Wysa Ltd.’s artificial intelligence-based digital therapy received FDA breakthrough device designation for adults with chronic musculoskeletal pain, depression and anxiety. The device delivers cognitive behavioral therapy (CBT) via a digital companion or conversational agent on a smartphone.

Blue Note Therapeutics Inc. took a new approach to expanding its pipeline of prescription digital therapeutics (PDT) with an exclusive licensing agreement with the University of Sydney for Conquerfear, a metacognitive intervention that helps cancer survivors cope with the fear of disease recurrence. Blue Note has developed its PDTs internally to date but hopes to convert Conquerfear’s elements, which are typically delivered face-to-face, into a PDT for the U.S. and Canada. As a digital therapy, the program could potentially reach many more patients.

Bionomics Ltd.’s U.S. debut last December, when the firm raised about $23 million through the sale of American depositary shares, called new attention to the Australian firm and its prospects in social anxiety disorder (SAD) and post-traumatic stress disorder (PTSD).

Investigators at the University of Wisconsin have decreased anxiety-related behaviors in monkeys with an anxious temperament by treating them with a combination of gene therapy and low doses of the atypical antipsychotic drug clozapine, which is approved for the treatment of schizophrenia and schizoaffective disorder.

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.

While the founder of Woebot Health says that the app is not intended to replace human therapists, for the majority of the world who cannot locate an available psychologist or afford one once found, Woebot aims to offer a “radically accessible” option for mental health care.

LONDON – Former CEO of Novartis AG Joe Jimenez is emerging back into the limelight as founder and managing director of Aditum Bio, a new $135 million venture capital fund set up to create five to six companies to take forward early stage compounds in-licensed from pharma.

Oncomfort SA finalized a €10 million (US$11.8 million) series A fundraising round to further develop its Digital Sedation product and pursue international expansion. Debiopharm and Crédit Mutuel Innovation led the round with participation from Wallonia Innovation and Growth and previous investors.