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    ROG   CH0012032048

ROCHE HOLDING AG

(ROG)
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Delayed Swiss Exchange  -  11:30 2022-12-01 am EST
310.00 CHF   +0.71%
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Roche Announces U.S. FDA approval of Xofluza to treat influenza in children aged five years and older

08/12/2022 | 01:00am EST

Roche announced that the United States (U.S.) Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza® (baloxavir marboxil) for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours. This marks the first single-dose oral influenza medicine approved in the US for children in this age group. Additionally, the FDA approved Xofluza for the prevention (post-exposure prophylaxis) of influenza in children aged five to less than 12 years of age following contact with someone with influenza.

According to the U.S. Centers for Disease Control and Prevention, influenza can be a serious illness for young children.1 During the ongoing COVID-19 pandemic there have been significantly fewer influenza cases, likely due in large part to social distancing and mask wearing.2 However, in the US 2018-2019 influenza season, there were more than 6 million illnesses, thousands of hospitalisations and over 100 deaths among children aged five to 17 caused by influenza.3 The FDA approval is based on results from two phase III studies: miniSTONE-2, which evaluated the use of Xofluza in children, and BLOCKSTONE, which evaluated Xofluza as a preventive treatment for household members, in both adults and children. The results from these studies were published in The Pediatric Infectious Disease Journal and The New England Journal of Medicine respectively.4,5 Xofluza is already FDA-approved to treat influenza in people 12 years of age and older who have had influenza symptoms for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. Xofluza is also approved to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis).

Xofluza is available as a one-dose, single-tablet.


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Financials
Sales 2022 63 378 M 66 712 M 66 712 M
Net income 2022 14 821 M 15 601 M 15 601 M
Net Debt 2022 11 209 M 11 799 M 11 799 M
P/E ratio 2022 16,7x
Yield 2022 3,13%
Capitalization 254 B 268 B 268 B
EV / Sales 2022 4,19x
EV / Sales 2023 4,05x
Nbr of Employees 100 920
Free-Float 89,0%
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Mean consensus OUTPERFORM
Number of Analysts 24
Last Close Price 307,80 CHF
Average target price 373,83 CHF
Spread / Average Target 21,5%
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Managers and Directors
Severin Schwan Chief Executive Officer & Executive Director
Alan Hippe Chief Financial & Information Officer
Christoph Franz Chairman
Levi A. Garraway Chief Medical Officer
Pascale Schmidt Chief Compliance Officer
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