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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(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])

On February 26, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported financial results for the fourth quarter and full-year 2025, along with recent product highlights and corporate updates.

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"2025 was a year of disciplined execution across both engines of our business with significant advancement across our global innovation pipeline and steady progress in our commercial business," said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. "We accelerated multiple global programs, including the rapid progression of zoci into pivotal development, enabled by our integrated U.S./China infrastructure which allows us to operate with speed and capital efficiency. In 2026, our focus is on executing against important catalysts – advancing late-stage immunology and oncology programs while preparing for the next wave of commercial growth. Together, these efforts mark an important step in Zai Lab’s continued evolution into a global biopharma leader."

"KarXT represents a significant new growth driver for Zai Lab, and its recent inclusion in a national expert consensus underscores the growing recognition of its novel mechanism and potential to meaningfully impact patients living with schizophrenia," said Josh Smiley, President and Chief Operating Officer of Zai Lab. "We are strengthening the VYVGART franchise by expanding hospital coverage and supporting longer treatment persistence. Concurrently, we are preparing for the potential approvals of TIVDAK, which would further strengthen our women’s health franchise, and TTFields in pancreatic cancer. Looking beyond 2026, the combination of new launches, potential label expansions and advancing global programs, positions us for multi-year growth and continued financial improvement."

Fourth Quarter and Full-Year 2025 Financial Results
•Total revenue was $127.6 million in the fourth quarter of 2025 and $460.2 million for the full-year 2025. Product revenue, net was $127.1 million in the fourth quarter of 2025, compared to $108.5 million for the same period in 2024, representing 17% y-o-y growth and 16% at constant exchange rate (CER); and was $457.2 million in full-year 2025, compared to $397.6 million for the same period in 2024, representing 15% y-o-y growth and 16% y-o-y growth at CER. This increase was primarily due to higher revenue for XACDURO and NUZYRA.
–ZEJULA was $56.0 million in the fourth quarter of 2025, an increase of 16% y-o-y from $48.4 million; and was $189.0 million in full-year 2025, compared to $187.1 million for the same period in 2024. ZEJULA continued to be the leading PARP inhibitor in hospital sales for ovarian cancer despite evolving competitive dynamics within the PARPi class in mainland China.
–VYVGART and VYVGART Hytrulo were $21.9 million in the fourth quarter of 2025 which includes a $5.6 million rebate for VYVGART related to the National Reimbursement Drug List (NRDL) renewal, compared to $30.0 million for the same period in 2024; and was $94.2 million in full-year 2025, compared to $93.6 million for the same period in 2024.
–XACDURO, which was launched in the fourth quarter of 2024, was $10.7 million in the fourth quarter of 2025, an increase of 225% y-o-y from $3.3 million; and was $22.9 million in full-year 2025, an increase of 593% y-o-y from $3.3 million. Growth was driven by strong patient demand and expanding hospital adoption but was partially constrained by supply limitations during the year.
–NUZYRA was $16.0 million in the fourth quarter of 2025, an increase of 45% y-o-y from $11.0 million; and was $60.8 million in full-year 2025, an increase of 41% y-o-y from $43.2 million. This growth was supported by increased market coverage and penetration.
•Research and Development (R&D) expenses were $61.6 million in the fourth quarter of 2025, compared to $52.3 million for the same period in 2024, and $220.9 million for full-year 2025, compared to $234.5 million for the same period in 2024. The fourth-quarter increase resulted from progress in clinical trials. The full year decline was primarily driven by lower personnel compensation due to strategic resource optimization.
•Selling, General and Administrative (SG&A) expenses were $73.0 million in the fourth quarter of 2025, compared to $82.6 million for the same period in 2024, and $277.6 million for full-year 2025, compared to $298.7 million for the same period in 2024. The decrease was primarily due to a reduction in general and administrative expenses due to strategic resource optimization.
•Loss from operations was $69.4 million and $229.4 million in the fourth quarter of 2025 and full-year 2025, respectively, and $49.6 million and $148.8 million, respectively, when adjusted to exclude non-cash expenses, including depreciation, amortization, and share-based compensation. Loss from operations was $67.9 million and $282.1 million in the fourth quarter of 2024 and full-year 2024, respectively. A reconciliation of loss from operations (GAAP) to adjusted loss from operations (non-GAAP) is included at the end of this release.
•Net loss was $50.4 million in the fourth quarter of 2025, or a loss per ordinary share attributable to common stockholders of $0.05 (or loss per American Deposit Share (ADS) of $0.46), compared to a net loss of $81.7 million for the same period in 2024 or a loss per ordinary share of $0.08 (or loss per ADS of $0.80). The net loss was $175.5 million for full-year 2025, or a loss per ordinary share attributable to common stockholders of $0.16 (or loss per ADS of $1.60), compared to a net loss of $257.1 million for full-year 2024, or a loss per ordinary share of $0.26 (or loss per ADS of $2.60). These decreases in net loss were primarily due to product revenue growing faster than net operating expenses and shift from foreign currency losses to foreign currency gains, offset by decreased interest income.
•Cash and cash equivalents, short-term investments and current restricted cash totaled $789.6 million as of December 31, 2025, compared to $879.7 million as of December 31, 2024.

