On February 26, 2026 TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) reported its financial results for the fourth quarter and full year ended December 31, 2025, along with recent company developments and 2026 financial guidance.

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Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, "2025 was a strong year of execution for TG Therapeutics, driven by continued momentum for BRIUMVI and meaningful progress across our organization. BRIUMVI delivered significant year-over-year growth in the U.S., supported by increasing adoption and expanding global availability, while we advanced multiple late-stage clinical programs and strengthened our financial position."

Michael continued, "As we enter 2026, we are focused on building on this foundation. With strong financial guidance, several important clinical milestones ahead, and a disciplined approach to operations, we believe we are well positioned to continue delivering value for patients, healthcare providers, and shareholders."

2025 Highlights & Recent Developments

Next In MS Platform Launch in Collaboration with Christina Applegate

Announced collaboration with Christina Applegate to raise awareness of multiple sclerosis (MS) via a Super Bowl LX commercial
Launched, Next In MS, a platform designed to foster honest, real-world conversations about life with MS—featuring unfiltered dialogue, including discussions with Christina Applegate—and to support people living with MS in continuing those conversations with family, friends, and healthcare professionals on their own terms.
BRIUMVI (ublituximab-xiiy) Commercialization

BRIUMVI U.S. net product revenue of $182.7 million for the fourth quarter 2025, representing approximately 20% quarterly growth over Q3 2025 and $594.1 million for the full year of 2025, representing approximately 92% growth year over year
Total global full year 2025 revenue of $616.3 million
Expansion of commercialization outside of the U.S. with our partner, Neuraxpharm, with BRIUMVI now approved in the European Union, United Kingdom, Switzerland, Australia, Kuwait and the United Arab Emirates
BRIUMVI Data Presentations & Publications

Presented updated data presentations at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting including:
New six year data from the open label extension (OLE) of the ULTIMATE I & II trials which demonstrated that 89.9% of patients with relapsing forms of multiple sclerosis (RMS) were free from 24-week confirmed disability progression after 6 years of continuous BRIUMVI treatment and an overall safety profile which remained consistent with no new safety signals emerging with prolonged treatment.
An update from the open-label arm of the ENHANCE trial demonstrating that consolidating the Day 1 (150 mg) and Day 15 (450 mg) infusions into a single 600 mg dose was well tolerated. This regimen is being evaluated in a double-blinded, randomized, label-enabling trial design compared to standard dosing.
An update from ENABLE, the first real world observational study showcasing real world clinical experience of people with RMS initiating BRIUMVI, which demonstrated consistent clinical outcomes to that observed in pivotal clinical studies of BRIUMVI.
Published three articles in medical journals:
February 2026: "Five Years of Ublituximab in Multiple Sclerosis: ULTIMATE I and II Open-Label Extension (OLE) Study", published in JAMA Neurology, highlighting five-year data from the OLE of the ULTIMATE I and II trials.
April 2025: "Switching to Ublituximab from Prior anti-CD20 Monoclonal Antibody Therapy: A Case Report Series", published in Frontiers in Immunology, demonstrating a retrospective case series of seven individuals with MS treated in private practice or at an MS clinic who switched to ublituximab from a different anti-CD20 monoclonal antibody therapy due to efficacy or tolerability concerns, published in Frontiers in Immunology.
April 2025: "The Evolution of Anti-CD20 Treatment in Multiple Sclerosis", published in CNS DRUGS, demonstrating the differentiating characteristics within the anti-CD20 monoclonal antibody class used to treat MS, published in CNS DRUGS.
Pipeline

Achieved approximately 75% patient enrollment into the Phase 3 pivotal program evaluating subcutaneous ublituximab
Completed patient enrollment into the randomized Phase 3 pivotal program to evaluate a consolidated Day 1 and Day 15 dosing regimen for intravenous (IV) BRIUMVI in the ongoing ENHANCE trial
Continued enrollment for patients with progressive multiple sclerosis into the ongoing Phase 1 clinical trial evaluating azer-cel for the treatment of autoimmune diseases
Share Repurchase Update

Completed the previously announced $100 million share repurchase program in the third quarter of 2025, purchasing approximately 3.5 million shares of TGTX common stock at an average price of $28.55 per share, and announced board authorization of a new share repurchase program to acquire up to an additional $100 million of TGTX common stock
2026 Financial Guidance

Full year 2026 target total global revenue of approximately $875-$900 million, including BRIUMVI U.S. net product revenue of approximately $825-$850 million
Q1 2026 target BRIUMVI U.S. net product revenue of approximately $185-$190 million
Full year 2026 target operating expense, defined as R&D and SG&A, of approximately $350 million excluding non-cash compensation, in addition to approximately $100 million in expenses associated with the subcutaneous BRIUMVI manufacturing costs and secondary manufacturer start-up costs
2026 Development Pipeline Anticipated Milestones

Announce pivotal topline data for ENHANCE trial combining Day 1 and Day 15 doses of IV BRIUMVI mid-year 2026
Present preliminary Phase 1 azer-cel data in Progressive MS in the second half of 2026
Announce pivotal topline data for subcutaneous BRIUMVI (ublituximab) year-end 2026/1Q 2027
Commence registration-directed trial for BRIUMVI in an indication outside of MS
Commence additional exploratory studies for BRIUMVI and azer-cel in autoimmune disease (outside MS)
Financial Results for Fourth Quarter and Full Year 2025

