Amicus Therapeut Stock Price, News & Analysis

Amicus Therapeutics (Nasdaq: FOLD) will participate in a fireside chat at the Stifel 2022 Healthcare Conference on November 16, 2022, at 9:45 a.m. E.T., held in New York, NY. Investors can access a live audio webcast of the presentation through the investors section of the Amicus corporate website. The company is dedicated to developing innovative medicines for rare diseases, emphasizing a strong commitment to patient care and a robust pipeline of first- or best-in-class treatments. For more details, visit the Amicus website or follow them on social media.

Amicus Therapeutics (Nasdaq: FOLD) announced an update regarding its investigational therapy AT-GAA. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has altered its agenda for its November meeting, indicating that oral explanations for miglustat and cipaglucosidase alfa will not occur as previously expected on November 9. Despite this setback, Amicus remains focused on preparing for a potential CHMP opinion on AT-GAA by December 2022 and will evaluate any changes to the anticipated timelines.

Amicus Therapeutics (Nasdaq: FOLD) reported a 3% increase in Q3 2022 revenue, totaling $81.7 million, with operational growth at 14% at constant exchange rates. Year-to-date revenue grew by 8% and is on track for 15-20% growth for the full year. Non-GAAP operating expenses guidance has been updated to $430-$440 million, down from $470-$485 million. The company anticipates non-GAAP profitability in H2 2023. Regulatory reviews for AT-GAA for Pompe disease are progressing, with an EU opinion expected in December 2022, while FDA actions are deferred due to inspection delays.

The FDA has issued a deferred action letter regarding Amicus Therapeutics' Biologics License Application for cipaglucosidase alfa, a key component of AT-GAA, due to COVID-19 travel restrictions preventing a required manufacturing site inspection. The company is committed to working with the FDA to finalize plans for this inspection. The FDA has not provided any anticipated action dates while monitoring the public health situation. Despite this setback, Amicus remains optimistic about the approval timeline for AT-GAA and is also pleased with the progress of its review in the EU, expecting a CHMP opinion by year-end.

Amicus Therapeutics (Nasdaq: FOLD) announced a conference call on November 7, 2022, at 8:30 a.m. ET, to discuss its third-quarter financial results for the period ending September 30, 2022. Interested participants can register online for phone access and a live audio webcast will also be available via the company’s investor relations page. An archived version of the webcast and presentation materials will be uploaded on the company's website after the event.

Amicus Therapeutics (Nasdaq: FOLD) announced that four poster presentations showcasing its Pompe disease development program will be presented at the 27th International Hybrid Annual Congress of the World Muscle Society from October 11-15, 2022, in Halifax, Canada. The presentations include long-term studies and patient surveys highlighting the impacts of Pompe disease. Notable abstracts focus on treatment comparisons and patient experiences during the COVID-19 pandemic. The posters will be accessible on Amicus's website following the congress.

Amicus Therapeutics (Nasdaq: FOLD) announced that three poster presentations on its Pompe disease program will be featured at the 2022 AANEM Annual Meeting, occurring from September 21-24 in Nashville, TN. The studies include an open-label Phase I/II trial of cipaglucosidase alfa/miglustat, a Phase III study on immunogenicity compared to alglucosidase alfa, and an analysis of pharmacokinetic profiles. The posters will be published on the company's website following the presentations, underscoring its commitment to innovative therapies for rare metabolic diseases.

Amicus Therapeutics (Nasdaq: FOLD) announced participation in a fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference, scheduled for September 14, 2022, at 12:20 p.m. E.T. in New York City. The event will be accessible via a live audio webcast on the company’s investor relations website. Amicus Therapeutics focuses on developing innovative therapies for rare metabolic diseases, emphasizing high-quality patient care and a commitment to expanding its pipeline of medicines.

Amicus Therapeutics (Nasdaq: FOLD) reported Galafold revenue of $159.4 million for H1 2022, showing an 11% increase year-over-year, driven by 18% operational growth, despite a 7% currency impact. The company anticipates a full-year revenue growth of 15-20% at constant exchange rates. Key regulatory reviews for AT-GAA are advancing, with FDA action dates set for August 29 and October 29, 2022. Amicus has strengthened its patent portfolio with 17 new U.S. patents and aims for non-GAAP profitability by 2023. Cash reserves stood at $386.8 million as of June 30, 2022.