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TRVN

Trevena

$0.87

-0.0727 (-7.74%)

12:28
10/12/18
10/12
12:28
10/12/18
12:28

H.C. Wainwright says FDA nod for Trevena's oliceridine unlikely, but possible

H.C. Wainwright analyst Ed Arce said he does not believe the FDA's approval decision about Trevena's oliceridine is "a foregone conclusion" following yesterday's advisory committee meeting given the mixed vote on approvability. After the vote, at least three panelists who voted "no" said that they struggled with their decision and could have easily voted "yes," according to Arce, who said there is a possibility, "however unlikely," that the FDA could still approve the drug. While he views the November 2 decision as "too hard to call" and keeps a Buy rating on Trevena shares, Arce lowered his price target on the stock to $3 from $7.

  • 02

    Nov

TRVN Trevena
$0.87

-0.0727 (-7.74%)

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.
10/12/18
NEED
10/12/18
DOWNGRADE
NEED
Hold
Trevena downgraded to Hold from Buy at Needham
10/12/18
NEED
10/12/18
DOWNGRADE
NEED
Hold
Trevena downgraded to Hold at Needham on oliceridine recommendation
As reported earlier, Needham analyst Alan Carr downgraded Trevena to Hold after the FDA's Administration Anesthetic and Analgesic Drug Products Advisory Committee, or AADPAC, voted 7-8 against the approval of oliceridine use in acute pain management. The analyst notes that documents from the FDA released this week also showed some reluctance in the drug's overall profile, and combined with this latest AADPAC decision, render the approval of oliceridine as improbable. Carr adds that Trevena will likely face challenges obtaining financial resources to support commercial launch even if oliceridine was approved next month, noting that he now awaits the official FDA decision and discussion of development for Trevena's other pipeline programs.
10/12/18
JMPS
10/12/18
NO CHANGE
Target $4
JMPS
Outperform
Trevena price target lowered to $4 from $15 at JMP Securities
JMP Securities analyst Jason Butler said the mixed Advisory Committee vote on Trevena's application for oliceridine is likely to result in an approval delay, but he has not given up on the potential for issues raised by the panel to be addressed with label modifications and post-marketing studies. He now assume the company receiving a CRL as his base case scenario, which would result in an 18-month delay to approval. Butler, who cut his probability of approval for oliceridine to 70% from 90% and lowered his peak sales estimate, reduced his price target on Trevena shares to $4 from $15 but keeps an Outperform rating on the stock.

TODAY'S FREE FLY STORIES

FSFG

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MSFT

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INFU

InfuSystem

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KALU

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ALDR

Alder Biopharmaceuticals

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RF

Regions Financial

$16.24

-0.01 (-0.06%)

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HL

Hecla Mining

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BMY

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, CELG

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TEN

Tenneco

$36.29

0.76 (2.14%)

16:48
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Earnings
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TEN

Tenneco

$36.29

0.76 (2.14%)

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Earnings
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XRX

Xerox

$31.50

0.16 (0.51%)

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TWTR

Twitter

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ALLY

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DAL

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REN

Resolute Energy

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ORI

Old Republic

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VIX

Volatility Index S&P 500 Options

$0.00

(0.00%)

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$NSD

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EFC

Ellington Financial

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