Revumenib Drug Asset Due Diligence Report 2026: Clinical, IP, Market, Deals, and Go/No-Go
This Revumenib Drug Asset Due Diligence Report was built with PatSnap Life Sciences MCP workflows. Drug & Asset MCP establishes identity, ownership and stage; Clinical Trials MCP checks design, endpoints and readouts; Company & Deal Intelligence MCP reconstructs transaction precedent. Explore the MCP servers used in this report.
Decision date: 15 July 2026. Currency fields are presented in US$ millions as returned by the deal dataset. This is a screening memorandum, not legal, medical, patent or investment advice.
Approved
Highest phase
29
Registered trials
39
Result records
5
Matched deals
Executive recommendation: GO
Decision memo
Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.
The central underwriting question is whether Revumenib can convert its Small molecule drug profile and menin biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.
1. Asset identity and development status
| Asset | Revumenib (query alias: revumenib) |
|---|---|
| Modality / target | Small molecule drug; menin; menin inhibitors |
| Highest global status | Approved |
| Originator | Syndax Pharmaceuticals, Inc. |
| Active developers | Syndax Pharmaceuticals, Inc., The Children's Oncology Group Foundation, Inc., AbbVie, Inc. |
The MCP disease footprint includes Acute myeloid leukemia with mutated NPM1, Acute Leukemia with a KMT2A Translocation, Acute Myeloid Leukemia. The highest-phase flag is a useful orientation point, but the licensing case depends on indication-level evidence and rights, not the global label alone.
2. Clinical program: design and endpoint audit
| Registry | Phase | Status | Enrollment | Lead primary endpoint |
|---|---|---|---|---|
| NCT07563010 | Phase 2 | Not yet recruiting | 146 | Relapse free survival (RFS) in KMT2Ar, NPM1m, and NUP98r AML in the Intent-to-Treat (ITT) population with a minimum of 1 year of follow-up post-randomization. |
| NCT07636564 | Phase 2 | Not yet recruiting | 90 | Dose limiting toxicities (Safety run-in: Cohort A) |
| NCT07605949 | Phase 2 | Not yet recruiting | 88 | Complete remission rate |
The trial set should be diligenced for randomization, comparator relevance, endpoint hierarchy, analysis population, multiplicity, geographic mix and readout timing. For early-stage studies, safety and dose selection can be as decision-critical as response rate.
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3. Clinical readouts: what is known
A Phase 1/2 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SNDX-5613 in Patients With Colorectal Cancer and Other Solid Tumors
Phase 1/2; n=41; evaluation: not stated. Reported fields: -; -; Phase 1a: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) = 0 Participants
A phase 3 study of revumenib in combination with intensive chemotherapy in patients with newly diagnosed NPM1-mutated acute myeloid leukemia (REVEAL-ND NPM1).
Phase 3; n=468; evaluation: Positive. Reported fields: CRS = 68.0 % ; -
REVUMENIB + VENETOCLAX/AZACITIDINE IN ADULTS WITH NEWLY DIAGNOSED NPM1M OR KMT2AR ACUTE LEUKEMIA INELIGIBLE FOR INTENSIVE CHEMOTHERAPY (EVOLVE-2/HO177/AMLSG35-24/ACT-HOV-AML-002): TRIAL IN PROGRESS
Phase 3; n=448; evaluation: Positive. Reported fields: -; CRS = 73.0 %
These fields are structured evidence signals, not a substitute for statistical review. The next diligence pass should reconcile denominators, confidence intervals, follow-up, censoring, dose cohorts and treatment-emergent toxicity against the original abstract, registry and protocol.
4. Market and competitive position
Revumenib addresses Acute myeloid leukemia with mutated NPM1, Acute Leukemia with a KMT2A Translocation, Acute Myeloid Leukemia. Commercial attractiveness rests on addressable biomarker-positive patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Small molecule drug—must demonstrate a benefit large enough to offset class-specific safety and operational costs.
The strongest market-validation signal in this screen is partner behavior: 5 matched transaction record(s) indicate that sophisticated counterparties have assigned strategic value to the asset or its rights. That does not establish net present value; probability of success, remaining R&D spend, royalties, cost sharing and territorial scope still need modeling.
5. Transaction precedent and economics
Transaction-scope note: No direct asset-specific transaction was returned. The table below shows target-level comparable: menin records as comparable precedents only.
| Date | Transaction | Phase at deal | Disclosed economics |
|---|---|---|---|
| 2025-05-23 | Servier To Acquire a Potential Best-in-Class Precision Therapy for Acute Leukemias, from BioNova Pharmaceuticals | Phase 1/2 | Financial terms not disclosed |
| 2025-02-18 | Foundation Medicine Collaborates with Sumitomo Pharma America to Advance Investigational Treatment for Patients with Acute Leukemia with NPM1 Mutations or KMT2A Rearrangements Using the FoundationOne®Heme Platform | Phase 1/2 | Financial terms not disclosed |
| 2024-11-20 | Kura Oncology and Kyowa Kirin Announce Global Strategic Collaboration to Develop and Commercialize Ziftomenib in Acute Leukemias | NDA/BLA | US$330.0M upfront; US$1,161.0M milestones |
Headline values are not directly comparable. Diligence should normalize upfront cash, equity, development and sales milestones, tiered royalties, opt-in mechanics, cost sharing, change-of-control clauses and geography.
6. IP and freedom-to-operate screen
The milestone feed surfaced a patent-application signal described as “Methods of treating acute leukemias with a menin inhibitor in a combination therapy”. The milestone feed surfaced a patent-application signal described as “Methods of improving glycemic control with a menin inhibitor”. The milestone feed surfaced a patent-application signal described as “Salts and polymorphic forms of menin inhibitors and pharmaceutical compositions thereof”.
The claim chart should separately test composition or sequence coverage, formulation and dosing, indication and biomarker claims, combinations, manufacturing know-how, prosecution history, term extensions and third-party blocking rights. Confirm that licensed patents, data and know-how track every granted territory and field.
7. Principal risks and diligence gates
- Therapeutic index across KRAS/BRAF mutation subgroups
- On-target toxicity and adaptive MAPK resistance
- Lack of matched efficacy results in the current MCP result set
Cross-functional diligence should also test CMC comparability, supply chain, pharmacovigilance, regulatory correspondence, data integrity, investigator concentration, partner obligations and change-of-control restrictions.
8. Final go/no-go memorandum
GO
Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.
Required pre-signing gates: reproduce key efficacy analyses; complete an indication-specific safety review; run a full patent-family and freedom-to-operate search; model risk-adjusted economics by territory; and reconcile all rights, sublicenses and encumbrances.
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Data provenance: PatSnap Drug & Asset MCP, Clinical Trials MCP, and Company & Deal Intelligence MCP; accessed 15 July 2026. Counts and status fields may change as source records update.
