MapLight Therapeutics Receives Fast Track Designation for ML-007C-MA for Alzheimer’s Disease Psychosis
MapLight Therapeutics, Inc. (MPLT)
Company Research
Source: GlobeNewswire
SAN FRANCISCO and BOSTON, Jan. 05, 2026 (GLOBE NEWSWIRE) -- MapLight Therapeutics, Inc. (“MapLight”) (Nasdaq: MPLT) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ML-007C-MA, an investigational novel M1/M4 muscarinic agonist, for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). The Fast Track process is intended to facilitate the development and expedite the review of investigational therapies for serious conditions with unmet medical need. A drug with Fast Track designation may be eligible for more frequent interactions with the FDA, as well as accelerated approval and priority review, if applicable criteria are met. “FDA’s Fast Track designation underscores the significant unmet need of the millions of people with Alzheimer’s disease psychosis with no currently approved treatment options,” said Erin Foff, M.D., Ph.D., Chief Medical Officer of MapLight. “This designation is a
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News
- MapLight Therapeutics Updates Expected Timing of Topline Results for Ongoing Phase 2 Studies to Q3 2026 [Yahoo! Finance]Yahoo! Finance
- MapLight Therapeutics Updates Expected Timing of Topline Results for Ongoing Phase 2 Studies to Q3 2026GlobeNewswire
- Maplight Therapeutics (NASDAQ:MPLT) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=MPLT&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall StrMarketBeat
- SandboxAQ and MapLight Therapeutics Announce Strategic Collaboration to Discover and Develop Novel CNS TherapiesGlobeNewswire
- MapLight Therapeutics Reports Third Quarter Financial Results and Highlights Corporate ProgressGlobeNewswire
MPLT
Sec Filings
- 1/9/26 - Form 8-K
- 12/4/25 - Form 10-Q
- 12/4/25 - Form 8-K
- MPLT's page on the SEC website