Drugs / SNDX-5613
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | R/R KMT2Ar acute leukemia | — | “was granted Priority Review and is being reviewed under the U.S. FDA's Real-Time Oncology Review (RTOR) Program” syndax.com ↗ “NDA filing for revumenib in R/R KMT2Ar acute leukemia is being reviewed under RTOR” syndax.com ↗ “Revumenib NDA in R/R KMT2Ar acute leukemia is being reviewed under RTOR” syndax.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05360160 | Oct 2022 → Dec 2026 expected | acute myeloid leukemia | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03013998 | Nov 2016 → Dec 2032 expected | acute myeloid leukemia | Beat AML, LLC | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 42
| Date | Issuer | Release |
|---|---|---|
| 2026-06-11 | Syndax Pharmaceuticals | Results Syndax Showcases Revuforj® (revumenib) Clinical Activity in Multiple Acute Leukemia Subtypes and Settings at EHA 2026 syndax.com ↗
97% (34/35) composite complete remission (CRc) and 77% (27/35) complete remission (CR) rate observed among newly diagnosed patients with NPM1m or KMT2Ar AML who received revumenib at dose level (DL) 1 or 2 in combination with intensive chemotherapy. |
| 2026-06-11 | Syndax Pharmaceuticals | Results Syndax Announces Publication of SAVE Data on Revuforj® (revumenib) in Combination with Decitabine/Cedazuridine and Venetoclax in Relapsed/Refractory NPM1m, KMT2Ar, and NUP98r AML in the Journal of Clinical Oncology syndax.com ↗ |
| 2026-06-02 | Syndax Pharmaceuticals | Results Syndax Highlights Revuforj® (revumenib) Data Presented at ASCO 2026, Including an Oral Presentation of Post-Transplant Data syndax.com ↗
Pooled analysis of 24 adults and children with KMT2Ar, NPM1m, or NUP98r acute leukemia who resumed revumenib post-transplant shows favorable outcomes, including a 2-year overall survival rate of 90% vs historical benchmark of 51% |
| 2026-05-12 | Syndax Pharmaceuticals | Results Syndax Highlights 12 Revuforj® (revumenib) Abstracts Accepted for EHA 2026, Advancing Leadership in Menin Inhibition syndax.com ↗ |
| 2025-12-08 | Syndax Pharmaceuticals | Results Syndax Highlights Leadership in Menin Inhibition at ASH 2025 with Multiple Revuforj® (revumenib) Presentations Spanning the Acute Leukemia Treatment Continuum syndax.com ↗
Ph 2 SAVE trial of revumenib with venetoclax/HMA in newly diagnosed NPM1m and KMT2Ar AML shows 86% ORR (18/21), 76% CR (16/21), and 100% (18/18) MRD negativity among responders |
| 2025-10-24 | Syndax Pharmaceuticals | Regulatory Syndax Announces FDA Approval of Revuforj® (revumenib) in Adult and Pediatric Patients with Relapsed or Refractory NPM1 Mutated Acute Myeloid Leukemia syndax.com ↗ |
| 2025-06-24 | Syndax Pharmaceuticals | Regulatory Syndax Announces FDA Priority Review of sNDA for Revuforj® (revumenib) in Relapsed or Refractory mNPM1 Acute Myeloid Leukemia syndax.com ↗ |
| 2025-06-12 | Syndax Pharmaceuticals | Results Syndax Presents New Revuforj® (revumenib) Data in Relapsed/Refractory mNPM1 and NUP98r Acute Leukemia from AUGMENT-101 Trial at EHA 2025 syndax.com ↗
26% (20/77) CR+CRh rate and 48% (37/77) ORR in efficacy-evaluable pivotal R/R mNPM1 AML population |
| 2025-06-12 | Syndax Pharmaceuticals | Results Syndax Announces Publication of Revumenib Data from the BEAT AML Trial in the Journal of Clinical Oncology and Simultaneous Presentation at EHA 2025 syndax.com ↗
Promising clinical activity and deep responses observed with 67% (29/43) CR rate, 88% (38/43) ORR, and 100% (37/37) MRD negativity among responders |
| 2025-05-07 | Syndax Pharmaceuticals | Results Syndax Announces Publication of Pivotal Revumenib Data in Relapsed or Refractory mNPM1 Acute Myeloid Leukemia in the Journal Blood syndax.com ↗
In the older, heavily pretreated population enrolled in this trial, it is very encouraging to observe that nearly 50% of patients achieved an overall response and that revumenib was generally well-tolerated. |
| 2024-12-09 | Syndax Pharmaceuticals | Results Syndax Announces Additional Positive Data for Revuforj® (revumenib) from AUGMENT-101 Trial in Relapsed or Refractory mNPM1 AML and BEAT AML Frontline Combination Trial syndax.com ↗
