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Reunion secures Breakthrough Therapy Designation from the FDA, paving the way for its postpartum depression treatment.
The FDA granted Breakthrough Therapy Designation to Reunion Neuroscience’s investigational drug luvesilocin (RE104) for the treatment of postpartum depression (PPD).
The designation is based on Phase 2 clinical data showing that a single subcutaneous dose produced rapid and durable reductions in depressive symptoms, with a significant proportion of participants achieving remission within the first month.
Breakthrough Therapy status is reserved for drugs that treat serious conditions and show preliminary evidence of substantial improvement over existing therapies. This designation provides Reunion with more frequent interaction with the FDA and the potential for an expedited development and review process as the company prepares to initiate pivotal Phase 3 trials. Here’s more: https://reunionneuro.com/2026/02/23/u-s-fda-grants-reunion-neurosciences-luvesilocin-re104-breakthrough-therapy-designation-status/
QurAlis Corporation reported new data from its ANQUR Phase 1/2 clinical trial evaluating QRL-201. This is a precision medicine being developed for sporadic ALS.
The interim results showed that QRL-201 engaged its intended biological target in key nervous system tissues and increased levels of STATHMIN-2, a protein linked to nerve cell health that is reduced in ALS. Biomarker analyses also showed reductions in neurofilament levels, which are associated with neuronal injury, suggesting a favorable biological effect.
Based on these results, Canadian regulators have approved an open-label extension so participants can receive treatment outside the placebo-controlled portion of the study, and QurAlis plans to advance QRL-201 into a Phase 3 trial as early as 2027. Check it out: https://substack.com/home/post/p-189017997
AtaiBeckley reported positive early results for EMP-01, an oral form of R-MDMA being tested for social anxiety disorder.
In a small Phase 2a study, the drug was safe and well-tolerated, with no serious side effects. More importantly, patients who took it showed meaningful improvements in social anxiety symptoms compared to placebo after just two doses over six weeks. Nearly half of treated patients were rated as “much improved,” verses about 15% on placebo.
Did you know that China has taken the lead in the acceleration of the global brain-computer interface (BCI) industry?
As detailed in a new article published in TechCruch, backed by aggressive government funding, policy support, and fast-tracked clinical trials, Chinese companies are rapidly moving BCIs from lab research into real patient use. Both implantable and noninvasive systems are advancing, narrowing the perceived lead held by Western players.
The near-term focus is on paralysis, stroke rehab, neurological disorders. The long-term play, however, is now being pitched as human-machine integration at scale. It’s a fascinating article, and you can check it out here: https://techcrunch.com/2026/02/22/chinas-brain-computer-interface-industry-is-racing-ahead/
