Earnings summaries and quarterly performance for Syndax Pharmaceuticals.
Executive leadership at Syndax Pharmaceuticals.
Board of directors at Syndax Pharmaceuticals.
Research analysts who have asked questions during Syndax Pharmaceuticals earnings calls.
Jason Zemansky
Bank of America
4 questions for SNDX
Peter Lawson
Barclays PLC
4 questions for SNDX
George Farmer
Scotiabank
3 questions for SNDX
Justin Zelin
BTIG, LLC
3 questions for SNDX
Michael Schmidt
Guggenheim Securities
3 questions for SNDX
Salim Syed
Mizuho Securities
3 questions for SNDX
Yigal Nochomovitz
Citigroup Inc.
3 questions for SNDX
Anupam Rama
JPMorgan Chase & Co.
2 questions for SNDX
Bradley Canino
Stifel
2 questions for SNDX
Chris Shibutani
Goldman Sachs Group, Inc.
2 questions for SNDX
Kalpit Patel
B. Riley Securities
2 questions for SNDX
Kelly Shi
Jefferies
2 questions for SNDX
Philip Nadeau
TD Cowen
2 questions for SNDX
Priyanka Grover
JPMorgan Chase & Co.
2 questions for SNDX
Xiaochuan Dai
UBS
2 questions for SNDX
Ashiq Mubarack
Citigroup Inc.
1 question for SNDX
Chloe
Scotiabank
1 question for SNDX
David Dai
UBS Group AG
1 question for SNDX
Dingding Shi
Jefferies
1 question for SNDX
Ellen Horste
TD Cowen
1 question for SNDX
Jeet Mukherjee
Leerink Partners
1 question for SNDX
Kevin Strang
Goldman Sachs Group
1 question for SNDX
Mayank Mamtani
B. Riley Securities
1 question for SNDX
Recent press releases and 8-K filings for SNDX.
- Syndax achieved a transformational 2025, becoming a commercial-stage oncology company with the launch of Revuforge and Niktimvo, securing three FDA approvals in 14 months, and is on the road to profitability with approximately $400 million on its balance sheet.
- Revuforge generated $44 million in preliminary net revenue for Q4 2025 (up 38% quarter-over-quarter) and $125 million for full-year 2025, surpassing benchmarks for other AML therapies. The recent NPM1 indication approval in November 2025 tripled the patient population, expanding its total addressable market to potentially $5 billion.
- Niktimvo delivered $56 million in preliminary net revenue for Q4 2025 (up 22% quarter-over-quarter) and $152 million for full-year 2025, exceeding competitor benchmarks. Syndax books 25-30% of Niktimvo net revenue.
- Key milestones for 2026 include reporting top-line Phase 2 Axatilimab (Niktimvo) data in Idiopathic Pulmonary Fibrosis (IPF) in the second half of 2026 and advancing global enrollment in pivotal first-line trials for Revuforge.
- Syndax reported strong preliminary net revenues for Q4 2025 and full-year 2025: Revuforge generated $44 million in Q4 2025 (up 38% quarter-over-quarter) and $125 million for the full year, while Niktimvo generated $56 million in Q4 2025 (up 22% quarter-over-quarter) and $152 million for the full year.
- Revuforge received its second FDA approval in November 2025 for relapsed refractory NPM1 mutation, expanding its total addressable market to $2 billion for current indications and potentially $5 billion in the front-line setting.
- Niktimvo has an estimated $2 billion total addressable market in third-line plus GVHD and a significant opportunity in Idiopathic Pulmonary Fibrosis (IPF) with 150,000 patients in the US.
- Key milestones for 2026 include reporting top-line Phase 2 Axatilimab data for IPF in the second half of 2026 and advancing pivotal first-line trials for Revuforge.
- Syndax successfully transitioned to a commercial-stage oncology company in 2025 with the launch of Revuforj and Niktimvo.
- Revuforj generated $44 million in preliminary net revenue for Q4 2025 (up 38% quarter-over-quarter) and $125 million for full-year 2025, surpassing benchmarks for other AML therapies.
- Niktimvo generated $56 million in preliminary net revenue for Q4 2025 (up 22% quarter-over-quarter) and $152 million for full-year 2025, exceeding competitor first-year sales.
- The company has approximately $400 million on its balance sheet and is on the road to profitability.
- A key upcoming milestone is the top-line Phase 2 data for Niktimvo in idiopathic pulmonary fibrosis (IPF), expected in the second half of 2026.
- Syndax Pharmaceuticals reported preliminary (unaudited) Revuforj net revenue of approximately $44 million for Q4 2025 and $125 million for full year 2025, reflecting a 38% increase in Q4 2025 compared to Q3 2025.
- Preliminary (unaudited) Niktimvo net revenue was $56 million for Q4 2025 and $152 million for full year 2025.
- The company ended 2025 with approximately $394 million in cash, cash equivalents, and marketable securities, stating it is fully funded through profitability.
