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.

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.

Karuna Therapeutics Inc. remains on track to launch a phase III study by the end of this year with Karxt against acute psychosis in schizophrenia by way of the broad-based program called Emergent, and the company continues planning for a phase II study testing the combo drug as adjunctive therapy with standard of care in the same indication.

Neurocrine Biosciences Inc.’s chief business development and strategy officer, Kyle Gano, said “there was really no playbook” for the deal in which his firm is paying Takeda Pharmaceutical Co. Ltd. $120 million up front for an exclusive license to seven programs, including three clinical-stage assets targeting the notoriously difficult indications of schizophrenia and treatment-resistant depression (TRD), as well as depression-related anhedonia.

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.

Pairing the in-licensed muscarinic acetylcholine receptor agonist xanomeline with the well-known muscarinic antagonist trospium chloride in the single drug called Karxt gave Karuna Therapeutics Inc. the required phase II efficacy against acute psychosis in schizophrenia, while keeping a quite satisfactory safety and side-effect profile.

A subtype of schizophrenia is related to abnormally high brain levels of hydrogen sulfide (H2S), which has important implications for the development of new treatments, according to a study by researchers at the RIKEN Center for Brain Science (CBS) in Japan.