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BrainStorm Cell Therapeutics Inc.

http://www.brainstorm-cell.com

Latest From BrainStorm Cell Therapeutics Inc.

Congress Pushes US FDA On Trial Diversity, Accelerated Approval In Approps Report

The House Appropriations Committee indicates in fiscal year 2025 appropriations report language that lawmakers will closely monitor the FDA’s implementation of clinical trial diversity action plans. 

Legislation Rare Diseases

FDA's LDT Overhaul Should Go Back To Congress, Appropriations Report Says

A fiscal 2025 report from the US House Appropriations Committee instructs the FDA to halt implementation of its overhaul of LDT regulation. Members also showed concern about overseas device manufacturing and the availability of over-the-counter diagnostics. 

Legislation Regulation

Relyvrio’s Failure Sparks NeuroSense ALS Development Changes

NeuroSense plans to adjust its upcoming clinical trial to avoid the fate of Amylyx’s ALS candidate, which was recently withdrawn from the market due to a lack of efficacy.

Neurology Clinical Trials

Finance Watch: Though Flush With Cash, Theseus Seeks Alternatives, Gets Two Quick Offers

Restructuring Edition: OrbiMed/Foresite and Concentra responded quickly after Theseus implemented a 72% workforce reduction and began a search for strategic alternatives despite having $225.4m in cash. REGENXBIO, Novavax and Lyell also revealed job cuts despite large cash stockpiles.

Restructuring Financing
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