With the urea cycle disorder treatment Olpruva launched and the NPC therapy arimoclomol closing in on US approval, Zevra is one to watch in the rare disease space.

Newly announced US FDA advisory committee meetings on Lilly’s Alzheimer’s antibody, Lykos’ pioneering psychedelic therapy for PTSD relieve drought in non-oncology AdComms as the 2024-‘25 COVID vaccine strain selection meeting is postponed.

Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.

Acer's bank reserves have dwindled down to next to nothing following the failure of its menopause drug, osanetant, in a Phase II trial some six months ago. Enter Zevra, which is getting hold of the company and its just-launched urea cycle disorder drug, Olpruva, in what looks like a bargain.