Arecor said it is in talks on a broader AT278 partnership as it targets a phase II trial start in the second half of 2026. The company also cited FDA feedback, Ligand financing and year-end cash of £6.1 million.
The FDA has shifted from regulatory ambiguity to coordinated enforcement against compounded oral semaglutide, culminating in a 2026 announcement of intent to take action against non-approved GLP-1 drugs. Hims & Hers Health's 2024 oral semaglutide offering marked the beginning of a broader regulatory reckoning that saw manufacturer pressure, formal shortage declarations, and warning letters targeting compounding practices.
Drug candidates designed via generative artificial intelligence are achieving a 90% success rate in Phase I safety trials in early 2026, nearly double the historical industry average of approximately 50%, while compressing development timelines from six years to under 18 months.
A University of South Australia study finds salcaprozate sodium (SNAC), the compound enabling oral semaglutide tablets to work, may alter gut bacteria and increase inflammatory markers in rats, though human effects remain unclear.
BioNxt Solutions Inc. receives European Patent No. 4539857 for its proprietary sublingual cladribine oral thin film drug delivery technology, providing protection across up to 39 European Patent Convention states through at least June 14, 2043.
