Zai Lab Limited Stock Price, News & Analysis

Zai Lab will present new translational and clinical biomarker data for its oncology program ZL-1211 at the AACR Annual Meeting 2023 in Orlando, scheduled for April 14-19, 2023. The anti-CLDN18.2 antibody, currently in a Phase 1 clinical trial for advanced solid tumors (NCT05065710), aims to induce cancer cell death via antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). The data to be presented will include results from clinical patient samples that validate the mechanism of action for ZL-1211 and highlight potential predictive biomarkers for patient selection in the ongoing trial.

Additionally, Zai will present findings on tebotelimab, a PD-1/LAG-3 bispecific antibody, with poster presentations scheduled for April 18, 2023. This activity underscores Zai Lab's commitment to strengthening its oncology pipeline to address significant unmet patient needs.

Zai Lab Limited (NASDAQ: ZLAB) announced positive results from its partner Karuna Therapeutics' Phase 3 EMERGENT-3 trial of KarXT for schizophrenia. The trial achieved its primary endpoint, showing an 8.4-point reduction in the PANSS total score at Week 5 (p<0.0001). KarXT was generally well tolerated, with adverse effects similar to earlier trials. Zai Lab plans to begin a bridging study for schizophrenia treatment in China mid-2023. The New Drug Application (NDA) for KarXT is expected to be submitted to the FDA in mid-2023, with a potential commercial launch in late 2024, contingent on approval.

Zai Lab Limited (NASDAQ: ZLAB) reported a remarkable 49.0% increase in total revenue for 2022, totaling $215.0 million, attributed to strong sales growth across its product portfolio.

ZEJULA® sales surged by 55.2% year-over-year. The company boasts a robust cash position of $1.0 billion as of December 31, 2022. Zai Lab aims for commercial profitability in 2023 and plans to launch at least 8 new products by 2025, supported by a rich pipeline of late-stage data readouts.

The company has made substantial progress in oncology and autoimmune disorders, positioning itself for future growth and innovation.

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced that its senior management will participate in two upcoming investor conferences in March 2023. The conferences are the Jefferies 2023 Biotech on the Bay Summit on March 16 in Miami and the 26th Credit Suisse Asian Investment Conference from March 20 to 23 in Hong Kong. Zai Lab is a biopharmaceutical company focusing on innovative medicines for various diseases, including oncology and autoimmune disorders. For more information, visit their website.

Zai Lab will present significant findings from the NORA Phase 3 study of ZEJULA (niraparib) at the ESMO Gynaecological Cancers Congress on February 23-24, 2023. Preliminary results show that niraparib maintenance therapy improved overall survival in platinum-sensitive recurrent ovarian cancer patients. The median overall survival was 46.3 months versus 43.4 months for placebo (HR=0.82). Additionally, a post hoc analysis from the Phase 3 PRIME trial revealed enhanced progression-free survival with niraparib compared to placebo across various surgical statuses. The presentations highlight the ongoing commitment to improving treatment options for ovarian cancer patients in China.

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced the acceptance of their New Drug Application (NDA) for sulbactam-durlobactam (SUL-DUR) by China's National Medical Products Administration (NMPA). This investigational drug targets Acinetobacter baumannii infections, particularly multidrug-resistant and carbapenem-resistant strains, addressing a significant medical need. The drug shows promise in reducing mortality and renal toxicity over standard colistin therapy. SUL-DUR has also received priority review status in both China and the U.S. Zai Lab holds exclusive development rights for SUL-DUR in multiple countries across Asia and Oceania.

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced it will report financial results for the twelve months ended December 31, 2022, after U.S. market closure on March 1, 2023. A live conference call and webcast will take place on March 2, 2023, at 8:00 a.m. ET. Investors can access the webcast via the company's website, and advance registration is required. This event will highlight the company's progress and future direction in the biopharmaceutical sector, particularly in oncology, autoimmune disorders, infectious diseases, and neurological disorders.

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced its participation in several investor conferences in February 2023. Key events include a fireside chat at the Guggenheim Oncology Conference on February 8, and two chats on February 14 at the SVB Securities Global Biopharma Conference and the Citi Biotech C-Suite Fireside Chat Series. Interested parties can access the webcast links in the Investor Relations section of Zai Lab's website. The company aims to deliver transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders globally.

Zai Lab Limited (NASDAQ: ZLAB) announced that China's Center for Drug Evaluation (CDE) has granted priority review status to the New Drug Application (NDA) for sulbactam-durlobactam (SUL-DUR). This investigational drug targets infections by Acinetobacter baumannii, especially multidrug-resistant strains. The grant emphasizes the urgent need for new treatments in light of the high mortality rates associated with these infections in ICU settings. The FDA has also accepted the NDA for SUL-DUR for priority review, with an action date of May 29, 2023. Zai Lab holds exclusive commercialization rights for SUL-DUR in multiple Asia-Pacific regions.