Syndax’s Revumenib Solid-Tumor Trial Completion: What Investors Should Watch Next

Syndax Pharmaceuticals Inc. (SNDX) announced an update on their ongoing clinical study.

Syndax’s Revumenib Study Offers New Angle on Hard‑to‑Treat Solid Tumors

The study, officially titled “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,” set out to test whether Syndax’s drug revumenib can safely help patients with advanced colorectal cancer and other solid tumors who have already failed at least one prior treatment. The goal is to see if this targeted pill can control tumor growth in a population with limited options, a key step in expanding revumenib beyond blood cancers and broadening Syndax’s long‑term growth story.

The main treatment in the trial is revumenib (SNDX‑5613), an oral drug taken as tablets or capsules two or three times per day in 28‑day cycles. Revumenib is designed to act as a targeted cancer therapy with the aim of slowing or shrinking tumors while keeping side effects manageable. In the later phase of the study, revumenib is compared against standard chemotherapy drugs Lonsurf and Stivarga, which are current options for late‑line colorectal cancer.

This is an interventional trial, meaning researchers are actively giving treatments and tracking outcomes. In early Phase 1, patients are placed in non‑randomized groups as the team slowly increases doses to find a safe and tolerable range. The model is sequential: dose‑finding first, then a “signal‑seeking” expansion to see if there are early signs the drug works. In Phase 2, the design shifts to a randomized layout, with patients assigned to either revumenib or standard chemotherapy in about a two‑to‑one ratio. There is no masking or placebo; both doctors and patients know which treatment is given. The main aim is treatment benefit, not prevention or diagnosis.

The trial was first submitted in February 2023, marking the start of formal regulatory tracking and signaling early pipeline visibility for investors. As a Phase 1/2 study, early parts focus on safety and dosage, while later parts look at clinical benefit over standard care. The study’s overall status is now listed as completed, and the most recent update was filed on January 27, 2026, indicating that data collection has wrapped up and the sponsor is refining and organizing the results. These updates matter because they often precede data disclosures at conferences or in press releases, which can quickly move the stock.

For investors, this update underscores Syndax’s push to turn revumenib into a multi‑indication asset beyond its lead use in blood cancers. A completed solid‑tumor study, even at an early phase, expands the optionality around future trials and partnering discussions. Positive signals versus Lonsurf or Stivarga could support a premium valuation and strengthen Syndax’s position against other small‑cap oncology developers, especially those focused solely on hematologic cancers. On the other hand, weak efficacy or safety issues could limit revumenib’s scope to blood cancers, tempering long‑term revenue expectations. The latest ClinicalTrials listing activity suggests the company is moving toward a data event, which tends to heighten volatility and trading interest around SNDX and, by comparison, other late‑line colorectal cancer players.

The study has been completed and recently updated, with further details available on the ClinicalTrials portal.

To learn more about SNDX’s potential, visit the Syndax Pharmaceuticals Inc. drug pipeline page.