Product Revenue, net: Product revenue, net was $189.1 million and $606.9 million for the three and twelve months ended December 31, 2025, respectively, compared to $107.3 million and $313.7 million for the three and twelve months ended December 31, 2024, respectively. Product revenue, net consists primarily of net product sales of BRIUMVI in the United States, which totaled $182.7 million and $594.1 million during the three and twelve months ended December 31, 2025, respectively. Also included in product revenue, net for the twelve months ended December 31, 2025 and 2024 are sales of BRIUMVI to our ex-U.S. licensing partner, Neuraxpharm, of $12.8 million and $3.7 million, respectively.
License, milestone, royalty and other revenue: License, milestone, royalty and other revenue was approximately $3.5 million and $9.4 million for the three and twelve months ended December 31, 2025, respectively, compared to approximately $0.8 million and $15.3 million for the three and twelve months ended December 31, 2024, respectively. License, milestone, royalty and other revenue for the twelve months ended December 31, 2024 is predominantly comprised of a one-time $12.5 million milestone from our ex-U.S. commercial partner recognized in the first quarter of 2024 as a result of the first key market commercial launch of BRIUMVI in the European Union (EU).
R&D Expenses: Total research and development (R&D) expense was approximately $41.2 million and $160.2 million for the three and twelve months ended December 31, 2025, respectively, compared to $23.9 million and $94.3 million for the three and twelve months ended December 31, 2024, respectively. The increase in R&D expense during the three and twelve months ended December 31, 2025 was primarily attributable to the increase in manufacturing expense, including manufacturing and development costs in connection with our subcutaneous ublituximab development work, as well as increased clinical trial related expenses pertaining to our clinical pipeline, and increased personnel costs during the period ended December 31, 2025. These increases were partially offset by $8.8 million in license and milestone expense incurred in 2024 pertaining to the Precision License Agreement.
SG&A Expenses: Total selling, general and administrative (SG&A) expense was approximately $62.7 million and $232.0 million for the three and twelve months ended December 31, 2025, respectively, compared to $39.0 million and $154.3 million for the three and twelve months ended December 31, 2024, respectively. The increase in selling, general and administrative costs during the three and twelve months ended December 31, 2025 was primarily due to an increase in marketing, personnel and external costs associated with the commercialization of BRIUMVI.
Net income: Net income was $23.0 million and $447.2 million for the three and twelve months ended December 31, 2025, respectively, compared to net income of $23.3 million and $23.4 million for the three and twelve months ended December 31, 2024, respectively. Our 2025 results include a non-recurring income tax benefit of approximately $339.8 million, driven by the release of our deferred tax asset valuation allowance in the third quarter of 2025.
Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $199.5 million as of December 31, 2025. We anticipate that our cash, cash equivalents and investment securities as of December 31, 2025, combined with the projected revenues from BRIUMVI, will be sufficient to fund our business based on our current operating plan.
CONFERENCE CALL INFORMATION
The Company will host a conference call today, February 26, 2026, at 8:30 AM ET, to discuss the Company’s financial results from fourth quarter and full year ended December 31, 2025.

To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source An audio recording of the conference call will also be available for a period of 30 days after the call.

ABOUT BRIUMVI (ublituximab-xiiy) 150 mg/6 mL Injection for IV
BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.

BRIUMVI is indicated in the U.S. for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and in several countries outside of the U.S. for the treatment of adult patients with RMS with active disease defined by clinical or imaging features.

A list of authorized specialty distributors can be found at www.briumvi.com.

IMPORTANT SAFETY INFORMATION

Contraindications: BRIUMVI is contraindicated in patients with:

Active Hepatitis B Virus infection
A history of life-threatening infusion reaction to BRIUMVI
WARNINGS AND PRECAUTIONS

Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization.

Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.

Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved.

Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.

Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.

Progressive Multifocal Leukoencephalopathy (PML): PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. JCV infection resulting in PML has been observed in patients treated with anti-CD20 antibodies, including BRIUMVI, and other MS therapies.

If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.

MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.

If PML is confirmed, treatment with BRIUMVI should be discontinued.

Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines, at least 4 weeks and, whenever possible, at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.

Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.

Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.

Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy, until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.

Liver Injury: Clinically significant liver injury, without findings of viral hepatitis, has been reported in the postmarketing setting in patients treated with anti-CD20 B-cell depleting therapies approved for the treatment of MS, including BRIUMVI. Signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred from weeks to months after administration.

Patients treated with BRIUMVI found to have an alanine aminotransaminase (ALT) or aspartate aminotransferase (AST) greater than 3x the upper limit of normal (ULN) with serum total bilirubin greater than 2x ULN are potentially at risk for severe drug-induced liver injury.

Obtain liver function tests prior to initiating treatment with BRIUMVI, and monitor for signs and symptoms of any hepatic injury during treatment. Measure serum aminotransferases, alkaline phosphatase, and bilirubin levels promptly in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. If liver injury is present and an alternative etiology is not identified, discontinue BRIUMVI.

Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections.

Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com.

ABOUT BRIUMVI PATIENT SUPPORT in the U.S.
BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com.

ABOUT MULTIPLE SCLEROSIS
Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.

(Press release, TG Therapeutics, FEB 26, 2026, View Source [SID1234663089])

On February 26, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported that a clinical data abstract submission by cancer experts at Moffitt Cancer Center to the 2026 Society of Interventional Radiology (SIR) Annual Scientific Meeting has been accepted. The meeting will be held April 11-15, 2026, in Toronto, Ontario.

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The abstract, titled "What PET/CT Reveals After Transarterial Microperfusion for Pancreatic Cancer," was submitted by a multidisciplinary team of cancer experts, including Dr. Mustafa Al-Roubaie, an Interventional Radiologist at Moffitt Cancer Center and member of RenovoRx’s Medical Advisory Board. The abstract explores the hypothesis, based on a review of metabolic response observations, that local, targeted intra-arterial delivery of chemotherapy using RenovoRx’s patented TAMP (Trans-Arterial Micro-Perfusion) therapy platform may help address the poor vascularity commonly associated with locally advanced pancreatic cancer (LAPC). The abstract data further evaluates the potential role of metabolic imaging (FDG (fluorodeoxyglucose) PET/CT)) in evaluating therapeutic activity following targeted intra-arterial treatment in patients with refractory disease.

"Patients diagnosed with LAPC carry a difficult prognosis, partly due to a dense, hypovascular stroma that limits the efficacy of traditional systemic (intravenous) chemotherapy," said Dr. Al-Roubaie. "Regional intra-arterial therapeutic delivery, which is the core attribute of RenovoRx’s TAMP therapy platform, aims to overcome this barrier by delivering high-concentration chemotherapy directly near the tumor. We are excited to present our findings at the upcoming 2026 SIR Meeting."

Abstract Details:
Presentation Date & Time: Monday, April 13, 2026, from 4:45-5:45 PM ET
Title: What PET/CT Reveals After Transarterial Microperfusion for Pancreatic Cancer
Location: Metro Toronto Convention Centre – Toronto, Canada
Abstract Number: 2229370

About RenovoCath

Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to select sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.

(Press release, Renovorx, FEB 26, 2026, View Source [SID1234663105])

On February 26, 2026 Oncoinvent (OSE: ONCIN), a biotech company developing a receptor-independent alpha radiopharmaceutical to eradicate cancer cells in the abdominal cavity after surgery with a single, targeted dose, reported its second half 2025 results.

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Oncoinvent’s management team will give an online presentation to investors, analysts and the press at 09:30 CET today (details below).

Highlights:

Radspherin

Reported positive final data from Phase 1 Trial of Radspherin to treat ovarian cancer
Published Phase 1 trial results for Radspherin in ovarian cancer in Gynecologic Oncology
Presented final safety and efficacy results from the Phase 1/2a trial of Radspherin to treat colorectal cancer at the 15th PSOGI International Congress on Peritoneal Surface Malignancies
Corporate

Completed merger with BerGenBio and successfully uplisted to Oslo Stock Exchange
Raised NOK 130 million in equity
Appointed Dr Ramzi Amri as Chief Financial Officer
Post-period highlights

January 2026: Included four additional sites in Oncoinvent’s Phase 2 trial
February 2026: Present positive 24-month follow-up data from Phase 1 ovarian cancer trial of Radspherin at 27th Congress of the European Society of Gynecological Oncology (ESGO) 2026
Oystein Soug, CEO, commented: "The second half of 2025 marked another productive period for Oncoinvent, with solid advances across our clinical programs together with important corporate and financial milestones. During the period, we progressed the Radspherin Phase 2 trial in ovarian cancer, delivered meaningful scientific updates in two cancer indications, completed significant strategic transactions, and in the process strengthened the company’s financial foundation ahead of the planned Phase 2 interim readout."

Presentation:

We invite to a live webcast today at 09.30 CET. It will be possible to submit questions during the presentation.

Date: Thursday, 26 February 2026
Time: 9:30am CET
Webcast link: View Source
A recording of the webcast will be made available on www.oncoinvent.com after the live sending.

Reporting material:

Oncoinvent 2H 2025 report
Oncoinvent 2H25 presentation
The reporting material are also available in the Investor Relations section of the Company’s website at www.oncoinvent.com.

(Press release, Oncoinvent, FEB 26, 2026, https://www.oncoinvent.com/press-release/oncoinvent-asa-second-half-2025-results/ [SID1234663008])

On February 26, 2026 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported financial results and corporate updates from the fourth quarter and full year 2025.
"These strong financial results for the fourth quarter and full year 2025 underscore our continued evolution as a global oncology leader with durable competitive advantages in clinical development and manufacturing and one of the industry’s deepest and most differentiated pipelines," said John V. Oyler, Co-Founder, Chairman and CEO at BeOne. "BRUKINSA has firmly established itself as the global leader in the BTK inhibitor class, distinguished by broad regulatory approvals, expanding geographic reach, strong physician adoption, and unmatched long-term efficacy and safety data in CLL. At the same time, we are securing new indications and expanded reimbursement for TEVIMBRA across key markets worldwide. With our late-stage, foundational hematology assets nearing commercialization and a robust solid tumor portfolio delivering encouraging data, we are well positioned to extend our leadership and drive the next phase of sustainable global growth."

