fda-fast-track
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858 Therapeutics
858 Therapeutics is a clinical-stage biotechnology company in San Diego building small-molecule cancer drugs aimed at novel targets in DNA damage response, RNA modulation, and innate immunity. Its lead candidate, the oral PARG inhibitor ETX-19477, is in a first-in-human Phase 1/2 trial for advanced solid tumors and has won FDA Fast Track designation for BRCA-mutated, platinum-resistant ovarian cancer. Founded in 2019 by a serial team of San Diego drug developers, the company has raised $110 million across Series A and B financings.
Autobahn Therapeutics, Inc.
Autobahn Therapeutics is a San Diego clinical-stage biotech building small-molecule medicines that reach the brain on purpose. Using a brain-targeting chemistry and prodrug platform, the company tunes where a drug goes - central versus peripheral - to unlock validated CNS biology that has been hard to drug safely. Its lead program, elunetirom (ABX-002), is an oral, once-daily, brain-penetrant CNS thyroid hormone receptor agonist in Phase 2 trials for major depressive disorder and bipolar depression, backed by more than $200 million in venture funding and a 2026 FDA Fast Track designation.
Vima Therapeutics
Vima Therapeutics is a Cambridge, Massachusetts clinical-stage biotechnology company developing VIM0423, a potential first-in-class once-daily oral therapy for isolated dystonia and Parkinson's disease. The drug selectively targets muscarinic cholinergic receptors in the brain to correct the dopamine-acetylcholine imbalance underlying these movement disorders. Incubated at Atlas Venture and led by neurologist Bernard Ravina, the company emerged from stealth in 2025 and has raised a $100 million Series A.
Star Therapeutics
Star Therapeutics is a South San Francisco clinical-stage biotech building first-in-class antibody medicines for serious diseases, with a 'pipeline-in-a-product' approach. Its lead asset VGA039, developed through subsidiary Vega Therapeutics, is a once-monthly subcutaneous monoclonal antibody targeting Protein S, now in Phase 3 for von Willebrand disease.