Phase III
GSK is carving out a niche for Blenrep in the second-line multiple myeloma setting, for which it projects multi-blockbuster potential for the antibody-drug conjugate.
With the Phase III failure, Syros will discontinue the study of tamibarotene for myelodysplastic syndrome and will default on its loan from Oxford Finance LLC.
The companies did not provide detailed data for Tezspire, however, and William Blair’s Matt Phipps said in a note he does not expect the antibody to outperform Dupixent.
A fatal, highly hereditary illness with no disease-modifying treatments, Huntington’s is long overdue for a therapeutic win. Here, BioSpace looks at five candidates that could change the trajectory for patients.
In part 1 of the pivotal ESSENCE trial, Novo Nordisk’s weight loss drug Wegovy demonstrated “statistically significant and superior improvement” in liver fibrosis in patients with metabolic dysfunction–associated steatohepatitis.
Approved by the FDA in July to treat adults with early symptomatic Alzheimer’s disease, Eli Lilly’s Kisunla reduced the brain swelling of patients in a late-stage trial following an adjusted dosing regimen.
Eli Lilly and Johnson & Johnson are seeking label expansions for Omvoh and Tremfya, respectively, in Crohn’s disease following approvals for ulcerative colitis. GlobalData projects total sales for Tremfya to reach $7.8 billion globally by 2029.
Following an end-of-Phase II meeting with the FDA in the fourth quarter, Viking Therapeutics plans to push its subcutaneous obesity therapy VK2735 into late-stage development and to start a Phase II trial for an oral formulation.
Novo Nordisk on Monday reported the oral version of its drug semaglutide reduced the risk of major adverse cardiovascular events in adults with type 2 diabetes by 14% in a large Phase III trial.
BMO Capital Markets analyst Evan Seigerman in a note to investors said the late-stage data for Vertex’s experimental non-opioid pain medication “reaffirms our confidence in the strength of suzetrigine’s profile.” However, William Blair analysts view these data as “an incremental positive” as the company faces challenges in targeting the acute pain market.
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