Phase 3
If approved, the oral GLP-1 would be Eli Lilly’s second marketed drug for obstructive sleep apnea after the GIP/GLP-1 injectable Zepbound secured the first approval in the space in December 2024.
Vir Biotechnology is targeting a mid-2027 regulatory submission for its monthly chronic hepatitis delta regimen, with head-to-head data against Gilead’s Hepcludex expected next quarter.
Full data from the Phase 3 HORIZON trial of Novartis’ pelacarsen failed to show any apparent benefit, leading analysts to further reduce the odds of success for Lp(a)-lowering competitors such as Amgen’s olpasiran.
At the American Heart Association conference, investigators were supportive of further studying Novo’s IL-6 inhibitor ziltivekimab in patients with less severe cardiovascular and kidney disease.
Analysts hailed the Phase 3 head and neck cancer results as a big victory for an asset central to Genmab’s growth plans.
Sac-TMT significantly extended overall and progression-free survival for patients with advanced or recurrent endometrial cancer by 6.9 months over chemotherapy in a Phase 3 trial—becoming the first TROP2-directed ADC to do so in this setting, Merck told BioSpace.
When used alongside AstraZeneca’s Imfinzi, the bispecific T cell engager Imdelltra extended survival by eight months versus Imfinzi alone in Phase 3 study testing the combo in a first-line maintenance setting—a potentially “practice-changing” outcome, according to Truist Securities.
Extending both progression-free and overall survival, Genmab’s Rina-S “sets a high bar for future competition” in a market served by AbbVie, analysts said.
After cardiac safety signals led to a full clinical hold on Aardvark Therapeutics’ studies of ARD-101, the biotech conducted an additional safety study, in which no cardiac events were detected. Aardvark plans to resume testing the candidate next year.
AbbVie is eyeing regulatory filings in 2027 for the skin disease drug lutikizumab after clearing multiple endpoints in a late-stage trial, but the results have disappointed some analysts, raising questions about its commercial prospects.
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