Rare breakthrough for promising autism candidate

The pRED research base of Switzerland’s Roche (ROG: SIX) has scored an R&D win in the form of US Food and Drug Administration Breakthrough Therapy status for balovaptan for autism spectrum disorder (ASD).

The agency judged there to be enough data from the Phase II VANILLA trial to show the vasopressin 1a (V1a) receptor antagonist has promise in improving social interaction and communication in people with ASD.

The news may be unexpected as Roche has tended to lag behind its US-based subsidiary Genentech in terms of development productivity. It's also noteworthy for the therapeutic target - ASD remains an intractable disorder with no approved medications.