MapLight Therapeutics Reports Phase 2 IRIS Trial Missed Primary Endpoint in Autism

Earnings
โดย Insider Monkey·Read original
Summary · why it matters

MapLight Therapeutics announced that its Phase 2 IRIS trial evaluating ML-004 in autism spectrum disorder did not meet its primary endpoint of improving social communication at Week 12. A prespecified analysis showed clinically meaningful improvements in irritability among adolescents with moderate or higher baseline irritability compared with placebo, and the treatment was generally well tolerated with mostly mild-to-moderate adverse events. Separately, Raymond James initiated coverage with a Strong Buy rating and a $46 price target, highlighting potential upside ahead of the Phase 2 ZEPHYR trial readout for ML-007C-MA expected by mid-August. The firm also noted MapLight's Alzheimer's disease psychosis program as a potential value driver.

Impact on stocks 3

Biotech & Genomic Medicine▼ · 2 stocks
Financials▲ · 1 stocks

Theme Impact 1

Related news

▲2

Novartis Acquires Full Rights to Sironax Brain Delivery Platform

Novartis agreed to acquire full rights to Sironax's proprietary brain delivery platform for neurological disease treatments. The deal gives Novartis control of Sironax's technology designed to transport therapeutics across the blood brain barrier, expanding its toolkit for research into central nervous system disorders where treatment options remain limited. Novartis is a large pharmaceuticals group with a CHF218.8 billion market cap that researches, develops, manufactures, distributes, markets, and sells medicines globally, so gaining access to differentiated delivery technology directly links into its existing focus on complex neurological treatments. The Sironax platform speaks to the same advanced-therapy thesis that underpins Cosentyx's CHMP progress and remibrutinib's Phase 3 data, as Novartis seeks to own hard-to-reach biology where rivals like Roche and Biogen also compete for neurologists' attention. The flip side is that every new modality adds complexity, and recent trial setbacks such as pelacarsen and del-desiran keep development risk front and center, with analysts flagging that stacking capital-intensive projects on top of share buybacks could stretch the balance sheet of a business already carrying a high level of debt.
NOVN.SW ▲
Biotech & Genomic Medicine ▲
Simply Wall St·2hRead more →
2

AbbVie Unveils New VRAYLAR Real-World and Pediatric Safety Data at Psych Congress 2026

AbbVie shared new real-world and pediatric safety data for VRAYLAR in major depressive disorder and bipolar I at Psych Congress 2026. The findings covered routine clinical practice settings, including patients with complex comorbidities and underserved groups, while the pediatric data added information on safety and use in younger patients with mood disorders. AbbVie, a research-focused biopharmaceutical group with a US$466.6b market cap, positions VRAYLAR within a broad portfolio targeting chronic conditions including complex psychiatric disorders. The company said the next concrete checkpoint will be how these data feed into prescribing and label use over the next year, particularly uptake of newly approved low dose VRAYLAR in pediatric and adjunctive MDD settings, trackable in reported prescription trends and segment sales through 2027.
ABBV ▲
Biotech & Genomic Medicine
Simply Wall St·2hRead more →

Teva Study Finds Providers Prioritize Drowsiness Risk When Choosing Tardive Dyskinesia Treatment for Older Patients

Teva Pharmaceuticals announced new data showing that healthcare providers prioritize drowsiness risk, the duration of available long-term response data and drug-drug interaction profile when selecting a VMAT2 inhibitor for tardive dyskinesia in patients aged 55 and older. In a discrete choice experiment, 489 healthcare providers ranked somnolence risk, accounting for 26.8% to 36.2% of decision-making weight, and short-term symptom improvement, at 24.4% to 29.5%, as their top priorities, followed by dose formulation at 16.7% to 20.2% and drug-drug interaction risk at 14.4% to 17.3%. Applying those preferences across four patient profiles, AUSTEDO, also known as deutetrabenazine, had the highest predicted choice probability, driven mainly by somnolence risk, duration of long-term response data and drug-drug interaction. The findings were presented at Psych Congress, held September 15 to 19, 2026, in New Orleans. A separate interim analysis from the IMPACT-TD Registry found that among patients with probable tardive dyskinesia who remained untreated with any VMAT2 inhibitor for 24 months, roughly 89% to 96% experienced at least a mild global impact and 60% to 74% experienced moderate-to-severe impact, while 55% to 69% reported stable or worsening severity with no evidence of spontaneous resolution.
TEVA
Aging Population Biotech & Genomic Medicine
GlobeNewswire·9hRead more →
© 2026 MarketDXNews