San Diego-based Neurocrine Biosciences Inc.’s good-and-bad top-line phase II data with d-amino acid oxidase inhibitor luvadaxistat, also known NBI-1065844 and TAK-831, in schizophrenia likely came as little surprise to many, given earlier experience in the general pathway.
Recently published findings in JAMA Psychiatry related to the sharply increased risk of death from COVID-19 in people with schizophrenia put the spotlight on drug development in the space, which has been steadily heating up the past few years.
Concert Pharmaceuticals Inc. is scratching further work on CTP-692 after the deuterated form of D-serine missed the primary endpoint in a phase II study in schizophrenia. The news sent shares of Concert (NASDAQ:CNCE) falling 28% Feb. 1 and shifts focus to the firm’s sole remaining clinical-stage program in the competitive alopecia areata space.
A genome-wide look at variants in RNA-binding proteins has revealed that such variants were disproportionately linked to the risk of multiple psychiatric disorders.
Luye Pharma Group Ltd. won marketing approval in China for its risperidone microspheres for injection to treat schizophrenia, which the company said is the first formulation developed by a Chinese company in the space to get a green light. Under the trade name Ruixintuo, the long-acting drug is administered once every two weeks by intramuscular injection.
TORONTO – Scan the literature on mental health technologies, and you’ll find treatment apps for everything from depression to addiction. What you won’t find, said Claude Hariton, vice president and chief scientific officer at Quebec City-based Diamentis Inc., are tools to diagnose mental diseases. It’s a gap the company hopes to fill with Retinal Signal Processing and Analysis (RSPA), a tool just accepted into the U.S. FDA’s breakthrough devices program that diagnoses mental diseases from retinal signals in the eye.
By acquiring privately held Cadent Therapeutics Inc., Novartis AG gains full rights to Cadent’s allosteric modulator program, part of which the two companies began collaborating on in 2015, and all the company’s outstanding stock. Cambridge, Mass.-based Cadent will receive as much as $770 million, $210 million of it up front, plus $560 million in milestones.
Even as Alkermes plc works to resolve the complete response letter (CRL) sent by the FDA regarding ALKS-3831, labeling talks are underway for the compound, an oral therapy for schizophrenia and bipolar I disorder in adults. Regulators reviewed manufacturing records and said the Dublin-based firm needs to supply documents related to making the tablet’s coating at the Wilmington, Ohio, facility. No clinical or non-clinical concerns were raised, the firm said, and shares (NASDAQ:ALKS) hardly moved, closing Nov. 17 at $18.30, up 45 cents.
As expected, weight mitigation and opioid-related risks turned up as the main concerns in briefing documents for the joint advisory panel meeting Oct. 9 to mull the approvability of Alkermes plc’s ALKS-3831.
Click Therapeutics Inc. and Boehringer Ingelheim GmbH inked a deal valued at more than $500 million to collaborate on the development and commercialization of a prescription-based digital therapeutic for schizophrenia. The mobile application, currently called CT-155, uses cognitive and neurobehavioral techniques to reduce the symptoms of schizophrenia, such as cognitive deficits and impaired social functioning.