GILEAD SCIENCES, INC.

(GILD)
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Delayed Nasdaq  -  04:00 2022-08-17 pm EDT
66.02 USD   -0.47%
11:01aGilead Sciences Announces Collaboration With Morehouse School of Medicine and Xavier University of Louisiana College of Pharmacy to Address Inequities in HIV Care
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Gilead Resubmits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting HIV-1 Capsid Inhibitor

06/27/2022 | 04:30pm EDT

Gilead Sciences, Inc. announced the resubmission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection. Gilead resubmitted the NDA in response to the FDA Complete Response Letter (CRL) issued in February 2022, which cited Chemistry Manufacturing and Controls (CMC) issues relating to the compatibility of lenacapavir in borosilicate vials as the reason for the FDA action. The NDA resubmission contains comprehensive CMC data to support the compatibility of lenacapavir with an alternative vial type made from aluminosilicate glass. In addition, the NDA is supported by extensive pre-clinical and earlier clinical research data as well as data from the Phase 2/3 CAPELLA study, which evaluated the antiviral activity of lenacapavir administered every six months as a subcutaneous injection, in combination with other antiretroviral(s), in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. Once accepted by the FDA, a new Prescription Drug User Fee Act (PDUFA) date will be established. Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not established. There is no cure for HIV or AIDS.


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All news about GILEAD SCIENCES, INC.
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Financials (USD)
Sales 2022 25 182 M - -
Net income 2022 3 913 M - -
Net Debt 2022 16 314 M - -
P/E ratio 2022 20,8x
Yield 2022 4,42%
Capitalization 82 747 M 82 747 M -
EV / Sales 2022 3,93x
EV / Sales 2023 3,91x
Nbr of Employees 14 400
Free-Float 99,9%
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Mean consensus OUTPERFORM
Number of Analysts 29
Last Close Price 66,02 $
Average target price 70,57 $
Spread / Average Target 6,88%
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Managers and Directors
Daniel P. O'Day Chairman & Chief Executive Officer
Andrew D. Dickinson Chief Financial Officer
Merdad V. Parsey Chief Medical Officer
Flavius Martin Executive Vice President-Research
Kevin E. Lofton Lead Independent Director
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