In a day marked by translational momentum across digital therapeutics, gene therapy, neuroimmunology, regenerative medicine, and biomarker-driven discovery, neurology advanced on multiple fronts, from FDA clearance of a prescription cognitive-training app for adult ADHD to a new CNS-penetrant TYK2 inhibitor entering Formation Bio’s portfolio.
Formation Bio In-Licenses Phase 1-Ready CNS-Penetrant TYK2 Inhibitor From Lynk Pharmaceuticals
Formation Bio acquired worldwide rights (ex-Greater China) to LNK01006, a next-generation CNS-penetrant, highly selective allosteric TYK2 inhibitor, which recently received IND clearance from the FDA. The asset is now housed within Formation’s newly formed subsidiary, Bleecker Bio, poised for Phase 1 initiation in 1H 2026. With a pharmacologic profile optimized for central immune modulation, LNK01006 opens strategic optionality in autoimmune, inflammatory, and CNS-immune interface disorders. The acquisition aligns with Formation Bio’s “Known-in-New” strategy, applying validated immunology mechanisms to neurologic and centrally mediated disease pathways.
Give Back Health Partners With Inteligex to Propel First-in-Class Regenerative Therapy for Spinal Cord Injury
Give Back Health Innovation Foundation launched its inaugural partnership with Inteligex to accelerate the commercialization of a groundbreaking human cell therapy for spinal cord injury (SCI) in Canada. The philanthropic-venture hybrid model aims to close the notorious “translation gap,” enabling validated lab discoveries to progress toward clinical trials and national deployment. SCI affects 86,000 Canadians, with 3,600 new injuries annually. Inteligex’s cell therapy is engineered to replace specialized neural cells and restore communication between the brain and body, representing a potential step-change in functional recovery. Give Back’s reinvestment-driven funding mechanism is positioned as a scalable model to seed future Canadian neuro-innovations.
EpilepsyGTx Secures $33M Series A to Advance Single-Dose Gene Therapy for Focal Refractory Epilepsy
London-based EpilepsyGTx closed a $33M Series A to drive its AAV gene therapy EPY201 into Phase 1/2a trials for focal refractory epilepsy (FRE). EPY201 is locally delivered to the epileptogenic focus, enabling targeted reduction of neuronal hyperexcitability while avoiding systemic exposure and invasive resective procedures. FRE affects ~10 million patients globally, including 2 million across the US, UK, and EU, and EPY201 aims to provide seizure freedom with a single, minimally invasive intervention. Investors including XGEN Venture and the British Business Bank, position the company to scale a pipeline of gene therapies for additional hyperexcitability disorders.
LumosityRx Earns FDA Clearance, Cementing PDTs in Adult ADHD
Lumos Labs secured FDA 510(k) clearance for LumosityRx, a prescription digital therapeutic designed to improve attention in adults aged 22–55 with ADHD. The mobile-based PDT integrates 13 clinically validated cognitive-training modules and demonstrated statistically significant improvement on sustained and selective attention in the GAMES randomized, double-blind, sham-controlled trial (primary endpoint: TOVA ACS, p=0.0149). Clinician-rated improvement on CGI-I also favored the therapeutic, with ~33% rated “much improved” or better, exceptional adherence (97%), and no serious adverse events. The clearance marks Lumos Labs’ evolution from consumer brain training to regulated digital medicine, with national rollout now underway.
Cleveland Clinic & Baszucki Group Expand Landmark 20-Year Brain Study Into Gut–Brain Metabolism
The Cleveland Clinic Neurological Institute and the Baszucki Group deepened their collaboration by incorporating metabolic and stool-based biomarkers into the world-first, 20-year longitudinal Cleveland Clinic Brain Study, now backed with $450,000 in total. With more than 4,300 healthy volunteers already enrolled, the study aims to decode pre-symptomatic “disease fingerprints” across the body, positioning metabolic health and potentially the microbiome as early predictors of neurodegenerative, psychiatric, and functional neurological disorders. Investigators expect the expanded biomarker set to accelerate early-diagnostic algorithms and enable pre-emptive interventions across neurology.
Related: Yesterday’s NeuroPulse Daily recap offers further background on emerging CNS trends.
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