Neurological
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.
AbbVie stressed its continued revenue growth driven by Skyrizi and Rinvoq, while trying to sound unconcerned about unsettled drug-pricing policies such as MFN negotiations.
The Basel-based company has faith in its existing rare disease commercial platform to successfully market the newly-acquired assets.
The company will gain Lumryz, an oxybate for narcolepsy, paving the commercial path ahead of the eventual launch of its own Phase III-ready asset alixorexton.
The company said the INFRONT-3 trial in FTN-GRN failed to meet a co-primary endpoint and secondary endpoints. Alector is cutting 49% of its staff to conserve cash.
Neuphoria said that its Phase III trial of BNC210 in social anxiety disorder did not meet the primary or secondary endpoints, but its PTSD program will continue.
Global generics-focused giant acquires Japanese venture with late-stage, two-asset CNS pipeline as it looks to build presence in Japan.
Praxis hopes to file ulixacaltamide for approval early next year, with a goal of joining a generic beta blocker as the only approved therapy for the movement disorder.
Adcytherix and Step Pharma join Tubulis in raising funds for their cancer drug projects.
The regulator has agreed to a six-month preliminary analysis of its pivotal study which could accelerate filing of TSHA-102 for Rett syndrome.
By combining novel drug mechanisms with genetic biomarkers, HMNC Brain Health hopes to transform depression care.
A second pipeline setback within a year for the Finland-based firm has not dented optimism about its growth trajectory.
Larimar reported data from an ongoing open-label study with its protein therapy in FA, showing encouraging skin frataxin levels, but shareholders walked away due to safety worries.
The company expects to target 6,000 individuals in the US initially if the US FDA approves AMT-130. A completed financing will improve flexibility to fund the launch.
The company said the Phase III RECONNECT trial of the cannabidiol-based drug did not meet the primary endpoint, which it attributed to a high rate of placebo response.
The company’s gene therapy AMT-130 appears to be the first disease-modifying treatment for the neurodegenerative genetic disease.
The company plans to set the UK price of its new schizophrenia drug at the same level as in the US.
The biotech announced positive topline results from its pivotal study in Alexander disease, which has an estimated population of about 300 in the US.
Sanofi’s MS hopeful tolebrutinib hits a regulatory hurdle in the US, renewing pressure on the firm’s pipeline. Analysts hope the delay won’t prove material.
The privately owned biotech said it would pause its Phase I/II study of CAP-002 in STXBP1-related disorders after the first patient in the study died.