Syndax Pharmaceuticals, Inc. (SNDX) Business Model Canvas

Syndax Pharmaceuticals, Inc. (SNDX): Business Model Canvas [Dec-2025 Updated]

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You're looking at Syndax Pharmaceuticals, Inc. (SNDX) right now, and honestly, they've hit that critical inflection point where the science meets the street. This is a commercial-stage biotech, driven by two novel assets, but still running that calculated burn rate needed to expand their pipeline. Seeing $45.9 million in Q3 2025 revenue from Revuforj and Niktimvo is a huge step, especially with $456.1 million in the bank as of September 30, 2025, to fund that heavy R&D spend. This canvas breaks down exactly how they plan to turn first-in-class science-like Revuforj for rare leukemias-into sustainable business, balancing near-term sales against the high costs of clinical expansion. They are betting big on targeted therapy. Let's dig into the nine blocks that define their strategy right now.

Syndax Pharmaceuticals, Inc. (SNDX) - Canvas Business Model: Key Partnerships

You're looking at the core relationships that power Syndax Pharmaceuticals, Inc.'s commercial engine and pipeline development as of late 2025. These aren't just handshake agreements; they are deep, financially significant alliances that dictate revenue sharing and R&D scope. Honestly, for a company with two commercial products, these partnerships are the backbone of the business model.

Incyte Corporation for Co-commercialization of Niktimvo (axatilimab) in the U.S.

The co-commercialization agreement with Incyte Corporation for Niktimvo (axatilimab-csfr) is a major revenue driver. Syndax Pharmaceuticals, Inc. doesn't just get a royalty; it shares the commercial risk and reward directly. Specifically, Syndax records 50% of the Niktimvo net commercial profit or loss, which is calculated as net product revenue (recorded by Incyte) minus the cost of sales and commercial expenses. This structure means Syndax is deeply integrated into the U.S. sales execution.

Here's a look at the recent financial flow from this collaboration:

Metric Period Incyte Reported Niktimvo Net Revenue Syndax Collaboration Revenue Share
Third Quarter 2025 3Q 2025 $45.8 million $13.9 million
Second Quarter 2025 2Q 2025 $36.2 million $9.4 million
First Partial Quarter 2025 1Q 2025 $13.6 million ($0.2 million) loss share

It's worth noting that Niktimvo generated $50 million in net revenue in just its first 5 months on the market. Furthermore, Syndax secured a significant non-dilutive financing event in March 2025, receiving $350 million upfront from Royalty Pharma in exchange for a 13.8% capped synthetic royalty on U.S. net sales of Niktimvo. That cash infusion helps fund operations to profitability.

UCB S.A. as the Original Licensor of Exclusive Worldwide Rights for Niktimvo (axatilimab)

The foundation of the Niktimvo asset rests on the original agreement with UCB S.A. Syndax Pharmaceuticals, Inc. licensed the exclusive worldwide rights to develop and commercialize axatilimab from UCB back in 2016. This is a classic biotech partnership structure where the originator licenses out development/commercialization rights to a focused company.

The financial obligations tied to this original license are structured as follows:

  • Potential milestone payments due to UCB: up to $119.5 million in one-time development and regulatory payments.
  • Ongoing obligation: low double-digit royalties on commercialized axatilimab sales.

This deal structure ensures UCB retains a stake in the long-term success of the asset Syndax developed.

Academic Medical Centers like MD Anderson for Clinical Trial Collaboration

Syndax Pharmaceuticals, Inc. relies heavily on academic collaborations to advance its pipeline, particularly for combination studies that explore new treatment settings. The SAVE Phase 1/2 trial, which evaluates an all-oral combination of revumenib with venetoclax and decitabine/cedazuridine, is being conducted by investigators from MD Anderson Cancer Center. Data presented at the 2025 ASH Annual Meeting from this trial showed impressive early results:

  • Overall Response Rate (ORR): 82% (27/33 patients).
  • Complete Remission (CR) / CR with incomplete blood count recovery (CRh) rate: 48% (16/33 patients).

