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TRVN

Trevena

$0.94

(0.00%)

17:06
10/11/18
10/11
17:06
10/11/18
17:06

Trevena announces negative outcome of AADPAC meeting on oliceridine

Trevena announced the outcome of the meeting of the U.S. Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee, or AADPAC to review and discuss oliceridine. At the meeting, the Advisory Committee voted 8 against, and 7 in favor of, the approval of oliceridine for the management of moderate to severe acute pain in adult patients for whom an intravenous opioid is warranted. The Advisory Committee reviewed data from oliceridine's full clinical development program with a focus on the Phase 3 APOLLO 1 and APOLLO 2 efficacy studies, as well as the Phase 3 ATHENA open-label safety study that was intended to emulate real world use of oliceridine in a broad spectrum of surgical and medical acute pain conditions. In controlled clinical trials, oliceridine demonstrated efficacy compared to placebo along with a safety and tolerability profile consistent with the class. Trevena's New Drug Application submission for oliceridine was accepted for review by the FDA on January 2, 2018 with a Prescription Drug User Fee Act target date for completion of review by the FDA of November 2, 2018. The FDA is not bound by the Advisory Committee's recommendations but takes its advice into consideration when making its decision.

  • 11

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    Nov

TRVN Trevena
$0.94

(0.00%)

10/10/18
JEFF
10/10/18
DOWNGRADE
Target $1
JEFF
Hold
Trevena downgraded to Hold from Buy at Jefferies
Jefferies analyst Biren Amin downgraded Trevena to Hold and cut his price target for the shares to $1 from $10. The FDA has an unfavorable view on both efficacy and safety profile of the company's oliceridine versus morphine, Amin tells investors in a research following yesterday's briefing documents. More critically, the documents make clear that Trevena failed to heed critical FDA advice in its Phase III trial design, the analyst adds. He sees no clear path forward for oliceridine.
03/08/18
HCWC
03/08/18
NO CHANGE
Target $7
HCWC
Buy
Trevena price target raised to $7 from $5 at H.C. Wainwright
H.C. Wainwright analyst Ed Arce raised his price target for Trevena to $7 amid the "countdown to critical near-term value inflection points." The analyst notes the FDA action date for Olinvo in moderate to severe acute pain is November 2, 2018. He reaffirms a Buy rating on the shares.
10/16/17
LEHM
10/16/17
DOWNGRADE
Target $2.5
LEHM
Equal Weight
Trevena downgraded to Equal Weight from Overweight at Barclays
Barclays analyst Douglas Tsao downgraded Trevena to Equal Weight and cut his price target for the shares to $2.50 from $15. The analyst says the downgrade reflects uncertainty in the commercial outlook for Olinvo. He sees a financing overhang and limited catalysts for the shares.
10/13/17
OPCO
10/13/17
NO CHANGE
Target $5
OPCO
Outperform
Trevena selloff yesterday likely overdone, says Oppenheimer
Oppenheimer analyst Derek Archila views Trevena's restructuring plan as a "smart move" with the company needing to conserve cash for an Olinvo approval/launch in the second half of 2018. The analyst continues to believe Olinvo for post-surgical pain will find its "niche" as a treatment for patients at high risk of opioid related adverse events. He views yesterday's 15% pullback as likely overdone and keeps an Outperform rating on Trevena. The analyst, though, cut his price target for the shares to $5 from $8.

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WIN

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AMGN

Amgen

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CE

Celanese

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WIN

Windstream

$3.37

0.2 (6.31%)

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Uniti Group

$20.00

0.53 (2.72%)

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GLD

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MDLZ

Mondelez

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FN

Fabrinet

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UBER

Uber

$0.00

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SPX

S&P 500

$0.00

(0.00%)

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$277.40

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S&P 500

$0.00

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SPY

SPDR S&P 500 ETF Trust

$277.40

2.93 (1.07%)

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ORCL

Oracle

$51.71

0.25 (0.49%)

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