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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(Amounts in thousands of U.S. dollars full year GAAP amounts audited, all other amounts unaudited)

Fourth Quarter Full Year
2025 2024 % Change 2025 2024 % Change
Net product revenues $ 1,476,442 $ 1,118,035 32 % $ 5,282,061 $ 3,779,546 40 %
Other revenue $ 21,728 $ 9,789 122 % $ 60,972 $ 30,695 99 %
Total revenue $ 1,498,170 $ 1,127,824 33 % $ 5,343,033 $ 3,810,241 40 %
GAAP income (loss) from operations $ 185,035 $ (79,425) 333 % $ 447,136 $ (568,199) 179 %
Adjusted income from operations* $ 344,476 $ 78,603 338 % $ 1,099,962 $ 45,356 2325 %

GAAP net income (loss) $ 66,502 $ (151,881) 144 % $ 286,933 $ (644,786) 145 %
Adjusted net income (loss)* $ 224,979 $ 16,101 1297 % $ 917,601 $ (54,919) 1771 %
GAAP basic earnings (loss) per ADS $ 0.60 $ (1.43) 142 % $ 2.63 $ (6.12) 143 %
Adjusted basic earnings (loss) per ADS* $ 2.03 $ 0.15 1253 % $ 8.41 $ (0.52) 1717 %
GAAP diluted earnings (loss) per ADS $ 0.58 $ (1.43) 141 % $ 2.53 $ (6.12) 141 %
Adjusted diluted earnings (loss) per ADS* $ 1.95 $ 0.15 1200 % $ 8.09 $ (0.52) 1656 %
Free Cash Flow* $ 379,825 $ (17,320) 2293 % $ 941,741 $ (633,294) 249 %

* For an explanation of our use of non-GAAP financial measures refer to the "Note Regarding Use of Non-GAAP Financial Measures" section later in this press release and for a reconciliation of each non-GAAP financial measure to the most comparable GAAP measures, see the table at the end of this press release.

Fourth Quarter and Full Year 2025 Financial Results
Product Revenue, which represents 99% of total revenue, totaled $1.5 billion and $5.3 billion for the fourth quarter and full year of 2025, representing growth of 32% and 40%, compared to the prior-year periods.
•BRUKINSA: Global sales totaled $1.1 billion and $3.9 billion the fourth quarter and full year of 2025, representing growth of 38% and 49%, compared to the prior-year periods; U.S. sales of BRUKINSA totaled $845 million and $2.8 billion in the fourth quarter and full year of 2025, representing growth of 37% and 45%, compared to the prior-year periods.

•TEVIMBRA (tislelizumab): Global sales totaled $182 million and $737 million, in the fourth quarter and full year of 2025, representing growth of 18% and 19%, compared to the prior-year periods.

•Amgen in-licensed products: Global sales totaled $112 million and $486 million for the fourth quarter and full year of 2025, representing growth of 11% and 33%, compared to prior-year periods.

Gross Margin as a percentage of global product sales for the fourth quarter and full year of 2025 was 90.4% and 87.3%, compared to 85.6% and 84.3%, in the prior-year periods on a GAAP basis. On an adjusted basis, which does not include depreciation and amortization, gross margin as a percentage of global product sales increased to 90.7% and 87.8% for the fourth quarter and full year of 2025, compared to 87.4% and 85.5%, in the prior-year periods.
Operating Expenses
The following table summarizes operating expenses for the fourth quarter of 2025 and 2024:
GAAP Non-GAAP
(in thousands, except percentages) Q4 2025 Q4 2024 % Change Q4 2025 Q4 2024 % Change
Research and development $ 615,423 $ 542,012 14 % $ 544,823 $ 474,874 15 %
Selling, general and administrative $ 555,290 $ 504,677 10 % $ 471,468 $ 433,059 9 %
Total operating expenses $ 1,170,713 $ 1,046,689 12 % $ 1,016,291 $ 907,933 12 %

The following table summarizes operating expenses for the full year 2025 and 2024:
GAAP Non-GAAP
(in thousands, except percentages) FY 2025 FY 2024 % Change FY 2025 FY 2024 % Change
Research and development $ 2,145,868 $ 1,953,295 10 % $ 1,855,979 $ 1,668,368 11 %
Selling, general and administrative $ 2,081,489 $ 1,831,056 14 % $ 1,743,118 $ 1,549,864 12 %
Total operating expenses $ 4,227,357 $ 3,784,351 12 % $ 3,599,097 $ 3,218,232 12 %

Research and Development (R&D) Expenses increased for the fourth quarter and full year of 2025 compared to the prior-year periods on both a GAAP and adjusted basis. Upfront fees and milestone payments related to in-process R&D for in-licensed assets totaled nil and $0.7 million in the fourth quarter and full year of 2025, compared to $63 million and $114 million in the prior-year periods.

