MapLight to Announce Schizophrenia Trial Findings in Second Half of 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 04 2025
0mins
Should l Buy MPLT?
Source: NASDAQ.COM
Financial Results: MapLight Therapeutics reported a net loss of $29.4 million in Q3 2025, an increase from $19.0 million in the same quarter last year, with R&D expenses rising to $27.1 million due to higher clinical trial costs.
Pipeline Progress: The company is advancing several drug candidates, including ML-007C-MA for schizophrenia and Alzheimer's disease psychosis, with Phase 2 trial results expected in 2026 and 2027, respectively.
Upcoming Studies: ML-004 for autism spectrum disorder has completed enrollment in its Phase 2 study, with results anticipated in late 2026, while ML-021 for Parkinson's disease is set for IND-enabling studies completion in the same timeframe.
Stock Performance: Following the financial report, MPLT shares surged 31% to close at $16.92, with the stock trading between $12.24 and $20.86 over the past year.
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Analyst Views on MPLT
Wall Street analysts forecast MPLT stock price to rise
4 Analyst Rating
4 Buy
0 Hold
0 Sell
Strong Buy
Current: 17.220
Low
28.00
Averages
31.00
High
34.00
Current: 17.220
Low
28.00
Averages
31.00
High
34.00
About MPLT
MapLight Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on improving the lives of patients suffering from debilitating central nervous system disorders (CNS). Its lead product candidate, ML-007C-MA, is a fixed-dose combination of an M1/M4 muscarinic agonist, ML-007, co-formulated with a peripherally acting anticholinergic (PAC), which it is initially developing for the treatment of schizophrenia and Alzheimer’s disease psychosis (ADP). ML-007C-MA is designed to activate both M1 and M4 muscarinic receptors in the CNS to drive efficacy, while synchronizing the pharmacokinetics of the agonist and antagonist components to mitigate peripheral cholinergic side effects. Its second product candidate, ML-004, is a 5-HT1B/1D agonist that the Company is developing for the treatment of social communication deficit and/or irritability in autism spectrum disorder. It is also advancing two preclinical programs, ML-021 and ML-009.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Strategic Partnership Support: Aktis disclosed a $100 million investment from partner Eli Lilly, which will provide robust support for the company's R&D and market expansion, further strengthening its position in the competitive biotech landscape.
- Optimistic Market Outlook: As the first major biotech IPO of 2026, Aktis's success could attract more investor attention to the biotech sector, potentially driving recovery and growth across the industry.
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MapLight Accelerates Phase 2 Trial Timelines for Schizophrenia and Autism Studies
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- IRIS Trial Update: The IRIS trial has completed enrollment, with topline results for approximately 160 autism patients also anticipated in Q3 2026, further enhancing the company's research capabilities in central nervous system disorders.
- Strategic Commitment: CEO Chris Kroeger emphasized that the rapid enrollment pace not only narrows timing guidance but also demonstrates the company's commitment to advancing its programs, potentially boosting investor confidence and attracting more funding support.
- Market Potential: With a focus on developing drugs for mental health disorders, MapLight is positioned to fill the market gap for specific therapies as clinical trials progress, driving future business growth.
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MapLight Therapeutics Receives FDA Fast Track Designation for ML-007C-MA in Alzheimer's Treatment
- Fast Track Designation: MapLight Therapeutics' ML-007C-MA has received FDA Fast Track designation, enabling more frequent interactions with the FDA, which may accelerate drug development and increase the likelihood of priority review.
- Clinical Trial Progress: In a Phase 1 study, ML-007C-MA demonstrated a favorable safety and tolerability profile in healthy elderly participants, with enrollment ongoing in the Phase 2 VISTA study, and topline results expected in the second half of 2027.
- Market Reaction: Despite the FDA designation, MapLight Therapeutics shares closed at $16.77 on Friday, down 4.5%, indicating cautious market sentiment regarding the drug's development progress.
