Thursday, July 04, 2019 6:41:15 PM
Probably buyers of the news last week lost patience as well...Nanoflu has buyout potential...
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Novavax Up 17%; To Use Accelerated Approval Pathway for NanoFlu >NVAX
7:30 am ET June 27, 2019 (Dow Jones) Print
By Michael Dabaie
Novavax Inc. (NVAX) shares rose 17% to $6.48 premarket Thursday.
The late-stage biotechnology company said it will use the accelerated approval pathway for licensure for seasonal influenza vaccine candidate NanoFlu. The U.S. Food and Drug Administration said in a recent letter the accelerated approval pathway is available to Novavax for NanoFlu.
Novavax said it expects to initiate its pivotal Phase 3 clinical trial by the fall of 2019 with top-line clinical data expected in the first quarter of 2020.
Novavax also said Thursday that it is in an arrangement with Catalent Biologics' Paragon Gene Therapy unit for Paragon to assume the leases to two Novavax product development and manufacturing facilities.
Novavax said the arrangement significantly reduces its operating costs and provides a cash payment at closing of about $18 million.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
June 27, 2019 07:30 ET (11:30 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
Stingrays fall into two general categories, bottom feeders and swimmers...um hungry
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