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RETA Stock Price At 100.07: Here’s All You Need To Know

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Reata Pharmaceuticals, Inc. (NASDAQ: RETA)’s stock price increased by 13.19% as of April 26’21, 4PM EDT Market close. The closing price of April 26 was 100.07, showing a surge of 11.66 over the previous closing price of 88.41. The volume was 537,653 and the day’s range was between 84.17 – 186.82. 

Reata Pharmaceuticals, Inc. (NASDAQ: RETA) is a clinical-stage biopharmaceutical company whose stock’s pre-market price stands at 102.02  as of 6:15AM EDT, Apri 27. A surge of 1.95 is observable. April 26’s highest price was 101.48 and the lowest price was 90.21. 

Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” or “we”), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (“FDA”) accepted for filing the New Drug Application (“NDA”) for bardoxolone methyl (“bardoxolone”) for the treatment of patients with chronic kidney disease (“CKD”) caused by Alport syndrome.

This NDA submission is based on the efficacy and safety data from the CARDINAL Phase 3 clinical trial. The FDA will review the application under a Standard Review timeline. The Prescription Drug User Fee Act (“PDUFA”) date, the FDA action date for the application, is scheduled for February 25, 2022. The FDA also advised the Company that it is currently planning to hold an Advisory Committee meeting to discuss the application.

“We are pleased with the FDA’s decision to accept filing our NDA for bardoxolone and look forward to continuing to work with the Division during the review process,” said Warren Huff, Reata’s President and Chief Executive Officer. “Alport syndrome is one of the most rapidly progressive forms of CKD and a truly devastating disease to those patients and the families who are affected by it. If approved, bardoxolone may be the first therapy to slow the progression of kidney disease in patients with this serious and debilitating disease.”

The CARDINAL Phase 3 study was a double-blind, placebo-controlled, randomized trial that enrolled 157 patients with CKD caused by Alport syndrome at approximately 50 study sites in the United States, Europe, Japan, and Australia. Patients were randomized 1:1 to once-daily, oral bardoxolone or placebo. The primary endpoint for Year 2 of the study was the change from baseline in eGFR after 100 weeks of treatment. The key secondary endpoint for Year 2 of the study was the change from baseline in eGFR at Week 104 (four weeks after the last dose in the second year of treatment). Results from CARDINAL demonstrated that patients treated with bardoxolone experienced a statistically significant improvement in kidney function as measured by eGFR at Week 100 and Week 104, compared to patients treated with placebo. Bardoxolone was generally reported to be well tolerated in this study, and the safety profile was similar to that observed in prior trials. The reported adverse events (“AE”) were generally mild to moderate in intensity, and the most common AEs observed more frequently in patients treated with bardoxolone compared to patients treated with placebo were muscle spasms and increases in aminotransferases.

Bardoxolone is an investigational, once-daily, orally administered activator of Nrf2, a transcription factor that induces molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling. The FDA has granted Orphan Drug designation to bardoxolone for the treatment of Alport syndrome and autosomal dominant polycystic kidney disease (“ADPKD”). The European Commission has granted Orphan Drug designation in Europe to bardoxolone for the treatment of Alport syndrome.

In addition to the CARDINAL Phase 3 study, bardoxolone is currently being studied in FALCON, a Phase 3 study for the treatment of ADPKD, MERLIN, a Phase 2 study for the treatment of patients with CKD at risk of rapid progression, and AYAME, a Phase 3 study for the treatment of diabetic kidney disease that is being conducted by our licensee, Kyowa Kirin Co., Ltd., in Japan. Bardoxolone treatment has produced positive results in Phase 2 studies in patients with CKD caused by ADPKD, IgA nephropathy, focal segmental glomerulosclerosis, and type 1 diabetes.

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