- Strategic Implications: This designation not only enhances the market potential of ML-007C-MA but also supports the company's competitive position in the Alzheimer's treatment space, particularly in addressing unmet medical needs for patients.
See More
MapLight Receives FDA Fast Track Designation for ML-007C-MA in Alzheimer's Disease Psychosis
- Fast Track Designation: MapLight Therapeutics announced that its investigational drug ML-007C-MA has received FDA Fast Track designation for treating hallucinations and delusions associated with Alzheimer's disease psychosis, marking a significant milestone in addressing unmet medical needs.
- Clinical Trial Progress: ML-007C-MA demonstrated a favorable safety and tolerability profile in a Phase 1 trial and is currently undergoing a Phase 2 VISTA study, aiming to enroll 300 participants and report topline results in the second half of 2027, further advancing drug development.
- Market Demand: Alzheimer's disease psychosis affects approximately 40% of patients, with symptom occurrence increasing as the disease progresses; the development of ML-007C-MA could significantly improve the quality of life for this population and fill a critical market gap.
- Strategic Implications: This FDA designation not only enhances MapLight's competitiveness in the CNS field but may also expedite the drug's market entry, potentially leading to increased economic returns and market share growth for the company.
See More
MapLight Receives FDA Fast Track Designation for ML-007C-MA in Alzheimer's Disease Psychosis
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- Clinical Trial Progress: The Phase 1 trial of ML-007C-MA demonstrated a favorable safety and tolerability profile in healthy elderly participants, with the ongoing Phase 2 VISTA study aiming to enroll 300 participants and report topline results in the second half of 2027.
- Market Potential: Alzheimer's disease psychosis affects approximately 40% of patients, with increasing symptom incidence as the disease progresses, and the development of ML-007C-MA could significantly improve patient quality of life and slow cognitive decline.
- Strategic Implications: This FDA designation not only accelerates the drug development process but may also provide MapLight with more frequent interactions with the FDA, thereby expediting the approval process and enhancing the company's competitiveness in the biopharmaceutical sector.
See More
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- Funding Background: Since its inception, Aktis Oncology has raised approximately $346 million, including a $175 million Series B funding round in 2024, reflecting institutional investors' confidence in its potential to develop treatments for various solid tumors.
- Financial Performance: For the nine months ended September 30, Aktis Oncology reported a net loss of $48.6 million, up from $31.9 million a year earlier, while revenue surged from $0.6 million to $4.6 million, indicating rising market demand.
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- IPO Market Recovery: Aktis Oncology launched a $200 million IPO on Monday, indicating a resurgence in the biotech IPO market after a period of uneven performance, and is set to be the first significant IPO of 2026.
- Increased Financing Size: Just two days after the IPO launch, Aktis upsized the deal by 50%, which not only reflects growing investor confidence in its prospects but also indicates a rising interest in the biotech sector.
- Strategic Partnership Support: Aktis disclosed a $100 million investment from partner Eli Lilly, which will provide robust support for the company's R&D and market expansion, further strengthening its position in the competitive biotech landscape.
- Optimistic Market Outlook: As the first major biotech IPO of 2026, Aktis's success could attract more investor attention to the biotech sector, potentially driving recovery and growth across the industry.
See More
MapLight Accelerates Phase 2 Trial Timelines for Schizophrenia and Autism Studies
- Clinical Trial Progress: MapLight Therapeutics' ZEPHYR trial is accelerating enrollment, with topline results for 300 schizophrenia patients now expected in Q3 2026, showcasing the company's efficient execution under high-quality standards.
- IRIS Trial Update: The IRIS trial has completed enrollment, with topline results for approximately 160 autism patients also anticipated in Q3 2026, further enhancing the company's research capabilities in central nervous system disorders.
- Strategic Commitment: CEO Chris Kroeger emphasized that the rapid enrollment pace not only narrows timing guidance but also demonstrates the company's commitment to advancing its programs, potentially boosting investor confidence and attracting more funding support.
