Needham upgrades Amicus to Buy on reduced regulatory risk

Needham upgraded Amicus (FOLD) to Buy from Hold with a $14 price target The FDA’s decision to no longer require a panel meeting for Travere’s (TXTX) Filspari, coupled with last year’s Parasol recommendation and Dimerix’s prior Type C meeting with the FDA, indicate reduction in proteinuria is a suitable primary endpoint for full approval in focal segmental glomerulosclerosis, the analyst tells investors in a research note. The firm believes this lowers the regulatory risk for Amicus’ DMX-200. Despite DMX-200 being a Phase III program with peak sales potential of over $1.5B in the U.S., Amicus’ opportunity in FSGS is not priced into the stock, contends Needham.