News & Events zu KALA BIO Inc (KALA)KALAKALA BIO Inc

KALA BIO Celebrates Trump's Executive Order on Psychedelics

KALA BIO "celebrated the landmark Executive Order" signed by U.S. President Donald Trump on April 18, 2026. The Order directs the FDA to prioritize the review of psychedelic compounds, instructs the DEA to reduce research restrictions, establishes expanded patient access pathways under the Right to Try Act, and allocates $50 million in federal funding to accelerate psychedelic therapy research.

Red Light Holland Partners with Kala Bio to Advance PEX010 Clinical Development

Red Light Holland and Kala Bio announced that Red Light has engaged Kala Bio's with its Researgency.ai agentic artificial intelligence platform under world wide license from Younet to support the clinical development strategy for PEX010, the patented botanical psilocybin drug candidate originated by Filament Health. The engagement will deploy Kala Bio's purpose-built AI research agents to assist in clinical planning, protocol optimization and scenario modeling as Red Light advances PEX010 through its regulated drug development program. Red Light recently announced a definitive arrangement agreement to acquire Filament's business, including its portfolio of 76 issued patents across 15 patent families, representing one of the largest intellectual property portfolios in botanical psilocybin drug development, as well as its lead drug candidate, PEX010. The engagement of the Kala's Researgency.ai platform represents a key element of Red Light's strategy to integrate advanced AI-driven research capabilities as it expands its regulated psychedelic drug development platform. PEX010 is Filament's patented botanical psilocybin drug candidate and is currently supplied to more than 70 clinical research sites worldwide, making it one of the most widely studied botanical psilocybin drug candidates in regulated clinical research. PEX010 is being studied across multiple indications, including alcohol use disorder, methamphetamine use disorder, treatment-resistant depression, cancer-related anxiety and depression, and cannabis use disorder, at leading research institutions including Johns Hopkins University and Dana-Farber Cancer Institute, among others. The drug candidate has received both Health Canada and FDA authorization for clinical trials and has demonstrated positive Phase 2 clinical data in alcohol use disorder.