MapLight pauses preclinical work to focus on ML-007C-MA for schizophrenia; ADC Therapeutics weighs Zynlonta's future after FDA flags safety concerns in LOTIS-5 trial.

MapLight Therapeutics (Nasdaq: MPLT) reported second quarter 2026 results and a business update, highlighting positive topline data from the potentially registrational Phase 2 ZEPHYR trial of ML-007C-MA in schizophrenia. The study met its primary endpoint, showing a statistically significant and clinically meaningful PANSS total score reduction at Week 5 versus placebo at the 210/3 mg twice-daily dose, plus improvements on prespecified cognitive and key secondary endpoints, with a generally well-tolerated safety profile. MapLight plans an End-of-Phase 2 FDA meeting and a Phase 3 ZEPHYR-2 trial, with topline results expected in 2028.ML-007C-MA is also in the Phase 2 VISTA trial for Alzheimer’s disease psychosis, which has FDA Fast Track designation and topline data expected in the second half of 2027. The company reported Phase 2 IRIS results for ML-004 in autism spectrum disorder; the trial did not meet its primary endpoint, although a prespecified adolescent subgroup showed clinically meaningful improvements in irritability. MapLight ended the quarter with $351.3 million in cash, cash equivalents and investments and, together with a recent $150 million private placement, expects to fund ML-007C-MA through 2028. Quarterly R&D expenses were $53.4 million, G&A expenses were $10.1 million, and net loss was $60.2 million, all higher than the prior-year period, as the company focuses resources on advancing ML-007C-MA and pauses preclinical and discovery-stage programs.

The trial, designed and sized to support registration, met its primary endpoint, with the 210/3 mg BID dose demonstrating a statistically significant improvement in PANSS total score compared to placebo at Week 5 with an effect size of 0.37 (LS mean difference vs PBO -4.5, p=0.015) Cognitive

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Sponsor(s): MapLight Therapeutics Status: Recruiting

MapLight Therapeutics (Nasdaq: MPLT) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational therap

MapLight Therapeutics has filed for an initial public offering to boost its operations targeting CNS disorders, aiming to enhance patient care. This IPO marks a significant step in its mission.

MapLight Therapeutics has launched a Phase 2 trial to assess ML-007C-MA's potential in treating Alzheimer's disease psychosis, a critical step for patients.

MapLight Therapeutics has begun its Phase 2 trial of ML-007C-MA, a novel treatment for schizophrenia, focusing on efficacy, safety, and tolerability.

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 M 1 /M 4 muscarinic agonist, for the

MapLight Therapeutics (Nasdaq: MPLT) reported third quarter 2025 results and program milestones on Dec 4, 2025. Key clinical timelines: ZEPHYR Phase 2 topline for ML-007C-MA in schizophrenia expected in H2 2026; VISTA Phase 2 topline for Alzheimer’s disease psychosis expected in H2 2027; IRIS Phase 2 topline for ML-004 in ASD expected in H2 2026. The company completed enrollment in IRIS (~160 participants) and nominated ML-009 for IND-enabling studies; ML-021 IND-enabling studies expected complete H2 2026. Financing: completed an IPO and private placement in Oct 2025 raising $296.5 million gross ($269.8 million net). Cash, cash equivalents and short-term investments were $227.2 million at quarter end, expected to fund operations through 2027.

SAN FRANCISCO and BOSTON, Sept. 17, 2025 /PRNewswire/ -- MapLight Therapeutics today announced the initiation of a Phase 2 study to evaluate the efficacy, safety and tolerability of ML-007C-MA, an investigational novel M1/M4 agonist, as a potential treatment for Alzheimer's disease...

REDWOOD CITY, Calif., July 7, 2025 /PRNewswire/ -- MapLight Therapeutics today announced the initiation of a Phase 2 study to evaluate the efficacy, safety and tolerability of ML-007C-MA, an investigational novel M1/M4 agonist, as a potential treatment for schizophrenia. The Phase 2...