Shares of AC Immune rose by double-digits on news that the company, encouraged by new data, now intends to ask drug regulators for feedback to “potentially accelerate” the time to an approval filing.
Finalized minutes from a late-October meeting with the FDA confirm the agency doesn't see the data collected so far as enough to support an approval filing.
SciNeuro Pharmaceuticals represents the latest in a string of Arch investments directed at the nervous system, a notoriously challenging area of drug development.
A decades-old way to bridge buyers and sellers on price, contingent value rights have recently seen an uptick in use due to a turbulent biotech market.
The studies offer perhaps the most concrete rebuttal yet to an idea that GLP-1 drugs, which have profound benefits on weight loss and heart health, might also help combat neurodegeneration.
Shares of Contineum Therapeutics dipped by the double-digits late Thursday after investors learned of a clinical setback for a drug that’s also piqued Johnson & Johnson’s interest.
Winrevair, which Merck has identified as a “growth driver,” significantly improved blood flow through the lungs to the heart in a study of adults with a common form of heart failure.
The drug appears effective against both “relapsing” and “primary progressive” forms of the disease, though some analysts question if Roche has collected enough data to ask for approval in the latter.
While the launches of Journavx and Casgevy have started to build steam, “investors may not be inclined to look past the clear revenue misses,” wrote a Raymond James analyst.