The Week of

Autobahn Therapeutics received FDA Fast Track designation for elunetirom, its lead experimental therapy for bipolar depression.

The drug is a once-daily oral treatment designed to target thyroid hormone receptors in the brain while limiting unwanted side effects associated with traditional thyroid hormone therapies. Autobahn is currently evaluating elunetirom in a Phase 2 study for bipolar depression, with topline data expected in the second quarter of 2026. The company is also studying the drug in major depressive disorder, with additional Phase 2 data expected later this year. Check it out: https://substack.com/home/post/p-199343254

Optimi Health announced it produced its highest-purity natural psilocybin extract to date, reaching approximately 6% psilocybin concentration through improved cultivation and extraction processes.

The company said the extract will support its ongoing supply efforts in Australia, where psychiatrists can prescribe psilocybin for treatment-resistant depression under the country's regulated access framework. Higher-purity extracts could improve manufacturing efficiency because less raw material is needed to achieve targeted dosages while also helping improve consistency across production batches. Here’s more: https://substack.com/home/post/p-199403816

Actinogen Medical received positive scientific advice from the European Medicines Agency (EMA) for its Alzheimer's disease program involving Xanamem, an experimental cortisol-modulating therapy designed to target cognitive decline.

The EMA guidance was reportedly aligned with prior feedback from the FDA, giving the company a clearer regulatory framework as it prepares for later-stage development.

Xanamem works by inhibiting the 11β-HSD1 enzyme, which is associated with elevated cortisol levels in the brain and has been linked to memory impairment and neurodegeneration. Actinogen is currently advancing the drug through Phase 2 studies, including trials focused on Alzheimer's disease and major depressive disorder. Check it out: https://www.biospace.com/press-releases/actinogen-receives-positive-ema-scientific-advice-aligned-with-prior-fda-guidance-for-its-alzheimers-disease-program

Did you know researchers are beginning to move optical brain implant technology out of laboratory settings and into real-world clinical use?

A company called Science Corp. recently announced that its optical brain-computer interface system is now being evaluated in human patients, representing another step forward in the broader brain implant industry.

Unlike traditional electrical implants, optical systems use light-based technology designed to improve signal resolution while potentially reducing some of the limitations associated with electrode-based approaches.

The company's implant is initially being developed to help restore communication and functionality for patients with severe neurological impairments, including paralysis and vision loss. Here’s more: https://abilityneuro.com/