The U.S. FDA issued new guidance for the development of non-opioid analgesics for chronic pain indications, with specific details on trial design, patient populations and meaningful outcomes, including reducing the nation’s reliance on opioids.

Neurosciences specialist NRG Therapeutics Ltd. is poised to put its new class of small-molecule regulators of the mitochondrial permeability transition pore to the test after closing an oversubscribed £50 million (US$67 million) series B.

Medicxi Ventures’ asset-focused investment model has scored another hit, in a $450 million deal with Servier SA, for KER-0193, an oral small molecule that is ready for phase II development in the treatment of the inherited autism spectrum disorder, fragile X.

Robust efficacy, competitive tolerability and ease of administration. Those are the qualities for a potential blockbuster antiseizure medication, according to Abe Ceesay, CEO of Rapport Therapeutics Inc., which reported a successful phase IIa trial testing RAP-219 in patients with drug-resistant focal onset seizures and aims to move into a large-scale phase III program in 2026.

The BioWorld Neurological Diseases Index showed signs of recovery in August, narrowing its year-to-date decline to 14.31%, compared to a steeper drop of 22.34% at the end of May. Momentum shifted notably over the summer, with 17 of the 20 component companies posting gains between June and August. This marks a reversal from May, when 15 of the 20 stocks were in the red.

Argenica Therapeutics Ltd. saw its stock drop 56% following mixed results for its ARG-007 phase II Seancon trial in acute ischemic stroke patients undergoing endovascular revascularization, or thrombectomy.

Twenty-two years since its formation, Bioarctic AB expects to become profitable in 2025, as milestones for marketing approvals and royalties on sales of the Alzheimer’s drug Leqembi (lecanemab) roll in, and partners sign up to use its proprietary Braintransporter drug delivery technology.

Leal Therapeutics Inc. is taking advantage of new genetic data that suggest products from metabolic pathways are involved in psychiatric and neurodegenerative diseases.

With new and positive phase III data in treating agitation in patients – at home instead of in a clinic – with bipolar disorders or schizophrenia, Bioxcel Therapeutics Inc. is preparing to submit an sNDA in the first quarter of 2026 to expand the label of the company’s Igalmi (BXCL-501). These data also bring the company closer to having the first such treatment that is approved by the U.S. FDA for home use. The unmet need for patients is huge, Vimal Mehta, the CEO of Bioxcel, told the BioWorld Insider podcast. Watch the interview, below.

In another deal between the two companies that could be worth more than $1 billion, Abbvie Inc. is buying Gilgamesh Pharmaceuticals Inc.’s lead candidate bretisilocin (GM-2505) for up to $1.2 billion, including an undisclosed up-front payment and development milestones. Privately held Gilgamesh has the psychedelic compound for treating moderate to severe major depressive disorder in a phase II study.