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TTPH

Tetraphase

$2.87

0.67 (30.45%)

08:07
02/27/18
02/27
08:07
02/27/18
08:07

Tetraphase announces FDA acceptance of NDA submission for Eravacycline

Tetraphase Pharmaceuticals announced that it has received notification from the U.S. Food and Drug Administration that the FDA has completed its initial 60-day review of the New Drug Application for eravacycline for the treatment of complicated intra-abdominal infections, and determined that the application is sufficiently complete to permit a substantive review. The PDUFA goal date for the completion of the FDA's review of the eravacycline NDA is set for August 28, 2018. This date reflects a priority 6-month review period. The NDA submission includes data from the IGNITE1 and IGNITE 4 phase 3 clinical trials, in which twice-daily IV eravacycline was well tolerated and achieved high clinical cure rates in patients with cIAI. Both studies demonstrated statistical non-inferiority of eravacycline to two widely used comparators - ertapenem in IGNITE1 and meropenem in IGNITE4 - for the primary efficacy endpoint of clinical response at the test-of-cure visit.

TTPH Tetraphase
$2.87

0.67 (30.45%)

02/14/18
STFL
02/14/18
NO CHANGE
Target $6
STFL
Buy
Tetraphase still has path forward for eravacycline, says Stifel
Stifel analyst Stephen Willey said the failure of Tetraphase's Phase 3 IGNITE3 trial in complicated urinary tract infection patients meaningfully alters the peak addressable market opportunity for eravacycline, decreases confidence in management's ability to successfully move earlier-stage pipeline assets to market, eliminates any longer-term optionality around a potentially-viable oral version and increases long-term financing concerns. With all of that said, he cut his price target on Tetraphase to $6 from $13, though he keeps a Buy rating on the stock, as he is still confident in the regulatory paths forward for eravacycline in complicated intra-abdominal infections. In pre-market trading, Tetraphase is down $2.68, or 49%, to $2.75 per share.
02/14/18
BMOC
02/14/18
DOWNGRADE
Target $2.75
BMOC
Market Perform
Tetraphase cut to Market Perform at BMO Capital after IGNITE3 Phase 3 trial fail
As reported earlier, BMO Capital analyst M. Ian Somaiya downgraded Tetraphase to Market Perform from Outperform and slashed his price target to $2.75 from $24. Somaiya points to the failure of the IGNITE3 Phase 3 trial on the company's lead drug, eravacycline, for complicated UTI, adding that the lack of insight into reasons for the trial's failure and more limited opportunity in cIAI could keep shares range bound.
02/14/18
BMOC
02/14/18
DOWNGRADE
BMOC
Market Perform
Tetraphase downgraded to Market Perform from Outperform at BMO Capital
02/14/18
PIPR
02/14/18
NO CHANGE
Target $8
PIPR
Overweight
Tetraphase price target lowered to $8 from $14 at Piper Jaffray
Piper Jaffray analyst Edward Tenthoff lowered his price target for Tetraphase Pharmaceuticals to $8 after the company's Phase III trial of intravenous eravacycline in complicated urinary tract infection failed to show non-inferiority to ertapenem on co-primary endpoints of response at the end-of-IV treatment and test-of-cure. The analyst, however, does not see read-through to eravacycline in complicated intra-abdominal infections and remain confident in U.S. and European approval. He maintains an Overweight rating on Tetraphase shares.

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Crispr Therapeutics

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CRSP

Crispr Therapeutics

$59.09

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STMicroelectronics

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EDIT

Editas Medicine

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-1.71 (-4.51%)

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EDIT

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NTLA

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