NEW YORK, July 14, 2026
Syndax Pharmaceuticals unveiled two new pipeline candidates during its 2026 R&D Event, expanding its precision oncology portfolio with SNDX-4321, a mutant-selective allosteric EGFR inhibitor for non-small cell lung cancer (NSCLC), and SNDX-62122, a next-generation menin inhibitor selected for development in myelofibrosis (MF). The company also highlighted progress across its late-stage clinical programs, including Revuforj® (revumenib), Niktimvo™ (axatilimab-csfr), and the ongoing Phase 2 trial of axatilimab in idiopathic pulmonary fibrosis (IPF), with topline results expected in the fourth quarter of 2026.
SNDX-4321 Targets Unmet Needs in EGFR-Mutated NSCLC
Syndax introduced SNDX-4321, a novel mutant-selective allosteric EGFR inhibitor designed to address treatment-resistant EGFR-mutated NSCLC, including patients with L858R mutations, central nervous system metastases, atypical activating mutations, and acquired resistance to current EGFR therapies. Unlike conventional ATP-binding EGFR inhibitors, SNDX-4321 targets an adjacent allosteric binding pocket accessible only in specific mutant forms of EGFR. The company plans to submit an Investigational New Drug (IND) application by the end of 2026 and initiate a Phase 1 clinical trial in 2027, supported by encouraging preclinical data demonstrating its differentiated mechanism.
Next-Generation Menin Inhibitor Selected for Myelofibrosis
Syndax also announced SNDX-62122 as the first internally developed next-generation menin inhibitor selected for clinical development beyond leukemia. The candidate will be advanced for myelofibrosis, supported by preclinical findings indicating that menin is a key dependency in proliferative megakaryocytes involved in disease progression. The company expects to file an IND and begin a Phase 1 study in 2027, while a proof-of-principle Phase 1/2 trial of revumenib in myelofibrosis is scheduled to begin in the fourth quarter of 2026, with initial clinical data anticipated during the second half of 2027.
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Late-Stage Programs Continue to Generate Multiple Catalysts
In addition to its newly announced assets, Syndax highlighted ongoing development of Revuforj® (revumenib) in newly diagnosed acute leukemia and Niktimvo™ (axatilimab-csfr) in chronic graft-versus-host disease. The company also reaffirmed that the Phase 2 study evaluating axatilimab in idiopathic pulmonary fibrosis (IPF) remains on track to deliver topline results in the fourth quarter of 2026. Syndax stated that its expanding portfolio, internally developed drug discovery capabilities, and multiple upcoming clinical milestones position the company to further strengthen its leadership in precision oncology and targeted therapies.
Source: Syndax Pharmaceuticals press release