- For the full year 2026, total research and development plus selling, general and administrative expenses are expected to be approximately $400 million, excluding estimated non-cash stock compensation expense.
- Syndax Pharmaceuticals and the World Orphan Drug Alliance (WODA) have partnered to launch a Managed Access Program for Revuforj® (revumenib).
- This program aims to expand access to Revuforj in regions outside the U.S. where the drug is not commercially available, but local regulations permit access to novel medicines and funding can be secured.
- The program will be launched in parts of Eurasia, Central and Southeast Europe, Israel, the Middle East and Turkey, Latin America, and Africa.
- Revuforj is an FDA-approved first-in-class menin inhibitor for the treatment of relapsed or refractory acute leukemia with a KMT2A translocation and acute myeloid leukemia (AML) with an NPM1 mutation in adult and pediatric patients.
- Syndax Pharmaceuticals' Revuforj® (revumenib), a first-in-class menin inhibitor, was recognized as Best New Drug at the Scrip Awards 2025.
- Revuforj received FDA approval in November 2024 for the treatment of relapsed or refractory acute leukemia with a KMT2A translocation.
- A second FDA approval was granted in October 2025 for relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation.
- Syndax has made significant progress in the last 15 months, building a sustainable growth engine with two products, Niktimvo and Revuforj, addressing a $10 billion total addressable market and is on track for profitability in the next few years.
- Revuforj, the first and only menin inhibitor, achieved $88 million in net revenue as of Q3 since its 2025 launch, treating 750 new patients and is on track to treat 1,000 KMT2A patients by year-end, with a second indication in NPM1 as of October.
- Niktimvo, the first and only CSF1R blocking antibody for chronic GVHD, has generated $96 million in net sales since launch and is annualizing about $200 million within its first eight months, with trials underway for expansion into frontline GVHD and IPF.
- Clinical data presented at ASH 2025 for Revuforj in combination therapies showed high efficacy, including an 86% objective response rate and 79% CR/CR8 in the SAVE trial, and 100% response rate and MRD negativity in the Study 708 for KMT2A patients.
- Syndax Pharmaceuticals has made significant progress in building a sustainable growth engine with its two products, Niktimvo and Revuforj, addressing a $10 billion total addressable market.
- Revuforj, FDA approved for multiple acute leukemia subtypes including KMT2A and NPM1, generated $88 million in net revenue as of the third quarter and is on track to treat approximately 1,000 KMT2A patients by year-end 2025, representing 50% penetration of the 2,000 incidence market.
- Niktimvo, the first and only CSF-1R blocking antibody FDA approved for chronic GVHD in the third line plus, achieved $96 million in net sales since launch and is annualizing at approximately $200 million within its first eight months, having been profitable to Syndax since its first full quarter of launch.
- The company is pursuing an extensive development program for both products, including expanding Revuforj into frontline settings with studies like EVOLVE-2 and REVEAL, and exploring Niktimvo for frontline GVHD and new indications such as Idiopathic Pulmonary Fibrosis (IPF), with IPF data expected in the second half of next year.
- Syndax Pharmaceuticals has successfully transitioned to a commercial organization, with its two key products, Niktimvo and Revuforj, exceeding industry benchmarks in their respective launches.
- Revuforj, the first and only menin inhibitor for acute leukemia, has generated $88 million in net revenue since launch as of Q3 and is on track to treat 1,000 KMT2A patients by year-end, representing 50% penetration of that market. The total addressable market is projected to expand from $2 billion+ to $5 billion+ with newly diagnosed patients.
- Niktimvo, an FDA-approved CSF-1R blocking antibody for chronic GVHD, has achieved $96 million in net sales since launch and is annualizing about $200 million within its first eight months, demonstrating profitability since its first full quarter of launch.
- The company is advancing an extensive development program for both products, including trials for earlier lines of therapy and new indications, with 23 presentations at the ASH conference showcasing scientific progress.
- Syndax Pharmaceuticals is experiencing strong launches for Revuforj and Niktimvo, with Revuforj recently approved for a second indication (NPM1) and achieving 50% penetration in the KMT2A incidence population by year-end.
- Revuforj is significantly improving transplant rates for KMT2A patients (up to 30% vs. 5% historically) and seeing high rates of maintenance therapy (currently 35-40%, with potential for 70-90%), driving substantial market growth.
- Niktimvo for chronic GVHD is performing exceptionally well, tracking with a competitor's $550 million third-year sales and demonstrating high patient persistency (over 80% staying on therapy from launch).
- The company is actively pursuing label expansion for Revuforj into frontline AML with two pivotal trials underway, showing promising early data for the Ven-Aza combination with 70% CR rates.
- Syndax expects to achieve profitability, supported by $456 million in cash, the significant contributions from both high-margin products, and the efficiency of targeting the same physician audience.
Quarterly earnings call transcripts for Syndax Pharmaceuticals.
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