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Syndax Pharmaceuticals, Inc. (symbol: SNDX) is a clinical-stage biopharmaceutical company headquartered in Waltham, Massachusetts. Dedicated to the development of combination therapies, the company primarily focuses on innovative treatments for various cancer indications.
Syndax's pipeline is rich with promising drugs aimed at improving the lives of cancer patients. The company's leading candidates include entinostat, an agent that targets both cancer cells and immune regulatory cells, and revumenib, a selective inhibitor of the menin-KMT2A binding interaction. This agent is particularly geared towards addressing acute leukemias such as KMT2A-rearranged (KMT2Ar) and NPM1-mutant acute myeloid leukemia (AML). Another notable product in development is axatilimab, a monoclonal antibody designed to enhance the immune response against tumors through CSF-1R inhibition.
Syndax operates primarily within the United States and has achieved several milestones. Recently, the company completed enrollment in the pivotal AUGMENT-101 trial for revumenib targeting relapsed/refractory mutant nucleophosmin (mNPM1) AML. The trial aims to evaluate revumenib's safety, tolerability, and efficacy, with topline data expected by the end of 2024. Positive results from this trial could support new drug applications in early 2025.
Revumenib has achieved several regulatory designations, including Orphan Drug, Fast Track, and Breakthrough Therapy by the FDA, reflecting its potential to address unmet clinical needs in leukemias. Syndax has also reported encouraging outcomes from its studies, including high response rates and favorable safety profiles in both adult and pediatric populations suffering from acute leukemia.
Financially, Syndax maintains a robust position to advance its clinical programs. The company regularly updates stakeholders through earnings calls and investor presentations, with a recent update scheduled for May 2024. Syndax's progress is further bolstered by strategic partnerships and collaborations that support its mission to innovate and deliver significant value to patients and shareholders alike.
Syndax Pharmaceuticals (SNDX) announced additional positive data from two clinical trials for Revuforj® (revumenib): the AUGMENT-101 trial in relapsed/refractory mNPM1 AML and the BEAT AML frontline combination trial. Key highlights include:
In the AUGMENT-101 trial's Phase 2 cohort, the protocol-defined efficacy population showed 23% CR+CRh rate and 47% ORR. In the expanded analysis of 77 evaluable patients, 26% achieved CR+CRh and 48% achieved overall response.
The BEAT AML trial, combining revumenib with venetoclax/azacitidine in newly diagnosed patients, demonstrated remarkable results with 100% ORR (37/37) and 95% CRc (35/37). The safety profile remained consistent with previous data, showing manageable differentiation syndrome and QTc prolongation events.
Syndax Pharmaceuticals (SNDX) presented positive data from multiple trials of Revuforj® (revumenib) at the 66th ASH Annual Meeting. Key highlights include:
- SAVE trial: 82% overall response rate (27/33 patients) and 48% CR/CRh rate (16/33 patients) in combination with venetoclax and decitabine/cedazuridine in R/R AML
- AUGMENT-101 trial: 64% overall response rate (62/97 patients) and 23% CR/CRh rate (22/97 patients) in R/R KMT2Ar acute leukemia patients, with high MRD negativity rates
- INTERCEPT trial: 54% (6/11) of evaluable mNPM1 patients showed MRD reduction, with 36% (4/11) achieving MRD negativity
The drug demonstrated rapid responses, durability, and favorable tolerability across trials.
Syndax Pharmaceuticals (NASDAQ: SNDX) announced the granting of inducement awards to two new employees under its 2023 Inducement Plan. The awards consist of stock options to purchase up to 23,900 shares of common stock. The options have a four-year vesting schedule, with 25% vesting after one year and the remaining shares vesting monthly over the following 36 months at a rate of 1/48th per month, contingent on continued employment with Syndax.
Syndax Pharmaceuticals (NASDAQ: SNDX) announced that CEO Michael A. Metzger will participate in a panel discussion focused on novel mechanisms in oncology at the Citi 2024 Global Healthcare Conference. The panel is scheduled for Thursday, December 5, 2024, at 11:00 a.m. ET. A live webcast will be available on the company's website investor section, with a replay option available for a time.
Syndax Pharmaceuticals (SNDX) has received FDA approval for Revuforj® (revumenib), the first menin inhibitor for treating relapsed or refractory acute leukemia with KMT2A translocation in patients aged one year and older. The approval is based on the AUGMENT-101 trial results, where 21% of patients achieved complete remission plus CR with partial hematological recovery. The median duration of response was 6.4 months, and 23% of patients underwent stem cell transplantation following treatment. The drug will be available in the US through specialty distributors in November 2024, with 25mg tablets expected in early 2025.
Syndax Pharmaceuticals (SNDX) announced positive topline results from the AUGMENT-101 trial of revumenib in relapsed/refractory mNPM1 AML patients. The trial met its primary endpoint with a 23% complete remission rate (p-value = 0.0014) and achieved a 47% overall response rate in a heavily pre-treated population. The safety profile was favorable, with only 5% of patients discontinuing due to treatment-related adverse events. The company plans to submit a supplemental New Drug Application (sNDA) in the first half of 2025, following anticipated FDA approval for KMT2Ar acute leukemia in Q4 2024.
Syndax Pharmaceuticals (SNDX) reported Q3 2024 financial results with a net loss of $84.1 million ($0.98 per share). The company secured FDA approval for Niktimvo for chronic GVHD treatment and expects its launch by early Q1 2025. A $350 million royalty funding agreement with Royalty Pharma was announced. The company's revumenib NDA for R/R KMT2Ar acute leukemia has a PDUFA date of December 26, 2024. Cash position stands at $399.6 million, with R&D expenses increasing to $71.0 million and SG&A expenses rising to $31.1 million. Full-year 2024 operating expenses are projected at $365-370 million.
Syndax Pharmaceuticals (SNDX) has announced an upcoming investor event scheduled for December 9, 2024, at 7:00 a.m. PT/10:00 a.m. ET during the 66th American Society of Hematology Annual Meeting in San Diego. The event will be held both in-person and via webcast.
The company's management team will collaborate with key opinion leaders to present updates on their revumenib and Niktimvo™ (axatilimab-csfr) programs. Interested parties can access the live webcast through the Investor section of Syndax's website, where a recording will also be available temporarily.
Syndax Pharmaceuticals (SNDX) announced new data from secondary analysis of the AGAVE-201 trial for Niktimvo™ (axatilimab-csfr) in chronic graft-versus-host disease to be presented at the ASH Annual Meeting. The pivotal trial met its primary endpoint with a 75% overall response rate at the approved dose of 0.3 mg/kg. More than half of responders showed clinical response by day 56, with an estimated 60% maintaining response at 12 months. Organ-specific responses ranged from 1.2 to 3.7 months, with GI tract, liver, and joints responding faster than lung, mouth, eye, and skin manifestations.
Syndax Pharmaceuticals (SNDX) presented positive data for revumenib, their oral menin inhibitor, at the ASH Annual Meeting. Key highlights include:
- 64% Overall Response Rate (62/97) in patients with R/R KMT2Ar acute leukemia in Phase 2 AUGMENT-101 pivotal cohort
- 88% Overall Response Rate (23/26) in SAVE trial testing revumenib combination therapy in R/R AML
The FDA has granted Priority Review for revumenib's New Drug Application with a PDUFA date of December 26, 2024. The company also completed enrollment for the final AUGMENT-101 pivotal trial cohort in R/R mNPM1 AML patients, with topline data expected in Q4 2024.
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