Nektar Rises on FDA Notification (revised) - Analyst Blog
March 27 2014 - 2:50PM
Zacks
Nektar Therapeutics’ (NKTR) shares gained more
than 9% on Mar 18, after the U.S. Food and Drug Administration
(FDA) notified the company and its partner
AstraZeneca (AZN) that the Anesthetic and
Analgesic Drug Products Advisory Committee meeting on mu-opioid
antagonists, including naloxegol, is tentatively scheduled for Jun
11-12, 2014.
Naloxegol is being developed for the treatment of opioid-induced
constipation. If approved, naloxegol would be the first once-daily
oral treatment for patients with chronic OIC.
The advisory board meeting was originally scheduled on Mar 10-11,
2014, but had to be rescheduled due to some conflicts. The agenda
of the meeting will be to discuss the cardiovascular safety and
potential additional safety study requirements of the mu-opioid
antagonists.
As per a 2009 agreement, AstraZeneca was granted worldwide and
exclusive rights to develop, market and sell naloxegol and
naloxegol fixed-dose combination program. We note that naloxegol is
under review in the U.S. for the treatment of opioid induced
constipation. A final decision on the approval of the candidate is
expected by Sep 16, 2014. Naloxegol is also under review in the EU
and Canada for the same indication.
Upon approval and launch of naloxegol, Nektar is entitled to up to
$175 million in milestones from AstraZeneca. If naloxegol is
approved without the need for a significant additional safety
study, Nektar will receive $35 million. The company will receive
$100 million in the U.S. upon launch, and $40 million upon launch
in Europe.
Nektar currently carries a Zacks Rank #3 (Hold). Some better-ranked
stocks in the same sector include Alexion
Pharmaceuticals (ALXN) with a Zacks Rank #1 (Strong
Buy).
(We are reissuing this article to correct a mistake. The
original article, issued Wednesday, March 19, 2014, should no
longer be relied upon.)
ALEXION PHARMA (ALXN): Free Stock Analysis Report
ASTRAZENECA PLC (AZN): Free Stock Analysis Report
NEKTAR THERAP (NKTR): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research
Nektar Therapeutics (NASDAQ:NKTR)
Historical Stock Chart
From Mar 2024 to Apr 2024
Nektar Therapeutics (NASDAQ:NKTR)
Historical Stock Chart
From Apr 2023 to Apr 2024