Regulatory wobble unnerves Acadia backers

Stumbling 7% before the closing bell on Monday, shares in San Diego’s Acadia Pharmaceuticals (Nasdaq: ACAD) fell a further 38% in after-hours trading, following a regulatory setback.

The company has been told by the US Food and Drug Administration that there is a problem with its supplemental New Drug Application (sNDA) for pimavanserin, a selective serotonin inverse agonist and antagonist, in dementia-related psychosis.

The agency said it had “identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.”