Welcome to our dedicated page for Amicus Therapeut news (Ticker: FOLD), a resource for investors and traders seeking the latest updates and insights on Amicus Therapeut stock.
Amicus Therapeutics was a Nasdaq-listed biotechnology company focused on medicines for rare diseases. Company news centered on Galafold® (migalastat) for adults with Fabry disease who have amenable GLA variants and POMBILITI® + OPFOLDA® for adults with late-onset Pompe disease, including clinical and real-world data presentations, regulatory language, financial results, and corporate updates.
Amicus also reported investor-conference participation, operating performance, material agreements, governance matters, shareholder voting topics, and capital-structure developments. In 2026, the company completed a merger and became a wholly owned subsidiary of BioMarin Pharmaceutical Inc., making later coverage part of its corporate-status history.
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 An archived version of the webcast and presentation materials will be uploaded on the company's website after the event.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.
Amicus Therapeutics (Nasdaq: FOLD) will host a conference call on August 4, 2022, at 8:30 a.m. ET to discuss its financial results for Q2 2022, which ended on June 30, 2022. Participants can access the call by dialing 1-833-634-2601 or 1-412-902-4113 for international callers. A live audio webcast will also be available on the company's investor website. A replay will be accessible for seven days following the event. Amicus focuses on developing therapies for rare metabolic diseases and has a commitment to a robust pipeline of innovative medicines.
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.
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