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April 2, 2014
08:34 EDTTTPHTetraphase awarded Fast Track status by FDA for IV, oral eravacycline
Tetraphase Pharmaceuticals announced that the U.S. Food & Drug Administration has granted Fast Track designations for both the intravenous and oral formulations of the company’s lead antibiotic candidate, eravacycline. Tetraphase is investigating the safety and efficacy of eravacycline in its ongoing Phase 3 global clinical program; the IGNITE 1 study is evaluating the IV formulation of eravacycline for the treatment of complicated intra-abdominal infections; IGNITE 2 is evaluating eravacycline IV-to-oral step-down therapy for the treatment of complicated urinary tract infections. Fast Track designation is awarded to expedite the study and regulatory review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Eravacycline became eligible for Fast Track status as a result of being designated a Qualified Infectious Disease Product; the QIDP designation also makes eravacycline eligible for priority review and an additional five years of U.S. market exclusivity, if approved. These incentives are part of the Generating Antibiotic Incentives Now Act, which was enacted in July 2012 as part of the FDA Safety and Innovation Act and was part of the fifth authorization of the Prescription Drug User Fee Act.
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November 19, 2015
10:00 EDTTTPHOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Dick's Sporting (DKS) upgraded to Buy from Neutral at Monness Crespi... Fairchild (FCS) upgraded to Neutral from Underperform at Credit Suisse... Fiesta Restaurant (FRGI) upgraded to Strong Buy from Outperform at Raymond James... General Dynamics (GD) upgraded to Buy from Hold at Argus... Genomic Health (GHDX) upgraded to Outperform from Market Perform at Cowen... National Grid (NGG) upgraded to Outperform from Sector Perform at RBC Capital... ON Semiconductor (ON) upgraded to Buy from Neutral at Citi... Papa John's (PZZA) upgraded to Buy from Neutral at Sidoti... QEP Resources (QEP) upgraded to Buy from Neutral at Goldman... Seagate (STX) upgraded to Buy on selloff, dividend yield at Craig-Hallum... Sunoco (SUN) upgraded to Outperform at Credit Suisse... Tetraphase (TTPH) upgraded to Buy from Neutral at SunTrust... Wendy's (WEN) upgraded to Conviction Buy from Neutral at Goldman.
06:30 EDTTTPHTetraphase upgraded to Buy from Neutral at SunTrust
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