Neuros Medical Inc.’s Altius direct electrical nerve stimulation system significantly reduced pain in 30 minutes and continued to reduce pain for a year, a study published Sept. 24, 2024, in Neuromodulation: Technology at the Neural Interface found.
As Eli Lilly and Co. launches its recently approved Ebglyss (lebrikizumab) in an atopic dermatitis market already dominated by established biologic Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), investors tuned into an Amgen Inc. investor call disclosing positive top-line phase III results for rocatinlimab, a monoclonal antibody that could potentially offer patients a new mechanism of action. While data from the Rocket Horizon study showed rocatinlimab hit all co-primary and secondary endpoints, the early findings fell below expectations in a highly competitive market.
Interim phase II data of Wave Life Sciences Ltd.’s oligonucleotide, WVE-N531, revealed “impressive” dystrophin expression, solid safety and the potential for once-monthly dosing for boys with Duchenne muscular dystrophy who are amenable to exon 53 skipping. The findings drove Wave Life’s stock (NASDAQ:WVE) up by 53.4%, or $2.85, to close Sept. 24 at $8.19, after peaking earlier in the day at $8.35, its 52-week high.
Despite a phase IIa failure in 2018 for lupus, Biogen Inc. and UCB Inc. maintained their collaboration and now have new positive data for their anti-CD40L candidate. Top-line phase III data show dapirolizumab pegol, along with the standard of care (SOC), met the primary endpoint in demonstrating an improvement in moderate to severe systemic lupus erythematosus compared to placebo and SOC at 48 weeks.
Innovent Biologics Inc. unveiled for the first time safety and efficacy data of IBI-354, an HER2 monoclonal antibody-camptothecin derivative conjugate that shows promising efficacy signals across a range of advanced solid tumors, during the European Society of Medical Oncology (ESMO) 2024 Congress. An HER2-targeted antibody-drug conjugate developed using Innovent's topoisomerase inhibitor NT3 platform, IBI-354 combines a hydrophilic linker design with a hydrophobic payload to enhance the bystander effect, targeting adjacent antigen-low or negative tumor cells.
Ascletis Pharma Inc. is entering the obesity space, announcing it has begun two phase I trials for ASC-30, a small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist that can be dosed once monthly subcutaneously and once daily orally for treating obesity.
A little more than a year after the U.S. FDA refused to review the NDA for Biohaven Ltd.’s ultra rare disease treatment, new and positive phase III data have changed the treatment’s momentum. The upbeat results came as a surprise to analysts and investors, with the stock having a strong day and the company prepping an NDA for a fourth quarter submission.
What the results might mean for the future of other developers in the cannabinoid receptor 1 (CB1) weight-loss arena came into question after Novo Nordisk A/S unveiled phase IIa findings with monlunabant, a small-molecule oral inverse agonist, formerly INV-202.
Onward Medical NV successfully implanted its Arc-BCI system, which restores direct communication from the brain to the spinal cord enabling lower limb mobility, into a third patient.
Ascletis Pharma Inc. is entering the obesity space, announcing it has begun two phase I trials for ASC-30, a small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist that can be dosed once monthly subcutaneously and once daily orally for treating obesity.
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