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Advancing Innovation: Creating More Transformative Moments

on May 29, 2026

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KOL Bulletin: Brilaroxazine's Potential Differentiation on EPS Over Risperidone in Schizophrenia

A leading US KOL states that brilaroxazine shows placebo-like extrapyramidal symptoms (EPS) at week 4, potentially differentiating it from risperidone which cannot achieve this 1 . Reviva plans to initiate the RECOVER-2 Phase 3 trial for brilaroxazine in schizophrenia in H1 2026 following FDA recommendation for additional efficacy and safety data 2 . Brilaroxazine demonstrates broad-spectrum efficacy across schizophrenia symptom domains, including negative symptoms, with a well-tolerated safety profile in over 900 subjects 2 4 . Phase 3 RECOVER trial data shows low EPS and akathisia, mild weight gain (1.52 kg pooled), reductions in prolactin levels, and improvements in sexual function over 1 year 4 . New publication highlights speech latency as an objective vocal biomarker for brilaroxazine's effect on negative symptoms, reinforcing efficacy 3 5 . Sources: 1. https://firstwordhealthtech.com 2. https://www.biospace.com/press-releases/reviva-announces-regulatory-update-...

Xaira Therapeutics Launches X-Cell: First AI Virtual Cell Model Testing Scaling Laws on Massive Perturbation Data

Xaira Therapeutics announced X-Cell on March 17, 2026, a 4.9-billion-parameter diffusion language model, the largest virtual cell model to date, trained on X-Atlas/Pisces, the largest genome-wide CRISPRi Perturb-seq dataset with 25.6 million perturbed single-cell transcriptomes across seven diverse contexts. 1 2 X-Cell predicts cell responses to genetic perturbations, outperforming existing models by up to five-fold on metrics like Pearson delta, and generalizes zero-shot to unseen biological contexts such as iPSC-derived melanocyte progenitors and primary human CD4+ T cells. 1 2 The model follows power-law scaling dynamics similar to large language models, using a novel diffusion architecture that iteratively refines predictions. 2 Xaira, founded in 2024 with over $1 billion funding, plans to expand X-Atlas to primary cells, organoids, and in vivo perturbations, focusing on inflammatory/immunological diseases and antibody therapeutics. 1 3 A subset of the Pisces dataset and X-...

Ultragenyx Resubmits BLA for UX111 Gene Therapy with New Long-Term Data for Sanfilippo Syndrome Type A

Ultragenyx resubmitted its Biologics License Application (BLA) to the FDA for UX111, an AAV9 gene therapy for Sanfilippo syndrome type A (MPS IIIA), including long-term clinical data on neurologic, biomarker, and safety improvements. 1 2 3 4 5 The resubmission addresses a Complete Response Letter from July 2025 related to manufacturing (CMC) observations and adds durable biomarker reductions, such as CSF heparan sulfate, with favorable safety profile. 2 4 5 FDA's six-month priority review has begun; PDUFA action date expected in Q3 2026. 2 4 5 If approved, UX111 would be the first therapy for this fatal pediatric neurodegenerative disorder. 1 3 4 5 New long-term data announced February 3, 2026, shows substantial biomarker improvements and functional benefits vs. natural history, consistent across age and severity. 2 Sources: 1. https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-rare/ultragenyx-pharmaceutical/news/ultragenyx-bla-resubmission-puts-ux111-and-ra...

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