Also, the BEAT AML trial, part of The Leukemia & Lymphoma Society's Master Clinical Trial, showed an ORR of 100% (37/37) and a composite complete remission (CRc) rate of 95% (35/37) in its Phase 1b cohort.

Contract Manufacturing Organizations (CMOs) for Drug Production and Supply Chain

While Syndax Pharmaceuticals, Inc. does not publicly name its specific Contract Manufacturing Organizations (CMOs), the company has emphasized its supply chain resilience. Management stated at the June 2025 Jefferies Global Healthcare Conference that they source ingredients and build/manufacture final goods in The U.S. This domestic focus is positioned as a strength, minimizing impact from potential international policy changes.

The company's operational update in June 2025 suggested strong commercial readiness:

Product Metric Status/Target
Revuforj (revumenib) Institution Penetration 44% of Tier 1 and Tier 2 institutions by March 2025; expectation to exceed 50% soon.
Revuforj (revumenib) Payer Coverage Increased from 70% to over 90%.
Niktimvo (axatilimab) Patient Access Time 80% of patients receive the drug within a week.

Strategic Collaborations for Pipeline Expansion into Frontline Settings

The partnerships are key to unlocking the next level of value, specifically by moving both assets into earlier lines of therapy. For Niktimvo, Syndax and Incyte are actively conducting combination trials in earlier chronic GVHD settings. These include a Phase 2 trial with ruxolitinib (NCT06388564) and a Phase 3 trial with steroids (NCT06585774).

For Revuforj, the move to the frontline setting is a massive opportunity. Syndax estimates the frontline market for Revuforj could represent a $5 billion market, significantly larger than the estimated $2 billion market for relapsed disease. This expansion is being pursued through ongoing and planned Phase 3 combination trials, such as the EVOLVE-2 pivotal trial investigating revumenib plus venetoclax and azacitidine in unfit newly diagnosed mNPM1 AML patients.

Also, Syndax is exploring an entirely new indication for axatilimab in idiopathic pulmonary fibrosis (IPF) via an ongoing Phase 2 clinical trial (MAXPIRe, NCT06132256).

Finance: draft 13-week cash view by Friday.

Syndax Pharmaceuticals, Inc. (SNDX) - Canvas Business Model: Key Activities

You're looking at the core actions Syndax Pharmaceuticals, Inc. is taking right now to turn its pipeline into revenue, which is all about execution on two approved drugs and pushing the next wave of data. Here's the quick math on what's keeping the team busy as of late 2025.

Commercialization and U.S. launch execution for Revuforj and Niktimvo

The immediate focus is driving uptake for both Revuforj (revumenib) and Niktimvo (axatilimab-csfr). You see the results of this execution in the quarterly revenue figures. For the third quarter of 2025, total revenue hit $45.9 million, which was a 21% increase from the second quarter of 2025. Honestly, the combined net sales for Q3 2025 were over $75 million.

Revuforj, launched in late November 2024, is showing strong adoption in its initial indication (R/R acute leukemia with a KMT2A translocation) and is now expanding into the new one. Niktimvo, launched in late January 2025, is also gaining traction in chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy.

Metric Revuforj (Revumenib) Niktimvo (Axatilimab-csfr)
Q3 2025 Net Revenue (Syndax) $32.0 million N/A (Collaboration Revenue)
Q2 2025 Net Revenue (Syndax) $28.6 million N/A (Collaboration Revenue)
Q3 2025 Collaboration Revenue (Syndax Share) N/A $13.9 million
Q2 2025 Collaboration Revenue (Syndax Share) N/A $9.4 million
Prescription Growth (QoQ) 25% increase in Q3 2025 over Q2 2025 N/A
Niktimvo Net Revenue (Incyte Reported) N/A $45.8 million in Q3 2025

Ongoing Research and Development (R&D) for new indications and pipeline assets

You have to fund the pipeline to get to profitability, and that means significant R&D spend. For the full year 2025, the guidance for Research and Development expenses alone was set between $260 million and $280 million. For the second quarter of 2025, R&D expenses were $62.2 million. The company is definitely focused on expanding Revuforj into the frontline setting and advancing Niktimvo in other areas, like idiopathic pulmonary fibrosis (IPF).