Subgroup analyses from Ph 2 protocol-defined R/R mNPM1 AML efficacy population (N=64) show responses across all major subgroups, including heavily pretreated patients |
| 2024-12-07 | Syndax Pharmaceuticals | Results Syndax Presents Positive Revuforj® (revumenib) Data in Acute Leukemias from Multiple Trials, Including the SAVE Combination and AUGMENT-101 Trials, at 66th ASH Annual Meeting syndax.com ↗
82% ORR (27 of 33 pts) and 48% CR/CRh (16 of 33 pts) in SAVE trial studying revumenib in combination with venetoclax and decitabine/cedazuridine in R/R AML |
| 2024-11-15 | Syndax Pharmaceuticals | Regulatory Syndax Announces FDA Approval of Revuforj® (revumenib), the First and Only Menin Inhibitor to Treat Adult and Pediatric Patients with Relapsed or Refractory Acute Leukemia with a KMT2A Translocation syndax.com ↗ |
| 2024-11-12 | Syndax Pharmaceuticals | Results Syndax Announces Positive Pivotal Topline Results from Relapsed or Refractory mNPM1 AML Cohort in AUGMENT-101 Trial of Revumenib syndax.com ↗
The primary endpoint was met with a complete remission (CR) plus CR with partial hematological recovery (CRh) rate of 23% (15/64; 95% confidence interval [CI]: 14%, 36%; one-sided p-value =0.0014) among the efficacy evaluable adults with R/R mNPM1 AML in the Phase 2 portion of the AUGMENT-101 trial. |
| 2024-11-05 | Syndax Pharmaceuticals | Results Syndax Announces Revumenib Abstracts to Be Presented at the 66th ASH Annual Meeting syndax.com ↗
The most common (>20%) Grade ≥3 TEAEs were febrile neutropenia (46%) and lung infection (42%), while Grade ≥3 TRAEs (any agent) were thrombocytopenia (12%), neutropenia (8%), QT prolongation (8%), and DS (4%). |
| 2024-08-12 | Syndax Pharmaceuticals | Results Syndax Announces Publication in the Journal of Clinical Oncology of Data from the Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia syndax.com ↗
Pivotal AUGMENT-101 trial met its primary endpoint at interim analysis of patients with KMT2Ar AML and ALL (p-value = 0.0036) |
| 2024-07-29 | Syndax Pharmaceuticals | Regulatory Syndax Announces PDUFA Action Date Extension for Revumenib NDA for Relapsed or Refractory KMT2Ar Acute Leukemia syndax.com ↗ |
| 2024-06-14 | Syndax Pharmaceuticals | Results Syndax Presents Updated Positive Data from BEAT AML and AUGMENT-102 Phase 1/2 Combination Trials of Revumenib in Patients with Acute Leukemias at EHA 2024 Congress syndax.com ↗
Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced updated data from multiple combination trials of revumenib, the Company's potent, selective, small molecule menin inhibitor, in patients with acute leukemias. |
| 2024-06-06 | Syndax Pharmaceuticals | Results Syndax Announces Plans to Advance into Phase 1b Portion of Trial Evaluating Revumenib in Relapsed or Refractory Metastatic MSS CRC syndax.com ↗
The Company's decision was supported by the trial's Independent Data Monitoring Committee (IDMC) following its recent pre-planned review of initial data from the Phase 1a portion of the trial. |
| 2024-04-08 | Syndax Pharmaceuticals | Results Syndax Presents Positive Pediatric Data from Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia at ASPHO Plenary Session syndax.com ↗
The pediatric data was featured in a Plenary Session titled "Pivotal Phase 2 Results of AUGMENT-101 for Revumenib in KMT2Ar Acute Leukemia: Pediatric Experience" at the 2024 American Society of Pediatric Hematology/Oncology (ASPHO) Conference held April 3 – 6, 2024 in Seattle , Washington. |
| 2024-03-26 | Syndax Pharmaceuticals | Regulatory Syndax Announces FDA Priority Review of NDA for Revumenib for the Treatment of Relapsed/Refractory KMT2Ar Acute Leukemia syndax.com ↗ |
| 2023-12-12 | Syndax Pharmaceuticals | Results Syndax Presents Positive Data from Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia at Late-Breaking Oral Presentation During 65th ASH Annual Meeting syndax.com ↗ |
| 2023-12-11 | Syndax Pharmaceuticals | Results Syndax Announces Positive Data for Revumenib in Patients with Acute Leukemias from the BEAT AML, SAVE AML and AUGMENT-102 Phase 1 Combination Trials syndax.com ↗
