Sponsor: MapLight Therapeutics, Inc. (MPLT). Review status: Phase 2 ZEPHYR met its primary endpoint: statistically significant improvement in PANSS total score versus placebo at Week 5 on the 210/3 mg BID dose in acute schizophrenia. Generally well tolerated; no serious or drug-related severe adverse events reported. We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
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