FDA delays review of Optinose's sNDA for Xhance

The US Food and Drug Administration (FDA) has extended by three months the review period of its supplemental new drug application (sNDA) requesting approval of Xhance (fluticasone propionate) as a treatment for chronic rhinosinusitis.

Making the announcement yesterday, the drug’s developer, USA-based ENT and allergy specialist Optinose (Nasdaq: OPTIN), saw its shares plunge 16.3% to $1.23 (having slid as much as 22%) on the news.

The company explained that, on November 15, as part of the ongoing sNDA review, the FDA requested that Optinose submit additional efficacy subset analyses of existing clinical data from one of the two trials submitted in the sNDA: ReOpen1. Optinose submitted the requested analyses on November 22.