MapLight Therapeutics Updates Expected Timing of Topline Results for Ongoing Phase 2 Studies to Q3 2026

Rhea-AI Summary

MapLight Therapeutics (Nasdaq: MPLT) updated timing for topline results from two Phase 2 studies to Q3 2026. The Phase 2 ZEPHYR trial of ML-007C-MA for schizophrenia is enrolling ahead of schedule and is expected to randomize 300 hospitalized adult participants with acute psychosis. The Phase 2 IRIS trial of ML-004 for autism spectrum disorder has completed enrollment and randomized approximately 160 adult and adolescent participants. Both trials are double-blind, placebo-controlled. Management said accelerated enrollment allowed the company to narrow timing guidance to the third quarter of 2026.

Positive

• ZEPHYR enrollment expected to reach 300 participants
• IRIS enrollment completed with ~160 participants
• Topline results for both Phase 2 trials now expected in Q3 2026

Negative

• None.

News Market Reaction

+4.83%

4 alerts

+4.83% News Effect

+$38M Valuation Impact

$820M Market Cap

0.2x Rel. Volume

On the day this news was published, MPLT gained 4.83%, reflecting a moderate positive market reaction. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $38M to the company's valuation, bringing the market cap to $820M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

ZEPHYR sample size: 300 participants IRIS sample size: 160 participants VISTA sample size: 300 participants +5 more

8 metrics

ZEPHYR sample size 300 participants Phase 2 schizophrenia trial ML-007C-MA

IRIS sample size 160 participants Phase 2 ML-004 trial in autism spectrum disorder

VISTA sample size 300 participants Planned Phase 2 VISTA study in AD psychosis

Milestone potential $200 million SandboxAQ collaboration milestones

IPO shares 16,962,500 shares Initial public offering including overallotment

IPO price $17.00 per share IPO offering price on Nasdaq

Cash balance $227.2 million Quarter end cash, cash equivalents and short-term investments

Price change 7.04% 24h move before this Phase 2 timing update

Market Reality Check

Price: $17.00 Vol: Volume 112,568 vs 20-day ...

low vol

$17.00 Last Close

Volume Volume 112,568 vs 20-day average 361,867 (relative volume 0.31). low

Technical Price $17.19 is trading above 200-day MA at $16.76 before this update.

Peers on Argus

No peers in the provided universe showed momentum flags; recent move in MPLT app...

No peers in the provided universe showed momentum flags; recent move in MPLT appears stock-specific based on available data.

Historical Context

4 past events · Latest: Jan 05 (Positive)

Pattern 4 events

Date	Event	Sentiment	Move	Catalyst
Jan 05	Regulatory milestone	Positive	+2.7%	Fast Track designation for ML-007C-MA in Alzheimer’s disease psychosis.
Dec 16	Strategic partnership	Positive	-3.5%	SandboxAQ collaboration with up to $200M potential milestones.
Dec 04	Earnings and pipeline	Positive	+7.7%	Q3 2025 results with strong cash and multiple Phase 2 timelines.
Oct 29	IPO completion	Neutral	-1.2%	Completion of IPO and overallotment at $17.00 per share.

Pattern Detected

Clinical and regulatory milestones have generally seen positive or mixed price reactions, with one notable divergence on a partnership headline.

Recent Company History

Over the last few months, MapLight reported several key milestones. An IPO on Oct 29, 2025 raised capital at $17.00 per share, followed by Q3 2025 results highlighting $227.2 million in cash and topline Phase 2 readouts targeted through 2027. A strategic collaboration with SandboxAQ added potential milestones up to $200 million. Most recently, Fast Track designation for ML-007C-MA on Jan 5, 2026 supported the development path. Today’s Phase 2 timing update fits this ongoing clinical execution narrative.

Market Pulse Summary

This announcement narrows expected topline timing for the ZEPHYR and IRIS Phase 2 studies to Q3 2026...

Analysis

This announcement narrows expected topline timing for the ZEPHYR and IRIS Phase 2 studies to Q3 2026, indicating faster-than-anticipated progress and completed enrollment for IRIS. It builds on prior disclosures of Phase 2 plans across multiple CNS indications and a solid cash position through 2027. Investors may focus on enrollment quality, consistency across ZEPHYR, IRIS, and VISTA, and future updates on safety and efficacy once topline data become available.

Key Terms

phase 2, randomized, double-blind, placebo-controlled

4 terms

phase 2 medical

"expected timing of topline results for its ongoing Phase 2 ZEPHYR and IRIS clinical studies"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

randomized medical

"The ZEPHYR study is a randomized, double-blind, placebo-controlled trial"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

double-blind medical

"The ZEPHYR study is a randomized, double-blind, placebo-controlled trial"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"The ZEPHYR study is a randomized, double-blind, placebo-controlled trial"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

AI-generated analysis. Not financial advice.

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 and enrollment in the ZEPHYR trial. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, are intended to identify forward-looking statements. While the company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in the company’s filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility; expectations regarding the initiation, progress, and expected results of the company’s preclinical studies, clinical trials and research and development programs; the unpredictable relationship between preclinical study results and clinical study results; the risk that results obtained in any clinical trials to date may not be indicative of results obtained in ongoing or future trials; the timing or likelihood of regulatory filings and approvals; expectations regarding the company’s ability to fund its current operations; and other risks and uncertainties identified in the company’s Quarterly Report on Form 10-Q filed with the SEC on December 4, 2025, and subsequent disclosure documents the company may file with the SEC. The company claims the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The company expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

For investor inquiries: investors@maplightrx.com

For media inquiries: media@maplightrx.com

FAQ

When will MapLight Therapeutics (MPLT) report topline results for ZEPHYR and IRIS?

Topline results for both Phase 2 ZEPHYR and IRIS studies are expected in Q3 2026.

What is the sample size and population for the MPLT ZEPHYR trial?

ZEPHYR is expected to enroll 300 hospitalized adult participants with schizophrenia experiencing acute exacerbation of psychosis.

Has enrollment finished for the MPLT IRIS trial and how many were randomized?

Enrollment in the IRIS trial has completed, with approximately 160 adult and adolescent participants randomized.

What drugs are being tested in MapLight's Phase 2 ZEPHYR and IRIS trials (MPLT)?

The ZEPHYR trial is testing ML-007C-MA for schizophrenia and the IRIS trial is testing ML-004 for autism spectrum disorder.

Are the ZEPHYR and IRIS trials randomized and blinded for MPLT?

Yes; both studies are described as double-blind, placebo-controlled randomized trials.