100% CRc observed in BEAT AML trial exploring revumenib in combination with venetoclax/azacitidine in newly diagnosed mNPM1 or KMT2Ar AML |
| 2023-11-02 | Syndax Pharmaceuticals | Results Syndax Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Clinical and Business Update syndax.com ↗
We are also pleased to announce final Phase 1 mNPM1 data with a 36% CR/CRh rate, which demonstrates revumenib's ability as a monotherapy with excellent safety and tolerability to drive patients with mNPM1 AML to durable MRD negative remissions. |
| 2023-11-02 | Syndax Pharmaceuticals | Results Syndax Announces Updated Data Supporting Impressive Clinical Profile of Revumenib in Genetically-Defined Acute Leukemias to Be Presented at the 65th ASH Annual Meeting syndax.com ↗
Seven of eight patients were response-evaluable, and all seven attained a morphologic remission (overall response rate of 100%). |
| 2023-10-24 | Syndax Pharmaceuticals | Regulatory Syndax to Initiate NDA Submission of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia Under FDA's Real-Time Oncology Review Program syndax.com ↗
During the Company's pre-NDA meeting, the FDA indicated that it would review the revumenib NDA submission for adult and pediatric KMT2Ar acute leukemia under the Oncology Center of Excellence RTOR Program . |
| 2023-10-02 | Syndax Pharmaceuticals | Results Syndax Announces Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia Meets Primary Endpoint and Stopped Early for Efficacy Following Protocol-Defined Interim Analysis syndax.com ↗ |
| 2023-03-15 | Syndax Pharmaceuticals | Results Syndax Pharmaceuticals Announces Two Publications in Nature of Data from the Phase 1 Portion of AUGMENT-101 in Acute Leukemia Patients syndax.com ↗
In these heavily pretreated patients with a median of four prior therapies, 30% (18/60) experienced a CR/CRh with a median duration of CR/CRh response of 9.1 months. |
| 2022-12-10 | Syndax Pharmaceuticals | Results Syndax Announces Positive Updated Data from Phase 1 Portion of AUGMENT-101 Trial of Revumenib in Patients with Acute Leukemias During Oral Presentations at 64th ASH Annual Meeting syndax.com ↗
In the efficacy evaluable population, the ORR was 53% (32/60) with a CR/CRh rate of 30% (18/60), and 78% (14/18) of patients with CR/CRh attaining minimal residual disease (MRD) negativity. |
| 2022-12-05 | Syndax Pharmaceuticals | Regulatory Syndax Announces U.S. FDA Breakthrough Therapy Designation Granted for Revumenib for the Treatment of Adult and Pediatric Patients with Relapsed or Refractory KMT2A- Rearranged (MLLr) Acute Leukemia syndax.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for revumenib for the treatment of adult and pediatric patients with relapsed or refractory (R/R) acute leukemia harboring a KMT2A rearrangement (KMT2Ar). |
| 2022-11-03 | Syndax Pharmaceuticals | Results Syndax Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Clinical and Business Update syndax.com ↗
Updated positive data from Phase 1 portion of AUGMENT-101 trial demonstrates CR/CRh rate of 30% and a median durability of response of 9.1 months |
| 2022-11-03 | Syndax Pharmaceuticals | Results Syndax Announces Positive Updates to Clinical Activity and Durable Remissions in Phase 1 Portion of AUGMENT-101 Trial of Revumenib in Patients with Acute Leukemias syndax.com ↗
Nine of the 12 patients (75%) who received a stem cell transplant remained in remission as of the data cutoff date, with a median follow-up of 12.3 months, and four patients experienced remission for longer than one year. |
| 2021-12-22 | Syndax Pharmaceuticals | Regulatory Syndax Announces Orphan Drug Designation Granted to SNDX-5613 by European Commission for the Treatment of Acute Myeloid Leukemia syndax.com ↗
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 European Commission has granted Orphan Drug Designation to SNDX-5613, the Company's highly selective oral menin inhibitor, for the treatment of acute myeloid leukemia (AML). |