Selling, General and Administrative (SG&A) Expenses increased for the fourth quarter and full year of 2025 compared to the prior-year periods on both a GAAP and adjusted basis. SG&A expenses as a percentage of product sales were 38% and 39% for the fourth quarter and full year of 2025, compared to 45% and 48% in the prior-year periods.

Net Income/(Loss) and Basic/Diluted Earnings Per Share
GAAP net income for the fourth quarter and full year of 2025 was $67 million and $287 million, an increase of $218 million and $932 million, over the prior-year periods, primarily attributable to revenue growth and improved operating leverage. Included within GAAP net income for full year 2025 were $76 million of equity investment impairment charges, $25 million of non-recurring tax expenses and $20 million of timing related tax expenses in certain jurisdictions, which were primarily incurred in the fourth quarter.

For the fourth quarter of 2025, basic and diluted earnings per share were $0.05 and $0.04 per share and $0.60 and $0.58 per American Depositary Share (ADS), compared to basic loss of $0.11 per share and $1.43 per ADS in the prior-year period. For the full year of 2025, basic and diluted earnings per share were $0.20 and $0.19 per share and $2.63 and $2.53 per ADS, compared to basic loss of $0.47 per share and $6.12 per ADS in the prior-year period.
Free Cash Flow for the fourth quarter of 2025 was $380 million, representing an increase of $397 million over the prior-year period. For the full year of 2025, free cash flow was $942 million, representing an increase of $1.6 billion over the prior-year period.
For further details on BeOne’s 2025 Financial Statements, please see BeOne’s Annual Report on Form 10-K for fiscal year 2025 filed with the U.S. Securities and Exchange Commission.
Full Year 2026 Guidance
BeOne’s financial guidance is summarized below:
FY 20261
Total revenue $6.2 – $6.4 billion
GAAP gross margin % High-80% range
GAAP operating expenses2
(combined R&D and SG&A)
$4.7 – $4.9 billion
GAAP operating income2
$700 – $800 million
Non-GAAP operating income2,3
$1.4 – $1.5 billion

1Assumes January 1, 2026 foreign exchange rates.
2Does not assume any potential new, material business development activity or unusual/non-recurring items.
3Non-GAAP operating income is a financial measure that excludes from the corresponding GAAP measure costs related to share-based compensation, depreciation and amortization expense. Guidance assumes that Non-GAAP expenses track overall expense growth.
BeOne’s total revenue guidance for full year 2026 of $6.2 billion to $6.4 billion includes expectations for strong revenue growth driven by BRUKINSA’s U.S. leadership position and continued global expansion in both Europe and other important rest of world markets. Gross margin percentage is expected to be in the high-80% range and includes the impact of product mix and a full year of 2026 productivity improvements. Guidance for combined operating expenses on a GAAP basis includes expectations of investment to support growth in both commercial and research at a pace that continues to deliver meaningful operating leverage.

The Company is providing the following additional guidance on items impacting net income and earnings per ADS:

•Other income (expense): estimated range of $25 million to $50 million in expense, includes interest amortization from Royalty Pharma arrangement.
•Income tax outlook: earnings may provide sufficient positive evidence to reverse certain valuation allowances in 2026, resulting in a material tax benefit when recognized; the timing and magnitude of a potential reversal is uncertain; prior to reversal, income tax expense should trend with earnings per historical relationship.
•Diluted ADS outstanding: the Company expects diluted ADSs outstanding of approximately 118 million.

Fourth Quarter Business Highlights
Core Marketed Products
BRUKINSA (zanubrutinib)
•Presented 6-year landmark results from the Phase 3 SEQUOIA trial and long-term results from the Phase 3 ALPINE trial at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, confirming sustained benefit for the treatment of adult patients with treatment-naïve (TN) and relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), respectively.

Sonrotoclax (BCL2 inhibitor)
•Received first global approvals in China for the treatment of adult patients with:
◦R/R mantle cell lymphoma (MCL) who have received at least two systemic therapies, including a Bruton tyrosine kinase (BTK) inhibitor;
◦and R/R CLL/SLL who have previously received at least one systemic therapy, including a BTK inhibitor.
•Granted U.S. Food and Drug Administration (FDA) priority review for the treatment of adult patients with R/R MCL.

•Submitted Marketing Authorization Application in the European Union for the treatment of adult patients with R/R MCL.
•Enrolled first subject in Phase 3 trial in combination with BRUKINSA as a fixed-duration regimen versus acalabrutinib plus venetoclax for the treatment of adult patients with TN CLL.
TEVIMBRA (tislelizumab)
•Presented full results in partnership with Jazz Pharmaceuticals and Zymeworks from the HERIZON-GEA-01 trial in combination with ZIIHERA (zanidatamab) and chemotherapy, demonstrating statistically significant and clinically meaningful improvement in overall survival versus trastuzumab plus chemotherapy for the first-line treatment of adult patients with HER2-positive gastroesophageal adenocarcinoma (GEA).
Select Clinical-Stage Programs
Hematology
•BGB-16673 (BTK chimeric degradation activation compound (CDAC)): Presented results at ASH (Free ASH Whitepaper) from the Phase 1 CaDAnCe-101 trial for the treatment of adult patients with R/R CLL.
Breast and Gynecologic Cancers
•BG-75202 (KAT6A/B inhibitor): Initiated first in human study.

