frontline treatment options for AML patients.
Read Announcement- Drug:
- Revumenib
- Announced Date:
- December 7, 2024
- Indication:
- Relapsed/Refractory KMT2Ar Acute Leukemia
Announcement
Syndax Pharmaceuticals presented positive data from multiple trials of Revuforj® (revumenib) as a single-agent and in combination with standard of care agents in patients with acute leukemias in oral sessions at the 66th American Society of Hematology (ASH) Annual Meeting being held in San Diego, December 7-10, 2024.
AI Summary
Syndax Pharmaceuticals presented promising clinical data for Revuforj® (revumenib) at the 66th American Society of Hematology Annual Meeting in San Diego, December 7–10, 2024. The data included multiple trials assessing Revuforj as both a single agent and in combination with standard treatments in patients with acute leukemias. Notably, in the Phase 1/2 SAVE trial for relapsed/refractory AML, the combination regimen of Revuforj with venetoclax and decitabine/cedazuridine achieved an 82% overall response rate and a 48% complete remission/complete remission with partial hematologic recovery rate.
Additional findings from the Phase 2 AUGMENT-101 trial in patients with R/R KMT2A-rearranged acute leukemia showed rapid and durable responses across all major patient subgroups, high rates of minimal residual disease negativity, and successful transitions to hematopoietic stem cell transplant. These encouraging results support further development and future combination trials, including studies in the frontline therapy setting.
Read Announcement- Drug:
- Revumenib
- Announced Date:
- November 15, 2024
- Indication:
- Relapsed/Refractory KMT2Ar Acute Leukemia
Announcement
Syndax Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Revuforj® (revumenib) as the first and only menin inhibitor for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older.
AI Summary
Syndax Pharmaceuticals recently announced that the U.S. Food and Drug Administration (FDA) has approved Revuforj® (revumenib) as the first and only menin inhibitor for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation. This approval is significant because Revuforj is now available for both adult and pediatric patients aged one year and older who are facing this aggressive form of leukemia.
The FDA’s decision was based on strong data from the AUGMENT-101 clinical trial, which demonstrated that Revuforj delivered robust and durable rates of remission in patients. This breakthrough in precision medicine provides a much-needed treatment option for those with limited alternatives, offering new hope for improved outcomes in this high-risk patient population.
Read Announcement
Syndax Pharmaceuticals FDA Events - Frequently Asked Questions
Yes, Syndax Pharmaceuticals (SNDX) has received FDA approval for Revumenib. This page tracks recent and historical FDA regulatory events related to Syndax Pharmaceuticals' drug portfolio.
In the past two years, Syndax Pharmaceuticals (SNDX) has reported FDA regulatory activity for Revumenib.
The most recent FDA-related event for Syndax Pharmaceuticals occurred on June 11, 2026, involving Revumenib. The update was categorized as "Data," with the company reporting: "Syndax Pharmaceuticals announced that data from the Phase 1/2 SAVE trial of an all-oral regimen of Revuforj® (revumenib), decitabine/cedazuridine, and venetoclax in relapsed or refractory (R/R) NPM1 mutated (NPM1m), KMT2A-rearranged (KMT2Ar), or NUP98-rearranged (NUP98r) acute myeloid leukemia (AML) were published in the Journal of Clinical Oncology and simultaneously presented at the European Hematology Association (EHA) 2026 Congress in Stockholm, Sweden."
Currently, Syndax Pharmaceuticals has one therapy (Revumenib) targeting the following condition: Relapsed/Refractory KMT2Ar Acute Leukemia.
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:SNDX last updated on 6/11/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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