Reata Pharmaceuticals, Inc. - RETA STOCK NEWS

Reata Pharmaceuticals, Inc. (NASDAQ: RETA) will announce its third quarter financial results for the period ending September 30, 2022, on November 8, 2022, before U.S. market open. The company will discuss these results in a conference call scheduled for the same day at 8:30 AM ET. Interested parties can access the call by dialing the provided numbers or through a webcast link available on Reata’s investor relations page.

Reata Pharmaceuticals (NASDAQ: RETA) is set to present significant clinical data on its investigational drug, omaveloxolone, at the International Congress for Ataxia Research from November 1-4, 2022, in Dallas, Texas. Key presentations include an oral discussion led by Dr. David Lynch on the use of natural history data in analyzing clinical trials and multiple poster sessions detailing efficacy and disease burden in Friedreich’s ataxia. The company emphasizes the current lack of approved therapies for this debilitating condition affecting around 5,000 patients in the U.S.

Reata Pharmaceuticals (NASDAQ: RETA) announced that the FDA will not hold an advisory committee meeting regarding its New Drug Application for omaveloxolone, aimed at treating Friedreich’s ataxia. This rare, genetic condition lacks approved therapies, affecting about 5,000 individuals in the U.S. The investigational drug has received multiple designations, including Orphan Drug and Fast Track. Reata remains committed to securing approval for omaveloxolone to aid patients suffering from this debilitating disorder.

Reata Pharmaceuticals (NASDAQ: RETA) has announced management's participation in investor meetings during the Citi 17th Annual BioPharma Conference on September 7-8, 2022, in Boston, Massachusetts. The company focuses on developing novel therapeutics for severe diseases by targeting key molecular pathways related to metabolism and inflammation. Their primary clinical candidates, omaveloxolone and bardoxolone methyl, are investigational drugs aimed at reducing oxidative stress. However, their safety and efficacy remain unverified by regulatory agencies.

Reata Pharmaceuticals announced that the FDA has extended the PDUFA date for their New Drug Application (NDA) for omaveloxolone, a treatment for Friedreich's ataxia, by three months. The new deadline is set for February 28, 2023. This extension follows the submission of updated analyses intended to address FDA concerns raised during a mid-cycle communication meeting. The FDA will review these new data before proceeding with the planned advisory committee meeting, which is currently on hold.

Reata Pharmaceuticals (RETA) reported its second quarter 2022 financial results and provided updates on its NDA for omaveloxolone in Friedreich’s ataxia. The FDA granted Priority Review and confirmed that no significant safety issues had been identified. Omaveloxolone demonstrated sustained efficacy in the MOXIe Extension study, with a maintained significant difference in mFARS scores at 120 weeks. However, the FDA expressed ongoing concerns about the strength of efficacy evidence. Cash and equivalents as of June 30, 2022, amounted to $481.5 million, sufficient to fund operations through the end of 2024.

Reata Pharmaceuticals (NASDAQ: RETA) will release its financial results for Q2 2022 on August 8, 2022, prior to market opening. The company will also provide updates on its business operations and clinical programs during a conference call at 8:30 AM ET. The earnings press release will be available on their website ahead of the call. Reata is focused on developing therapeutics targeting inflammation and cellular metabolism through its candidates, omaveloxolone and bardoxolone methyl, which are still under investigation.

Reata Pharmaceuticals (NASDAQ: RETA) announced on July 11, 2022, the appointment of Dr. Steven W. Ryder to its Board of Directors. Dr. Ryder, with over 35 years in the biopharmaceutical industry, joins at a pivotal moment as the Company awaits FDA review for its New Drug Application for omaveloxolone, aimed at treating Friedreich’s ataxia. His extensive experience includes roles at Rallybio and Alexion Pharmaceuticals. The Company aims to leverage Dr. Ryder's expertise to enhance its development efforts and prepare for a potential U.S. market launch of omaveloxolone.

Reata Pharmaceuticals announced that the FDA has accepted its New Drug Application (NDA) for omaveloxolone, a treatment for Friedreich's ataxia, and granted it Priority Review. The FDA's decision indicates no review issues at this time, with a Prescription Drug User Fee Act (PDUFA) target action date set for November 30, 2022. If approved, omaveloxolone would be the first therapy for this rare disease affecting approximately 5,000 patients in the U.S. The application is supported by data from the MOXIe clinical trials.