Schizophrenia

On Monday, AbbVie Inc (NYSE:ABBV) stock is trading lower after it released data from its two Phase 2 EMPOWER trials of emraclidine for schizophrenia. The trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia. The patients experienced an...

Last week, the FDA approved Bristol Myers Squibb & Co’s (NYSE:BMY) Cobenfy (xanomeline and trospium chloride, KarXT), an oral medication for schizophrenia in adults. Analysts at investment bank EF Hutton says, “This bodes well for Reviva’s Brilaroxazine, a...

Each week, Benzinga’s Stock Whisper Index uses a combination of proprietary data and pattern recognition to showcase five stocks that are just under the surface and deserve attention. Investors are constantly on the hunt for undervalued, under-followed and emerging stocks. With...

Addex Therapeutics (NASDAQ: ADXN) has moved a selective and potent M4 muscarinic receptor positive allosteric modulator (PAM) program into lead optimization, with a potential treatment of schizophrenia and other neuropsychiatric disorders. Using its proprietary allosteric modulator...

According to an SEC filing, Karuna Therapeutics Inc (NASDAQ: KRTX) is withdrawing its prior guidance for the timing of topline data for its Phase 3 EMERGENT-3 trial evaluating KarXT in schizophrenia.  The Company had expected topline data from the EMERGENT-3 trial in 2H of 2022. At...

Alkermes plc's (NASDAQ: ALKS) ENLIGHTEN-Early Phase 3b study of Lybalvi (olanzapine & samidorphan) met its prespecified primary endpoint on body weight in young schizophrenia adult patients in the early stage of the disease.  Patients treated with Lybalvi experienced...

The FDA has notified Reviva Pharmaceuticals Holdings Inc (NASDAQ: RVPH) that it may proceed with Phase 3 trial of its lead candidate, brilaroxazine, a serotonin and dopamine receptor modulator for schizophrenia. The FDA has also signed off an additional Phase 3 trial focused on...

The FDA has extended the review period for BioXcel Therapeutics Inc's (NASDAQ: BTAI) marketing application seeking approval for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II. In connection with the FDA's...

Neurocrine Biosciences Inc (NASDAQ: NBIX) has outlined a deal that provides Sosei Heptares Corporation $100 million upfront, R&D expenses, and a motherlode of milestones worth up to $2.6 billion if successful.  Under the terms of the agreement, Neurocrine...

ATAI Life Sciences NV (NASDAQ: ATAI) announced interim data from the first 8-patient cohort of its Phase 2a trial of RL-007 for Cognitive Impairment Associated with Schizophrenia (CIAS). Related Link: Peter Thiel Backed Atai Life Launches New Mental Health Disorders-Focused...

Teva Pharmaceuticals Industries Ltd (NYSE: TEVA) announced results from the Phase 3 trial comparing TV-46000/mdc-IRM once monthly (q1m) and TV-46000/mdc-IRM once every two months (q2m) with placebo for schizophrenia patients who underwent stabilization on oral risperidone. ...

Minerva Neurosciences Inc (NASDAQ: NERV) announced results from a bioequivalence study comparing roluperidone formulations used in Phase 2b and Phase 3 trials and the planned commercial formulation.  Related Link: Minerva's Schizophrenia Candidate Shows Long Term...

The FDA has approved a long-acting schizophrenia drug from Janssen, a unit of Johnson & Johnson (NYSE: JNJ) Previously known as paliperidone palmitate, Invega Hafyera is a twice-yearly injectable. It's the first and only twice-yearly med for the condition. ...

The FDA has accepted Teva Pharmaceutical Industries Ltd (NYSE: TEVA) and MedinCell's marketing application seeking approval for TV-46000/mdc-IRM in schizophrenia.  TV-46000/mdc-IRM is a risperidone extended-release injectable suspension for subcutaneous use. The...

Cerevel Therapeutics Holdings Inc (NASDAQ: CERE) has announced results from its Phase 1b trial of CVL-231 in adult patients with schizophrenia.  CVL-231 was generally well-tolerated, and discontinuation rates were similar between CVL-231 and placebo in the six weeks of dosing,...