| 2021-12-13 | Syndax Pharmaceuticals | Results Syndax Pharmaceuticals Announces Additional Positive Data Demonstrating Continued Robust Clinical Activity with Durable Responses in Phase 1 Portion of AUGMENT-101 Trial of SNDX-5613 syndax.com ↗
today announced updated positive data from the Phase 1 dose escalation portion of the AUGMENT-101 trial of SNDX-5613 in patients with mutant nucleophosmin (mNPM1) or mixed lineage leukemia rearranged (MLLr) relapsed/refractory (R/R) acute leukemias. |
| 2021-11-04 | Syndax Pharmaceuticals | Results Syndax Pharmaceuticals to Present Updated Data from SNDX-5613 and Axatilimab Clinical Programs During Oral Sessions at 63rd ASH Annual Meeting syndax.com ↗
For SNDX-5613, updated data from the Phase 1 portion of AUGMENT-101 continue to demonstrate robust clinical activity and a well-tolerated safety profile in heavily pretreated patients with mixed lineage leukemia rearranged (MLLr) or nucleophosmin (NPM1c) mutations. |
| 2021-06-28 | Syndax Pharmaceuticals | Regulatory SNDX-5613 Granted FDA Fast Track Designation for the Treatment of Relapsed/Refractory Acute Leukemias syndax.com ↗
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 Fast Track Designation (FTD) to SNDX-5613 for the treatment of adult and pediatric patients with relapsed or refractory acute leukemias harboring a mixed lineage leukemia rearranged (MLLr) or nucleophosmin (NPM1) mutation. |
| 2021-05-11 | Syndax Pharmaceuticals | Results Syndax Pharmaceuticals Reports First Quarter 2021 Financial Results and Provides Clinical and Business Update syndax.com ↗
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% |
| 2021-04-20 | Syndax Pharmaceuticals | Results Syndax Announces Positive Interim Data Demonstrating Robust Clinical Activity in Phase 1 Portion of the AUGMENT-101 Trial of SNDX-5613 in Patients with Genetically-Defined Acute Leukemias syndax.com ↗ |
| 2020-05-07 | Syndax Pharmaceuticals | Results Syndax Pharmaceuticals Reports First Quarter 2020 Financial Results and Provides Clinical and Business Update syndax.com ↗
Preliminary Phase 1 results from AUGME-T-101 trial of menin inhibitor SNDX-5613 represent first clinical evidence that inhibition of the menin-MLL1 interaction can induce response in patients with MLL-r acute leukemias |
| 2020-04-27 | Syndax Pharmaceuticals | Results Syndax Pharmaceuticals Announces Preclinical Profile and Initial Phase 1 Data Demonstrating Clinical Activity of Menin Inhibitor SNDX-5613 in Adults with Relapsed/Refractory Acute Leukemias syndax.com ↗
Notably, clinical activity was achieved rapidly after a single, 28-day cycle, a highly encouraging sign in this population of patients who face a particularly poor prognosis with few effective treatment options. |
| 2019-12-09 | Syndax Pharmaceuticals | Results Syndax Announces Preclinical Results Supporting Development of its Portfolio of Menin Inhibitors In Mixed Lineage Leukemias syndax.com ↗
Cell lines carrying MLL rearrangements were selectively responsive to VTP-50469, triggering disruption of menin containing transcription complexes and causing changes to gene expression that induced terminal differentiation and cell death. |
| 2019-07-10 | Syndax Pharmaceuticals | Regulatory Syndax Pharmaceuticals Announces FDA Clearance of IND Application for Targeted Menin Inhibitor SNDX-5613 for Relapsed/Refractory Acute Leukemias syndax.com ↗
today announced that the U.S. Food and Drug Administration ( FDA ) has cleared the Company's Investigational New Drug (IND) application to begin a Phase 1/2 trial for SNDX-5613, a targeted Menin inhibitor, in patients with relapsed/refractory (R/R) acute leukemias. |
All press releases naming this drug 53 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SNDX-5613 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03013998 ↗ |
| Known as | revumenib | “treated with the menin inhibitor revumenib (NCT04065399 and NCT05360160).” PMID 41621809 ↗ Jan 2026 |
| Action | Inhibit | “Menin Inhibitor SNDX-5613” NCT05360160 ↗ |
| Route | Oral | “113 mg capsule or 110 mg tablet, oral, every 12 hours” NCT03013998 ↗ |