Shares in Solvonis Therapeutics PLC rose 15% after the company confirmed that the US Food and Drug Administration (FDA) supports AWKN-002 progression directly to phase IIb clinical trials without additional data.
AWKN-002, an oral thin film of esketamine combined with structured alcohol education, is being developed to treat alcohol use disorder.
The FDA also approved the use of the 505(b)(2) pathway, allowing existing data from other esketamine products to streamline development and accelerate market access.
CEO Anthony Tennyson called the FDA’s feedback a “significant milestone” for Awakn Life Sciences, the Canadian company behind AWKN-002, which Solvonis is set to acquire in the first half of this year.
In opening deals, the stock was up 0.029p at 0.22p.