The companies hope that the drug – an under-the-skin version of a generic antipsychotic medicine called olanzapine – can be used as a once-monthly treatment for patients with the chronic mental disorder.
Tag Archive for: schizophrenia
Neumora Therapeutics said the U.S. Food and Drug Administration (FDA) had placed a clinical hold on early-stage study of its experimental schizophrenia drug, sending its shares down more than 23% in premarket trading.
Bristol Myers Squibb on Saturday unveiled interim data from the Phase III open-label EMERGENT-4 study, showing that the investigational antipsychotic KarXT (xanomeline and trospium) can elicit significant and sustained symptom improvement in patients with schizophrenia.
Acadia Pharmaceuticals is terminating development of its antipsychotic drug pimavanserin, which did not demonstrate a statistically significant improvement over placebo in the late-stage study’s primary endpoint.
As the last full month of winter 2024 nears an end, the FDA has two target action dates: one for a Humira biosimilar and another for a schizophrenia treatment.
Iovance’s lifileucel for advanced melanoma and Madrigal’s resmetirom for nonalcoholic steatohepatitis are just a couple of the key decisions on the FDA’s docket this quarter.
The regulator accepted Karuna Therapeutics’ NDA and set a PDUFA date of September 26, 2024. If approved, it would be the first new mechanism of action to treat schizophrenia in decades, the company contends.
Reviva Pharmaceuticals Holdings said on Monday its lead experimental drug to treat adults with schizophrenia helped reduce disease symptoms in a late-stage study.
At the six-month follow-up, about 40% of patients treated with Newron Pharmaceuticals’ evenamide improved so much that they no longer meet the Phase II study’s original eligibility criteria.
The company said it will prioritize the development of its drug BXCL501, which is being evaluated for use in at-home settings for treatment of agitation related to schizophrenia, bipolar disorders and in patients with mild-to-moderate dementia due to probable Alzheimer’s disease.
