Reata Pharmaceuticals, Inc. - RETA STOCK NEWS

Reata Pharmaceuticals (Nasdaq: RETA) announced that the FDA reviewed results from the Baseline-Controlled Study of omaveloxolone for Friedreich’s ataxia, concluding they do not reinforce the MOXIe study’s findings. The FDA proposed additional analyses but expressed skepticism due to limited patient numbers. Reata plans to submit these analyses and potentially conduct a second pivotal study. Despite showing improvement in motor function in studies, the FDA's feedback is a setback for Reata and its future development efforts.

Reata Pharmaceuticals reported positive Year 2 results from the Phase 3 CARDINAL study of bardoxolone methyl in patients with chronic kidney disease due to Alport syndrome, demonstrating a significant increase in eGFR. The company plans to submit a New Drug Application (NDA) for bardoxolone in Q1 2021. In addition, the Baseline-Controlled Study for omaveloxolone in Friedreich’s Ataxia showed a notable treatment effect, supporting further regulatory submissions. However, Reata experienced a GAAP net loss of $65.5 million for Q3 2020, influenced by decreased collaboration revenue and increased expenses.

Reata Pharmaceuticals announced that the Phase 3 CARDINAL study of bardoxolone methyl met its primary and key secondary endpoints in patients with chronic kidney disease due to Alport syndrome. At Week 100, bardoxolone showed a statistically significant improvement in eGFR of 7.7 mL/min/1.73 m² compared to placebo (p=0.0005). The treatment, particularly effective in pediatric patients, was well-tolerated. Reata plans to submit a New Drug Application for full approval in 1Q21, aiming to be the first approved therapy for this life-threatening condition affecting up to 60,000 patients in the U.S.

Reata Pharmaceuticals (Nasdaq: RETA) will report its Q3 2020 financial results and development program updates on November 9, 2020, before market opening. A conference call is scheduled for 8:00 a.m. ET, accessible via toll-free and international numbers. The earnings press release will be available prior to the call on the company's website. Reata develops innovative therapies targeting critical molecular pathways for serious diseases, with two leading candidates, bardoxolone methyl and omaveloxolone, currently under investigation.

Reata Pharmaceuticals (Nasdaq: RETA) recently announced the publication of pivotal results from the MOXIe trial in Annals of Neurology, highlighting the efficacy of omaveloxolone in treating Friedreich's ataxia (FA). In this double-blind study, patients receiving 150 mg daily of omaveloxolone showed a statistically significant improvement in mFARS scores (mean improvement of 2.40 points, p=0.014) after 48 weeks, with good tolerability. Currently, omaveloxolone is an investigational drug with orphan drug designation from the FDA for FA, which affects ~5,000 U.S. patients.

Reata Pharmaceuticals announces the presentation of its KIDNEYCODE program, focusing on genetic testing for patients with chronic kidney disease, at the American Society of Nephrology Kidney Week 2020. The e-poster will be available on October 22, 2020, at 10:00 a.m. EDT. Over 1,000 KIDNEYCODE tests have been conducted in the U.S., illustrating the program's significance. Reata, a clinical-stage biopharmaceutical company, is developing therapies targeting cellular metabolism and inflammation, with investigational drugs bardoxolone methyl and omaveloxolone.

Reata Pharmaceuticals (Nasdaq: RETA) will present efficacy and safety results from the pivotal MOXIe Part 2 study of its investigational drug, omaveloxolone, for Friedreich’s ataxia on September 24, 2020. This presentation is part of the Emerging Science series hosted by the American Academy of Neurology. The study, led by Dr. David Lynch, was selected from over 150 abstracts. In addition, Dr. Lynch will also share findings at the FARA 2020 Biomarker & Clinical Endpoint Meeting, scheduled for the same day. The safety and efficacy of omaveloxolone have not yet been established.

Reata Pharmaceuticals (Nasdaq: RETA) reported its Q2 2020 financial results and provided a regulatory update on its drug candidates. The FDA has granted a pre-NDA meeting for Bardoxolone in Alport Syndrome, aiming for NDA submission by Q4 2020. For Omaveloxolone, a required second pivotal trial was suggested by the FDA. The company recorded a GAAP net loss of $67.6 million, compared to $34.4 million in Q2 2019. Reata secured a $350 million investment from Blackstone Life Sciences, bolstering its cash reserves of $610.4 million as of June 30, 2020. The cash is expected to fund operations through 2023.

Reata Pharmaceuticals (Nasdaq: RETA) will release its financial results for Q2 2020 and provide updates on its development programs on August 10, 2020, before market hours. A conference call will follow at 8:30 a.m. ET, accessible via phone or webcast. Reata specializes in novel therapeutics targeting serious diseases, with key candidates bardoxolone methyl and omaveloxolone focusing on inflammation and mitochondrial function. These drugs are still in development, and their safety and efficacy remain unproven.