Life Molecular Imaging Receives FDA Fast Track Designation for [18F]PI-2620 in Tau PET Imaging Across Three Neurodegenerative Conditions [Yahoo! Finance]
AC Immune SA (ACIU)
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BOSTON Aug. 28, 2024 /PRNewswire/ -- Life Molecular Imaging (LMI) is pleased to announce that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to [18F]PI-2620 Injection, an investigational PET imaging agent targeting tau neurofibrillary tangles. The Fast Track Designation has been granted for clinical development in Alzheimer's disease (AD), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD). The FDA's Fast Track program is designed to accelerate the development and review of drugs that address serious conditions and fulfill unmet medical needs. This designation underscores the significant potential of [18F]PI-2620 to improve diagnosis of these three devastating neurodegenerative diseases. [18F]PI-2620 is a next-generation, F18-labeled PET imaging agent currently in Phase 3 clinical development for detecting tau pathology in Alzheimer's disease. The compound is also being investigated in other neurodegenerative diseases and setting
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News
- AC Immune SA (NASDAQ: ACIU) was upgraded by analysts at StockNews.com from a "hold" rating to a "buy" rating.MarketBeat
- AC Immune SA (NASDAQ: ACIU) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $16.00 price target on the stock.MarketBeat
- AC Immune Receives Second Milestone Payment Following Progress in Phase 2b ReTain Trial of ACI-35.030 in Preclinical Alzheimer’s DiseaseGlobeNewswire
- FDA grants fast track designation to Life Molecular Imaging's tau PET diagnostic [Yahoo! Finance]Yahoo! Finance
- AC Immune’s PI-2620 Tau-PET Diagnostic in Phase 3 Receives Fast Track Designation in Three Neurodegenerative ConditionsGlobeNewswire
ACIU
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- 8/6/24 - Miss
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- 9/19/24 - Form 6-K
- 9/18/24 - Form 144
- ACIU's page on the SEC website