Reata Pharmaceuticals, Inc. - RETA STOCK NEWS

Reata Pharmaceuticals (NASDAQ: RETA) will report its third-quarter financial results and provide updates on development programs on November 8, 2021, pre-market. A conference call will take place at 8:30 a.m. ET the same day, with calls accessible for both domestic and international participants. The earnings press release will be available on the company’s website prior to the call. Reata focuses on developing novel therapeutics targeting cellular metabolism and inflammation, with investigational drugs bardoxolone methyl and omaveloxolone currently in clinical stages.

Reata Pharmaceuticals (NASDAQ: RETA) announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency for bardoxolone methyl, aimed at treating chronic kidney disease (CKD) due to Alport syndrome. This follows the acceptance of their New Drug Application (NDA) by the FDA, with a Prescription Drug User Fee Act (PDUFA) date set for February 25, 2022. Bardoxolone holds Orphan Drug designation in both the U.S. and Europe, targeting a rare genetic disorder affecting up to 60,000 individuals in the U.S.

Reata Pharmaceuticals (NASDAQ: RETA) announced the presentation of clinical data related to bardoxolone methyl at the American Society of Nephrology Kidney Week 2021, scheduled virtually from November 4-7. Key presentations include integrated analyses of bardoxolone's efficacy and safety in Chronic Kidney Disease and Alport syndrome, along with interim findings from various clinical trials. Bardoxolone has Orphan Drug designation for treating Alport syndrome from the FDA and the European Commission. The company continues to advance its clinical programs targeting significant renal diseases.

Reata Pharmaceuticals (NASDAQ: RETA) announced the completion of its pre-New Drug Application (NDA) meeting with the FDA for omaveloxolone to treat Friedreich’s ataxia, a severe, ultra-rare neuromuscular disorder affecting around 5,000 patients in the U.S. The company plans to submit the NDA in the first quarter of 2022. The FDA has allowed the submission of certain study results post-approval, indicating a possible pathway for approval. If successful, omaveloxolone could be the first approved treatment for Friedreich’s ataxia.

Reata Pharmaceuticals (Nasdaq: RETA) announced its financial results for Q2 2021, reporting a GAAP net loss of $72.7 million, or $2.00 per share, compared to $67.6 million, or $2.03 per share, in Q2 2020. Cash and equivalents stood at $755.7 million. The FDA is reviewing its NDA for bardoxolone for Alport syndrome, with a PDUFA date of February 25, 2022. A pre-NDA meeting for omaveloxolone has been scheduled. The company plans to submit a Marketing Authorization Application in Europe in Q4 2021 and reaffirmed its cash runway through mid-2024.

Reata Pharmaceuticals (Nasdaq: RETA) will report its financial results and update on development programs after market close on August 9, 2021. A conference call will follow at 4:30 pm ET, accessible domestically at (866) 270-1533 and internationally at (412) 317-0797, using access code 10157197. Reata focuses on developing therapeutics targeting crucial molecular pathways for serious diseases, with investigational drugs bardoxolone methyl and omaveloxolone aiming to reduce inflammation and oxidative stress. Further details will be available on their investor website.

Reata Pharmaceuticals (Nasdaq: RETA) announced management's participation in a virtual Fireside chat and 1x1 meetings at the Goldman Sachs 42nd Annual Global Healthcare Conference on June 8, 2021. The company focuses on developing novel therapeutics targeting molecular pathways involved in serious diseases, with two advanced candidates: bardoxolone methyl and omaveloxolone. Both drugs aim to combat inflammation and restore mitochondrial function but are investigational and not yet approved. Forward-looking statements regarding their development are subject to uncertainties and risks.

Reata Pharmaceuticals (Nasdaq: RETA) has received guidance from the FDA suggesting a transition from a Type C meeting to a pre-NDA meeting regarding omaveloxolone for Friedreich's ataxia treatment. This change aims to facilitate regulatory discussions pertinent to the drug's development program. Reata plans to comply by withdrawing its current Type C meeting request and submitting a pre-NDA meeting request promptly. The FDA previously granted Orphan Drug designation to omaveloxolone, which addresses a critical unmet need in a rare, debilitating disease.

Reata Pharmaceuticals (RETA) announced the FDA's acceptance of its New Drug Application (NDA) for bardoxolone, aimed at treating chronic kidney disease (CKD) from Alport syndrome, potentially making it the first approved therapy for this condition. The PDUFA date is set for February 25, 2022. The company also confirmed completion of enrollment in the Phase 3 FALCON trial for ADPKD by end of 2021. Reata maintains a robust cash runway through mid-2024, with Q1 2021 cash and equivalents at $777.6 million. However, share losses increased to $67.5 million, or $1.86 per share, from $48.9 million compared to the prior year.