The overall operating expense guidance for the full year 2025 (R&D plus SG&A, excluding stock compensation) is $370 to $390 million. Still, as of September 30, 2025, the cash reserve was $456.1 million, which management expects will fund the company to profitability.

Regulatory affairs and securing expanded FDA approvals (e.g., Revuforj for R/R NPM1m AML in Oct 2025)

This is a huge win for the Key Activities section. Syndax secured the second indication for Revuforj on October 24, 2025, when the FDA approved it for relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients one year and older. This makes Revuforj the first and only therapy approved for both R/R AML with an NPM1 mutation and R/R acute leukemia with a KMT2A translocation.

The data supporting this approval came from the AUGMENT-101 trial, where the main efficacy outcome measures showed:

  • CR plus CRh rate was 23.1% (95% CI: 13.5, 35.2).
  • Median CR+CRh duration was 4.5 months (95% CI: 1.2, 8.1).
  • 17% (8 of 46 patients) converted to RBC and platelet transfusion independence.

Also, in late September 2025, Revuforj was added to the NCCN Clinical Practice Guidelines in Oncology for R/R NPM1m AML as a category 2A recommended treatment option.

Clinical trial management for frontline and combination therapies

The company is actively managing several trials to expand the use of its assets beyond the currently approved indications. For Revuforj, data from a trial combining it with intensive chemotherapy (7+3) in newly diagnosed patients was anticipated in the second half of 2025. Furthermore, the Phase 2 IPF trial for Niktimvo is complete with enrollment in 2025, and topline data is expected in 2026.

Key ongoing combination trials include:

  • Revuforj with venetoclax and azacitidine in newly diagnosed mNPM1 or KMT2Ar AML unfit for intensive chemotherapy, initiated in Q1 2025.
  • Niktimvo in combination with ruxolitinib in newly diagnosed chronic GVHD patients (Phase 2 trial ongoing).

Intellectual Property (IP) defense and portfolio management

Managing and defending the IP portfolio is a necessary activity to secure the long-term value of Revuforj. Syndax has a pending patent application related to its menin inhibitor franchise. Specifically, Publication ID US-20250170132-A1, titled 'Salts and polymorphic forms of menin inhibitors and pharmaceutical compositions thereof,' has a First Filing Date of 04-Nov-2023 and is currently listed as Pending. This is defintely a core activity to protect the menin inhibition space.

Finance: draft 13-week cash view by Friday.

Syndax Pharmaceuticals, Inc. (SNDX) - Canvas Business Model: Key Resources

You're looking at the core assets Syndax Pharmaceuticals, Inc. has built to drive its commercial success and pipeline value as of late 2025. These aren't just line items; they are the validated science and the capital needed to execute.

The most tangible resource is the balance sheet strength. As of September 30, 2025, Syndax Pharmaceuticals, Inc. held $456.1 million in cash, cash equivalents, and investments. This figure is explicitly stated to be expected to fund the company to profitability.

Intellectual Property (IP) forms the foundation, centered around two distinct, first-in-class assets:

  • Revuforj (revumenib) IP as the first FDA-approved menin inhibitor. This is a massive resource, securing leadership in a novel oncology category. The FDA approval for relapsed or refractory (R/R) NPM1m AML was granted on October 24, 2025. The drug was first approved in 2024 for R/R acute leukemia with a KMT2A translocation.
  • Niktimvo (axatilimab-csfr) IP as a first-in-class CSF-1R blocking antibody. This asset addresses chronic graft-versus-host disease (GVHD) after failure of at least two prior systemic therapies.

