Clinical research
Shares of Akero Therapeutics took a hit after the company missed the primary endpoint in a Phase IIb study of efruxifermin in nonalcoholic steatohepatitis.
More than 54% of patients treated with mirikizumab achieved clinical remission at 52 weeks versus 19.6% of those on placebo. Eli Lilly will submit a marketing application in Crohn’s disease to the FDA in 2024.
In a Phase Ib/II study, Tempest Therapeutics’ investigational PPAR⍺ antagonist—combined with Roche’s Avastin and Tecentriq—showed strong signs of survival benefits in liver cancer patients.
The subcutaneous version of its blockbuster multiple sclerosis drug notched a victory in a key late-stage study. Roche will submit the OCARINA II data to global health authorities in the coming months.
Following the recommendations of an independent Data Monitoring Committee, Novo Nordisk has halted a Phase III kidney outcomes study of semaglutide ahead of schedule due to strong efficacy signals.
The pharma giant’s anti-PD-1 therapy met its dual primary endpoint of overall survival as a treatment regimen for non-small cell lung cancer patients, as the FDA’s Oct. 16 PDUFA date looms.
Both low and high doses of Akero Therapeutics’ lead candidate efruxifermin failed to significantly outperform placebo at improving liver fibrosis without worsening non-alcoholic steatohepatitis.
Patients treated with Xenon Pharmaceuticals’ investigational potassium channel opener XEN1101 experienced a significant and dose-dependent reduction in seizure frequency.
At the six-month follow-up, about 40% of patients treated with Newron Pharmaceuticals’ evenamide improved so much that they no longer meet the Phase II study’s original eligibility criteria.
Though data became an issue in two separate meetings, the FDA’s Oncologic Drugs Advisory Committee made a potentially precedent-setting decision by voting in favor of US WorldMeds’ neuroblastoma treatment.
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