The Plano, TX-based biotech and partner Kyowa Kirin said Wednesday morning that they are scrapping development of the asset in chronic kidney disease programs, which include CKD caused by Alport syndrome, people with diabetic CKD and a rare, hereditary form of the disease.
Reata and Kyowa Kirin gave bardoxolone the old college try, but ultimately decided to end development after a new late-stage failure.
Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” “our,” “us,” or “we”), a clinical-stage biopharmaceutical company, today announced that it will report financial results for the second quarter ended June 30, 2022, and provide an update on the Company’s business operations and clinical development programs on August 8, 2022, before the U.S. financial markets open.
Reata Pharmaceuticals (NASDAQ:RETA) has lost ~4% in the post-market Friday after the company announced that the U.S. Food and Drug Administration (“FDA”) issued a Complete Response Letter (CRL) regarding its New Drug Application (“NDA”) for bardoxolone methyl (“bardoxolone”).
The FDA on Monday offered an overwhelmingly negative opinion on Reata Pharmaceuticals’ potential drug to slow the loss of kidney function in those with the rare disease Alport syndrome, according to briefing documents released ahead of an advisory committee meeting Wednesday.
PLANO, Texas, March 01, 2021 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” or “we”), a clinical-stage biopharmaceutical company, today announced that it has submitted a New Drug Application (“NDA”) for bardoxolone methyl (“bardoxolone”) for the treatment of chronic kidney disease (“CKD”) caused by Alport syndrome to the U.S. Food and Drug Administration (“FDA”).
PLANO, Texas, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (“Reata” or the “Company,” or “we”), a clinical-stage biopharmaceutical company, today announced that the Phase 3 CARDINAL study of bardoxolone methyl (“bardoxolone”) in patients with chronic kidney disease (“CKD”) caused by Alport syndrome met its primary and key secondary endpoints at the end of Year 2. At Week 100, in the intent-to-treat (“ITT”) population, which included estimated glomerular filtration rate (“eGFR”) values for patients who either remained on or discontinued study drug, patients treated with bardoxolone had a statistically significant improvement compared to placebo in mean change from baseline in eGFR of 7.7 mL/min/1.73 m2 (p=0.0005). In the modified ITT (“mITT”) analysis, which assessed the effect of receiving treatment by excluding values after patients discontinued treatment, patients treated with bardoxolone had a statistically significant improvement compared to placebo in mean change from baseline in eGFR at Week 100 of 11.3 mL/min/1.73 m2 (p<0.0001). At Week 104 (four weeks after last dose in second year of treatment), patients in the ITT population treated with bardoxolone had a statistically significant improvement compared to placebo in mean change from baseline in eGFR of 4.3 mL/min/1.73 m2 (p=0.023). Bardoxolone treatment was generally reported to be well-tolerated. In the long-term extension study (“EAGLE”), for the 14 patients who completed three years of treatment, bardoxolone treatment resulted in a mean increase from baseline in eGFR of 11.0 mL/min/1.73 m2. Based on these positive results and following a recently completed pre-NDA meeting with the U.S. Food and Drug Administration (“FDA”), we plan to proceed with the submission of an NDA for full marketing approval in the United States in the first quarter of 2021. We also plan to pursue marketing approval outside of the United States and work has commenced on preparations to file for marketing approval in Europe.
PLANO, Texas, July 28, 2020 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” or “we”), a clinical-stage biopharmaceutical company, today announced that researchers at NYU Grossman School of Medicine (“NYU”), led by Sripal Bangalore, MD, interventional cardiologist and professor of Medicine, are initiating an Investigator-Sponsored Trial (“IST”), known as BARCONA, to study the effect of bardoxolone methyl (“bardoxolone”) in patients suffering from COVID-19. At NYU’s request, Reata is providing drug supply for the trial. NYU will be initiating the Phase 2 BARCONA study with a primary endpoint of safety.
These days, there’s virtually no raise too big for biotech. Case in point: 2 looming IPOs where the executive team is sketching out some mega-money that can fuel their operations for some time. Avidity Biosciences, which has a preclinical program for myotonic dystrophy type 1, believes it can gin up to $248 million or more now, based on the high end of their range. They’re looking for a market cap of around $619 million. Geoff McDonough at Generation Bio, meanwhile, has his eyes set on $218 million-plus with a top-end range of $19 a share. Generation is also preclinical, something that would have scared off investors earlier. Today, that profile can be worth more than $880 million in market value.
After surprising Wall Street with positive data on its drug, omaveloxolone, in patients suffering from a notoriously hard-to-treat degenerative neuromuscular disorder last month, Reata Pharma on Monday unveiled pivotal results from a trial testing another drug, bardoxolone, in patients with a rare, genetic form of chronic kidney disease for which there exist no approved therapies.