Cubist Pharma (CBST) SIVEXTRO Approval Outlook Improves; Aegis Maintains 'Buy' Rating

Aegis Capital reaffirmed its Buy rating and $85 price target on Cubist Pharmaceuticals (Nasdaq: CBST) following the FDA's Anti-Infective Drugs Advisory Committee (AIDAC) voting unanimously (14-0) on Monday that substantial evidence of the safety and efficacy of SIVEXTRO (tedizolid phosphate) in treatment of acute bacterial skin and skin structure infections (ABSSSIs) was demonstrated.

Analyst Ram Selvaraju commented, In our view, the drug now has an extremely high likelihood of approval. Since it would only be the second oxazolidinone antibiotic to reach the U.S. market after Zyvox (linezolid), marketed by Pfizer Inc. (NYSE: PFE), we believe that SIVEXTRO could be an important future revenue driver for Cubist and may play a key role in enabling the firm to weather the expiration of patent protection on Cubicin (daptomycin). Cubist has also filed for approval of tedizolid phosphate in Europe, where a decision is expected in early 2015.

Cubist is also planning in the coming months to file a New Drug Application (NDA) for CXA-201 (ceftolozane / tazobactam) in the U.S. CXA-201 and tedizolid could enable Cubist to provide a comprehensive treatment solution for both Gram-positive and Gram-negative lung infections. Cubist is also aiming to re-launch DIFICID (fidaxomicin) in the U.S. in 2014, and received approval of a supplemental NDA (sNDA) for Entereg (alvimopan) for accelerating time to upper and lower GI tract recovery after bowel surgery, Selvaraju noted.

For an analyst ratings summary and ratings history on Cubist Pharma, click here. For more ratings news on the stock, click here.

Cubist Pharma closed at $73.15 yesterday.

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