- Market Potential: With a focus on developing drugs for mental health disorders, MapLight is positioned to fill the market gap for specific therapies as clinical trials progress, driving future business growth.
See More
MapLight Therapeutics Receives FDA Fast Track Designation for ML-007C-MA in Alzheimer's Treatment
- Fast Track Designation: MapLight Therapeutics' ML-007C-MA has received FDA Fast Track designation, enabling more frequent interactions with the FDA, which may accelerate drug development and increase the likelihood of priority review.
- Clinical Trial Progress: In a Phase 1 study, ML-007C-MA demonstrated a favorable safety and tolerability profile in healthy elderly participants, with enrollment ongoing in the Phase 2 VISTA study, and topline results expected in the second half of 2027.
- Market Reaction: Despite the FDA designation, MapLight Therapeutics shares closed at $16.77 on Friday, down 4.5%, indicating cautious market sentiment regarding the drug's development progress.
- Strategic Implications: This designation not only enhances the market potential of ML-007C-MA but also supports the company's competitive position in the Alzheimer's treatment space, particularly in addressing unmet medical needs for patients.
See More
MapLight Receives FDA Fast Track Designation for ML-007C-MA in Alzheimer's Disease Psychosis
- Fast Track Designation: MapLight Therapeutics announced that its investigational drug ML-007C-MA has received FDA Fast Track designation for treating hallucinations and delusions associated with Alzheimer's disease psychosis, marking a significant milestone in addressing unmet medical needs.
- Clinical Trial Progress: ML-007C-MA demonstrated a favorable safety and tolerability profile in a Phase 1 trial and is currently undergoing a Phase 2 VISTA study, aiming to enroll 300 participants and report topline results in the second half of 2027, further advancing drug development.
- Market Demand: Alzheimer's disease psychosis affects approximately 40% of patients, with symptom occurrence increasing as the disease progresses; the development of ML-007C-MA could significantly improve the quality of life for this population and fill a critical market gap.
- Strategic Implications: This FDA designation not only enhances MapLight's competitiveness in the CNS field but may also expedite the drug's market entry, potentially leading to increased economic returns and market share growth for the company.
See More
MapLight Receives FDA Fast Track Designation for ML-007C-MA in Alzheimer's Disease Psychosis
- Fast Track Designation: MapLight Therapeutics' ML-007C-MA has received FDA Fast Track designation for treating hallucinations and delusions associated with Alzheimer's disease psychosis, marking a significant milestone in addressing unmet medical needs.
- Clinical Trial Progress: The Phase 1 trial of ML-007C-MA demonstrated a favorable safety and tolerability profile in healthy elderly participants, with the ongoing Phase 2 VISTA study aiming to enroll 300 participants and report topline results in the second half of 2027.
- Market Potential: Alzheimer's disease psychosis affects approximately 40% of patients, with increasing symptom incidence as the disease progresses, and the development of ML-007C-MA could significantly improve patient quality of life and slow cognitive decline.
- Strategic Implications: This FDA designation not only accelerates the drug development process but may also provide MapLight with more frequent interactions with the FDA, thereby expediting the approval process and enhancing the company's competitiveness in the biopharmaceutical sector.
See More
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- IPO Filing: Aktis Oncology filed for its initial public offering in the U.S. on Friday, signaling a rebound in biotech listings after a slowdown, as interest rates decline and capital inflows increase.
- Funding Background: Since its inception, Aktis Oncology has raised approximately $346 million, including a $175 million Series B funding round in 2024, reflecting institutional investors' confidence in its potential to develop treatments for various solid tumors.
- Financial Performance: For the nine months ended September 30, Aktis Oncology reported a net loss of $48.6 million, up from $31.9 million a year earlier, while revenue surged from $0.6 million to $4.6 million, indicating rising market demand.
- R&D Progress: The company's lead candidate, AKY-1189, is in early-stage studies, with preliminary data expected in the first quarter of 2027, focusing on treating multiple solid tumors, including advanced bladder cancer, breast cancer, and colorectal cancer.
See More
