Neuroscience
The majority of the large pharmas have now reported third quarter earnings—spoiler alert: Eli Lilly made more money than anyone expected. Plus, the FDA dropped another initiative aimed at accelerating rare disease treatments; HHS greenlights the compounding of six unapproved peptides; and uniQure’s embattled gene therapy for Huntington’s disease has finally been accepted for review.
Compass Pathways revealed that an FDA filing for COMP360 will be complete “in the next two weeks,” with an expected drug launch in the first half of next year. The update follows a reported regulatory submission for Usona Institute’s own psilocybin candidate for depression on Monday.
Novartis is discontinuing a neurodegeneration alliance with BioArctic in which the companies aimed to develop a drug candidate that could cross the blood-brain barrier.
In a mid-stage trial, the lower dose of Tiziana’s intranasal monoclonal antibody reduced microglial activation in a specific type of multiple sclerosis. But the path forward remains unclear after the higher dose failed to deliver the same benefit.
After a year of controversial regulatory reversals, the FDA has accepted uniQure’s application for ifezuntirgene inilparvovec for priority review, with a May 1 action date. If approved, the therapy—also called AMT-130—would be the first disease-modifying treatment for Huntington’s disease.
Strong immunology and neuroscience sales fueled AbbVie’s latest quarterly beat as the pharma’s stock continues to hit all-time highs.
Acumen will implement cash-saving strategies and assess its options after sabirnetug failed to beat placebo, leaving the biotech without a clinical program.
Ono Pharma’s ONO-1110 failed five Phase 2 trials, leading to the discontinuation of development in depression and social anxiety. Work will continue for three pain indications.
Novartis remains “very happy” with its $12 billion acquisition of Avidity Biosciences, despite a Phase 3 disappointment for the antibody-oligonucleotide conjugate del-desiran.
The disclosure—which came ahead of a presentation of data from the Phase 1 Breakfree-2 study at the ACTRIMS-ECTRIMS meeting—follows Bristol Myers Squibb’s late summer revelation that it had paused certain trials of zolacabtagene autoleucel.
PRESS RELEASES