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The US FDA has approved Reata Pharmaceuticals' ( NASDAQ: RETA ) Friedreich's ataxia treatment omaveloxolone. Branded as Skyclarys, the drug is approved for those 16 years and older with the inherited neuronal disorder. The approval is the first FDA-approved therapy for t...
FRIEDREICH’S ATAXIA IS AN ULTRA-RARE, PROGRESSIVE, NEUROMUSCULAR DISEASE THAT AFFECTS APPROXIMATELY 5,000 DIAGNOSED PATIENTS IN THE UNITED STATES SKYCLARYS IS INDICATED FOR THE TREATMENT OF FRIEDREICH’S ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER ...
Reata Pharmaceuticals ( NASDAQ: RETA ) lost ~32% on Monday to reach the lowest level in over four months as a key FDA official leaves the agency while the company awaits the U.S. approval for its Friedreich's ataxia ((F.A.)) therapy, omaveloxolone. Earlier in the day, multiple new...
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Reata Pharmaceuticals ( NASDAQ: RETA ) climbed ~14% on above-average volume on Friday as Wall Street awaits the FDA decision on the company's marketing application for Friedreich's ataxia (FA) therapy, omaveloxolone. A favorable decision could mark a milestone for the clinical-sta...
Summary Reata Pharmaceuticals has submitted a New Drug Application to the US Food and Drug Administration for omaveloxolone, its experimental drug to treat Friedreich's ataxia. PDUFA date is February 28, 2023. The FDA granted the NDA priority review status and conducted a Mid-Cycle Comm...
Summary Shares of gene therapy concern Design Therapeutics fell 33% after releasing its first-ever data in the treatment of Friedreich’s ataxia on December 7, 2022. The market was disappointed by the lack of increase in FXN protein expression, a possibly unrealistic expectation a...
Summary Bardoxolone's Complete Response Letter caused the stock to lose much of its share price last year. The other lead medicine (omaveloxolone) is going to the FDA for Friedrich's Ataxia approval this February. The company is gearing up for what is seemingly a successful in-house...
Summary Reata Pharmaceuticals has an FDA decision (PDUFA) date of February 28 for omaveloxolone. Bardoxolone is in three Phase 3 trials for different types of polycystic kidney disease. The platform and pipeline promise significant revenue by 2030. Reata Pharmaceuticals ( ...
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Laser Photonics Corporation (LASE) is expected to report for Q2 2024 QuickLogic Corporation (QUIK) is expected to report $0.08 for Q3 2023 Stryve Foods Inc. (SNAX) is expected to report $-1.65 for Q3 2023 Reata Pharmaceuticals Inc. (RETA) is expected to report $-2.15 for Q3 2023 V...
Reata Pharmaceuticals Inc. (RETA) is expected to report $-2.15 for Q3 2023
Reata acquisition bolsters Biogen’s rare disease portfolio with the addition of SKYCLARYS ® (omaveloxolone), the first and only FDA approved treatment for Friedreich’s ataxia in the U.S. CAMBRIDGE, Mass., Sept. 26, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (N...