Tortugas Neurosciences’ two lead programs are in-licensed oral small molecules in development for schizophrenia and tinnitus. The startup is led by veterans of Sage Therapeutics, a neuroscience biotech that was acquired last year.
LB Pharmaceuticals found enough investor interest to boost the size of its IPO, which will finance clinical trials in schizophrenia and bipolar depression. The biotech has modified an old Sanofi drug with changes intended to reduce side effects and allow less frequent dosing.
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LB Pharmaceuticals’ planned IPO will fund late-stage clinical development of LB-102, a once-daily pill designed to improve on the old Sanofi schizophrenia drug Solian. The IPO filing follows a corporate restructuring in May that cut the jobs of LB’s chief financial and scientific officers to streamline operations and extend its cash runway.
Bristol Myers Squibb’s Cobenfy failed to outdistance a placebo in a Phase 3 test that evaluated the drug as an adjunct to antipsychotics in schizophrenia patients. Last September, the FDA approved Cobenfy as a standalone schizophrenia treatment.
AbbVie schizophrenia drug candidate emraclidine failed to beat a placebo in two Phase 2 clinical trials. The drug, once projected to compete with Bristol Myers Squibb’s Cobenfy, is from AbbVie’s $8.7 billion acquisition of Cerevel Therapeutics.
Bristol Myers Squibb’s Cobenfy treats schizophrenia by going after a different target than currently available antipsychotic drugs, which is intended to offer better efficacy and safety. The drug came from the pharma giant’s $14 billion acquisition of Karuna Therapeutics.
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With pimavanserin's Phase 3 failure in schizophrenia, Acadia Pharmaceuticals said it will no longer run clinical trials for the drug, whose lone approval is for treating psychosis from Parkinson's disease. The FDA previously rebuffed regulatory submissions for the drug in dementia and Alzheimer’s disease.
Sosei Heptares’ schizophrenia drug candidate addresses a novel, difficult-to-drug target for neurological disorders. Boehringer Ingelheim can exercise its option on the small molecule following a Phase 1 test expected to yield data in 2025.
Despite artificial intelligence’s growing role in drug research, a fully AI-generated molecule has yet to advance from discovery all the way through clinical development. A novel molecule may eventually meet that goal, but some industry observers say it’s too early to focus on winning a race that has many twists and turns yet to come.
A schizophrenia drug candidate from partners Sumitomo Pharma and Otsuka Pharmaceutical failed to outperform a placebo in two Phase 3 studies. The compound is the most advanced program from a psychiatry and neurology collaboration spanning four drugs discovered by an artificial intelligence technology platform.
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AbbVie returned the rights to the drugs to Sosei Heptares earlier this year. Now Neurocrine Biosciences has agreed to pay the Japanese drug company $100 million to license the rights to these preclinical and clinical-stage compounds that address muscarinic receptors to potentially treat a range of neurological disorders.
Bill Martin, the Global Therapeutic Area Head of Neuroscience at The Janssen Pharmaceutical Companies of Johnson & Johnson, shared some of the promising developments in the neuroscience space, such as the rise of neuro-immunology and the industry’s embrace of digital health tools to support drug development in a recent interview.
Alkermes antipsychotic drug Lybalvi now has FDA approval. Though the field of neuropsychiatric drugs is crowded with generic medications, Alkermes believes Lybalvi, designed to mitigate the weight gain side effect common with mood disorder drugs, could have an advantage.
The company said the decision to cancel the advisory committee meeting for lumateperone was made so the agency would have additional time to review information the firm had provided regarding the drug.
Nuplazid, which is FDA-approved for Parkinson's psychosis, failed to fully improve symptoms as an adjunctive treatment for schizophrenia.