WALTHAM,
Mass., Dec. 16, 2022 /PRNewswire/ -- Ardelyx,
Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a
mission to discover, develop and commercialize innovative
first-in-class medicines that meet significant unmet medical needs,
provided an update regarding the appeal to the Complete Response
Letter for the New Drug Application for XPHOZAH (tenapanor).
Earlier today, Peter Stein, M.D.,
Director of the Office of New Drugs, Center for Drug Evaluation and
Research of the U.S. Food and Drug Administration (FDA), requested
a meeting with Ardelyx to discuss the status of his review of the
appeal. After a productive conversation, Dr. Stein communicated
that the FDA is finalizing the response and may require up to a few
more weeks to do so. Ardelyx will communicate the response to the
appeal once it has been received from the FDA.
About Ardelyx, Inc.
Ardelyx was founded with a mission to discover, develop and
commercialize innovative first-in-class medicines that meet
significant unmet medical needs. Ardelyx's first approved product,
IBSRELA® (tenapanor) is available in the United States and Canada. Ardelyx is developing
XPHOZAH® (tenapanor), a novel product candidate to
control serum phosphorus in adult patients with CKD on dialysis,
which has completed three successful Phase 3 trials. Ardelyx has a
Phase 2 potassium lowering compound, RDX013, for the potential
treatment of elevated serum potassium, or hyperkalemia, a problem
among certain patients with kidney and/or heart disease and an
early-stage program in metabolic acidosis, a serious electrolyte
disorder in patients with CKD. Ardelyx has established agreements
with Kyowa Kirin in Japan, Fosun
Pharma in China and Knight
Therapeutics in Canada for the
development and commercialization of tenapanor in their respective
territories. For more information, please visit
https://ardelyx.com/ and connect with us on Twitter @Ardelyx,
LinkedIn and Facebook.
Forward Looking Statements
To the extent that statements contained in this press release
are not descriptions of historical facts regarding Ardelyx, they
are forward-looking statements reflecting the current beliefs and
expectations of management made pursuant to the safe harbor of the
Private Securities Reform Act of 1995, including Ardelyx's current
expectation regarding the timing of the OND's decision on its
appeal. Such forward-looking statements involve substantial risks
and uncertainties that could cause Ardelyx's future results,
performance or achievements to differ significantly from those
expressed or implied by the forward-looking statements. Such risks
and uncertainties include, among others, uncertainties associated
with the regulatory approval process. Ardelyx undertakes no
obligation to update or revise any forward-looking statements. For
a further description of the risks and uncertainties that could
cause actual results to differ from those expressed in these
forward-looking statements, as well as risks relating to Ardelyx's
business in general, please refer to Ardelyx's Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission on
November 3, 2022, and its future
current and periodic reports to be filed with the Securities and
Exchange Commission.
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SOURCE Ardelyx