Phase 2
The data, which come from a subgroup in an earlier trial that Truist Securities called “the most relevant” to Revolution Medicines’ ongoing Phase 3 test in RAS mutant NSCLC, showed a 42% overall response rate and overall survival of 16 months.
GSK’s vaccine—which targets two primary flu antigens—elicited higher immune responses in both younger and older adults in a mid-stage study. The Phase 3 launch, planned for September, follows the FDA’s recent approval for Moderna’s mRNA flu vaccine.
Shares of Germany-based BioNTech were down as much as 8% Friday after announcing a Phase 2 trial of autogene cevumeran would be discontinued for futility. The news follows Merck and Moderna’s Phase 3 win last week for their cancer vaccine plus Keytruda in melanoma.
While Bausch + Lomb’s dual-action eye drops failed to outperform active comparators at day 29, the investigational asset showed significant superiority at day 15.
A surprise flop in Phase 2a cystic fibrosis trial sent Sionna’s shares plummeting, but for Vertex, the news reinforced its standard-of-care standing with highly successful drugs like Trikafta.
The Phase 2 study was small and was not designed to establish the statistical difference between Vistagen’s drug candidate and placebo, according to Vistagen. The biotech plans to meet with the FDA to determine a registrational path for the asset.
BioVie’s stock fell by nearly 50% as the biotech claimed victory in a mid-stage Parkinson’s disease trial using an alternative endpoint to the primary clinical goal.
Agios Pharmaceuticals’ sickle cell disease candidate didn’t prove any better than Novo Nordisk’s investigational PK activator or the biopharma’s own asset that is currently under FDA review for the indication.
Insmed’s inhalable candidate showed “impressive” long-term efficacy in pulmonary arterial hypertension, according to analysts at Guggenheim Partners, with functional and biomarker improvements through one year of follow-up.
New mid-stage data from Biogen’s Ionis-partnered therapy diranersen served to both validate the tau hypothesis in Alzheimer’s disease and raise questions that could soon be elucidated by anti-tau candidates from Denali Therapeutics, Eisai and Eli Lilly.
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