The commercial engine is supported by a Specialized oncology and hematology commercial sales force. The investment in this resource is reflected in the operating expenses; for the three months ended September 30, 2025, selling, general and administrative expenses increased to $44.9 million, primarily due to higher commercial costs related to the launches of Revuforj and Niktimvo.

The value of the IP is directly validated by the Clinical data from pivotal trials. This data underpins the current revenue streams and future expansion potential:

Trial/Indication Product Key Efficacy Metric Value/Rate
AUGMENT-101 (R/R NPM1m AML) Revuforj (revumenib) CR+CRh Rate 23.1%
AUGMENT-101 (R/R NPM1m AML) Revuforj (revumenib) Median CR+CRh Duration 4.5 months
AUGMENT-101 (R/R NPM1m AML) Revuforj (revumenib) Q3 2025 Net Revenue $32.0 million
AGAVE-201 (R/R cGVHD) Niktimvo (axatilimab-csfr) Response Rate at Six Months (0.3 mg/kg dose) 75%
AGAVE-201 (R/R cGVHD) Niktimvo (axatilimab-csfr) Q3 2025 Collaboration Revenue (Syndax Share) $13.9 million

Further supporting the commercial and development efforts are ongoing clinical programs, including data accepted for presentation at ASH 2025 covering frontline settings for Revuforj and long-term benefits for Niktimvo.

The commercial performance in Q3 2025 demonstrates the immediate value extraction from these resources:

  • Total combined net sales for Revuforj and Niktimvo were over $75 million for the quarter.
  • Total Revuforj prescriptions in Q3 2025 were approximately 850, a 25% increase over Q2 2025.
  • Niktimvo net revenue reported by Incyte in Q3 2025 was $45.8 million.

Syndax Pharmaceuticals, Inc. (SNDX) - Canvas Business Model: Value Propositions

Syndax Pharmaceuticals, Inc. (SNDX) focuses its value propositions on delivering first-in-class, targeted therapies to patient populations with significant unmet medical needs in oncology and hematology.

Revuforj: Targeted Therapy for Genetically Defined Acute Leukemias

Revuforj (revumenib) is positioned as the first and only menin inhibitor approved for relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older, approved on November 15, 2024. The value is grounded in its ability to offer remission where third line treatment or beyond previously yielded only a 5% complete remission rate.

  • Targeted therapy for genetically defined R/R acute leukemias, specifically KMT2Ar and NPM1m AML.
  • In the AUGMENT-101 trial for R/R KMT2Ar AML (104 patients), the rate of complete remission (CR) plus CR with partial hematological recovery (CRh) was 21% (22/104 pts).
  • Median duration of CR+CRh in this population was 6.4 months.
  • Median time to CR or CRh was 1.9 months.
  • In R/R mNPM1 AML (expanded analysis of 77 evaluable patients), CR+CRh was 26% (20/77 pts).
  • Frontline combination data (BEAT AML trial) showed an Overall Response Rate (ORR) of 100% (37/37) and a composite complete remission (CRc) rate of 95% (35/37) in newly diagnosed mNPM1 or KMT2Ar AML.
  • Commercial traction: Revuforj net revenue reached $20.0 million in the first full quarter of launch (Q1 2025) and grew to $32.0 million in Q3 2025.

Niktimvo: Novel Treatment for Refractory Chronic GVHD

Niktimvo (axatilimab-csfr) is a first-in-class anti-CSF-1R antibody approved for chronic graft-versus-host disease (GVHD) after failure of at least 2 prior lines of systemic therapy. This addresses a serious condition that develops in an estimated 42% of allogeneic stem cell transplant recipients.

  • Novel, first-in-class treatment for chronic GVHD refractory to $\ge$2 prior systemic therapies.
  • Pivotal AGAVE-201 trial data showed an Overall Response Rate (ORR) of 75% within the first six months of treatment at the approved dose of 0.3 mg/kg every two weeks (N=79).
  • Commercial performance: Niktimvo net revenue reported by Incyte was $13.6 million in its first partial quarter (Q1 2025), growing to $45.8 million in Q3 2025.
  • Syndax Pharmaceuticals' collaboration revenue share for Niktimvo was $13.9 million in Q3 2025.
  • Over 1,250 infusions of Niktimvo were administered year-to-date as of the end of March 2025.

