Janney Upgrades Amicus, Says EU Approval 'Likely'

Janney’s Roy Buchanan upgraded the rating for Amicus Therapeutics, Inc. FOLD from Neutral to Buy, while raising the fair value estimate from $10 to $12. He said that although there was uncertainty regarding the FDA’s decision on migalastat in Fabry’s, a CHMP opinion likely in early April would be positive.

“We particularly like the 6-month podocyte data for migalastat, which seems to be a cell type of growing interest based on our observations at the meeting. Podocyte inclusions were clearly improved (p-value 0.02) and other efficacy measures either were significantly correlated (plasma lyso-GB3, p-value 0.02 with inclusion volume) or trended to improvement (urine protein, p-value 0.06),” analyst Roy Buchanan wrote.

Lack Of Clarity

Buchanan mentioned that it was unclear what the FDA would do in the near term is unclear. Moreover, there is lack of clarity into how the amenable mutation assay will be implemented, since Amicus has clinical data on about 50 mutations, assay data on about 250, and a database of about 800 mutations that are disease causing.

Probability Of Success

Buchanan said the probability of success for migalastat had gone up from 50 percent to 70 percent, better reflecting “a good chance” of EU approval. He added that Fabry contributed around 80 percent to Janney’s valuation of Amicus. Moreover, probability of success for Zorblisa for epidermolysis bullosa [EB], which is currently in phase 3, has been increased from 40 percent to 60 percent.