Gilead Announces Intent to Submit New Drug Application for Filgotinib to U.S. Food and Drug Administration This Year
July 01 2019 - 7:00PM
Business Wire
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that at a
recent pre-New Drug Application (NDA) meeting with the U.S. Food
and Drug Administration (FDA), the company provided an update about
the investigational, oral, selective JAK1 inhibitor filgotinib. The
company discussed with the agency the Phase 3 FINCH studies, as
well as the ongoing Phase 2 MANTA safety study assessing semen
parameters with filgotinib treatment in men with moderately to
severely active ulcerative colitis or Crohn’s disease. As a result
of this discussion, a path forward has been established to submit
the NDA for filgotinib as a treatment for rheumatoid arthritis in
2019.
Filgotinib is an investigational agent and not approved anywhere
globally. Its efficacy and safety have not been established.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City, California.
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com.
Gilead Forward-Looking
Statement
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including the possibility of unfavorable results from ongoing and
additional clinical trials involving filgotinib, the possibility
that the company is unable to file the filgotinib NDA on the
currently anticipated timelines and the possibility that the FDA
could refuse to approve filgotinib or significantly delay approval.
All statements other than statements of historical fact are
statements that could be deemed forward-looking statements. These
risks, uncertainties and other factors could cause actual results
to differ materially from those referred to in the forward-looking
statements. The reader is cautioned not to rely on these
forward-looking statements. These and other risks are described in
detail in Gilead’s Quarterly Report on Form 10-Q for the quarter
ended March 31, 2019, as filed with the U.S. Securities and
Exchange Commission. All forward-looking statements are based on
information currently available to Gilead, and Gilead assumes no
obligation to update any such forward-looking statements.
For more information about Gilead, please visit
the company’s website at www.gilead.com , follow Gilead on Twitter
(@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
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version on businesswire.com: https://www.businesswire.com/news/home/20190701005901/en/
Sung Lee, Investors (650) 524-7792 Arran Attridge, Media (650)
425-8975
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