Aeterna Zentaris leaps on planned growth hormone drug NDA
Canada-based Aeterna Zentaris’ (TSX: AEZS) saw its shares rise as much as 14% in pore-market trading today, after it announced that, following its meeting with the US Food and Drug Administration on March 29, 2017, the company intends to file a New Drug Application (NDA) seeking approval of Macrilen (macimorelin) for the evaluation of growth hormone deficiency in adults (AGHD).
In November 2014, Aeterna Zentaris received a Complete Response Letter from the FDA, saying the agency determined that the NDA cannot be approved in its present form.
Moreover, as recently as January this year, the biopharmaceutical group announced top-line results from a confirmatory trial of Macrilen, a synthetic small molecule and ghrelin agonist. The data showed macimorelin did not achieve equivalence to the insulin tolerance test (ITT) in the diagnosis of growth hormone deficiency in adults (AGHD).
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 accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- 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
More on this story...
Today's issue
Company Spotlight
More Features in Pharmaceutical
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze