Neurological
The US FDA approved Uplizna (inebilizumab) for generalized myasthenia gravis, an increasingly crowded market. Amgen believes it can compete due to the CD19-targeting antibody’s durable efficacy with twice-yearly dosing.
The Switzerland-based group’s alpha-synuclein-targeted immunotherapy shows promise in slowing progression of the degenerative brain condition.
Dyne’s data from a larger Phase I/II trial cohort showed much greater dystrophin production with z-rostudirsen (DYNE-251) than seen with Sarepta’s Exondys 51 and some functional gains.
A submission to the FDA in the coming months for essential tremor drug ulixacaltamide could be swiftly followed by a filing of relutrigine for two rare forms of epilepsy.
Doctors and biopharma executives discussed the opportunities and challenges for researching and administering combination therapy at the Clinical Trials on Alzheimer’s Disease meeting.
Novo Nordisk presented topline results from its Phase III semaglutide studies at the Clinical Trials on Alzheimer’s Disease meeting, Lilly SVP Ronald DeMattos advocated for anti-amyloid brain shuttles to reduce ARIA and Eisai presented subcutaneous Leqembi data.
The company will exclude data from patients at the “small number” of sites that experienced irregularities and enroll new patients in their place.
If approved, VER-01 would be the first cannabinoid-based therapy for chronic low back pain.
At the Clinical Trials On Alzheimer’s Disease meeting, Novo explained why it tested semaglutide in AD a day before the company’s Phase III EVOKE/EVOKE+ presentation, Roche updated Phase Ib/IIa results for its anti-amyloid trontinemab and UCB’s bepranemab remains in limbo.
Lundbeck does not plan to raise its offer for sleep specialist Avadel, clearing the way for Alkermes to win the two-way bidding war.
Johnson & Johnson said its microtubule binding region (MTBR)-targeting candidate posdinemab did not slow cognitive decline in early Alzheimer’s disease in the Phase II Autonomy trial, marking another setback as anti-tau agents continue to deliver mixed results.
Despite always being a long shot, the failure of the twin Phase III studies in Alzheimer’s disease have added to the gloom at Novo Nordisk.
Meg Alexander is taking the place of founder Jeremy Levin, who is transitioning to executive chair, as Ovid prepares to move lead drug OV329 into a Phase IIa epilepsy study and generate initial data for its first-in-class KCC2 direct activators.
Disappointing topline data in the Phase II VISTA multiple sclerosis trial for PIPE-307 shifts the spotlight to Contineum’s idiopathic pulmonary fibrosis candidate PIPE-791.
Deal Snapshot: Merck KGaA is looking to bolster its neuroscience pipeline with novel drugs for Parkinson’s disease and will team with Valo Health on AI-driven discovery work.
The drugmaker increased its offer to $21 per share – equal to Lundbeck’s counteroffer – with the same $1.50 CVR tied to Lumryz’s approval, which Avadel called superior.
The Danish drugmaker is offering more per share in cash and CVRs than Alkermes did in the deal announced in October.
The drugmaker plans to move into Phase III development of the drug, which has now posted positive Phase II results in narcolepsy types 1 and 2.
Small study fails to turn up efficacy signals in the major depressive disorder candidate, leaving Neurocrine with one remaining depression candidate in development.
The US FDA approved Caplyta (lumateperone) as an adjunctive treatment for major depressive disorder, the third indication for a drug J&J expects to deliver $5bn in peak sales.