2026 Strategic Priorities
Zai Lab will focus on the following strategic priorities in 2026 to drive near-term performance and long-term global value creation:
Advancing Differentiated Global Programs Across Oncology and Immunology
•Zocilurtatug pelitecan (zoci) (DLL3-targeting ADC): Advance three registration-enabling studies across 2L+ SCLC, 1L SCLC, and other neuroendocrine carcinomas (NECs) by the end of 2026. Three data readouts expected in 2026, including:
–2L+ SCLC: Updated global Phase 1 data highlighting intracranial response in patients with brain metastases.
–1L SCLC: Data from an ongoing Phase 1 combination study evaluating doublet and triplet regimens with a PD-L1 inhibitor, with or without chemotherapy; initiation of global Phase 1 study with novel combination.
–Extrapulmonary NECs: Data from the Phase 1b portion of the ongoing global Phase 1b/2 study.
•ZL-1503 (IL-13/IL-31Rα bispecific antibody): First-in-Human (FIH) data from the ongoing global Phase 1/1b study expected in the second half of 2026, paving the way for Phase 2 development in atopic dermatitis (AD).
•ZL-6201 (LRRC15-targeting ADC): Global Phase 1 ongoing.
•ZL-1222 (PD-1/IL-12 immunocytokine): Investigational New Drug (IND)-enabling studies expected to be completed in 2026.
•ZL-1311 (T-cell engager (TCE) targeting MUC17): IND submission expected by year end.
•Zai Lab is building capabilities in TCEs and exploring additional immunocytokines beyond IL-12, with further details to be provided throughout the year.
Commercial Execution and Key Near-Term Regional Launches to Drive Steady Growth
•VYVGART and VYVGART Hytrulo: Continue to increase patient utilization and duration of treatment in generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP).
•KarXT: Planned commercial launch in the first half of 2026, supported by a targeted commercial strategy, physician education, real-world evidence generation, and preparation for potential NRDL inclusion in 2027.
•Povetacicept and elegrobart: Both have pivotal readouts in 2026 and are expected to further strengthen regional revenue growth in the near term.

Key Corporate Updates
Below are key corporate updates since our last earnings release:
•Business Development:
–We obtained the exclusive worldwide rights to develop and commercialize ZL‑1311, a next‑generation TCE targeting MUC17, which is a promising and druggable antigen overexpressed in up to ~50% of gastric and gastroesophageal junction cancers. This program represents Zai Lab’s first globally owned TCE and strategically expands our immuno‑oncology portfolio while leveraging our established expertise in GI cancers. ZL‑1311 is expected to enter global clinical development this year.
–We formed a strategic collaboration with SciClone Pharmaceuticals (SciClone) for AUGTYRO (repotrectinib), which was approved in mainland China for ROS1‑positive non‑small‑cell lung cancer in May 2024 and for NTRK‑positive solid tumors in January 2026. Through this collaboration, Zai Lab will leverage SciClone’s commercialization infrastructure to broaden access and accelerate the commercial rollout of this innovative therapy for patients in need across mainland China.
•NRDL Updates: In December 2025, Zai Lab announced the successful renewals of VYVGART (efgartigimod alfa injection) for gMG patients who are anti-acetylcholine receptor (AChR) antibody positive, NUZYRA (omadacycline) for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) and ZEJULA (niraparib) for platinum-sensitive, first-line and recurrent ovarian cancer patients in China’s NRDL.

