Reata Pharmaceuticals, Inc. - RETA STOCK NEWS

Reata Pharmaceuticals (NASDAQ: RETA) is set to release its first quarter 2022 financial results on May 10, 2022. The announcement will include updates on its operations and clinical development programs. A conference call with management is scheduled for 8:30 am ET on the same day, accessible via phone or webcast. Reata focuses on developing novel therapeutics targeting cellular metabolism and inflammation, with key candidates being omaveloxolone and bardoxolone methyl.

Reata Pharmaceuticals has completed a rolling submission of a New Drug Application (NDA) for omaveloxolone, aimed at treating Friedreich’s ataxia, affecting approximately 5,000 patients in the U.S. Currently, there are no approved therapies for this degenerative disorder. The FDA has granted Fast Track and Orphan Drug Designations for omaveloxolone. This submission is based on data from the MOXIe studies, signaling a potential breakthrough for patients with this condition, which typically leads to severe motor incapacitation and reduced life expectancy.

Reata Pharmaceuticals (RETA) announced its financial results for Q4 and full year 2021, revealing a GAAP net loss of $297.4 million ($8.19 per share). The company reported cash and cash equivalents of $590.3 million, sufficient to fund operations through 2024. Key developments include the initiation of a rolling NDA submission for omaveloxolone for Friedreich’s ataxia and plans for a commercial launch. The company also faced challenges with bardoxolone in chronic kidney disease, receiving a complete response letter from the FDA. Collaboration revenue increased to $11.5 million, up from $9.0 million year-over-year.

Reata Pharmaceuticals (NASDAQ: RETA) announced that the FDA has issued a Complete Response Letter for the New Drug Application of bardoxolone methyl, intended for treating chronic kidney disease caused by Alport syndrome. The FDA concluded that the current data does not demonstrate the drug's efficacy in slowing kidney function loss. Further evidence from controlled studies is required, particularly regarding bardoxolone's safety and its effect on the QT interval. The company expresses disappointment but plans to work closely with the FDA on future steps.

Reata Pharmaceuticals, Inc. (Nasdaq: RETA) has announced it will report its financial results and provide a business update on February 28, 2022, before the market opens. A conference call will occur at 8:30 a.m. ET on the same day, accessible via phone or webcast. Reata focuses on developing novel therapeutics targeting cellular metabolism and inflammation, with its leading candidates being omaveloxolone and bardoxolone methyl. Both drugs are investigational and their safety and efficacy have not been established by regulatory authorities.

Reata Pharmaceuticals has initiated a rolling submission of a New Drug Application for omaveloxolone, targeting Friedreich’s ataxia, a rare disease affecting approximately 5,000 individuals in the U.S. If approved, it will be the first therapy for this condition. The company plans to complete the NDA submission by the end of Q1 2022. Omaveloxolone has received Fast Track and Orphan Drug Designations from the FDA, highlighting its potential in treating this debilitating disorder.

Reata Pharmaceuticals announced the FDA Advisory Committee's negative vote regarding bardoxolone methyl for treating chronic kidney disease (CKD) linked to Alport syndrome. The Committee concluded that the evidence did not sufficiently demonstrate efficacy or outweigh risks. Despite this, Reata remains optimistic about bardoxolone's approval and plans to collaborate with the FDA until the Prescription Drug User-Fee Act (PDUFA) date on February 25, 2022. Bardoxolone, an investigational drug, has Orphan Drug designation and is undergoing various clinical trials for CKD treatments.

Reata Pharmaceuticals, Inc. (NASDAQ: RETA) announced that Nasdaq has halted trading of its stock. This follows the U.S. FDA Cardiovascular and Renal Drugs Advisory Committee's review of the company's New Drug Application (NDA) for bardoxolone methyl, aimed at treating chronic kidney disease caused by Alport syndrome. The Advisory Committee meeting is set for December 8, with a review completion date on February 25, 2022. Bardoxolone and omaveloxolone are investigational drugs targeting inflammation and cellular metabolism, with their safety and efficacy not yet established.

Reata Pharmaceuticals (NASDAQ: RETA) announced that the U.S. FDA has granted Fast Track Designation for its investigational drug omaveloxolone, aimed at treating Friedreich's ataxia. This designation facilitates accelerated development and review processes for drugs addressing serious diseases with unmet needs. Reata plans to submit a New Drug Application in Q1 2022. Friedreich's ataxia affects around 5,000 individuals in the U.S., and no approved therapies currently exist. Omaveloxolone is designed to enhance mitochondrial function and reduce oxidative stress.