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OFFON

GILEAD SCIENCES, INC.

(GILD)
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Gilead Says FDA Approves Expanded Indication of Biktarvy for Treatment of HIV-1 in Pediatric Populations

10/18/2021 | 06:07am EST

By Michael Dabaie

Gilead Sciences Inc. said the U.S. Food and Drug Administration approved an expanded indication of its Biktarvy for treatment of HIV-1 in pediatric populations.

Gilead said the FDA approved a new low-dose tablet dosage form of Biktarvy for pediatric patients weighing at least 14 kilograms to less than 25 kg who are virologically suppressed or new to antiretroviral therapy.

The approval expands the indication for Biktarvy to include younger children living with HIV-1 infection and will help to close the gap between HIV treatment options available for adults and children, the company said.

The new approval of Biktarvy is based on data from cohort three of a Phase 2/3 open-label, single-arm study which found Biktarvy low-dose tablets to be effective and generally well-tolerated through 24 weeks in virologically suppressed children living with HIV-1.

"Children living with HIV are in need of effective and accessible formulations of antiretroviral therapy," said Chief Medical Officer Merdad Parsey. "To address this unmet need, innovations in pediatric formulations must strive towards expanding treatment options for children."

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

10-18-21 0807ET

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Financials (USD)
Sales 2021 26 515 M - -
Net income 2021 7 187 M - -
Net Debt 2021 22 390 M - -
P/E ratio 2021 12,0x
Yield 2021 4,11%
Capitalization 86 465 M 86 465 M -
EV / Sales 2021 4,11x
EV / Sales 2022 4,30x
Nbr of Employees 13 600
Free-Float 99,9%
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Number of Analysts 27
Last Close Price 68,93 $
Average target price 75,95 $
Spread / Average Target 10,2%
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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
Brett A. Pletcher Secretary, Chief Compliance Officer & Executive VP
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