MPLT

Enrollment completed in ML-007C-MA’s Phase 2 ZEPHYR trial in schizophrenia, with topline results expected by mid-August 2026 Last patient visit completed for ML-004’s Phase 2 IRIS trial in autism spectrum disorder, with topline results expected by mid-August 2026 Enrollment ongoing in ML-007C-MA’s Phase 2 VISTA trial in Alzheimer’s disease psychosis, with topline results expected in the second half of 2027 Ended the quarter with $395.2 million in cash, cash equivalents and investments, which is expected to fund operations through 2027 SAN FRANCISCO and BOSTON, May 14, 2026 (GLOBE NEWSWIRE) -- MapLight Therapeutics, Inc. (Nasdaq: MPLT), a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating central nervous system disorders, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. “We are continuing to see strong momentum across our clinical portfolio, including completion of enrollment in the Phase 2 ZEPHYR and IRIS trials,” said Chris Kroeger, co-Founder and Chief Executive Officer of the Company. “With topline results from both studies expected by mid-August, continued advancement of our VISTA trial in Alzheimer’s disease psychosis and progress across our early-stage pipeline, MapLight is entering an important inflection point in our mission to improve the lives of patients living with debilitating neuropsychiatric disorders.” Business Update and Upcoming Milestones ML-007C-MA (M1/M4 Muscarinic Agonist) for the Treatment of Schizophrenia and Alzheimer’s Disease Psychosis (ADP): Completed enrollment of 307 participants in the Phase 2 ZEPHYR trial for schizophrenia, with topline results expected by mid-August of 2026. ZEPHYR is a randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety, and tolerability of ML-007C-MA in inpatient adult participants with schizophrenia experiencing an acute exacerbation of psychosis. Participants in the trial were randomized 1:1:1 to receive either placebo, ML-007C-MA 210/3 mg twice daily, or ML-007C-MA 330/6 mg once daily. The primary endpoint for the trial is the change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to Week 5. Key secondary endpoints include change in PANSS-Marder positive and negative factor scores and CGI-S score from baseline to Week 5. Explorat...

Enrollment completed in ML-007C-MA’s ZEPHYR Phase 2 trial in schizophrenia Last patient visit completed for ML-004’s IRIS Phase 2 trial in autism spectrum disorder Topline results from both Phase 2 trials expected by mid-August 2026 SAN FRANCISCO and BOSTON, May 01, 2026 (GLOBE NEWSWIRE) -- MapLight Therapeutics, Inc. (Nasdaq: MPLT), a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating central nervous system disorders, today announced completion of enrollment in its Phase 2 ZEPHYR trial evaluating ML-007C-MA for the treatment of schizophrenia. The Company also announced completion of the final patient visit in its Phase 2 IRIS trial evaluating ML-004 for the treatment of autism spectrum disorder. The Company expects to report topline results from both Phase 2 trials by mid-August 2026. "The robust enrollment in the ZEPHYR trial reflects the critical unmet need for new treatment options in schizophrenia," said Chris Kroeger, Co-Founder and Chief Executive Officer. "We are grateful for the enthusiasm and commitment of both participants and investigators that enabled efficient study conduct while maintaining high quality standards. 2026 is shaping up to be an important year for MapLight and we look forward to sharing the topline data from these trials." The Phase 2 ZEPHYR trial is a randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety, and tolerability of ML-007C-MA in inpatient adult participants with schizophrenia experiencing an acute exacerbation of psychosis. 307 participants in the trial were randomized 1:1:1 to receive either placebo, ML-007C-MA 210/3 mg twice daily, or ML-007C-MA 330/6 mg once daily Primary endpoint is the change in PANSS total score from baseline to Week 5 Key secondary endpoints include change in CGI-S score, PANSS-Marder positive and negative factor scores from baseline to Week 5 Exploratory endpoints include change in cognitive function, assessed across multiple domains commonly impacted in schizophrenia, from baseline to Week 5 The Phase 2 IRIS trial is a randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety, and tolerability of ML-004 in adults and adolescents with autism spectrum disorder. 161 participants were randomized in the trial, consistent with our enrollment target of over 100 adolescents (aged 12-17) Pr...