Clinical Data and Future Potential

Syndax Pharmaceuticals is presenting data that supports the long-term utility and tolerability of its assets in high-need settings.

Value Proposition Aspect Product Metric/Data Point Value/Rate
High Response Rate (R/R AML) Revuforj CR+CRh Rate (AUGMENT-101, KMT2Ar) 21%
High Response Rate (Frontline AML Combo) Revuforj Composite CR Rate (BEAT AML) 95%
Durability (R/R AML) Revuforj Median Duration of CR+CRh 6.4 months
Response Rate (Refractory cGVHD) Niktimvo Overall Response Rate (ORR) at 6 Months (AGAVE-201) 75%
Infusion Safety (cGVHD) Niktimvo Grade 3 or 4 Infusion-Related Reactions 1.3%

The company is actively pursuing expansion into earlier lines of therapy and other indications, which represents the expansion of targeted therapy options for high-unmet-need patient populations.

  • New frontline datasets for Revuforj showcase high rates of complete remission and MRD negativity.
  • New data for Niktimvo highlight the potential for long-term benefit in chronic GVHD.
  • Niktimvo is being studied in combination with ruxolitinib in newly diagnosed chronic GVHD.
  • Revuforj is being evaluated in combination regimens for newly diagnosed mNPM1 or KMT2Ar AML patients unfit for intensive chemotherapy.

Financially, the combined net sales for Revuforj and Niktimvo exceeded $75 million in the third quarter of 2025. Syndax Pharmaceuticals, Inc. maintained $456.1 million in cash, cash equivalents, and investments as of September 30, 2025, with profitability expected within three years.

Syndax Pharmaceuticals, Inc. (SNDX) - Canvas Business Model: Customer Relationships

You're managing the relationship strategy for two newly launched specialty oncology/hematology drugs, Revuforj and Niktimvo. This means the relationship model has to be intensely focused on the prescribing specialists-the oncologists and hematologists-because these aren't drugs you sell over the counter; they require deep clinical trust.

The high-touch nature is evidenced by the rapid uptake and the expected duration of therapy. For Revuforj, which treats relapsed or refractory (R/R) acute leukemia with a KMT2A translocation, physicians are telling Syndax Pharmaceuticals, Inc. they plan to restart patients post-transplant for 1 to 2 years, suggesting a long-term, high-involvement relationship with the prescribing center. Similarly, for Niktimvo in chronic GVHD, approximately 80% to 90% of patients remain on therapy after receiving over 4,000 infusions to an estimated 700 patients since its late January 2025 launch. This level of adherence demands continuous, specialized support.

Here's a look at the commercial traction that drives the need for this specialized relationship model as of late 2025:

Metric Revuforj (KMT2A AML) Niktimvo (Chronic GVHD)
Q1 2025 Net Revenue $20.0 million $13.6 million (partial quarter, reported by Incyte)
Q2 2025 Revenue / Collaboration Share $28.6 million (Net Product Revenue) $9.4 million (Syndax 50% Share)
Patient Penetration (vs. Annual R/R KMT2A Patients) Reached approximately 10% of 2,000 patients annually Estimated 700 patients treated since launch
Key Coverage/Adoption (as of late 2025) 90% of revenue from KMT2A patients More than 80% of all U.S. bone marrow transplant centers using

Dedicated Medical Science Liaisons (MSLs) are the core of the clinical education component. The MSL role at Syndax Pharmaceuticals, Inc. is explicitly defined as the primary communicator of company science, focused on executing the strategic plan within their territory. This involves developing and fostering strong scientific relationships with Key Opinion Leaders (KOLs) and disease experts. They engage in peer-to-peer scientific exchange of complex clinical and scientific data, which is essential for driving appropriate use of novel therapies like Revuforj, the only FDA-approved menin inhibitor.

