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.

Wave Neuroscience Inc.’s study of the use of electromagnetic stimulation to treat post-traumatic stress disorder (PTSD) entered its second phase, building on the positive outcomes seen in the phase I collaboration with the U.S. military. Texas A&M University Health Science Center is directing the trial, which will expand the study to civilians.

The FDA has granted Magstim Co. Ltd. 510(k) clearance for its transcranial magnetic stimulation (TMS) platform Horizon 3.0. TMS is a series of repetitive, focused magnetic pulses, used to stimulate brain cells. The noninvasive therapy has been touted as a cost-effective treatment for depression and is typically prescribed when antidepressants have failed, or the side effects are too disruptive to a patient’s lifestyle.

Limbix Health Inc. released data demonstrating a 21% remission rate and 29% response rate for Sparkrx, its prescription digital therapeutic, in adolescents who completed the program as recommended. The company presented study results on Oct. 8 at the 2021 American Academy of Pediatrics National Conference in San Francisco.

"My fondest hope is that maybe depression and other mental health disorders may be diagnosed by underlying cause, rather than categorized dualistically," Edward Bullmore, director of the Wolfson Brain Imaging Centre, and head of the Department of Psychiatry at the University of Cambridge, told his audience at the European Congress of Neuropsychopharmacology (ECNP). "I think it's much more aligned with the way that the rest of medicine has been working for some time."

A series A fundraising round lifted the mood at Genetikaplus Ltd. (Genetika+), raking in $10 million, a healthy 33% more than the initial target of $7.5 million. Proceeds from the round will go to fund trials of the Jerusalem-based company’s “brain-in-a-dish” technology for evaluating the best antidepressant for each patient. Greybird Ventures led the round, with participation by Meron Capital, Jumpspeed Ventures and Sapir Venture Partners.

Preclinical neuroscience firm Delix Therapeutics Inc., a startup developing non-hallucinogenic analogues of psychedelics, has closed a $70 million series A financing. The new funds will help the Boston-based company advance two lead candidates through phase I trials, DLX-1 and DLX-7, with studies planned for starts in late 2022 or early 2023.

Rune Labs Inc. is on a mission to make the mysteries of the brain easier to read for both clinicians and biopharma companies. Having a fresh $22.8 million in a series A financing on the books will no doubt make the goal easier to reach.

Rune Labs Inc. is on a mission to make the mysteries of the brain easier to read for both clinicians and biopharma companies. Having a fresh $22.8 million in a series A financing on the books will no doubt make the goal easier to reach. The new round pushed total funding for development of the San Francisco-based company’s brain data software platform to $30.1 million.

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.