William Blair still sees approval for Alnylam after briefing docs

William Blair analyst Myles Minter keeps an Outperform rating on Alnylam Pharmaceuticals after the FDA released the briefing documents for the September 13 panel meeting to discuss the company’s application to expand approval for Onpattro to ATTR-cardiomyopathy patients. As expected, the documents highlight questions on meaningfulness of the degree of improvement on the functional 6-minute walk test, lack of powered cardiac outcomes data, and lack of differential benefit in patients receiving the TTR-stabilizer tafamidis from Pfizer (PFE), although the documents do emphasize the characterized safety profile and well-designed and executed clinical study, the analyst tells investors in a research note. Blair continues to expect full approval for Onpattro by the FDA action date of October 8.