H.C. Wainwright analyst Andrew Fein keeps a Buy rating on Amylyx Pharmaceuticals with a $35 price target ahead of tomorrow’s FDA panel meeting on AMX0035 for amyotrophic lateral sclerosis. The stock in midday trading is down 5% to $15.15. FDA committees have been overwhelmingly positive when the sponsors have shown clear clinical meaningfulness based on the pre-specified primary analyses along with a favorable safety profile, which are the strengths of Amylyx’s data package, Fein tells investors in a research note. The analyst believes Amylyx has provided convincing data to show that AMX0035 met the pre-specified endpoint and that the drug’s ability to slow the disease progression by 25% is clinically meaningful for the patients. In addition, the odds of a committee voting in favor of approval are 11.3 times higher when committee members are exposed to a positive open public hearing than a negative one, says Fein. The analyst highlights the “overwhelming support” Amylyx has from the patient community for AMX0035. He concludes that “persuasive clinically meaningful data and strong support from patient advocacy groups might favor AMX0035.”