Cempra (CEMP): Two Key Upcoming Catalysts - Needham
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Needham & Company analyst, Alan Carr, reiterated his Buy rating on shares of Cempra, Inc. (NASDAQ: CEMP) ahead of the FDA Advisory Committee (AdCom) meeting scheduled for 11/4/16 where the Solithera NDA will be reviewed.
Cempra announced positive efficacy results from two Phase 3 trials (SOLITAIRE-Oral and SOLITAIRE-IV) in Community Pneumonia (CABP) in 2015. The analyst is expecting a positive vote, followed by approval on the 12/27/16 PDUFA date.
Structural similarities to another macrolide derivatives (Telithromycin/ Ketek) have prompted concerns around Solithera safety. However, the analyst believes issues have been adequately addressed and the overall profile is acceptable for the FDA.
No change to the price target of $48.
Shares of Cempra, Inc. closed at $23.97 yesterday.
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Create E-mail Alert Related CategoriesAnalyst Comments, FDA
Related EntitiesNeedham & Company, PDUFA, Alan Carr, AdCom
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