The FDA granted 510(k) clearance to Neuronetics Inc.’s MT Cap technology for the company’s transcranial magnetic stimulation system, Neurostar Advanced Therapy for Mental Health. The MT Cap speeds the process used to determine the dose and motor threshold for treatment with the Neurostar system for major depressive disorder (MDD). The company expects to begin a limited introduction of the product within weeks, with national rollout to follow in the first quarter of 2022.
Neumora Therapeutics Inc., a neuroscience startup aiming to launch precision medicines for brain diseases, said Oct. 7 it has raised more than $500 million, including a $100 million equity investment from Amgen Inc. and a series A financing led by Arch Venture Partners. The company launches with a portfolio of eight clinical, preclinical and discovery-stage programs from internal discovery efforts, the acquisitions of multiple private companies and a new license agreement with Amgen.
LONDON – Fixed and constant deep brain stimulation has been successful in treating Parkinson’s disease and epilepsy, but heterogeneity in individual response means that despite promise, clinical studies in serious depression have to date delivered inconsistent results. U.S. researchers have now developed a method for identifying the neural circuits underlying symptoms of depression in individual patients and applied this to deliver tailored therapy, using a commercially available device to stimulate the brain when these circuits are activated.
Shares of Axsome Therapeutics Inc. (NASDAQ:AXSM) hit a 52-week low on Aug. 9, falling 46.5% to close at $24.37, after the FDA said deficiencies in an NDA in major depressive disorder for its drug, AXS-05 (dextromethorphan + bupropion), would "preclude labeling discussions" for now.
Happify Inc. launched Ensemble, a prescription digital therapy designed to treat patients with major depressive disorder (MDD) or generalized anxiety disorder (GAD). The app joins several others that target both depression and anxiety, including the eponymous apps made by Woebot Health (Woebot Labs Inc.) and Youper Inc., although it is the only one that requires a prescription in the pack.
Biogen Inc. has announced contrasting results from phase III trials of therapies for a rare eye disease and depression, following last week’s controversial FDA approval of Alzheimer’s drug Aduhelm. The Cambridge, Mass.-based firm said a phase III gene therapy study in the rare retinal disease choroideremia missed its primary and secondary endpoints, although the news was better from a potential therapy for major depressive disorder.
Depression treatment still isn’t “once and done,” but the time needed to reduce symptoms continues to drop for patients using electromagnetic stimulation. Brainsway Ltd.’s Theta Burst brings treatment times down to just three minutes with its FDA 510(k) clearance.
Sage Therapeutics Inc. on March 17 disclosed another batch of positive phase III data with zuranolone, its oral, once-daily, two-week therapy for the treatment of major depressive disorder (MDD) and postpartum depression. News regarding the GABAA receptor-positive allosteric modulator came the same day that Praxis Precision Medicines Inc. reported fourth-quarter and full-year financial results, updating investors on PRAX-114, its drug in the same class for MDD.
HONG KONG – Otsuka Pharmaceutical Co. Ltd. is celebrating its 100th anniversary by inking a collaboration and licensing agreement with Perception Neuroscience LLC to develop and commercialize the latter’s PCN-101 (r-ketamine) in Japan. The treatment targets mood disorders such as major depressive disorder and treatment-resistant depression. Perception is also developing PCN-101 to treat TRD outside Japan.
The whopper deal between Biogen Inc. and Sage Therapeutics Inc. – a global collaboration and licensing deal involving the latter’s zuranolone (also known as SAGE-217) for major depressive disorder (MDD), postpartum depression (PPD) and other psychiatric disorders, as well as SAGE-324 for essential tremor (ET) and neurological disorders – drew mixed reviews from Wall Street. And, for Biogen investors, the would-be Alzheimer’s disease (AD) therapy aducanumab remains front of mind.