Recent Pipeline Highlights
Below are key product candidate updates since our last earnings release:
Oncology Pipeline
•Zocilurtatug Pelitecan (zoci, DLL3 ADC):
–Second-Line+ ES-SCLC: The global Phase 3 study evaluating the efficacy and safety of zoci versus investigator’s choice therapy (topotecan, lurbinectedin, or amrubicin) in patients with relapsed SCLC is ongoing. This pivotal study plans to enroll approximately 480 patients in 2L SCLC or 3L post‑tarlatamab SCLC, with the majority of enrollment anticipated to be completed this year.
–Extrapulmonary NECs: In January 2026, Zai Lab dosed the first patient in the global Phase 2 portion of its ongoing Phase 1b/2 study in NECs. Zai Lab plans to present an initial data readout from the Phase 1b portion in the first half of 2026, complete enrollment for the Phase 2 portion, and advance the program into the registrational stage within the year.
•ZL-6201 (LRRC15 ADC): In January 2026, the FDA cleared the IND application for a global Phase 1 study in patients with sarcoma and potentially other LRRC15-positive solid tumors. The global Phase 1 study has been initiated.
•Tumor Treating Fields (TTFields): In February 2026, the FDA approved Optune Pax for the treatment of adult patients with locally advanced pancreatic cancer concomitant with gemcitabine and nab-paclitaxel. It is the first treatment approved by the FDA for locally advanced pancreatic cancer in nearly 30 years. China’s NMPA granted Innovative Medical Device Designation for the treatment of pancreatic cancer in August 2025.
•AUGTYRO (repotrectinib, ROS1/TRK): In December 2025, China’s NMPA approved the supplemental New Drug Application (sNDA) for AUGTYRO (repotrectinib) for the treatment of adult patients with solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
Immunology, Neuroscience, and Infectious Disease Pipeline
•ZL-1503 (IL-13/IL-31Rα): In December 2025, Zai Lab dosed the first participant in a global Phase 1/1b study evaluating the safety, tolerability, pharmacokinetics, and efficacy of ZL-1503 for the treatment of AD. Zai Lab expects to report the first-in-human data from the global Phase 1 portion in the second half of 2026.
•VYVGART (FcRn):
–Ocular myasthenia gravis (oMG): Zai Lab partner argenx announced in February 2026 that the Phase 3 ADAPT OCULUS met its primary endpoint (p-value=0.012), demonstrating that patients living with oMG and treated with VYVGART demonstrated statistically significant improvement from baseline in Myasthenia Impairment Index (MGII) Patient Reported Outcome (PRO) ocular scores at Week 4 compared to placebo. In the overall population, mean change from baseline in patients treated with VYVGART was a 4.04 point improvement in MGII PRO versus a mean change of 1.99 MGII PRO score in patients treated with placebo. VYVGART was well tolerated and had a favorable safety profile in patients with oMG, consistent with prior studies. Zai Lab participated in the study in Greater China (mainland China, Hong Kong, Macau, and Taiwan, collectively).
–Seronegative generalized myasthenia gravis (sn-gMG): In January 2026, the FDA accepted for Priority Review a supplemental Biologics License Application (sBLA) for the treatment of adults with acetylcholine receptor antibody (AChR-Ab) sn-gMG, with a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2026. Zai Lab participated in the Phase 3 ADAPT SERON study in Greater China.
•KarXT (xanomeline and trospium chloride) (M1/M4-agonist): In December 2025, China’s NMPA approved the NDA for KarXT for the treatment of schizophrenia in adults. KarXT is the first schizophrenia therapy with a novel mechanism of action approved in more than 70 years, offering a fundamentally new approach to treating schizophrenia. The commercial launch in China is planned for the second quarter of 2026.
•Povetacicept (APRIL/BAFF): In December 2025, Zai Lab joined the global pivotal Phase 2/3 OLYMPUS study in primary membranous nephropathy (pMN) and dosed the first patient in mainland China. The FDA granted Fast Track and Orphan Drug designations for povetacicept in pMN, and the EMA has granted Priority Medicines (PRIME) designation.

•Elegrobart (anti-IGF-1R, subcutaneous): In December 2025, Zai Lab dosed the first patient in a registrational study in thyroid eye disease (TED) in mainland China. Partner Viridian plans to report topline results from two global registrational studies in patients with active TED and chronic TED in the first half of 2026.
Anticipated Major Milestones in 2026

Expected Clinical Developments and Data Readouts

Global Pipeline
Zocilurtatug Pelitecan (zoci, DLL3 ADC) (formerly ZL-1310)
•Second-Line+ ES-SCLC: Zai Lab to present updated data on intracranial activity from the ongoing Phase 1 study in the first half of 2026.
•First-Line ES-SCLC: Zai Lab to provide data readout from the Phase 1 study evaluating zoci combination therapy (with atezolizumab and/or chemotherapy) in the second half of 2026 and advance zoci into a registrational study in 2026 based on emerging data. Zai Lab also plans to initiate a Phase 1 study to explore zoci in a novel combination in the first half of 2026.
•Extrapulmonary NECs: Zai Lab to provide data readout from the global Phase 1b portion of the ongoing Phase 1b/2 study evaluating zoci in patients with selected solid tumors in the first half of 2026 and advance into registrational development in 2026.
ZL-1503 (IL-13/IL-31Rα)
•Zai Lab to provide the first-in-human data readout from the global Phase 1/1b study in 2026.

