Cubist Pharmaceuticals, Inc. (CBST) said Monday that the U.S. Food and Drug Administration Anti-Infective Drugs Advisory Committee has voted to recommend approval of the company's investigational antibiotic Sivextro.
In the unanimous 14 - 0 decision, the Committee found that substantial evidence of the safety and effectiveness of Sivextro for the treatment of acute bacterial skin and skin structure infections was provided.
Sivextro is a once daily oxazolidinone being developed for both intravenous and oral administration for the treatment of serious infections caused by certain Gram-positive bacteria, including those caused by methicillin-resistant Staphylococcus aureus.
The company's New Drug Application submission to the FDA for Sivextro is based on positive data from two global Phase 3 clinical studies, which met the primary and secondary endpoints defined by the FDA and European Medicines Agency.
The Committee's recommendation is not binding on the FDA, but will help inform the FDA as it completes its Priority Review of the NDA for Sivextro, which has an assigned action date of June 20.
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May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.