U.S. FDA Grants Orphan Drug Designation to Zai Lab's DLL3-Targeting ADC for Neuroendocrine Carcinomas

Akeso has secured Phase I clinical trial clearance in China for AK158D1, a bispecific antibody drug conjugate targeting EGFR and TROP2 in advanced solid tumors. The clearance puts fresh attention on the company's pipeline as it pushes deeper into IO2.0 and ADC2.0. Akeso's shares recently traded at HK$90.5, up 3.37% over 90 days but down 20.12% year to date, against a consensus analyst price target of HK$158.28, with the most bullish target at HK$226.04 and the most bearish at HK$125.08. The company remains exposed to execution setbacks given its reliance on a handful of key drugs and a current net loss of CN¥967.2 million.

Merck received a positive opinion from the European Medicines Agency's CHMP for KEYTRUDA plus Padcev in muscle-invasive bladder cancer. The CHMP backed the combination as perioperative therapy for adults with resectable muscle-invasive bladder cancer in the European Union. If endorsed by the European Commission, the regimen would be the first PD-1 inhibitor plus antibody-drug conjugate option for this setting in Europe. The addressable group in Europe is relatively concentrated but clinically high need, with bladder cancer cases estimated at about 224,700 in 2022, roughly 25% of them classified as muscle invasive. The key near-term marker is the European Commission ruling expected by the fourth quarter of 2026, since the CHMP only issues recommendations.

AstraZeneca and Daiichi Sankyo reported DESTINY-Lung04 Phase III results showing ENHERTU delayed disease progression in HER2-mutant advanced NSCLC versus standard therapy, with 14.3 months median progression free survival and a 37% risk reduction versus pembrolizumab plus chemotherapy. Long-term follow-up data for TAGRISSO indicated eight-year survival benefits in early-stage EGFR-mutated lung cancer patients already on treatment protocols. Tozorakimab emerged as the first biologic to show efficacy in reducing exacerbations across a broad chronic obstructive pulmonary disease population in late-stage trials, with a 29% to 34% exacerbation reduction. Management has pointed to more than US$10b in potential peak risk adjusted revenue from new drugs, and investors will focus on US and EU COPD approval decisions ahead of the first quarter of 2027 Prescription Drug User Fee Act date. The article was produced by Simply Wall St.