A phase III test of roluperidone, a drug developed by Minerva Neurosciences Inc. with a goal of treating negative symptoms in schizophrenia, found that the experimental medicine failed to deliver statistically significant differences vs. placebo in improving both the trial's primary endpoint, a common measure of symptom severity, and its secondary endpoint, a score measuring social function.
Sunovion Pharmaceuticals Inc.’s apomorphine sublingual film (APL-130277), a dopamine agonist the company will market as Kynmobi, has won FDA approval for the acute intermittent treatment of motor fluctuations (off episodes) associated with Parkinson’s disease.
A new phase IIb readout at odds with earlier data suggesting PTI-125 would diminish key biomarkers of neuroinflammation and neurodegeneration in Alzheimer’s patients has left Cassava Biosciences Inc. President and CEO Remi Barbier looking for answers.
Despite evidence of efficacy in binge-eating disorder (BED), Sunovion Pharmaceuticals Inc.'s dasotraline's second lease on life is done, for now. Following an initial plan to discontinue the asset in a 2010 portfolio reshuffle, the drug is now being shelved due to the need for additional clinical studies on its benefit-risk profile, parent Sumitomo Dainippon Pharma Co. Ltd. said.
Though Quralis Corp., of Cambridge, Mass., has been developing its pipeline for more than three years, the company now has a $42 million series A in hand to continue researching and developing therapies for amyotrophic lateral sclerosis and frontotemporal dementia.
Shares of Newron Pharmaceuticals SpA (SIX:NWRN) fell more than 71% May 4 on news that sarizotan, its experimental therapy for the rare neurodevelopmental disorder Rett syndrome, failed to meet both the primary and secondary efficacy endpoints of the company's pivotal STARS study, leading it to terminate the program.
Praxis Precision Medicines Inc. CEO Marcio Souza told BioWorld that the line figuratively walked by PRAX-114, a GABAA positive allosteric modulator in major depressive disorder (MDD), means upside relief without the downside of adverse effects.
With regard to agitation in Alzheimer’s disease (AD), doctors “are in a very difficult position right now,” said Axsome Therapeutics Inc. CEO Herriot Tabuteau. That’s because the products currently used off-label are antipsychotics – all of which carry an FDA black box warning “specifically against their use in elderly patients with dementia, including AD,” since they double the risk of stroke and of mortality.