A yearslong bipartisan effort to end the patent-eligibility chaos the U.S. Supreme Court created more than a decade ago could finally come to fruition with the current Congress.
An uncommon route to the public markets – direct listing – paid off for Turn Therapeutics Inc., with shares (NASDAQ:TTRX) closing Oct. 9 at $9.20, up $2.20, or 31%, having risen as high as $26.50 in its second day of trading. The firm is advancing late-stage clinical programs in eczema and onychomycosis. Also in the works are global health initiatives in thermostable vaccine delivery designed to serve underserved areas.
In one of the biggest deals of the waning year, Novo Nordisk A/S is buying Akero Therapeutics Inc. to bolster its metabolic dysfunction-associated steatohepatitis (MASH)-treatment portfolio. In the $5.2 billion deal, Akero brings its fibroblast growth factor 21 analogue, efruxifermin, which is in a phase III study for treating those with moderate to advanced liver fibrosis and those with cirrhosis.
The transition from complex and costly ex vivo strategies to platforms that enable direct cellular intervention within the body, known as in vivo therapies, is marking a paradigm change in the field of gene and cell therapies by simplifying manufacturing, improving tissue targeting and expanding clinical access to treatments.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Advanz, Alzinova, Arcadia, Arcutis, Avobis, Cellectar, Cosmo, EG 427, Kashiv, Lexeo, Neurizon, Orca Bio, Precision Neuromed, Spruce.