Oppenheimer analyst Jay Olson notes that the FDA said the valbenazine advisory committee for tardive dyskinesia was canceled because it was "no longer needed," which bolsters his confidence in the valbenazine tardive dyskinesia NDA. Further, the comment appears to outweigh the announcement that the Phase 2 T-Forward study of valbenazine in adults with Tourette syndrome failed to meet its primary endpoint, he adds. Olson also thinks the adult Tourette syndrome result does not read-through to the ongoing pediatric Phase 2 study. He reiterates a Perform rating and $55 price target on the shares.

Voyager Therapeutics (VYGR) announced that the joint steering committee with its collaborator Neurocrine Biosciences (NBIX) has selected a lead development candidate in the GBA1 gene therapy program for the potential treatment of Parkinson's disease and other GBA1-mediated diseases. The candidate combines a GBA1 gene replacement payload with an intravenously administered, blood-brain barrier penetrant, novel capsid derived from Voyager's TRACER capsid discovery platform. The companies expect to file an Investigational New Drug application with the FDA for the program in 2025. Selection of the development candidate triggered a $3 million milestone payment to Voyager, which the Company expects to receive in the second quarter of 2024. Voyager is eligible to receive additional future development and commercialization milestone payments based on the further advancement of this program. The GBA1 program is being developed under the 2023 strategic collaboration agreement between Voyager and Neurocrine Biosciences for research, development, manufacture, and commercialization of certain AAV gene therapy products for programs targeting Parkinson's disease and other GBA1-mediated diseases and three other undisclosed programs to address central nervous system diseases or conditions associated with rare genetic targets. Under the terms of the 2023 collaboration agreement, Voyager is eligible to receive up to $1.5 billion in potential development milestone payments, as well as additional commercial milestone payments, tiered royalties on net sales, and program funding. Voyager maintains an option to elect 50/50 cost- and profit-sharing in the U.S. for the GBA1 program following topline data from the first Parkinson's disease clinical trial.