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28 note to investors, William Blair analysts wrote that Applied Therapeutics suspects the CRL was related to the efficacy package as opposed to [chemistry, manufacturing and controls] or safety. Results from the Phase III ACTION-Galactosemia Kids study, unveiled in April 2023, showed that govorestat fell short of its primary efficacy endpoint, a composite of four clinical measures designed to assess various domains of galactosemia symptoms
The peptide does not appear to significantly affect glucose metabolism or insulin sensitivity in the way that full-length growth hormone does - growth hormone causes insulin resistance through various mechanisms, whereas AOD9604 has been reported to be neutral or possibly even beneficial for insulin sensitivity
Experimental data indicates that the peptide fragment interacts with the 3-adrenergic pathway, which mediates the breakdown of triglycerides into free fatty acids and glycerol within adipose tissue
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A statistically significant increase in cancer was observed in rats receiving semaglutide at all dose levels (greater than 2X human exposure)
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