Reata Pharmaceuticals, Inc. (NASDAQ:RETA) Files An 8-K Other EventsItem 8.01.Other Events.
On July 23, 2018, Reata Pharmaceuticals, Inc. (the “Company”) issued a press release reporting data from two Phase 2 studies of bardoxolone methyl in patients with chronic kidney disease (“CKD”).The Company reported one-year results for the Phase 2 portion of CARDINAL, a study of bardoxolone in patients with CKD due to Alport syndrome, and final results for the Phase 2 autosomal dominant polycystic kidney disease (“ADPKD”) cohort of PHOENIX. A copy of the press release is attached as Exhibit 99.1 and incorporated herein by reference.
The Company plans to hold a conference call on July 23, 2018, at 8:00 a.m. EDT to discuss these results. Information about how to access the conference call is in the press release attached as Exhibit 99.1. The presentation slides that are to be used in connection with the conference call are attached as Exhibit 99.2 and incorporated herein by reference.
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 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 the Company’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 the Company’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.
Item 8.01.Financial Statement and Exhibits.
(d)Exhibits
REATA PHARMACEUTICALS INC ExhibitEX-99.1 2 reta-ex991_35.htm EX-99.1_PR CARDINAL 52 WEEKS DATA reta-ex991_35.htm Exhibit 99.1 REATA ANNOUNCES POSITIVE PHASE 2 DATA FOR BARDOXOLONE METHYL IN CKD CAUSED BY ALPORT SYNDROME AND AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE statistically Significant improvement in kidney function Maintained in alport syndrome patients after 48 weeks of treatment statistically significant retained benefit of 4.1 ml/min in alport syndrome patients following 48 weeks of treatment and 4 weeks of drug withdrawal statistically significant improvement in kidney function OBSERVED in adpkd PATIENTS AFTER 12 WEEKS OF TREATMENT Conference Call with management scheduled for today July 23rd at 8:00 am ET IRVING,…To view the full exhibit click here
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.