•BG-75908 (CDK2 CDAC): Initiated first in human study.
Lung Cancer
•BG-C0902 (EGFRxMETxMET antibody-drug conjugate): Initiated first in human study.
Gastrointestinal Cancers
•BGB-B2033 (GPC3x41BB bispecific antibody): Granted FDA Fast Track Designation for the treatment of adult patients with hepatocellular carcinoma who experience disease progression on or after post-systemic therapy

Anticipated R&D Milestones
Programs
Milestones
Timing
BRUKINSA
•Phase 3 MANGROVE trial interim analysis in combination with rituximab versus bendustamine plus rituximab for the treatment of adult patients with first-line MCL.
1H 2026
TEVIMBRA
•Supplemental Biologics License Application submissions in U.S. and China for the treatment of adult patients with first-line HER2-positive GEA in combination with zanidatamab.
1H 2026
•Japan regulatory approval for the treatment of adult patients with first-line gastric cancer.
2H 2026
Hematology
•Sonrotoclax (BCL2 inhibitor):
◦FDA regulatory action on New Drug Application as monotherapy treatment of adult patients with R/R MCL.
1H 2026
◦Phase 3 trial initiation for the treatment of adult patients with R/R multiple myeloma t(11;14).
2H 2026
•BGB-16673 (BTK CDAC):
◦Phase 2 potential accelerated approval submission (if data support) for the treatment of adult patients with R/R CLL.
2H 2026
Breast/Gynecologic Cancers
•BGB-43395 (CDK4 inhibitor):
◦Phase 3 trial initiation for the treatment of adult patients with first-line HR-positive, HER2-negative metastatic breast cancer.
1H 2026
Gastrointestinal Cancers
•BGB-B2033 (GPC3x41BB bispecific antibody):
◦Potentially registrational Phase 2 trial initiation.
2H 2026
Inflammation and Immunology
•BGB-45035 (IRAK4 CDAC):
◦Phase 1/2 trial data readout for the treatment of adult patients with rheumatoid arthritis.
2H 2026
•BGB-16673 (BTK CDAC):
◦Phase 1b trial data readout for the treatment of adult patients with moderate to severe chronic spontaneous urticaria.
1H 2026

BeOne’s Earnings Results Webcast
The Company’s earnings conference call for the fourth quarter and full year 2025 will be broadcast via webcast at 8:00 a.m. ET on Thursday, February 26, 2026, and will be accessible through the Investors section of BeOne’s website at www.beonemedicines.com. Supplemental information in the form of a slide presentation, transcript of prepared remarks, and a replay of the webcast will also be available.

(Press release, BeOne Medicines, FEB 26, 2026, View Source [SID1234663052])

On February 26, 2026 Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, reported its financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update.

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"We solidified our leadership position and proved the strength of Syndax’s R&D and commercial capabilities in 2025, achieving our third FDA approval and successfully launching two first- and best-in-class medicines. We reached thousands of patients with Revuforj and Niktimvo and generated over $275 million in 2025 sales, rapidly advancing the company towards profitability," said Michael A. Metzger, Chief Executive Officer. "With strong momentum and multiple growth drivers for both products, including increasing uptake of Revuforj in R/R NPM1m AML and the post-transplant setting, Syndax is well positioned for continued growth in 2026 and beyond."

Mr. Metzger continued, "We’ve also made excellent progress advancing our development programs designed to further unlock multi-billion-dollar opportunities for both our medicines. We are positioned to be first to frontline AML with a menin inhibitor, and to expand our impact on chronic GVHD and other fibrotic diseases through CSF-1R inhibition. Earlier this year, we completed enrollment in our Phase 2 IPF trial and remain on track for topline data later this year which could further unlock Niktimvo’s potential as a novel antifibrotic."

Recent Business Highlights and Anticipated Milestones

Revuforj (revumenib)

Achieved $44.2 million in Revuforj net revenue in the fourth quarter of 2025, a 38% increase over the third quarter of 2025. Revuforj net revenue for the full year 2025 totaled $124.8 million.
Observed continued acceleration in demand following the FDA’s approval on October 24, 2025, of Revuforj for the treatment of relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 mutation (NPM1m) in adult and pediatric patients one year and older who have no satisfactory alternative treatment options. Total Revuforj prescriptions in the fourth quarter of 2025 were approximately 1,150, an approximate 35% increase over the third quarter of 2025.
Initiated REVEAL-ND, a Phase 3, randomized, double-blind, placebo-controlled trial of revumenib in combination with intensive chemotherapy in newly diagnosed patients with NPM1m AML in November 2025. The trial has dual primary endpoints of measurable residual disease (MRD) negative complete remission (CR) and event free survival (EFS) to support the potential for accelerated approval and full approval, respectively.
Received the ‘Best New Drug’ award for Revuforj at the Scrip Awards in December 2025. The award recognizes excellence in pharmaceutical development and the drug that represents the best therapeutic advance in its area.
Highlighted the company’s leadership in menin inhibition with the presentation of 12 revumenib abstracts, including three oral presentations, at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2025. The presentations reported compelling results with revumenib in multiple acute leukemia subtypes across the R/R, frontline, and post-stem cell transplant maintenance setting.
The data presented included the first real-world evidence for a menin inhibitor. The results showed an overall response rate (ORR) of 77% (10/13), a measurable residual disease (MRD) negativity rate of 75% (9/12), and favorable tolerability among primarily R/R NPM1m, KMT2Ar, and NUP98r acute leukemia patients who received revumenib in combination with standard of care therapies or as a monotherapy outside of a clinical trial.
Multiple clinical trials evaluating revumenib across the acute leukemia treatment continuum are ongoing, such as:
EVOLVE-2: A pivotal, Phase 3, randomized, double-blind, placebo-controlled trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed NPM1m (primary efficacy analysis population) and KMT2Ar AML patients who are unfit for intensive chemotherapy. The trial is being conducted in collaboration with the HOVON network, a leading cooperative clinical trial group with extensive experience studying novel therapies for hematologic malignancies.
REVEAL-ND: A pivotal, Phase 3, randomized, double-blind, placebo-controlled trial of revumenib in combination with intensive chemotherapy in newly diagnosed NPM1m AML patients.
SAVE: A Phase 1/2 trial evaluating an all-oral combination of revumenib with venetoclax and decitabine/cedazuridine in pediatric and adult patients with newly diagnosed and R/R AML or mixed-lineage acute leukemia (MPAL) harboring either NPM1m, KMT2Ar, or NUP98r alterations. The trial is being conducted by investigators from MD Anderson Cancer Center. New data presented at the 2025 ASH (Free ASH Whitepaper) Annual Meeting from the first cohort of newly diagnosed patients showed a complete remission (CR) rate of 76% (16/21), an ORR of 86% (18/21), and a MRD negativity rate among responders of 100% (18/18).
Intensive chemotherapy: Two ongoing Phase 1 trials evaluating the combination of revumenib with intensive chemotherapy (7+3) in newly diagnosed NPM1m or KMT2Ar acute leukemia patients. Preliminary data presented from both trials at the 2025 ASH (Free ASH Whitepaper) Annual Meeting showed that the safety profile of the combination was consistent with the profile for intensive chemotherapy alone, along with high rates of response and MRD negativity.
BEAT AML: A Phase 1 trial evaluating the combination of revumenib with venetoclax and azacitidine in newly diagnosed older adults (≥60 years) with NPM1m or KMT2Ar AML. The trial is being conducted as part of the Leukemia & Lymphoma Society’s Beat AML Master Clinical Trial. Data presented at the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Congress and simultaneously published in the Journal of Clinical Oncology showed a CR rate of 67% (29/43), an ORR of 88% (38/43), and a MRD negativity rate of 100% (37/37) among responders.
Post-transplant maintenance: A Phase 1 trial evaluating the safety and preliminary efficacy of revumenib as post-transplant maintenance after hematopoietic stem cell transplant (HSCT) in patients with KMT2Ar or NPM1m acute leukemia. The trial is being conducted by investigators from the City of Hope Medical Center.
Break Through Cancer: A Phase 2 trial studying whether the combination of revumenib and venetoclax can eliminate MRD in patients with AML and extend progression-free survival. The trial is being conducted by Break Through Cancer, a collaboration between leading U.S. cancer research centers.
INTERCEPT: A Phase 1 trial evaluating the use of novel therapies, including revumenib, to target MRD and early relapse in AML. The trial is being conducted by the Australasian Leukaemia and Lymphoma Group as part of the INTERCEPT AML master clinical trial.
The Company expects to present additional revumenib data at major medical meetings throughout 2026, including additional real-world evidence and data from the frontline and post-HSCT maintenance setting.
The Company expects the RAVEN trial to initiate in the second half of 2026. RAVEN is a Phase 2 collaborative trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed KMT2Ar patients who would be considered eligible, or fit, for intensive chemotherapy.

Niktimvo (axatilimab-csfr)

