Reata Pharmaceuticals Announces FDA Filing Acceptance of SKYCLARYS® (Omaveloxlone) NDA Prior Approval Supplement
16 Giugno 2023 - 1:15AM
Business Wire
Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the
“Company,” “our,” “us,” or “we”), a global biopharmaceutical
company focused on developing and commercializing novel therapies
for patients with severe diseases, announced today that the U.S.
Food and Drug Administration (FDA) accepted for filing the Prior
Approval Supplement (PAS) to update the drug substance
specification for SKYCLARYS® (omaveloxolone). As per the US Code of
Federal Regulation, the filing means FDA has made a threshold
determination that the PAS is sufficiently complete to permit a
substantive review. As previously communicated, the PAS is being
reviewed under expedited Priority Review with a target action date
of mid-August 2023.
About Reata
Reata is a global biopharmaceutical company committed to
developing and commercializing novel therapeutics for patients with
serious or life-threatening diseases with few or no approved
therapies. We focus on molecular pathways involved in the
regulation of cellular metabolism and inflammation. Reata developed
the first and only U.S. Food and Drug Administration approved
product for Friedreich’s ataxia. In addition, Reata is developing
cemdomespib for the treatment of patients with diabetic neuropathic
pain and Nrf2 activators for neurological diseases. Cemdomespib
is an investigational drug, and its safety and efficacy has not
been established by any regulatory agency. For more information
visit www.reatapharma.com and follow us on LinkedIn and
Twitter.
Forward-Looking Statements
This press release includes certain disclosures that contain
“forward-looking statements,” including, without limitation, our
plans and objectives for the commercialization of SKYCLARYS and the
timing thereof, our expectations regarding the size of the patient
population for SKYCLARYS, and our plans to research, develop, and
commercialize our other product candidates. You can identify
forward-looking statements because they contain words such as
“believes,” “will,” “may,” “aims,” “plans,” “model,” and “expects.”
Forward-looking statements are based on Reata’s current
expectations and assumptions. Because forward-looking statements
relate to the future, they are subject to inherent uncertainties,
risks, and changes in circumstances that may differ materially from
those contemplated by the forward-looking statements, which are
neither statements of historical fact nor guarantees or assurances
of future performance. Important factors that could cause actual
results to differ materially from those in the forward-looking
statements include, but are not limited to, (i) the potential
market size and the size of the patient population for SKYCLARYS
and the market opportunities for SKYCLARYS; (ii) our ability to
successfully build our commercial infrastructure to manufacture,
market and sell SKYCLARYS, including the successful development and
implementation of our sales and marketing campaigns for SKYCLARYS;
(iii) the ability of our third-party suppliers and contract
manufacturers to manufacture SKYCLARYS at the required quality and
quantities and in compliance with applicable laws and regulations;
and (iv) other factors set forth in Reata’s filings with the U.S.
Securities and Exchange Commission, including its Annual Report on
Form 10-K for the fiscal year ended December 31, 2022, under the
caption “Risk Factors.” The forward-looking statements speak only
as of the date made and, other than as required by law, we
undertake no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events, or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20230615309751/en/
Reata Pharmaceuticals, Inc. (972) 865-2219
https://www.reatapharma.com/
Investor Relations & Media Relations: John Hunter
ir@reatapharma.com Wendy Segal media@reatapharma.com
https://www.reatapharma.com/contact-us/
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