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TRVN

Trevena

$1.22

0.175 (16.83%)

13:44
11/02/18
11/02
13:44
11/02/18
13:44

Trevena reports Complete Response Letter for oliceridine from FDA

Trevena announced the company has received a Complete Response Letter, or CRL, from the U.S. Food and Drug Administration regarding the New Drug Application for oliceridine. Consistent with the discussion at the recent Advisory Committee meeting, FDA has requested additional clinical data on QT prolongation and indicated that the submitted safety database is not of adequate size for the proposed dosing. FDA also requested certain additional nonclinical data and validation reports. "While we are disappointed with FDA's decision, we continue to believe in the strength of the data and the ultimate approvability of oliceridine. We plan to schedule a follow-up meeting with FDA as soon as possible with the goal of bringing this important medicine to clinicians and hospital patients," said CEO Carrie Bourdow. "Developing a novel chemical entity is complex, and we believe the data we have to support oliceridine advances the pharmacology of acute pain therapeutics. We were encouraged by the discussion at the Advisory Committee meeting and look forward to continuing a productive dialogue with FDA," said Mark A. Demitrack, M.D., SVP and Chief Medical Officer.

  • 02

    Nov

TRVN Trevena
$1.22

0.175 (16.83%)

10/12/18
HCWC
10/12/18
NO CHANGE
Target $3
HCWC
Buy
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.
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.
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
NEED
10/12/18
DOWNGRADE
NEED
Hold
Trevena downgraded to Hold from Buy at Needham

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RTN

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