THRX Planning Rapid Response To FDA Requests On Vibativ NP SNDA

Cowen and Co. maintains their “Neutral” rating for Theravance, Inc. (NASDAQ: THRX) after Theravance received a "complete response" letter from the FDA for the sNDA seeking the nosocomial pneumonia (NP) indication for Vibativ (telavancin).

The Firm Said “Although the Vibativ NP pivotal trials (ATTAIN 1 & 2) used clinical response as the primary endpoint, mortality was a secondary safety endpoint, and management believes the pooled mortality data will be sufficient to gain FDA approval. Those data will be submitted within the next several weeks and the AIDAC could review the Vibativ sNDA in Q2:2010, leaving open the possibility for an H2:2010 approval and launch.”

It further added that “We project a slow adoption of Vibativ in the cSSSI indication, and with low visibility on FDA approval for Vibativ in the NP indication and limited near-term news flow on the Horizon program with GSK, we remain Neutral on THRX shares.”

Today shares of THRX trading at $12.76, down 2.82%.