For patient access, the commercial success implies a functional support structure is in place, even if specific dollar amounts for patient assistance aren't public. The high patient retention for Niktimvo-80% to 90% remaining on therapy-suggests that barriers to continued treatment, often financial or logistical, are being effectively managed for the patient population. This is critical for specialty drugs where patient out-of-pocket costs can be substantial.

Direct engagement with KOLs is heavily weighted toward scientific data dissemination at major medical meetings. Syndax Pharmaceuticals, Inc. management is focused on presenting data to solidify the clinical profile. For instance, the company is set to present 23 abstracts at the upcoming ASH meeting in late 2025, showcasing data for both Revuforj and Niktimvo. Furthermore, the executive team, including the CEO, actively participates in investor conferences, such as the Stifel 2025 Healthcare Conference on November 13, 2025, and the Evercore Healthcare Conference on December 4, 2025, which serves as a high-level engagement point with the broader financial and medical community.

The financial stability supports this relationship-heavy model. Syndax Pharmaceuticals, Inc. reported $456 million in cash as of the last quarter (late 2025). This cash position, coupled with a guidance for stable expenses over the next few years, allows the company to focus resources on frontline and supportive trials, which directly feeds the educational material used by the MSLs and presented to KOLs.

  • MSL travel is expected to be frequent, with job descriptions noting an ability to travel 50-70%.
  • The company is actively initiating frontline randomized studies for Revuforj to expand its use beyond the initial R/R setting.
  • The expected market opportunity for Revuforj alone is projected to exceed $5 billion.

Finance: draft 13-week cash view by Friday.

Syndax Pharmaceuticals, Inc. (SNDX) - Canvas Business Model: Channels

Specialty pharmacy and distributor network for drug delivery

  • Niktimvo is co-commercialized by Syndax and Incyte in the U.S.
  • Niktimvo adoption reached nearly all 150 significant U.S. transplant centers.
  • Syndax records 50% of the Niktimvo net commercial profit/loss.
  • Revuforj payer coverage increased from 70% to over 90%.
  • 80% of Revuforj patients receive the drug within a week.

Direct sales force targeting U.S. hematology/oncology treatment centers

Syndax had 184 total employees as of September 30, 2025. Selling, General and Administrative expenses in the third quarter of 2025 were $44.9 million, compared to $31.1 million for the comparable prior year period, reflecting commercial launch costs. Revuforj was prescribed by 44% of Tier 1 and Tier 2 institutions by March 2025, with expectations to exceed 50% soon.

Metric Revuforj (Revumenib) Niktimvo (Axatilimab-csfr)
Q3 2025 Net Revenue (Syndax) $32.0 million $13.9 million (Collaboration Revenue)
Q2 2025 Net Revenue (Syndax) $28.6 million $9.4 million (Collaboration Revenue)
Prescription/Demand Growth (QoQ) Total prescriptions increased 25% in 3Q25 over 2Q25. Net revenue reported by Incyte in 3Q25 was $45.8 million.
Cumulative Launch Revenue N/A Generated $50 million in net revenue in its first five months of launch.

Medical and scientific conferences (e.g., ASH 2025) for data dissemination

  • Syndax presented data at the 30th European Hematology Association (EHA) Annual Congress Meeting held June 12-15, 2025, in Milan, Italy.
  • Syndax is set to present 23 abstracts at the upcoming ASH meeting.
  • Syndax is scheduled to host an ASH Investor Event in person and via webcast on December 8, 2025.
  • Presentations in 2025 included J.P. Morgan (January 14), Jefferies Global Healthcare (June 5), Goldman Sachs (June 11), and Stifel (November 13).

Digital and direct-to-physician marketing materials

  • Revuforj was added to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for AML and ALL.
  • The company submitted a supplemental New Drug Application (sNDA) for Revuforj in R/R mNPM1 AML in April 2025, with a PDUFA action date of October 25, 2025.
  • Total Revuforj prescriptions in the third quarter of 2025 were approximately 850.

