Syndax Pharmaceuticals Inc.

SNDX

Held by 10 specialist biotech funds

High ConvergenceHigh short interest · No specialist buying

10 funds opened new positions. Next phase2 readout (Axatilimab): Apr 2023. Short interest: 26.1% of float.

Catalysts

Phase 2PositiveQ4 2009EntinostatER+ Breast CancerNCT00828854

Primary: Clinical Benefit Rate (CBR) (6 months)Enrollment:27/27Sites: 6NA, TREATMENT

Phase 2Q1 2010EntinostatNon-Small-Cell Lung Carcinoma, Carcinoma, Non-Small Cell LungNCT00602030

Primary: Identification of Safe-dose for the Phase 2 Double-blind Phase in the Lead-in Phase (Cycle 1 of Lead-in Phase)Enrollment:141/141Sites: 30RANDOMIZED, TRIPLE, TREATMENT

Phase 2PositiveQ1 2011entinostatBreast Cancer, Estrogen Receptor-Positive Breast Cancer, Breast Cancer, Estrogen Receptor-PositiveNCT00676663

Primary: Progression-free Survival (PFS) (From date of randomization to discontinuation due to disease progression or death up to primary completion date (Median follow-up 6 months))Enrollment:130/130Sites: 38RANDOMIZED, TRIPLE, TREATMENT

Phase 2NegativeQ1 2013EntinostatHodgkin's LymphomaNCT00866333

Primary: Percentage of Participants With Best Overall Response Based on the Participant's Best Response That is Documented Within the First 6 Cycles of Protocol Therapy (Up to 6 months)Enrollment:49/49Sites: 6NA, TREATMENT

Phase 2Q1 2019entinostatEpithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube CancerNCT02915523

Primary: Phase 2: Progression Free Survival (PFS), as Determined by the Local Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (From date of randomization to PD or death due to any cause (maximum exposure: 24 cycles [each cycle = 14 days]))Enrollment:140/140Sites: 12RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2PositiveQ3 2022axatilimabChronic Graft-versus-host-diseaseNCT03604692

Phase 2Q3 2022entinostatNon-Small Cell Lung Cancer, Melanoma, Mismatch Repair-Proficient Colorectal CancerNCT02437136

Phase 2PositiveQ2 2023AxatilimabChronic Graft-versus-host-diseaseNCT04710576

Primary: Overall Response Rate (ORR) in the First 6 Cycles as Defined by the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-Versus-Host Disease (cGVHD) (First 6 cycles (up to Cycle 7 Day 1; each cycle = 4 weeks))Enrollment:241/241Sites: 121RANDOMIZED, TREATMENT

Phase 2NegativeQ2 2025RevumenibColorectal Cancer, Solid TumorsNCT05731947

Phase 2Q3 2026AxatilimabIdiopathic Pulmonary FibrosisNCT06132256

Phase 2Q4 2027revumenibAcute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Lineage Acute LeukemiaNCT04065399

Phase 3Q2 2029RevumenibAcute Myeloid LeukemiasNCT07211958

Recent News & Research

PubMed

Salvage With Revumenib: Targeting KMT2A-Rearranged Isolated Leukemia Cutis Identified in the Extramedullary Disease.

# Summary for SNDX Investors This case report describes successful salvage therapy with revumenib (a KMT2A inhibitor) in a patient with isolated leukemia cutis, demonstrating potential clinical utility in extramedullary disease where standard therapies fail. The finding is notable because it suggests revumenib may address an underserved patient population with KMT2A-rearranged acute leukemias presenting with cutaneous manifestations, potentially expanding the addressable market beyond primary hematologic indications. However, this represents a single case study rather than systematic evidence; investors should await prospective data on revumenib's efficacy in extramedullary disease to assess meaningful commercial impact on SNDX's marketed or pipeline assets.

Aug 1, 2026

PubMed

All-Oral Combination of Revumenib, Decitabine, and Venetoclax for Relapsed or Refractory AML (SAVE).

# Investment Summary: Syndax Pharmaceuticals (SNDX) **Clinical Finding:** The all-oral triplet combination of revumenib (SNDX-5613, Syndax's menin inhibitor), decitabine, and venetoclax demonstrated efficacy in relapsed/refractory AML, with potential to address a high-mortality patient population where treatment options are limited. **Commercial Implication:** If data supports favorable safety/efficacy profiles and regulatory approval, this combination could establish revumenib as a cornerstone agent in relapsed/refractory AML, expanding addressable market beyond monotherapy and potentially capturing combination therapy revenue streams alongside established agents (decitabine, venetoclax). **Investor Relevance:** Success here validates revumenib's clinical utility and strengthens Syndax's pipeline valuation; however, outcomes will depend on complete response rates, durability, and safety

Aug 1, 2026

PubMed

Successful Management of Lineage Switch Infant Leukemia With Revumenib and Hematopoietic Cell Transplantation.

# Investment Summary: SNDX Revumenib Case Report This case report documents clinical efficacy of revumenib (SNDX-5613), Syndax's menin inhibitor, in treating lineage switch infant leukemia—a rare but aggressive pediatric malignancy with limited treatment options. The successful response followed by hematopoietic cell transplantation demonstrates revumenib's potential utility in high-risk pediatric leukemia populations, though the case-report nature limits generalizability to broader commercial applicability. For investors, this adds clinical evidence supporting revumenib's label expansion potential in pediatric hematologic malignancies beyond the current approved adult KMT2r-rearranged acute leukemia indication, though regulatory pathway and market size for this rare pediatric subset remain uncertain.

Apr 2, 2026

PubMed

Revumenib-Induced QTc Prolongation Leading to Multiple Episodes of Torsades de Pointes and Ventricular Arrhythmias.

# Investment Summary: SNDX Cardiac Safety Signal This case report documents severe cardiac toxicity (QTc prolongation and torsades de pointes) associated with revumenib, Syndax's lead menin inhibitor program currently in clinical development for acute leukemias. The adverse event raises potential cardiac safety concerns that could complicate the clinical development pathway, require additional monitoring protocols, or trigger additional cardiac studies that extend timelines and increase development costs. Investors should monitor regulatory feedback and upcoming trial data for the frequency and severity of cardiac events, as this safety profile could impact market positioning relative to competing menin inhibitors and the ultimate commercial viability of the program.

Jan 1, 2026

Syndax Pharmaceuticals Inc.

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