ML-007C-MA Phase

ML-007C-MA Phase is a MapLight Therapeutics, Inc. program. Every date links its source.

MPLT catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

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.

Catalyst history

Specialist biotech funds holding MPLT, 13F for the quarter ended June 30, 2026

13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.

Questions

When is ML-007C-MA Phase's next FDA decision or readout?

ML-007C-MA Phase's most recent tracked catalyst has already reported: positive data on Jul 27, 2026, per the company's own release (linked in the history below). No further catalyst is on our calendar yet.

What happened at ML-007C-MA Phase's most recent FDA decision?

No FDA decision for ML-007C-MA Phase is in our archive yet.

Who makes ML-007C-MA Phase?

MapLight Therapeutics, Inc. (MPLT).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.