Reata Pharmaceuticals, Inc. Receives Orphan Drug Designation for Omaveloxolone for the Treatment of Malignant Melanoma
September 13 2017 - 5:26PM
Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (“Reata” or “the
Company”), a clinical-stage biopharmaceutical company, today
announced that the United States Food and Drug Administration
(“FDA”) has granted orphan designation to omaveloxolone for the
treatment of Stage IIb through IV malignant melanoma.
Reata is currently executing a Phase 1b/2 trial
evaluating the safety and efficacy of omaveloxolone in
combination with nivolumab or ipilimumab in patients with
unresectable or metastatic melanoma who have failed anti-PD-(L)1
therapies. The purpose of the Phase 1b portion of the trial
is to identify a recommended Phase 2 dose by collecting blood,
tumor biopsy, and radiographic data to determine if omaveloxolone
can unmask tumors, restore immune response, and demonstrate
anti-cancer activity.
Orphan status is granted to treatments for diseases
that affect fewer than 200,000 people in the United States and
provides specific incentives for therapies intended for the
treatment, diagnosis, or prevention of rare diseases. The
orphan designation will provide Reata with development incentives,
including tax credits for clinical testing, exemption from a
prescription drug user fee, and seven years of market
exclusivity.
About Reata Pharmaceuticals,
Inc.
Reata is a clinical-stage biopharmaceutical company
that develops novel therapeutics for patients with serious or
life-threatening diseases by targeting molecular pathways involved
in the regulation of cellular metabolism and inflammation.
Reata’s two most advanced clinical candidates, bardoxolone
methyl and omaveloxolone, target the important transcription factor
Nrf2 that promotes the resolution of inflammation by restoring
mitochondrial function, reducing oxidative stress, and inhibiting
pro-inflammatory signaling.
Forward-Looking Statements
This press release includes certain disclosures
that contain “forward-looking statements,” including, without
limitation, statements regarding the success, cost and timing of
our product development activities and clinical trials, our plans
to research, develop and commercialize our product candidates, and
our ability to obtain and retain regulatory approval of our product
candidates. You can identify forward-looking statements
because they contain words such as “believes,” “will,” “may,”
“aims,” “plans,” 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 timing, costs,
conduct, and outcome of our clinical trials and future preclinical
studies and clinical trials, including the timing of the initiation
and availability of data from such trials; (ii) the timing and
likelihood of regulatory filings and approvals for our product
candidates; (iii) the potential market size and the size of the
patient populations for our product candidates, if approved for
commercial use, and the market opportunities for our product
candidates; 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, 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.
Contact:Reata Pharmaceuticals, Inc.(972)
865-2219info@reatapharma.comhttp://news.reatapharma.com
Investor Relations:Vinny JindalVice President,
Strategy(469) 374-8721ir@reatapharma.com
Media:Matt Middleman, M.D.LifeSci Public
Relations(646)
627-8384matt.middleman@lifescipublicrelations.com
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