Summary
Amicus Therapeutics received approval from the FDA for their Fabry disease treatment, Galafold.
While FDA approvals are positive news, the approval only unlocks access to a specific corner of the market.
Amicus announced pricing that is relatively high when compared to other options readily available to patients. High prices, combined with a competitor like Sanofi raises, concerns.
All signs point to a dilutive offering and coming declines.
On Friday, the United States Food and Drug Administration (FDA) approved Amicus Therapeutics' (FOLD) New Drug Application (NDA) surrounding GalafoldTM (migalastat) 123 mg capsules, marking the first New Drug Approval in the Fabry disease space in around 15 years. Although the news seemed positive, concerns surrounding pricing and competition led to declines as the market became active on Monday. I believe that these declines represent the tip of the iceberg as the financial blues will likely lead to a dilutive offering ahead.
FDA Approval Only Unlocks Access To A Small Portion Of The Market
The Fabry disease community is a relatively small one. No one knows just how small it is, but it is estimated that there are only around 5,000 diagnosed cases of the condition in the United States. It's also worth mentioning that the FDA only approved the treatment for 348 amenable GLA variants, further limiting the size of the addressable market. To make matters worse, the company made sales harder on itself by pricing Galafold above already well-established competing drugs.