Phase 2 ZEPHYR trial of ML-007C-MA for schizophrenia expected to reach target enrollment (n=300) in April 2026, with topline results expected in the third quarter of 2026 Phase 2 IRIS trial for ML-004 for autism spectrum disorder has completed enrollment, with topline results expected in the third quarter of 2026 Received FDA Fast Track designation for ML-007C-MA for Alzheimer’s disease psychosis; topline results from Phase 2 VISTA trial expected in the second half of 2027 Expanded pipeline with a next-generation M1/M4 muscarinic agonist program, ML-055, with candidate nomination expected in 2026 Ended the year with $453.1 million in cash, cash equivalents and investments, which is expected to fund operations through 2027 SAN FRANCISCO and BOSTON, March 26, 2026 (GLOBE NEWSWIRE) -- MapLight Therapeutics, Inc. (Nasdaq: MPLT), a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating central nervous system disorders, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. “With a focused strategy, robust operational execution and a strong balance sheet, MapLight is well positioned to deliver on multiple key development milestones in 2026,” said Chris Kroeger, co-Founder and Chief Executive Officer of the Company. “While continuing to prioritize high-quality trial execution, we have maintained a robust enrollment pace in the ZEPHYR study and expect to reach target enrollment in April 2026. This is shaping up to be an exciting year for MapLight as we look forward to reporting topline results from our Phase 2 ZEPHYR trial and ML-004 Phase 2 IRIS trial in the third quarter. In addition, we expanded our earlier-stage pipeline with the addition of ML-055, our next-generation M1/M4 agonist program that we are rapidly advancing towards potential candidate nomination this year.” Business Update and Upcoming Milestones ML-007C-MA (M1/M4 Muscarinic Agonist) for the Treatment of Schizophrenia and Alzheimer’s Disease Psychosis (ADP): Phase 2 ZEPHYR trial for schizophrenia is expected to reach target enrollment in April 2026, with topline results expected in the third quarter of 2026. ZEPHYR is a randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety, and tolerability of ML-007C-MA in inpatient adult participants with sch...

MapLight Therapeutics (MPLT) said Friday that topline results from its Zephyr and Iris phase 2 trial

SAN FRANCISCO and BOSTON, Jan. 09, 2026 (GLOBE NEWSWIRE) -- MapLight Therapeutics, Inc. (MapLight) (Nasdaq: MPLT) today announced an update to the expected timing of topline results for its ongoing Phase 2 ZEPHYR and IRIS clinical studies, which are progressing ahead of schedule. The company’s Phase 2 ZEPHYR trial evaluating ML-007C-MA for the treatment of schizophrenia continues to enroll robustly, and topline results are now expected in the third quarter of 2026. The ZEPHYR study is a randomized, double-blind, placebo-controlled trial that is expected to enroll 300 hospitalized adult participants with schizophrenia experiencing acute exacerbation of psychosis. “The accelerated enrollment pace in the ZEPHYR trial allows us to narrow our timing guidance to the third quarter of 2026,” said Chris Kroeger, co-Founder and Chief Executive Officer of MapLight. “This momentum is testimony to our disciplined execution and commitment to advancing our programs efficiently while maintaining the highest quality standards.” In addition, following completion of enrollment in the Phase 2 IRIS trial for ML-004 in autism spectrum disorder, topline results for that study are now expected in the third quarter of 2026. The IRIS study is a double-blind, placebo-controlled trial that randomized approximately 160 adult and adolescent participants. About MapLight Therapeutics MapLight Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating central nervous system disorders. The company was founded by globally recognized leaders in psychiatry and neuroscience research to address the lack of circuit-specific pharmacotherapies available for patients. The company’s discovery platform holds the potential to fill this void by identifying neural circuits causally linked to disease and targeting those circuits for therapeutic modulation. For more information, please visit www.maplightrx.com. Forward Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including the company’s expectations regarding the potential benefits of its current and future product candidates and programs, plans for its current and future clinical trials, the anticipated timing of results from the company’s Phase 2 ZEPHYR and IRIS clinical trials...

Topline results from Phase 2 ZEPHYR trial of ML-007C-MA for schizophrenia expected in the second half of 2026 Topline results from Phase 2 VISTA trial of ML-007C-MA for Alzheimer’s disease psychosis expected in the second half of 2027 Raised $296.5 million in gross proceeds from initial public offering and concurrent private placement completed in October 2025 Cash, cash equivalents and short-term investments sufficient to fund operations through 2027 SAN FRANCISCO and BOSTON, Dec. 04, 2025 (GLOBE NEWSWIRE) -- MapLight Therapeutics, Inc. (Nasdaq: MPLT), a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating central nervous system disorders, today reported financial results for the third quarter of 2025 and highlighted recent progress and upcoming milestones. “2025 was a year of exceptional execution and acceleration for MapLight,” said Chris Kroeger, Chief Executive Officer of MapLight Therapeutics. “In the last year, we have made noteworthy progress across our entire product candidate portfolio, including the initiation of the Phase 2 ZEPHYR and VISTA studies for ML-007C-MA, completion of enrollment in our Phase 2 IRIS study of ML-004 and advancement of our preclinical programs. With a strengthened balance sheet following our recent public offering, we are in a strong financial position to continue this momentum to advance our broad and diversified pipeline of potentially best-in-class therapies for CNS disorders.” Business Highlights and Upcoming Milestones The Company continued to make significant progress across its pipeline of novel drug candidates with potential to address a breadth of debilitating CNS disorders. ML-007C-MA (M1/M4 Muscarinic Agonist) for the Treatment of Schizophrenia and Alzheimer’s Disease Psychosis (ADP): Topline results from Phase 2 ZEPHYR trial for schizophrenia expected in the second half of 2026. ZEPHYR is a randomized, double-blind, placebo-controlled, three-arm trial evaluating once- and twice-daily doses of ML-007C-MA for the treatment of hospitalized adult participants with schizophrenia experiencing an acute exacerbation of psychosis. The Company expects to enroll 300 participants in the trial, and the primary endpoint is the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 5. Topline results from Phase 2 VISTA trial for ADP e...