Achieved $56.0 million in Niktimvo net revenue in the fourth quarter of 2025, a 22% increase over the third quarter of 2025. Niktimvo net revenue for the full year 2025 totaled $151.6 million. Syndax and Incyte are co-commercializing Niktimvo. Syndax records 50% of the Niktimvo net commercial profit, defined as net product revenue minus the cost of sales and commercial expenses. Syndax’s share of the Niktimvo product contribution, reported as collaboration revenue, was $19.4 million and $42.4 million in the fourth quarter and full year 2025, respectively.
Presented data from 11 axatilimab abstracts, including three oral presentations, at the 2025 ASH (Free ASH Whitepaper) Annual Meeting. The abstracts highlighted the potential for axatilimab to provide long-term benefit in recurrent or refractory chronic graft-versus-host disease (GVHD) and the tolerability of axatilimab with ruxolitinib in newly diagnosed chronic GVHD.
Presented data from nine axatilimab abstracts, including one oral presentation, at the Tandem Meetings (Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR) in February 2026. The data presented included a comprehensive analysis of axatilimab in patients with chronic GVHD-related bronchiolitis obliterans syndrome (BOS) in two clinical studies. The results show clinical and symptom responses across a spectrum of lung involvement.
Two trials evaluating axatilimab in combination with standard of care therapies in newly diagnosed chronic GVHD patients are ongoing, including:
A Phase 2, open-label, randomized, multicenter trial of axatilimab in combination with ruxolitinib in patients ≥ 12 years of age with newly diagnosed chronic GVHD.
A pivotal Phase 3, randomized, double-blind, placebo-controlled, multi-center trial of axatilimab in combination with corticosteroids in patients ≥ 12 years of age with newly diagnosed chronic GVHD.
Completed enrollment in MAXPIRe, a Phase 2, 26-week randomized, double-blinded, placebo-controlled trial of axatilimab on top of standard of care in patients with idiopathic pulmonary fibrosis (IPF) in the first quarter of 2026. The Company expects to report topline data in the fourth quarter of 2026.

Fourth Quarter and Full Year 2025 Financial Results

As of December 31, 2025, Syndax had cash, cash equivalents, and short-term investments of $394.1 million and 87.7 million common shares and prefunded warrants outstanding.

Total revenue for the fourth quarter of 2025 was $68.7 million, which consisted of $44.2 million in Revuforj net revenue, $19.4 million in Niktimvo collaboration revenue, and $5.1 million in milestone, license and royalty revenue. Total revenue for the full year 2025 was $172.4 million, which consisted of $124.8 million in Revuforj net revenue, $42.4 million in Niktimvo collaboration revenue, and $5.1 million in milestone, license and royalty revenue. The Niktimvo collaboration revenue is derived from the $151.6 million in Niktimvo net revenue that was previously reported by the Company’s partner Incyte for the full year 2025. Syndax records 50% of the Niktimvo net commercial profit, defined as net revenue (recorded by Incyte) minus the cost of sales and commercial expenses.

Fourth quarter 2025 research and development expenses increased to $78.6 million from $65.5 million for the comparable prior year period, and for the full year 2025 increased to $258.8 million compared to $241.6 million for 2024. The year-over-year increase was primarily due to increased clinical, medical, and employee-related expenses.

Fourth quarter 2025 selling, general and administrative expenses increased to $49.9 million from $37.7 million for the comparable prior year period, and for the full year 2025 increased to $179.7 million compared to $120.9 million for 2024. The year-over-year increase was primarily due to increased employee-related expenses and increased sales and marketing expenses related to the U.S. commercial launches of Revuforj and Niktimvo.

For the three months ended December 31, 2025, Syndax reported a net loss attributable to common stockholders of $68.0 million, or $0.78 per share, compared to a net loss attributable to common stockholders of $94.2 million, or $1.10 per share, for the comparable prior year period. For the year ended December 31, 2025, Syndax reported a net loss attributable to common stockholders of $285.4 million or $3.29 per share, compared to a net loss attributable to common stockholders of $318.8 million or $3.72 per share for the comparable prior year period.

Financial Guidance

For the full year of 2026, the Company expects total research and development plus selling, general and administrative expenses to be approximately $400 million, excluding the impact of $50 million in estimated non-cash stock compensation expense.

Syndax expects that its operating expense base will remain stable over the next couple of years. As a result, Syndax expects that its cash, cash equivalents and short-term investments, combined with its anticipated product revenue, collaboration revenue and interest income, will enable the Company to reach profitability.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Thursday, February 26, 2026.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website. Alternatively, the conference call may be accessed through the following:

Conference ID: Syndax4Q25
Domestic Dial-in Number: (800) 590-8290
International Dial-in Number: (240) 690-8800
Live webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company’s website at www.syndax.com approximately 24 hours after the conference call and will be available for 90 days following the call.

About Revuforj (revumenib)

Revuforj (revumenib) is an oral, first-in-class menin inhibitor that is FDA approved for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation as determined by an FDA-authorized test in adult and pediatric patients one year and older. Revuforj is also indicated for the treatment of R/R acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients one year and older who have no satisfactory alternative treatment options.

Multiple trials of revumenib are ongoing or planned across the treatment landscape, including in combination with standard of care therapies in newly diagnosed patients with NPM1m or KMT2Ar AML.

Revumenib was previously granted Orphan Drug Designation for the treatment of AML, ALL and acute leukemias of ambiguous lineage (ALAL) by the U.S. FDA and for the treatment of AML by the European Commission. The U.S. FDA also granted Fast Track designation to revumenib for the treatment of adult and pediatric patients with R/R acute leukemias harboring a KMT2A rearrangement or NPM1 mutation and Breakthrough Therapy Designation for the treatment of adult and pediatric patients with R/R acute leukemia harboring a KMT2A rearrangement.

About Niktimvo (axatilimab-csfr)

Niktimvo (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).

In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.

Axatilimab is being studied in frontline combination trials in chronic GVHD, including a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774). Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).

(Press release, Syndax, FEB 26, 2026, View Source [SID1234663073])