GlobeNewswire·Aug 28, 2026, 6:17 AM ET

Teva Announces Proposed Acquisition of a Novel Neuroscience Product Reinforcing Disciplined Business Development Approach Under Pivot to Growth Strategy

Teva Pharmaceuticals has entered an agreement to acquire the novel dexmedetomidine sublingual film BXCL501 (IGALMI) from BioXcel Therapeutics via a court-supervised auction process.
The asset is under FDA review for potential at-home outpatient use to treat acute agitation in adults with schizophrenia or bipolar I or II disorder, with a PDUFA target date of November 14, 2026.
If approved, BXCL501 could become the first FDA-approved at-home treatment for this condition, potentially reducing emergency department visits & hospitalizations.
Teva is acting as the "stalking horse bidder" with an upfront payment of $57.5 million & potential contingent payments up to $67.5 million tied to FDA approval timing & sales milestones.
The transaction remains subject to bankruptcy court approval, potential higher bids, & customary closing conditions, with Teva entitled to a break-up fee if not selected.
IGALMI is currently a prescription medicine administered under healthcare provider supervision, with safety & effectiveness not studied beyond 24 hours or in children.
Common side effects include sleepiness, dizziness, dry mouth, & low blood pressure, while serious risks involve heart rhythm changes & potential fainting.
The acquisition aligns with Teva's "Pivot to Growth" strategy to expand its neuroscience portfolio & address unmet needs in mental health treatment.