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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"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])

On February 26 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a novel class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported it has entered into an agreement with Eckert & Ziegler, leading specialist in isotope-related components for nuclear medicine and radiation therapy, to enable the development and manufacturing of Radio-DARPin therapeutics.

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"We are pleased to work with Eckert & Ziegler, a global leader in radiopharmaceutical manufacturing. This agreement will expand the potential of Radio-DARPins as vectors for precise delivery of therapeutic alpha-emitting isotopes to tumors, now including Actinium-225, in addition to Lead-212 through our long-term strategic partnership with Orano Med," said Alexander Zürcher, COO of Molecular Partners. He added: "The promise of Radio-DARPins is underlined by the progress of our lead candidate MP0712, targeting DLL3, having just opened the Phase 1/2a trial for the treatment of patients with small cell lung cancer (SCLC)".

Under the non-exclusive agreement, Eckert & Ziegler will support Molecular Partners with a comprehensive range of services covering development activities for Radio-DARPins with Actinium-225 (225Ac) and Lutetium-177 (177Lu) payloads. The development agreement will leverage Eckert & Ziegler’s state-of-the-art laboratories, including its newly established Alpha Laboratory in Berlin, Germany, dedicated exclusively to work with alpha emitters.

For its growing Radio-DARPin pipeline, Molecular Partners is evaluating various radio-nuclides to tailor Radio-DARPin candidates to patient needs – matching vector and isotope properties with target and disease biology. The Company plans to present pre-clinical data on Radio-DARPins’ suitability with multiple isotopes at the 3rd Global Radiopharmaceuticals Development Summit in March 2026 in Shanghai, China.

Eckert & Ziegler is a globally leading specialist for isotope-related components in nuclear medicine and radiation therapy, offering a broad range of services and products from early development work to contract manufacturing and distribution.

"Supporting highly innovative companies such as Molecular Partners in developing their promising technology platforms is a key objective of our group," said Dr. Harald Hasselmann, CEO of Eckert & Ziegler. "Bringing together our expertise in isotopes, radiochemistry and development infrastructure with our partners’ innovations will enable patients worldwide to benefit from new treatments in the future."

About Radio-DARPins

Molecular Partners’ Radio-DARPins are designed as ideal vectors for precise delivery of potent alpha-emitting isotopes to tumor lesions and have the potential to unlock a broad range of tumor targets for targeted radiopharmaceuticals. Building on the DARPins’ unique properties, Molecular Partners has developed a proprietary Radio-DARPin platform to address historic limitations of radioligand therapy, such as kidney accumulation and toxicity, and suboptimal tumor uptake. Molecular Partners’ Radio-DARPins addresses these limitations through half-life extension technologies and surface engineering approaches, while preserving the advantages of the small protein format.

(Press release, Molecular Partners, FEB 26, 2026, View Source [SID1234663009])

On February 26, 2026 The European Organisation for Research and Treatment of Cancer (EORTC) reported that it has activated the first site for the EORTC-2361-GUCG RENALUT clinical trial. This phase II, single-arm, multicentre study investigates the potential of Pluvicto (177Lu]Lu‑PSMA‑617) as a new treatment option for patients with metastatic clear cell renal cell carcinoma (ccRCC) who have progressed after one or two previous systemic therapies.

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About ccRCC
Clear cell renal cell carcinoma is the most common subtype of kidney cancer and is often driven by mutations in the Von Hippel-Lindau (VHL) gene, contributing to the tumours highly vascular nature. Most patients today receive combinations or sequences of immunotherapy and targeted therapies, such as VEGFR tyrosine kinase inhibitors. However, after progression on these regimens, options are limited. This highlights the need for new therapeutic strategies for patients in later lines of treatment.

About the RENALUT study
The RENALUT trial explores a novel therapeutic approach for metastatic ccRCC by leveraging radioligand therapy (RLT) targeting PSMA (prostate-specific membrane antigen). Although PSMA is best known for its role in prostate cancer, it is also expressed in the tumour neovasculature of ccRCC, making it a promising therapeutic target1. PSMA‑targeted imaging has shown strong performance in identifying metastatic ccRCC, supporting the idea that PSMA‑directed therapy with [177Lu]Lu‑PSMA‑617 may also be an effective treatment for this disease2,3. By building on the established use of [177Lu]Lu‑PSMA‑617 in metastatic castration resistant prostate cancer, RENALUT aims to determine whether this approach can benefit ccRCC patients who have exhausted standard treatments and currently face very limited options.

Participating sites and collaboration
The activation of the first site marks a significant milestone for this innovative trial, which will involve 11 centres across Europe. The study is led by EORTC’s Genito-Urinary Cancer Group (GUCG) and supported by a network of international collaborators.

By exploring PSMA-targeted RLT in ccRCC, RENALUT aims to address an urgent unmet need and pave the way for future treatment strategies in kidney cancer.

(Press release, EORTC, FEB 26, 2026, View Source [SID1234663053])