Tetraphase Pharmaceuticals Inc TTPH announced Tuesday that the U.S. Food and Drug Administration accepted a New Drug Application for eravacycline, an antibiotic for complicated intra-abdominal infection, for priority review.
Traders initially reacted positively, and so did analysts.
The Rating
B Riley analyst Madhu Kumar reiterated a Buy rating on the stock with a $6 price target.
The Thesis
The NDA news is supportive of expectations for U.S. regulatory approval in the third quarter.
“We consider eravacycline receiving priority review a key positive, as the FDA gives this accelerated review process to drugs with the potential for ‘significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications,’” the analyst said in a Tuesday note.
That acknowledged superiority would position Tetraphase to seize market share.
Eravacycline posted successful results in both the IGNITE1 and IGNITE4 Phase 3 trials, and although it failed in IGNITE3 for complicated urinary tract infection, Kumar does not expect negative read across to the intra-abdominal infection prospects.
Price Action
Tetraphase shares were trading up 6.44 percent at $2.81.
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