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Name | Symbol | Market | Type |
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GSK plc | NYSE:GSK | NYSE | Depository Receipt |
Price Change | % Change | Price | High Price | Low Price | Open Price | Traded | Last Trade | |
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-0.25 | -0.62% | 39.76 | 40.005 | 39.675 | 39.97 | 811,050 | 15:34:26 |
By Colin Kellaher
ViiV Healthcare, the specialist HIV company majority owned by GlaxoSmithKline PLC, on Tuesday said the U.S. Food and Drug Administration granted priority review to its cabotegravir long-acting pre-exposure prophylaxis, or PrEP, therapy.
ViiV said cabotegravir, if approved, would be the first, long-acting therapy for the prevention of HIV for individuals at risk of sexually acquired HIV-1 infection who have a negative HIV-1 test prior to initiation.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period. ViiV said the agency set a target action date of Jan. 24, 2022, for the application.
ViiV, formed in November 2009, is majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi & Co. as shareholders. The company said it plans to initiate submissions of cabotegravir long-acting for PrEP to other regulatory authorities by the end of the year.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 28, 2021 07:57 ET (11:57 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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