---
title: "MapLight Therapeutics Autism Drug Shows Mixed Potential In Adolescents"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/290465697.md"
description: "MapLight Therapeutics reported mixed Phase 2 IRIS study results for autism drug ML-004. While the trial missed its primary endpoint in social communication, it showed clinically meaningful improvements in irritability among adolescents aged 12-17. The drug demonstrated a favorable safety profile with no serious adverse events. Consequently, MapLight's stock rose 5.52% to $30.41, as analysts believe these findings support further development in targeted populations."
datetime: "2026-06-22T17:26:38.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/290465697.md)
  - [en](https://longbridge.com/en/news/290465697.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/290465697.md)
---

# MapLight Therapeutics Autism Drug Shows Mixed Potential In Adolescents

**MapLight Therapeutics Inc.** (NASDAQ:MPLT) reported mixed topline results from its Phase 2 IRIS study of ML-004 in patients with autism spectrum disorder.

The trial missed the trial’s primary endpoint while demonstrating clinically meaningful improvements in irritability among a subgroup of adolescents.

**• MapLight Therapeutics stock is among today’s top performers. What’s fueling MPLT momentum?**

The findings, shared on Monday, could support further development of the drug in a more targeted patient population, reinforcing analysts’ views that ML-004 may still hold significant commercial potential.

## **Primary Endpoint Missed In Broad Autism Population**

The IRIS study enrolled 161 participants, including 102 adolescents and 59 adults, and was designed as an exploratory Phase 2 trial to assess multiple clinical outcomes and identify the most suitable development strategy for ML-004.

The study failed to achieve its primary endpoint, which measured changes from baseline through week 12 in caregiver-reported social communication scores using the Autism Behavioral Inventory Social Communication Domain.

MapLight noted that social communication remains an area without approved pharmacological treatments and that validated measures capable of detecting treatment-related changes continue to be actively studied.

**Read Also: MapLight's Psychosis Drug Could Deliver Billion-Dollar Upside, Says Analyst**

## **Adolescent Subgroup Demonstrates Strong Irritability Benefit**

Despite the primary endpoint miss, ML-004 produced encouraging results in a prespecified subgroup of adolescents ages 12 to 17 who entered the study with moderate or greater irritability.

Among these participants, ML-004 generated clinically meaningful improvements versus placebo on the Aberrant Behavior Checklist-Irritability subscale, with a least squares mean difference of negative 9.58 and an effect size of 1.33.

The company also reported favorable results on the Clinician Global Impression-Improvement irritability domain, where adolescents receiving ML-004 showed greater improvement than those receiving a placebo.

Treatment benefits appeared strongest among adolescents with the highest baseline irritability levels.

In the broader population of participants with elevated irritability scores, ML-004 achieved an effect size of 0.64 on a key secondary endpoint, although the result did not reach nominal statistical significance.

## **Safety Profile Remains Favorable**

MapLight said ML-004 was generally well tolerated, with all treatment-emergent adverse events classified as mild to moderate.

No serious or severe adverse events occurred among participants receiving ML-004. By comparison, placebo-treated participants experienced two severe treatment-emergent adverse events and one serious adverse event.

Investigators observed no extrapyramidal adverse events in patients receiving ML-004, while average weight gain during the study was lower in the treatment arm than in the placebo group.

**MPLT Stock Price Activity**: MapLight Therapeutics shares were up 5.52% at $30.41 at the time of publication on Monday, according to Benzinga Pro data.

_Image via Shutterstock/ tomertu_

**Read Also: India Races To Seal US Trade Deal Before Key Tariff Deadline, Eyes Preferential Rates: 'The Faster, The Better'**

### Related Stocks

- [MPLT.US](https://longbridge.com/en/quote/MPLT.US.md)

## Related News & Research

- [MapLight says Phase 2 ZEPHYR trial shows ML-007C-MA cuts PANSS score in schizophrenia](https://longbridge.com/en/news/293920685.md)
- [MapLight says Phase 2 IRIS trial of ML-004 in autism misses primary endpoint](https://longbridge.com/en/news/290424183.md)
- [James Michael Morrissey Expands Holdings With $54K Incyte Stock Options Acquisition](https://longbridge.com/en/news/294085325.md)
- [Fortress Biotech subsidiary Urica says Crystalys closes $130 million Series B financing](https://longbridge.com/en/news/293929289.md)
- [Incyte expects Opzelura to cross $1B in 2026](https://longbridge.com/en/news/294223769.md)