Maplight Therapeutics (MPLT) FDA Approvals $29.36 -0.73 (-2.43%) As of 03:00 PM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock Maplight Therapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Maplight Therapeutics (MPLT). Over the past two years, Maplight Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ML-007C-MA. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. ML-007C-MA FDA Regulatory Events ML-007C-MA is a drug developed by Maplight Therapeutics for the following indication: for Alzheimer's Disease Psychosis. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Enrollment Update - May 1,2026Enrollment Update Phase 2Drug: ML-007C-MAAnnounced Date: May 1, 2026Indication: for Alzheimer's Disease PsychosisAnnouncementMapLight Therapeutics, Inc announced completion of enrollment in its Phase 2 ZEPHYR trial evaluating ML-007C-MA for the treatment of schizophrenia.AI SummaryMapLight Therapeutics announced completion of enrollment in its Phase 2 ZEPHYR trial testing ML-007C-MA for schizophrenia. ZEPHYR is a randomized, double-blind, placebo-controlled study evaluating the drug’s efficacy, safety, and tolerability in inpatient adults experiencing an acute exacerbation of psychosis. With enrollment finished and patients being followed, MapLight expects topline results from ZEPHYR by mid‑August 2026. The company also reported the last patient visit has been completed in its IRIS Phase 2 trial of ML-004 for autism spectrum disorder, which enrolls adults and adolescents and uses a similar randomized, double-blind, placebo-controlled design. Topline data from both Phase 2 trials are anticipated by mid‑August 2026. For more information, visit MapLight’s website.Read AnnouncementDesignation Grant - January 5,2026Designation Grant Fast TrackDrug: ML-007C-MAAnnounced Date: January 5, 2026Indication: for Alzheimer's Disease PsychosisAnnouncementMapLight Therapeutics, Inc 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).AI SummaryMapLight Therapeutics announced that the U.S. Food and Drug Administration has granted Fast Track designation to ML-007C-MA, an investigational M1/M4 muscarinic agonist being developed to treat hallucinations and delusions in Alzheimer’s disease psychosis (ADP). Fast Track status is intended to speed development and review of treatments for serious conditions with unmet needs. ML-007C-MA is an oral, extended‑release, fixed‑dose combination of the central M1/M4 agonist ML‑007 co‑formulated with a peripherally acting anticholinergic (PAC). The design aims to activate brain M1 and M4 receptors to improve psychotic symptoms while reducing peripheral cholinergic side effects by synchronizing the two components’ effects. In Phase 1, ML‑007C‑MA showed a generally favorable safety and tolerability profile with twice‑daily dosing in healthy older adults. The randomized, double‑blind, placebo‑controlled Phase 2 VISTA study is ongoing, plans to enroll about 300 participants, and expects topline results in the second half of 2027.Read Announcement Maplight Therapeutics FDA Events - Frequently Asked Questions Has Maplight Therapeutics received FDA approval? As of now, Maplight Therapeutics (MPLT) has not received any FDA approvals for its therapy in the last two years. What drugs has Maplight Therapeutics submitted to the FDA? In the past two years, Maplight Therapeutics (MPLT) has reported FDA regulatory activity for ML-007C-MA. What is the most recent FDA event for Maplight Therapeutics? The most recent FDA-related event for Maplight Therapeutics occurred on May 1, 2026, involving ML-007C-MA. The update was categorized as "Enrollment Update," with the company reporting: "MapLight Therapeutics, Inc announced completion of enrollment in its Phase 2 ZEPHYR trial evaluating ML-007C-MA for the treatment of schizophrenia." What conditions do Maplight Therapeutics' current drugs treat? Currently, Maplight Therapeutics has one therapy (ML-007C-MA) targeting the following condition: for Alzheimer's Disease Psychosis. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Agios Pharmaceuticals FDA EventsAgenus FDA EventsArvinas FDA EventsBridgeBio Pharma FDA EventsBriacell Therap FDA EventsBeam Therapeutics FDA EventsCellectis FDA EventsCaribou Biosciences FDA EventsDare Bioscience FDA EventsDefinium Therapeutics FDA EventsGeron FDA EventsMiNK Therapeutics FDA EventsIncannex Healthcare FDA EventsKura Oncology FDA EventsOrchestra BioMed FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Kiniksa Pharmaceuticals International FDA Events Crinetics Pharmaceuticals FDA Events Travere Therapeutics FDA Events Edgewise Therapeutics FDA Events MANE FDA Events ACADIA Pharmaceuticals FDA Events Catalyst Pharmaceuticals FDA Events Viking Therapeutics FDA Events Organon & Co. FDA Events Tango Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:MPLT last updated on 5/1/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersNNVC FDA = New Momentum Wave!NanoViricides (NYSE: NNVC) just received FDA Orphan Drug Designation for NV-387, its antiviral candidate targe...Equiscreen | SponsoredBSEM: From OTC to Nasdaq Contender!BioStem Technologies (OTC: BSEM) has posted seven consecutive profitable quarters and just released audited fi...Huge Alerts | SponsoredIf You Have $50k+ on Coinbase, This Will Ruin Your DayIn 2009, Greece's debt-to-GDP ratio hit 130%. Within 24 months... Pensions were slashed 40% overnight. 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Enrollment Update - May 1,2026Enrollment Update Phase 2Drug: ML-007C-MAAnnounced Date: May 1, 2026Indication: for Alzheimer's Disease PsychosisAnnouncementMapLight Therapeutics, Inc announced completion of enrollment in its Phase 2 ZEPHYR trial evaluating ML-007C-MA for the treatment of schizophrenia.AI SummaryMapLight Therapeutics announced completion of enrollment in its Phase 2 ZEPHYR trial testing ML-007C-MA for schizophrenia. ZEPHYR is a randomized, double-blind, placebo-controlled study evaluating the drug’s efficacy, safety, and tolerability in inpatient adults experiencing an acute exacerbation of psychosis. With enrollment finished and patients being followed, MapLight expects topline results from ZEPHYR by mid‑August 2026. The company also reported the last patient visit has been completed in its IRIS Phase 2 trial of ML-004 for autism spectrum disorder, which enrolls adults and adolescents and uses a similar randomized, double-blind, placebo-controlled design. Topline data from both Phase 2 trials are anticipated by mid‑August 2026. For more information, visit MapLight’s website.Read Announcement
Designation Grant - January 5,2026Designation Grant Fast TrackDrug: ML-007C-MAAnnounced Date: January 5, 2026Indication: for Alzheimer's Disease PsychosisAnnouncementMapLight Therapeutics, Inc 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).AI SummaryMapLight Therapeutics announced that the U.S. Food and Drug Administration has granted Fast Track designation to ML-007C-MA, an investigational M1/M4 muscarinic agonist being developed to treat hallucinations and delusions in Alzheimer’s disease psychosis (ADP). Fast Track status is intended to speed development and review of treatments for serious conditions with unmet needs. ML-007C-MA is an oral, extended‑release, fixed‑dose combination of the central M1/M4 agonist ML‑007 co‑formulated with a peripherally acting anticholinergic (PAC). The design aims to activate brain M1 and M4 receptors to improve psychotic symptoms while reducing peripheral cholinergic side effects by synchronizing the two components’ effects. In Phase 1, ML‑007C‑MA showed a generally favorable safety and tolerability profile with twice‑daily dosing in healthy older adults. The randomized, double‑blind, placebo‑controlled Phase 2 VISTA study is ongoing, plans to enroll about 300 participants, and expects topline results in the second half of 2027.Read Announcement