Syndax Pharmaceuticals, Inc. (SNDX) - Canvas Business Model: Customer Segments

Oncologists and Hematologists prescribing for acute leukemia and GVHD

  • Prescribing for patients treated with Revuforj for KMT2A-rearranged acute leukemia.
  • Prescribing for patients treated with Revuforj for R/R NPM1-mutated AML, approved October 24, 2025.
  • Prescribing for adult and pediatric patients with chronic GVHD refractory to $\ge$2 prior lines with Niktimvo.
  • Over 80% of U.S. bone marrow transplant centers are using Niktimvo.

Adult and pediatric patients with R/R KMT2A-rearranged acute leukemia

This segment is the initial target for Revuforj (revumenib), launched in the U.S. in late November 2024.

Metric Data Point
Estimated US Patient Population (Initial Indication) 2,000 patients
US Market Opportunity (Initial Indication) $750 million
Patients Treated Since Launch (as of Q3 2025) Over 500 patients
US Market Penetration Target (by year-end 2025) Over 50% of the patient population
Revuforj Net Revenue (Q3 2025) $32.0 million
Revuforj Prescription Growth (Q3 2025 vs Q2 2025) 25% increase

Adult and pediatric patients with R/R NPM1-mutated acute myeloid leukemia (AML)

This segment gained access to Revuforj following FDA approval on October 24, 2025.

  • Total addressable R/R patient population across KMT2A and NPM1m subtypes: Over 6,000 patients.
  • Expanded US R/R market opportunity: $2 billion.

Adult and pediatric patients with chronic GVHD refractory to $\ge$2 prior lines

This segment is treated with Niktimvo (axatilimab-csfr), launched in the U.S. in late January 2025.

Metric Data Point
Niktimvo Net Revenue Reported by Incyte (Q3 2025) $45.8 million
Syndax Collaboration Revenue (50% Profit Share, Q3 2025) $13.9 million
Patient Retention Rate 80%-90% remaining on therapy
Niktimvo Net Revenue (First Full Quarter, Q2 2025) $36.2 million
Syndax Collaboration Revenue (Q2 2025) $9.4 million

Global pharmaceutical partners (Incyte, UCB) for ex-U.S. rights and co-development

These entities are key strategic customers/partners in the business model, facilitating global reach and development.

  • Incyte: Co-commercializes Niktimvo in the U.S.; holds exclusive commercialization rights for Niktimvo outside the U.S.
  • Syndax records 50% of the Niktimvo net commercial profit.
  • UCB: Syndax licensed exclusive worldwide rights to axatilimab (Niktimvo) from UCB in 2016.

Syndax Pharmaceuticals, Inc. (SNDX) - Canvas Business Model: Cost Structure

You're looking at the major cash drains for Syndax Pharmaceuticals, Inc. as they scale up from launch to profitability. The cost structure is heavily weighted toward getting their two commercial products, Revuforj and Niktimvo, established, alongside funding the next wave of pipeline development.

The full-year Research and Development (R&D) expenses guidance for 2025 remains high, set between $260 million to $280 million. This reflects the ongoing investment needed to advance their pipeline assets beyond the currently approved indications. Also, the company expects total R&D plus SG&A expenses for the full year 2025 to be in the range of $415 million to $435 million, excluding an estimated $45 million in non-cash stock compensation expense.

Selling, General, and Administrative (SG&A) costs are significant because of the dual commercial launches. For the third quarter of 2025 alone, SG&A expense reached $44.9 million. This increase, year-over-year, is primarily tied to employee-related expenses and professional fees supporting the U.S. commercial launch of Revuforj. Management has stated an expectation that the overall operating expense base will remain stable over the next few years.

