Amicus Therapeut Stock Price, News & Analysis

Amicus Therapeutics (Nasdaq: FOLD) will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference on June 15, 2022, at 11:20 a.m. P.T. The event will be held in Rancho Palos Verdes, CA. Investors can access a live audio webcast of the presentation on the company's investor relations website. Amicus focuses on developing innovative medicines for rare metabolic diseases, showcasing its commitment to patient-centered care and a robust pipeline of novel treatments.

Amicus Therapeutics (Nasdaq: FOLD) announced a 90-day extension to the FDA review period for the Biologics License Application (BLA) of cipaglucosidase alfa and the New Drug Application (NDA) for miglustat, both components of AT-GAA. The new action dates are August 29, 2022, and October 29, 2022, respectively. This extension allows additional time for the FDA to review submitted information and to complete pre-license inspections at the manufacturing site. The company remains optimistic about FDA approval for AT-GAA as a treatment for Pompe disease.

Amicus Therapeutics reported a strong first quarter of 2022, with Galafold® revenue reaching $78.7 million, an 18.5% year-over-year increase. The company strengthened its intellectual property with new patents extending protection through 2038. Regulatory reviews for AT-GAA in Pompe Disease are progressing, with the FDA's action dates set for May 29 and July 29, 2022. Amicus anticipates continued double-digit growth for Galafold, projecting $350 million to $365 million in revenue for the year. However, the net loss for the quarter was $85.3 million.

Amicus Therapeutics (Nasdaq: FOLD) announced participation in a fireside chat at the Bank of America 2022 Healthcare Conference on May 11, 2022, at 12:00 p.m. P.T. The event will take place in Las Vegas, NV. A live audio webcast will be available on the company's investor website. Amicus Therapeutics is dedicated to developing novel therapies for rare metabolic diseases, focusing on patient needs and advancing a robust pipeline of innovative medicines. For further details, visit their website or access the webcast.

Amicus Therapeutics (Nasdaq: FOLD) will host a conference call and live audio webcast on May 9, 2022, at 8:30 a.m. ET to discuss financial results for Q1 2022, covering the period ended March 31, 2022. Investors can participate by calling 877-303-5859 (U.S./Canada) or 678-224-7784 (international) and using conference ID 7867383. Additionally, a replay will be available for seven days post-call. The company focuses on developing innovative therapies for rare metabolic diseases and is dedicated to patient-centric care. For further information, visit their corporate website.

Amicus Therapeutics (Nasdaq: FOLD) announced the issuance of U.S. Patent No. 11,304,940, extending patent protection for Galafold (migalastat) through 2038. This new patent focuses on methods to treat Fabry disease patients with renal impairments and is part of a total of 35 issued patents in the U.S. for Galafold. CEO John Crowley emphasized the significance of this patent in strengthening the company’s intellectual property portfolio, which supports ongoing commercialization efforts of this novel precision medicine.

Amicus Therapeutics (Nasdaq: FOLD) released promising results from its Phase 1/2 study of AT-GAA for Pompe disease. Over 36 months, participants showed significant improvements in motor function, six-minute walk test distances, and reductions in muscle damage biomarkers. The therapy's safety profile remains consistent with prior data. Regulatory reviews are ongoing, with the FDA's PDUFA dates set for May 29 and July 29, 2022. The data may position AT-GAA as a new standard of care for Pompe disease, addressing both ERT-experienced and ERT-naïve patients.

Amicus Therapeutics (Nasdaq: FOLD) announced that its development program for Pompe disease will be featured in an oral presentation and two posters at the 2022 MDA Clinical & Scientific Conference. The oral presentation titled Long-term follow-up of cipaglucosidase alfa/miglustat is scheduled for March 16, 2022. In addition, two posters will discuss Immunogenicity of cipaglucosidase alfa versus alglucosidase alfa and the impact of COVID-19 on patients living with Pompe disease. Presentations will be available on the company’s website after the conference.