Trevena tumbles after opioid CRL

5 November 2018
2019_biotech_test_vial_discovery_big

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to US biopharma Trevena (Nasdaq: TRVN) in relation to the opioid painkiller, oliceridine.

Trevena, which closed 32% down on Friday and was a further 12% lower after an hour’s trading on Monday, was told in the letter that more data was needed for the FDA to consider approving the New Drug Application (NDA).

The company’s chief executive, Carrie Bourdow, said: “While we are disappointed with FDA’s decision, we continue to believe in the strength of the data and the ultimate approvability of oliceridine.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Biotechnology