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There were no issues with clinical or efficacy data and the FDA is not seeking additional trials or data to support pz-cels application, according to Abeonas announcement

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However, the story is nuancedthe failure of the EVOKE trials testing oral Semaglutide in symptomatic Alzheimers Disease does not invalidate the strong epidemiological signal for GLP-1 agonists in dementia prevention, and SS-31s approval establishes important regulatory precedent for mitochondrial-targeted therapeutics

These results drove enormous interest in tirzepatide and reshaped how clinicians think about peptides for weight loss as a category