Key Highlights

  • Alkermes reported positive Phase 1b proof-of-concept data for ALKS 7290 in adults with ADHD.
  • The trial showed dose-dependent, clinically meaningful improvements in AISRS and CGI-S scores.
  • The drug showed generally favorable tolerability with no serious treatment-emergent adverse events.
  • ALKS 7290 is now being evaluated in an ongoing approximately 312-patient Phase 2 study, with data expected in 2027.

Alkermes plc (NASDAQ: ALKS) reported positive Phase 1b proof-of-concept data for ALKS 7290 in adults with ADHD, showing dose-dependent, clinically meaningful improvements in AISRS and CGI-S scores with generally favorable tolerability and no serious treatment-emergent adverse events.

Company Overview

Alkermes is a fully integrated biopharmaceutical company that develops and commercializes medicines for central nervous system diseases, including addiction, schizophrenia, and bipolar disorder. The company markets several approved products, including VIVITROL and LYBALVI, while also maintaining a Research and Development pipeline focused on new mechanisms for treating CNS conditions.

ALKS 7290 represents an expansion of Alkermes' CNS pipeline into ADHD, applying the company's expertise in orexin receptor biology; the compound is described as a first-in-class orexin 2 receptor agonist, a novel mechanism of action being investigated for its potential to address ADHD symptoms through pathways distinct from currently available stimulant and non-stimulant therapies.

What Happened

The first-in-class orexin 2 receptor agonist is now being evaluated in an ongoing approximately 312-patient Phase 2 study, with data expected in 2027, building directly on the positive Phase 1b proof-of-concept results.

Market Reaction

The disclosed information does not include stock price or trading data for Alkermes following the ALKS 7290 data release.

Outlook

The ongoing Phase 2 study for ALKS 7290, with data expected in 2027, represents the next major disclosed milestone for this program as Alkermes builds out its ADHD-focused pipeline.