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Trevena (TRVN) Down on Negative Phase IIb Data on TRV027

Shares of Trevena, Inc. TRVN dropped 7.3% after the company announced disappointing data from a phase IIb study (BLAST-AHF) on TRV027, which failed to meet either the primary or secondary endpoints. TRV027 was being evaluated for the treatment of patients with acute heart failure.

The randomized, double-blind, standard of care controlled study was evaluating TRV027 plus standard heart failure therapy, in comparison to placebo plus standard therapy, in patients (n=618) with acute heart failure. The primary objective of the study was to determine outcomes such as mortality, worsening heart failure, hospital readmission rate, dyspnea and length of hospital stay.

Results from the study will be presented at the annual congress of the Heart Failure Association of the European Society of Cardiology. Nevertheless, the company intends to continue analyzing data from the study to further understand the outcomes.

Meanwhile, Trevena plans to concentrate on its lead candidate, oliceridine, and early-stage candidates. Currently, oliceridine is being evaluated in a phase III open-label study (ATHENA-1) in patients with moderate-to-severe acute pain caused by medical conditions or surgery. The company expects to initiate phase III APOLLO studies (APOLLO-1 and APOLLO-2) in the second quarter of 2016. Top-line data from the studies are expected in the first quarter of 2017. The company also expects to file a New Drug Application (NDA) in the U.S. in the second half of 2017. Earlier this year, the FDA granted Breakthrough Therapy designation to oliceridine for the management of moderate-to-severe acute pain.

Early-stage candidates in the company’s pipeline include – TRV734 (phase I) for moderate-to-severe acute and chronic pain and TRV250 (preclinical) for acute episodic migraine and other central nervous system disorders.

Currently, Trevena has a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Bristol-Myers Squibb Company BMY, Retrophin, Inc. RTRX and ANI Pharmaceuticals, Inc. ANIP, each  sporting a Zacks Rank #1 (Strong Buy).

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