GILEAD SCIENCES, INC.

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Gilead Sciences, Inc. - Investigational Lenacapavir Receives Positive CHMP Opinion for People With Multi-Drug Resistant HIV

06/27/2022 | 10:43am EDT

FOSTER CITY, Calif. - Gilead Sciences, Inc. (Nasdaq: GILD) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for investigational lenacapavir for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

The CHMP positive opinion is a scientific recommendation to the European Commission (EC) to grant marketing authorization in Europe and will be reviewed by the EC, which has the authority to authorize medicines in the 27 Member States of the European Union, as well as Norway, Iceland and Liechtenstein. The final European Commission decision is expected later this year.

'Treatment options are extremely limited for people living with HIV whose virus is no longer effectively controlled by their current regimen. We are encouraged by this CHMP positive opinion for lenacapavir, as it is an important step toward a potential new treatment option for individuals with multi-drug resistant HIV,' said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. 'We look forward to the final decision by the European Commission and the potential for lenacapavir to help fill a critical unmet need for persons living with HIV with complex prior treatment histories.'

The positive opinion is supported by data from the Phase 2/3 CAPELLA trial, a double-blinded, placebo-controlled global multicenter study designed to evaluate 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. In this patient population of high unmet medical need, 81% (n=29/36) of participants receiving lenacapavir in addition to an optimized background regimen achieved an undetectable viral load (

(C) 2022 Electronic News Publishing, source ENP Newswire

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Financials (USD)
Sales 2022 25 126 M - -
Net income 2022 3 912 M - -
Net Debt 2022 15 612 M - -
P/E ratio 2022 19,5x
Yield 2022 4,73%
Capitalization 77 266 M 77 266 M -
EV / Sales 2022 3,70x
EV / Sales 2023 3,68x
Nbr of Employees 14 400
Free-Float 99,9%
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Number of Analysts 29
Last Close Price 61,60 $
Average target price 70,35 $
Spread / Average Target 14,2%
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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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