Amicus Therapeutics Drug Scores FDA Approval For Rare Inherited Pompe Disease
Portfolio Pulse from Vandana Singh
The FDA has approved Amicus Therapeutics' (NASDAQ:FOLD) Pombiliti and Opfolda for Pompe disease, a rare inherited disease. The two-component therapy is indicated for adults with late-onset Pompe disease who are not improving on their current enzyme replacement therapy. The approval was based on data from the Phase 3 pivotal study (PROPEL). Despite the approval, FOLD shares are down 6.65% at $12.03.

September 28, 2023 | 4:41 pm
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NEGATIVE IMPACT
Despite FDA approval of Amicus Therapeutics' new drug for Pompe disease, the company's shares fell by 6.65%.
The FDA approval of a new drug typically leads to a positive reaction in the stock market. However, in this case, despite the approval, FOLD's shares fell by 6.65%. This could be due to a variety of factors, including market conditions, investor sentiment, or other company-specific news. It's also possible that the approval was already priced into the stock, and the 'sell the news' phenomenon is at play.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100