Zai Lab (ZLAB) Stock News

Zai Lab (NASDAQ: ZLAB) announced an oral presentation of updated data for zocilurtatug pelitecan (zoci) from its global Phase 1 trial (NCT06179069) at the AACR-NCI-EORTC conference in Boston, Oct 22–26, 2025.

The late-breaking abstract features additional follow-up in previously treated extensive-stage small cell lung cancer (ES-SCLC). Zai Lab said it remains on track to initiate a Phase 3 registrational study by year-end 2025. An investor webcast and conference call to discuss the data and plans is scheduled for Oct 24, 2025, 11:00 a.m. ET.

Zai Lab (NASDAQ: ZLAB) has received approval from the Hong Kong Department of Health for TIVDAK (tisotumab vedotin-tftv), a groundbreaking treatment for adult patients with recurrent or metastatic cervical cancer who experienced disease progression during or after chemotherapy.

TIVDAK represents a significant advancement as the first antibody-drug conjugate (ADC) therapy for cervical cancer, offering meaningful survival benefits. The company plans to leverage its existing ZEJULA commercial infrastructure in Hong Kong for immediate distribution. Additionally, TIVDAK's Biologics License Application is currently under review by China's National Medical Products Administration (NMPA), following its acceptance in March 2025.

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) announced its participation in two major healthcare investor conferences in September 2025. The company will present at the Cantor Global Healthcare Conference on September 4 at 10:20 a.m. ET and participate in a fireside chat at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9 at 2:35 p.m. ET. Both events will take place in New York.

Investors can access live webcasts of both presentations through Zai Lab's Investor Relations website, with recordings available for 90 days after the events.

Zai Lab (NASDAQ: ZLAB) has received Innovative Medical Device Designation from China's NMPA for Tumor Treating Fields (TTFields) in pancreatic cancer treatment, following positive Phase 3 PANOVA-3 trial results. This designation enables expedited regulatory review and allows submission before approval in the country of origin.

The Phase 3 PANOVA-3 trial evaluated TTFields with gemcitabine and nab-paclitaxel as first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma. The trial met its primary endpoint with statistically significant improvement in median overall survival. Zai Lab plans to submit for regulatory approval in China in H2 2025.

Zai Lab (NASDAQ: ZLAB) has announced the formation of its Oncology Scientific Advisory Board (SAB), comprising eight distinguished leaders in oncology research and clinical practice. The advisory board will support the advancement of the company's oncology products and pipeline, including internally developed therapies.

The newly formed SAB includes prominent experts from prestigious institutions such as Yale University School of Medicine, UCLA, University of Chicago, Sarah Cannon Research Institute, University of Manchester, Yale Cancer Center, University of Pittsburgh Medical Center, and MD Anderson Cancer Center. Dr. Rafael G. Amado, President and Head of Global R&D at Zai Lab, emphasized the significance of this development for advancing innovative treatment options for patients globally.

Zai Lab (NASDAQ: ZLAB) reported Q2 2025 financial results with total revenues growing 9% year-over-year to $110.0 million. The company reaffirmed its full-year 2025 revenue guidance of $560-590 million. Operating loss improved by 28% year-over-year to $54.9 million, with the company on track to achieve profitability in Q4 2025.

Key highlights include VYVGART's record patient utilization and ZL-1310's promising clinical data showing 67% overall response rate in second-line SCLC. The successful Phase 3 FORTITUDE-101 study of bemarituzumab in gastric cancer met its primary endpoint, with China regulatory submission expected in H2 2025.

The company maintains a strong financial position with $832.3 million in cash and equivalents as of June 30, 2025, supporting its commercial expansion and pipeline development.

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has scheduled its second quarter 2025 financial results announcement and corporate updates for August 7, 2025, before U.S. markets open. The company will host a conference call and webcast at 8:00 a.m. ET (8:00 p.m. HKT) on the same day.

Interested participants must register in advance through the provided links to access either the webcast or dial-in options. A replay of the event will be available on the company's website after the call.

Zai Lab (NASDAQ: ZLAB) announced positive Phase 3 results for bemarituzumab in treating FGFR2b-positive first-line gastric cancer. The FORTITUDE-101 clinical trial demonstrated that bemarituzumab plus chemotherapy achieved a statistically significant and clinically meaningful improvement in overall survival compared to placebo plus chemotherapy in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction cancer.

The study focused on patients with FGFR2b overexpression (defined as 2+/3+ staining in ≥10% of tumor cells) who are non-HER2 positive. Bemarituzumab is the first FGFR2b inhibitor to show significant overall survival benefit in a Phase 3 trial for first-line treatment of FGFR2b-positive gastric cancer.

The most common adverse events included reduced visual acuity, punctate keratitis, anemia, neutropenia, nausea, corneal epithelium defect, and dry eye. Ocular events occurred with greater frequency and severity in the bemarituzumab arm. The company plans to pursue regulatory submission in China, where the drug has already received Breakthrough Therapy designation.

Zai Lab (NASDAQ: ZLAB) presented promising preclinical data for ZL-1503, their IL-13/IL-31R bispecific antibody for treating moderate-to-severe atopic dermatitis, at EAACI Congress 2025. The study demonstrated ZL-1503's ability to simultaneously suppress both inflammatory and itch-causing pathways. Key findings showed that a single 10 mg/kg dose completely inhibited target pathways for at least 76 days, with some subjects showing effects beyond 118 days. The drug exhibited slow clearance, strong pharmacokinetic/pharmacodynamic relationships, and was well-tolerated at doses up to 150 mg/kg. Zai Lab plans to file an IND by the end of 2025, positioning ZL-1503 as a potential advancement over current treatments that only partially alleviate symptoms through IL-4/IL-13 inhibition alone.