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MarketScreener Homepage  >  Equities  >  Nasdaq  >  Gilead Sciences, Inc.    GILD

GILEAD SCIENCES, INC.

(GILD)
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Gilead shares slide after FDA knocks back rheumatoid arthritis drug

08/19/2020 | 07:42am EST
FILE PHOTO: Gilead Sciences Inc pharmaceutical company is seen during the outbreak of the coronavirus disease (COVID-19), in California

Shares of Gilead Sciences fell 3% after the U.S. Food and Drug Administration declined to approve its experimental rheumatoid arthritis treatment, a major setback for one of the drugmaker's important products.

Gilead's antiviral medicine remdesivir has put the company at the forefront of the fight against the COVID-19 pandemic, sending its shares soaring, but analysts said the FDA move could cost it millions in delayed sales while it fights to get the drug approved.

Last year, Gilead invested $5.1 billion in a major expansion of its partnership with Belgo-Dutch biotech Galapagos NV, banking on the potential of filgotinib and other drugs in development. Shares of Gilead were down 3% at $66.83 in Wednesday morning trade, while U.S. shares of Galapagos were down 27%.

In its complete response letter, the FDA expressed concerns regarding the overall benefit/risk profile of the 200 mg dose of the treatment and asked for additional data from ongoing studies before completing its review, according to Gilead.

J.P. Morgan analyst Cory Kasimov, who had forecast $2 billion in annual peak sales for the drug, said the request for data could delay any potential approval by at least a year, while "the potential lack of dosing flexibility" could hurt the drug's competitive profile.

"There is no simple fix to these complex issues, putting the entire filgotinib program (rheumatoid arthritis and beyond) at risk," Credit Suisse analyst Evan Seigerman said in a note.

Filgotinib belongs to a class of oral drugs called JAK inhibitors which target a range of autoimmune diseases and include AbbVie's Rinvoq and Eli Lilly's Olumiant as well as Pfizer's experimental drug abrocitinib.

The oral JAK inhibitor class of molecules has produced robust efficacy results in immune and inflammatory disorders but risk/benefit profiles of these molecules have been a constant overhang due to safety and tolerability concerns, Guggenheim analysts said in a note.

(Reporting by Trisha Roy and Ankur Banerjee in Bengaluru; editing by Lewis Krauskopf and Maju Samuel)


© Reuters 2020
Stocks mentioned in the article
ChangeLast1st jan.
CREDIT SUISSE GROUP AG -1.71% 11.795 Delayed Quote.5.26%
GALAPAGOS NV -1.16% 90.5 Real-time Quote.13.77%
GILEAD SCIENCES, INC. -1.83% 65.48 Delayed Quote.14.49%
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Financials (USD)
Sales 2020 24 397 M - -
Net income 2020 137 M - -
Net Debt 2020 23 031 M - -
P/E ratio 2020 1 171x
Yield 2020 4,06%
Capitalization 82 081 M 82 081 M -
EV / Sales 2020 4,31x
EV / Sales 2021 4,11x
Nbr of Employees 11 800
Free-Float 99,9%
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Technical analysis trends GILEAD SCIENCES, INC.
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Mean consensus OUTPERFORM
Number of Analysts 32
Average target price 72,89 $
Last Close Price 66,70 $
Spread / Highest target 49,9%
Spread / Average Target 9,28%
Spread / Lowest Target -13,0%
EPS Revisions
Managers and Directors
NameTitle
Daniel P. O'Day Chairman & Chief Executive Officer
Andrew D. Dickinson Chief Financial Officer
William A. Lee Executive Vice President-Research
Merdad V. Parsey Chief Medical Officer
George Pratt Shultz Director-Emeritus
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