fda-fast-track

(6)
Company
858 Therapeutics
Health

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.

biotech · biotechnologyRead →
Company
Autobahn Therapeutics, Inc.
Health · Enterprise

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.

biotech · cnsRead →
Company
Vima Therapeutics
Health

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.

biotech · neuroscienceRead →
Company
Star Therapeutics
Health · Enterprise

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.

biotech · antibody-therapyRead →
Legend
Cheng Liu
Founder · Executive · Scientist

Cheng Liu

Cheng Liu is the founder, President, and CEO of Eureka Therapeutics, Inc., a clinical-stage biopharmaceutical company based in Emeryville, California. A molecular cell biologist trained at UC Berkeley and Peking University, Liu invented a novel class of TCR mimic antibodies that allow engineered T cells to recognize intracellular tumor antigens - a major challenge in treating solid tumors. Since founding Eureka in 2006 after a decade at Chiron/Novartis, he has built a pipeline of ARTEMIS T-cell therapies targeting liver cancer, multiple myeloma, and neuroblastoma, with the company's ECT204 program earning FDA RMAT Designation in January 2026 - one of the highest-priority designations the FDA gives to regenerative medicine therapies. Eureka has raised over $168 million in total funding and holds more than 500 patents worldwide.

biotech · immunotherapyRead →
Legend
Adam Rosenthal
Founder · Executive · Scientist

Adam Rosenthal

Adam Rosenthal is the CEO and Founder of Star Therapeutics, a clinical-stage biotech he launched in 2018 with a mission to develop life-changing therapies for rare diseases. An MIT and Harvard-trained biomedical engineer, Rosenthal built Star around the insight that shared biology across multiple rare diseases can yield single therapies addressing many conditions at once. His lead asset VGA039 - a first-in-class monoclonal antibody targeting Protein S - entered Phase 3 trials in 2025 for von Willebrand disease, the most common inherited bleeding disorder. Star has raised over $315 million from top-tier life sciences investors including Sanofi Ventures and Viking Global Investors.

biotech · rare-diseaseRead →