- European Medicines Agency’s Committee for Orphan Medicinal Products recognized zoci’s preliminary clinical data as suggestive of a clinically relevant advantage over currently authorized therapies in relapsed or refractory extensive-stage small cell lung cancer (SCLC) - SCLC is the most
- TIVDAK is the first antibody-drug conjugate (ADC) approved for the treatment of previously treated recurrent or metastatic cervical cancer in China - TIVDAK demonstrated a statistically significant overall survival benefit in the global Phase 3 innovaTV 301 clinical trial, including in the
ALKIVIA+ data in myositis indicate efgartigimod provides sustained, clinically meaningful improvements and consistent safety RHO+ data in Sjogren’s disease indicate maintenance of response following switch to biweekly dosing Cross-indication analysis of efgartigimod data across rheumatology
- FDA assigns Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2026 – BOSTON --(BUSINESS WIRE)--Jun. 1, 2026-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application
SHANGHAI & CAMBRIDGE, Mass. --(BUSINESS WIRE)--May 21, 2026-- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced changes to its senior leadership team aimed at strengthening operational performance and efficiency. As part of these changes, the Board has made the decision that Josh Smiley,
- epNECs are aggressive malignancies with poor prognosis and no approved therapies, representing significant unmet medical need - Preliminary clinical data recently presented at the AACR Annual Meeting suggest zoci has potential to be a first-in-class therapy for epNECs - Zoci NEC clinical program
VYVGART and VYVGART Hytrulo are the first and only approved treatments for all serotypes of adult patients living with gMG – anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative Patients treated with VYVGART in the ADAPT SERON study experienced rapid,
– Total revenues of $99.6 million for the first quarter of 2026, reflecting anticipated first-quarter dynamics, including certain competitive impacts for ZEJULA and pricing adjustment related to NRDL renewal for VYVGART – Zocilurtatug pelitecan (zoci) delivered standout data at AACR 2026, with a
- REVEAL-2 met its primary endpoint with a highly statistically significant treatment effect - - Elegrobart Q4W and Q8W achieved 50% and 54% proptosis responder rates (PRR) at week 24, respectively, versus 15% placebo, both highly statistically significant results (p 0.0001) - - Elegrobart Q4W
- Company to host conference call and webcast on May 7, 2026, at 8:00 a.m. ET (8:00 p.m. HKT) SHANGHAI & CAMBRIDGE, Mass. --(BUSINESS WIRE)--Apr. 22, 2026-- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will report its first quarter 2026 financial results and provide recent
-Efficacy and safety data shared at IMMUNOLOGY2026 reinforce potential of ZL-1503 as a first-in-class treatment for moderate-to-severe atopic dermatitis and other IL-13 and IL-31-driven diseases -Strong inhibition of both inflammatory and pruritic pathways over 112 days following a single dose of
Zoci, a potential first-in-class DLL3-targeting antibody drug conjugate, showed a 53.7% confirmed intracranial objective response rate (iORR) for small cell lung cancer (SCLC) with brain metastases; at 1.6 mg/kg dose, the confirmed iORR was 62.5% (10/16), including complete responses Encouraging
Boehringer Ingelheim and Zai Lab launch a clinical collaboration to evaluate a dual DLL3‑targeting combination therapy in small cell lung cancer (SCLC) and other neuroendocrine carcinomas (NECs). Phase Ib/II study will test the combination of obrixtamig, a DLL3/CD3 T‑cell engager, with Zai Lab’s
- Collaboration with Amgen to explore the clinical potential of Zai Lab’s DLL3-targeting ADC, zocilurtatug pelitecan, in combination with Amgen’s IMDELLTRA ® - Amgen to sponsor and lead global Phase 1b study; Zai Lab to retain full ownership of zocilurtatug pelitecan SHANGHAI & CAMBRIDGE, Mass.
- REVEAL-1 met the primary endpoint of Q4W proptosis responder rate (PRR) with a highly statistically significant treatment effect - - Elegrobart Q4W and Q8W achieved clinically meaningful 54% and 63% PRR versus 18% placebo at week 24 - - Complete resolution of diplopia in 51% of patients treated
- Zoci data show intracranial response in small-cell lung cancer (SCLC) with brain metastases, as well as activity in other neuroendocrine carcinomas - ZL-6201 will be highlighted in a poster presentation showcasing its potential as an innovative ADC for the treatment of sarcoma and other
- For the primary endpoint, patients treated with povetacicept achieved a 52.0% reduction from baseline in proteinuria as measured by 24-hour urine protein to creatinine ratio (UPCR) and achieved a statistically significant and clinically meaningful 49.8% reduction in UPCR versus placebo (P
Study met primary endpoint (p-value = 0.012) First registrational study to specifically evaluate a targeted treatment for patients living with ocular MG Results support planned Supplemental Biologics License Application (sBLA) submission to U.S. Food and Drug Administration (FDA) to expand
– Total revenues grew 17% y-o-y to $127.6 million for the fourth quarter of 2025 and 15% y-o-y to $460.2 million for the full-year 2025 – Zocilurtatug pelitecan (zoci) on track to become Zai Lab’s first global oncology launch, with three registration-enabling studies across 2L+ SCLC, 1L SCLC, and