Reata Pharmaceuticals, Inc. (NASDAQ:RETA) Files An 8-K Other Events
Item 8.01.Other Events.
On June 1, 2017, Reata Pharmaceuticals, Inc. (the Company) issued
a press release announcing positive data from Part 1 of the
Companys Phase 2 trial (MOXIe) of omaveloxolone for the treatment
of Friedrichs ataxia (FA). FA is an inherited, progressively
debilitating, and fatal neurodegenerative disease that currently
has no approved therapies. A copy of the press release is
attached as Exhibit 99.1. The complete data will be presented by
Dr. David Lynch, Director of the Friedreichs Ataxia Program at
Childrens Hospital of Philadelphia, at 3:00 p.m. EDT on June 2,
2017, after the Patient-Focused Drug Development meeting hosted
by the Friedreichs Ataxia Research Alliance. Dr. Lynchs
presentation will be accessible via webcast as set forth in the
press release. Dr. Lynchs presentation slides are attached as
Exhibit 99.2.
The Company plans to hold a conference call on June 2, 2017, at
4:00 p.m. EDT to discuss the results of Part 1 of the Companys
MOXIe trial of omaveloxolone in FA and the timing and certain
details of Part 2 of the MOXIe trial. Managements presentation
will be accessible via webcast and via teleconference as set
forth in the press release. The presentation slides that are to
be used in connection with the conference call are attached as
Exhibit 99.3.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K and oral statements made with
respect to information contained in this report may contain
forward looking information within the meaning of the Private
Securities Litigation Reform Act of 1995. You may identify
forward-looking statements by the use of words such as believe,
expect, plan, intend, anticipate, estimate, predict, potential,
may, should, will or other words or expressions of similar
meaning, although not all forward-looking statements contain such
terms. These forward-looking statements include, but are not
limited to, statements about the MOXIe trial.
Forward-looking statements are subject to risks and
uncertainties, both known and unknown, that could cause actual
results to differ materially from those expressed or implied in
forward-looking statements. Such risks and uncertainties include,
but are not limited to: our expectations regarding the timing,
costs, conduct, and outcome of our clinical trials, including
statements regarding the timing of the initiation and
availability of data from such trials; the timing and likelihood
of regulatory filings and approvals for our product candidates;
our expectations regarding the potential market size and the size
of the patient populations for our product candidates, if
approved for commercial use, and the potential market
opportunities for commercializing our product candidates; our
expectations related to the use of our available cash; estimates
of our expenses, future revenue, capital requirements, and our
needs for additional financing; our ability to develop, acquire,
and advance product candidates into, and successfully complete,
clinical trials; the initiation, timing, progress, and results of
future preclinical studies and clinical trials, and our research
and development programs; the scope of protection we are able to
establish and maintain for intellectual property rights covering
our product candidates; our ability to maintain and establish
collaborations or obtain additional funding; our ability to
maintain and establish relationships with third parties, such as
contract research organizations, suppliers, and distributors; our
expectations regarding the time during which we will be an
emerging growth company under the JOBS Act; our ability to
establish and maintain arrangements for manufacture of our
product candidates; the impact of governmental laws and
regulations; developments and projections relating to our
competitors and our industry; and other risks and uncertainties
included in our most recent report on Form 10-K and subsequent
reports on Forms 10-Q and 8-K available on the Investor News
section of www.reatapharma.com. You should not place undue
reliance on forward-looking statements, which speak only as of
the date they are made, are not guarantees of future performance
or results, and are subject to risks, uncertainties and
assumptions that are difficult to predict or quantify.The Company
undertakes no obligation to update or revise any forward-looking
statement, whether as a result of new information, future events
or otherwise, except as may be required by law.
Item 9.01.Financial Statements and Exhibits.
(d)Exhibits
Exhibit No. |
Description |
99.1* |
Press release dated June 1, 2017. |
99.2* |
Dr. David Lynchs presentation slides in connection with a |
99.3* |
Company management presentation slides in connection with |
* |
Furnished herewith. |
About Reata Pharmaceuticals, Inc. (NASDAQ:RETA)
Reata Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on identifying, developing and commercializing product candidates that modulate the activity of regulatory proteins involved in the biology of mitochondrial function, oxidative stress, and inflammation to address the unmet medical needs of patients with a range of serious or life-threatening diseases. The Company’s lead product candidates include bardoxolone methyl, which is being studied in Phase III trial for the treatment of pulmonary arterial hypertension (PAH), associated with connective tissue disease (CTD-PAH), as well as a Phase II trial for the treatment of pulmonary hypertension due to interstitial lung disease (PH-ILD), and PAH, each of which are subsets of pulmonary hypertension (PH), Omaveloxolone, which is in Phase II clinical development for the treatment of multiple diseases, including Friedreich’s ataxia, mitochondrial myopathies and metastatic melanoma. Reata Pharmaceuticals, Inc. (NASDAQ:RETA) Recent Trading Information
Reata Pharmaceuticals, Inc. (NASDAQ:RETA) closed its last trading session down -0.93 at 28.36 with 71,362 shares trading hands.