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Biotech Stocks Facing FDA Decision In August

Tetraphase Pharmaceuticals
Tetraphase Pharmaceuticals

Tetraphase Pharmaceuticals Inc.’s (TTPH) New Drug Application for Eravacycline for the treatment of complicated intra-abdominal infections is under FDA review, with a decision expected on August 28, 2018.

In clinical trials, twice-daily IV Eravacycline was well tolerated and achieved high clinical cure rates in patients with complicated intra-abdominal infections.

The drug candidate also showed statistical non-inferiority to two widely used comparators – Merck’s Invanz (ertapenem) and AstraZeneca's Merrem (meropenem) - for the primary efficacy endpoint of clinical response at the test-of-cure (TOC) visit.

If approved, Stifel analysts expect IV Eravacycline to hit peak sales of $350 million.

TTPH closed Wednesday’s (Jul 25) trading at $2.87, down 4.01%.