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Newleos Therapeutics Receives Up To $15.5 Million NIH Grant And FDA Fast Track Designation For NTX-2001
Newleos Therapeutics wins up to $15.5 million NIH grant and FDA Fast Track designation for NTX-2001
Key points
- A five-year NIDA grant of up to $15.5 million supports development of NTX-2001 for cocaine use disorder.
- FDA granted Fast Track designation to NTX-2001 for alcohol use disorder, which does not mean FDA approval.
- Newleos expects topline results from its Phase 1b alcohol study in the first half of 2027.
Why it matters. The grant provides additional non-dilutive funding for Newleos' substance use disorder research, while the Fast Track designation supports continued regulatory engagement on its alcohol use disorder program.
Boston-based Newleos Therapeutics received a five-year grant of up to $15.5 million from the National Institute on Drug Abuse for NTX-2001 in cocaine use disorder. The milestone-based award funds a Phase 1 drug-drug interaction study and a Phase 2 efficacy trial, and it is the company's first federal research grant. The FDA granted Fast Track designation to the drug for alcohol use disorder, which affects approximately 30 million people in the United States.
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Newleos Therapeutics Receives Up To $15.5 Million NIH Grant And FDA Fast Track Designation For NTX-2001
Newleos Therapeutics, a Boston-based clinical-stage biotechnology company developing treatments for neuropsychiatric disorders, has received a five-year grant of up to $15.5 million from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health. The company also announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its investigati By Amit Chowdhry Today at 6:58 AM Newleos Therapeutics, a Boston-based clinical-stage biotechnology company developing treatments for neuropsychiatric disorders, has received a five-year grant of up to $15.5 million from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health. The company also announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its investigational therapy NTX-2001 for alcohol use disorder. The milestone-based federal grant will support the development of NTX-2001 for cocaine use disorder, including a Phase 1 drug-drug interaction study and a subsequent Phase 2 efficacy trial. The award represents Newleos’ first federal research grant and is intended to help advance the investigational therapy through clinical development for a condition that currently has no FDA-approved pharmacological treatment. NTX-2001 is a selective partial agonist of trace amine-associated receptor 1 (TAAR1), a receptor invo.