Amicus Therapeutics (NASDAQ: FOLD) shares were up 25% at 12:05 p.m. EDT after the biopharmaceutical company disclosed that the Food and Drug Administration is willing to look at the data it currently has to consider approving its Fabry disease treatment, migalastat.
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Things looked a little grim for the company last November, after the FDA told Amicus that it would need more data on how migalastat affects gastrointestinal symptoms before it would consider approving the drug. Considering that Amicus hadn't even started the new trial that would be required to gather that data, it looked like the FDA's decision had pushed back a potential approval by a few years.
But after a few more discussions with regulators, Amicus was able to convince the agency that its current data was good enough to warrant immediate consideration. It appears the company connected the dots for the agency, making the case that since the drug lowers GL-3, and GL-3 is believed to be what causes the pain, kidney failure, heart disease, and strokes, seen in Fabry disease patients, migalastat should help patients.
That logic had been enough to convince regulators to approve the drug in the European Union, where it goes by the brand name of Galafold. The drug is also approved in Israel and Switzerland.
Normally, the FDA accepting a marketing application doesn't say much about a drug's approvability, but considering the amount of time the agency has spent deciding whether Amicus has enough data just to apply, an approval of migalastat now that it has cleared that hurdle seems highly likely.
Unfortunately, there's no discount to be had here; shares are trading higher than they were in November before the initial announcement about the FDA wanting additional data.
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