Clinical trial costs are embedded within the R&D spend, specifically funding pipeline expansion efforts. For instance, R&D expenses in the second quarter of 2025 included costs related to ongoing trials and increased activities to support commercialization. This included costs for multiple trials evaluating revumenib (Revuforj) in mNPM1 and KMT2Ar acute leukemia. Furthermore, Syndax initiated a pivotal frontline trial of revumenib plus ven/aza in mNPM1 and KMT2Ar AML in the first quarter of 2025.

Manufacturing and Cost of Goods Sold (COGS) are now a factor with two commercial products on the market. For the first quarter of 2025, the Cost of sales for Revuforj was $0.9 million. For Niktimvo, Syndax records 50% of the net commercial profit or loss, which is defined as net product revenue (recorded by Incyte) minus the cost of sales and commercial expenses. In Q1 2025, the Niktimvo collaboration resulted in a net commercial loss, and Syndax's share of that collaboration loss amounted to $0.2 million.

You must account for potential future licensing and milestone payments. Under the UCB License Agreement for axatilimab (Niktimvo), Syndax may be required to pay UCB up to an aggregate of $119.5 million in one-time development and regulatory milestone payments over the term of the agreement. Additionally, there is a potential for up to an aggregate of $250.0 million in one-time, sales-based milestone payments based on annual sales thresholds. On the Revuforj side, R&D expenses in Q2 2025 included a 'milestone paid to AbbVie upon submission of the sNDA'.

Here's a quick look at the product revenue versus some associated costs for the initial commercial quarters:

Metric Q1 2025 Q2 2025 Q3 2025
Revuforj Net Revenue (Syndax) $20.0 million $28.6 million $32.0 million
Niktimvo Collaboration Revenue (Syndax Share) Net Loss of $0.2 million $9.4 million $13.9 million
Revuforj Cost of Sales (COGS) $0.9 million Not explicitly stated Not explicitly stated
SG&A Expense (Total) Not explicitly stated $43.8 million $44.9 million

The cost structure is clearly dominated by the combined operating expenses, which for the full year 2025 are guided to be between $380 million and $385 million, excluding stock compensation.

Syndax Pharmaceuticals, Inc. (SNDX) - Canvas Business Model: Revenue Streams

You're looking at the core ways Syndax Pharmaceuticals, Inc. (SNDX) brings in cash right now, based on their latest reported figures from the third quarter of 2025. The revenue picture is clearly dominated by their two key commercial assets, which is exactly what you'd expect from a company in this growth phase.

For the third quarter ended September 30, 2025, Syndax Pharmaceuticals reported a total revenue of $45.9 million. This figure is a blend of direct product sales and partnership economics. Honestly, seeing this level of revenue is a solid indicator of commercial traction following the recent FDA approval for Revuforj in a second indication in late October 2025.

Revenue Component Q3 2025 Amount (USD)
Net Product Revenue from Revuforj (revumenib) sales $32.0 million
Collaboration Revenue from Niktimvo (axatilimab) $13.9 million
Total Reported Revenue $45.9 million

The collaboration revenue stream, specifically from Niktimvo, is structured as Syndax's 50% share of the net commercial profit. This profit is defined as the net revenue recorded by their partner, Incyte, minus the cost of sales and commercial expenses. For Q3 2025, this share amounted to $13.9 million, which is based on Incyte reporting $45.8 million in Niktimvo net revenue for the same period.

Another component feeding into the financial health, which generates interest income, is the company's liquidity position. As of September 30, 2025, Syndax Pharmaceuticals held cash, cash equivalents, and short- and long-term investments totaling $456.1 million. This substantial reserve is what management expects will fund the company to profitability, and the interest earned on this balance is a non-product revenue stream.

Beyond the current sales and interest, the business model relies on future, less predictable income sources tied to their development pipeline and partnerships. You need to track these potential upsides:

  • Potential future milestone payments from existing collaborations.
  • Potential milestone payments from new collaboration agreements.

The near-term focus is clearly on maximizing the commercial uptake of Revuforj, which saw total prescriptions increase 25% over the prior quarter, and continuing to realize the profit share from Niktimvo. Finance: draft 13-week cash view by Friday.


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