FDA Fast Track

4 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Kymera Therapeutics Lands $45M Milestone as FDA Fast-Tracks Asthma Drug

Kymera Therapeutics receives $45M from Gilead option exercise and FDA Fast Track designation for asthma drug KT-621, with Phase 2b data expected late 2027.
GILDKYMRasthmaGilead Sciences
Investing.comInvesting.com··Jeffrey Neal Johnson

Psychedelics Eclipse Cannabis as Wall Street's Alternative Medicine Darling

Executive order fast-tracks psychedelics, spurring 40% surges in Compass Pathways and Atai Beckley, while cannabis operators like Curaleaf transition to stable income plays.
CMPSIIPRIIPRpAMSOSbiotechshort squeeze
GlobeNewswire Inc.GlobeNewswire Inc.··Adagene Inc.

Adagene Posts Promising ADG126 Data With $74.5M Cash Runway Into 2028

Adagene reports 29% response rate for ADG126 in colorectal cancer with improved safety profile. Company maintains $74.5M cash reserves extending runway into early 2028.
MRKSNYRHHBYADAGcolorectal cancerclinical trial
GlobeNewswire Inc.GlobeNewswire Inc.··Diamond Equity Research

MAIA Biotech Raises $30M, Eyes 2026 Milestones with Ateganosine Trial Data

MAIA Biotech secures $30M funding and FDA Fast Track designation for ateganosine cancer therapy, with Phase 2 data showing 17.8-month median survival.
MAIAclinical developmentPhase 3 trial