(RTTNews) - MapLight Therapeutics, Inc. (MPLT) on Monday said the U.S. Food and Drug Administration has granted Fast Track designation to ML-007C-MA for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis (ADP).
The company said Fast Track designation allows for more frequent interactions with the FDA and may make the drug eligible for accelerated approval and priority review, if applicable criteria are met.
In a Phase 1 study, ML-007C-MA demonstrated a generally favorable safety and tolerability profile in healthy elderly participants.
Enrollment is ongoing in a Phase 2 VISTA study evaluating ML-007C-MA for the treatment of hallucinations and delusions associated with ADP, with topline results expected in the second half of 2027.
MapLight Therapeutics shares closed at $16.77 on Friday, down 4.5%.
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