- Trial Phase
- Approved
- Time to Market
- Already FDA-approved and commercializing (first approval Nov 2024, second Oct 2025)
- Why 4/10
- Revuforj is already FDA-approved in two indications (Nov 2024 for KMT2A+ acute leukemia; Oct 2025 for NPM1-mutated AML) with no pending binary regulatory decision in the next 12 months. The next catalysts are pipeline expansion data readouts (frontline AML combination studies, myelofibrosis proof-of-principle trial starting 4Q26 with data in 2H27) and commercial sales growth, none of which constitute a hard binary. Score reflects an approved, growing commercial asset without an imminent make-or-break catalyst.
Watch quarterly Revuforj revenue growth and market share vs. Kura's Komzifti (ziftomenib), which entered the same NPM1-mutated AML space in Nov 2025. Also monitor the Phase 1/2 SAVE combination trial data and the planned myelofibrosis trial (4Q26 start) — any early efficacy signal would open a much larger market. Near-term stock direction hinges on commercial execution rather than binary trial reads.
Price Chart
Executive Summary
Revuforj (revumenib) is Syndax Pharmaceuticals' first-in-class oral menin inhibitor, FDA-approved for two types of relapsed/refractory acute leukemia: KMT2A-rearranged (Nov 2024) and NPM1-mutated AML (Oct 2025). It generated $125M in net revenue in its first full year (FY2025) and $48.9M in Q1 2026 (+144% YoY), with the company's two approved drugs (Revuforj + Niktimvo) annualizing at ~$200M combined. However, Kura Oncology's Komzifti (ziftomenib) won FDA approval for the same NPM1-mutated AML indication in Nov 2025, creating direct competition. Syndax carries a consensus Strong Buy rating with a mean 12-month price target of $39 (~76% upside) and a $352M cash position. The stock has seen insider option exercises and sales (CEO via 10b5-1 plan). The defining binary events are past; the bull case rests on commercial execution, market share retention, and pipeline expansion.
How It Works
Revuforj is a menin inhibitor — an oral pill that blocks a protein called menin which certain leukemia cells need to survive and grow. It targets acute leukemias driven by specific genetic alterations (KMT2A rearrangement or NPM1 mutation). Think of it as a molecular "key" that fits into a lock (menin) that cancer cells rely on, jamming it so the cells can't multiply.
Trial Status
Revuforj is FDA-approved for two indications: (1) Nov 2024 — relapsed/refractory acute leukemia with KMT2A translocation; (2) Oct 2025 — relapsed/refractory NPM1-mutated AML. Both approvals are based on the Phase 1/2 AUGMENT-101 trial. The company is now expanding into earlier treatment lines and new indications: a Phase 1/2 SAVE trial (revumenib + decitabine/cedazuridine + venetoclax) in R/R AML posted data at EHA 2026 and was published in JCO. A Phase 1/2 proof-of-principle trial of revumenib in myelofibrosis is planned to start Q4 2026 with initial data in 2H 2027.
The Two-Sided Case
Upcoming Catalysts
- Q3/Q4 2026 quarterly earnings — Revuforj revenue growth trajectory vs. Komzifti competition
- Phase 2 axatilimab IPF (MAXPIRe trial) topline data — Q4 2026
- Phase 2 axatilimab + ruxolitinib data in cGVHD — Q4 2026
- Revumenib myelofibrosis proof-of-principle trial initiation — Q4 2026 (initial data 2H 2027)
- SNDX-4321 (EGFR inhibitor) IND submission — YE 2026
- EHA / ASH conference presentations with updated Revuforj combination data
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Syndax Pharmaceuticals Inc 8-K SNDX ·Originating report