Avanir Pharmaceuticals announced today that the FDA issued an approvable letter for Zenvia for involuntary emotional expression disorder but will require additional data before it can be formally approved. Avanir said that it would need to meet with the FDA to determine exactly what the agency is seeking, and even then isn't certain "that it will choose to continue with the development of Zenvia as previously planned." The San Diego-based biotech markets FazaClo for schizophrenia. Avanir stock plunged 40 percent on the news of the FDA's decision.
- here's the report on Avanir from TheStreet.com
- and here's the release on the FDA's letter