Lilly loses Fed Circ rehearing bid, sparking enablement questions

Zasocitinib, an investigational TYK2 inhibitor by Takeda, showed superior efficacy in treating plaque psoriasis compared to deucravacitinib in a phase 3 trial. 36.5% of patients achieved PASI 100 with zasocitinib vs. 13.9% with deucravacitinib. The drug's higher TYK2 selectivity and longer IL-23 blockade were cited as key factors. Zasocitinib is under review by the FDA and EMA.

A phase 2 trial showed a regimen combining brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine achieved 92% complete response and 97% 2-year progression-free survival in early-stage Hodgkin lymphoma. The study, published in Advances in Therapy, involved 154 patients and was funded by Seagen (now Pfizer), Takeda, and Bristol-Myers Squibb.

CMS's GLOBE drug pricing plan's projected savings dropped from $11.9B to $400M, affecting about four manufacturers, including Biogen, Takeda, and Daiichi Sankyo. The reduction is due to exclusions for GARD participants. The final rule may face legal challenges and has raised concerns about its effectiveness.

Takeda's Oveporexton (Orzeyful) significantly improved wakefulness, daytime sleepiness, and cataplexy in narcolepsy type 1 patients over 12 weeks, according to two phase 3 trials. The FDA approved the drug in August 2026, positioning it as the first therapy addressing orexin deficiency. Adverse events included increased urinary frequency and transient insomnia. Trials showed mean sleep latency improvements of 14.3 to 19.8 minutes with Oveporexton vs. placebo.

Takeda announced Phase 3 trial results showing zasocitinib (TAK-279) demonstrated superior efficacy in treating moderate-to-severe plaque psoriasis compared to deucravacitinib. Key data: 36.5% of patients achieved complete skin clearance (PASI 100) at week 16 vs. 13.9% for deucravacitinib. Zasocitinib also showed durable skin clearance and improvements in itch and quality of life. The drug is under regulatory review for psoriasis treatment.

Takeda (TSE:4502/NYSE:TAK) will present data on its oncology pipeline at ESMO 2026, including Phase 3 results for arcotatug tavatecan in advanced gastric cancer and findings on TAK-928 for NSCLC. The company is expanding a global Phase 3 study for TAK-928.