Regional Pipeline

Upcoming Potential NMPA Approvals
•Tisotumab Vedotin (Tissue Factor ADC) in recurrent or metastatic cervical cancer following progression on or after chemotherapy
•Tumor Treating Fields (TTFields) in locally advanced pancreatic cancer

Efgartigimod (FcRn)
•Myositis: Zai Lab partner argenx to provide topline results from the global Phase 2/3 ALKIVIA study evaluating autoimmune inflammatory myopathies (AIM or myositis) in the third quarter of 2026. Zai Lab participated in the study in Greater China.
Povetacicept (APRIL/BAFF)
•IgA Nephropathy (IgAN): Zai Lab partner Vertex remains on track to release interim analysis data of the global Phase 3 RAINIER study in the first half of 2026 and also complete the submission in the first half of 2026, if data from the interim analysis are supportive. The FDA has granted Breakthrough Therapy Designation for this indication.
•pMN: Zai Lab and partner Vertex plan to complete the Phase 2 portion of the global pivotal Phase 2/3 OLYMPUS study and initiate the Phase 3 portion in mid-2026.
Elegrobart (anti-IGF-1R, subcutaneous)
•Viridian to provide topline results from the global registrational REVEAL-1 study in active TED patients in the first quarter of 2026 and global registrational REVEAL-2 study in chronic TED in the second quarter of 2026. Zai Lab, through its license agreement with Zenas, obtained a sublicense to the Viridian anti-IGF-1R antibody and is proceeding with clinical development.

Conference Call and Webcast Information
Zai Lab will host a live conference call and webcast today, February 26, 2026, at 8:00 a.m. ET (9:00 p.m. HKT). Listeners may access the live webcast by visiting the Company’s website at View Source Participants must register in advance of the conference call.

Details are as follows:

•Registration link for webcast (preferred): View Source
•Registration link for dial-in: View Source

All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering.
A replay will be available shortly after the call and can be accessed by visiting the Company’s website.

(Press release, Zai Laboratory, FEB 26, 2026, View Source [SID1234663090])

On February 26, 2026 Starton Therapeutics Inc. ("Starton"), a clinical-stage biotechnology company employing standard-of-care therapies with proprietary continuous delivery technologies, reported that it has filed a patent application for the use of multi-specific (i.e., bi- and tri-specific) antibody-based therapies in combination with the Company’s proprietary, continuous low-dose IMiD, which is a subcutaneous administration of lenalidomide, STAR-LLD, for the treatment of cancer.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

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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"We are pleased to announce the filing of this provisional patent application," stated Pedro Lichtinger, Chairman and Chief Executive Officer of Starton. "Although lenalidomide and other IMiDs are being studied in combination with multi-specific antibodies, side effect profiles are thought to limit widespread acceptance by oncologists. We believe our continuous subcutaneous delivery of a low-dose formulation of lenalidomide has the potential to improve the side effect profile while sustaining T-cell persistence and response durability."

About STAR-LLD

STAR-LLD is a continuous delivery lenalidomide (LLD) in development seeking to expand and replace the standard-of-care for the most common blood cancers, multiple myeloma (MM), and chronic lymphocytic leukemia (CLL). A preclinical proof-of-concept study for subcutaneous STAR-LLD demonstrated that MM tumors caused by human myeloma cells grew 25-fold if untreated, five-fold when treated with daily lenalidomide, and shrank by 80% with STAR-LLD over a single 28-day cycle. The study also showed a 100% overall response rate (ORR) using continuous delivery LLD with 20% of animals in this cohort tumor-free after 100 days; by contrast, there was a 0% ORR in animals treated with a 70% higher dose of lenalidomide given in single daily doses. In addition, a Phase 1b clinical study of six relapsed/refractory MM patients resulted in all patients that received STAR-LLD achieving an objective response (1 CR and 5 PRs); no patients experienced drug-related anemia, neutropenia, leukopenia, or thrombocytopenia greater than grade 2 in up to 12 cycles of therapy. The Phase 1b clinical study concluded that continuous delivery of low dose lenalidomide (STAR-LLD) provides meaningful efficacy and improved tolerability with no grade > 2 drug-related hematologic toxicity.

(Press release, Starton Therapeutics, FEB 26, 2026, View Source [SID1234663106])