Amicus Therapeutics, Inc - FOLD STOCK NEWS

Amicus Therapeutics (Nasdaq: FOLD) announced the positive opinion from the European Medicines Agency's CHMP for its two-component therapy, Opfolda (miglustat) combined with Pombiliti (cipaglucosidase alfa). This approval positions Pombiliti + Opfolda as the first two-component therapy for late-onset Pompe disease in the EU, anticipated to be fully approved by Q3 2023. The therapy aims to address a significant medical need for adults with late-onset Pompe disease, with clinical data suggesting meaningful improvements in patient outcomes. The CHMP's recommendation is based on Phase 3 trial results, which included both ERT-experienced and naïve patients. The company is preparing for a country-by-country reimbursement and launch process, highlighting the potential to establish a new standard of care in Pompe disease.

WuXi Biologics has announced its partnership with Amicus Therapeutics in celebrating the European Commission's approval of Pombiliti™ (cipaglucosidase alfa) for adults with late-onset Pompe disease. This therapy, a combined treatment with miglustat, is a significant milestone achieved through WuXi's advanced manufacturing capabilities since the therapy's inception in 2012. The approval is based on clinical data from the Phase 3 PROPEL trial, which included a diverse patient population. WuXi Biologics continues to support commercialization through its global sourcing strategy, reinforcing its position as a leader in biologics development.

Amicus Therapeutics (Nasdaq: FOLD) announced that the European Commission has approved Pombiliti™ (cipaglucosidase alfa) for use as a long-term enzyme replacement therapy in combination with miglustat for adults with late-onset Pompe disease (LOPD). This approval is based on positive clinical data from the Phase 3 PROPEL study, which included patients needing ERT. The company believes that AT-GAA could redefine standards of care for LOPD by providing significant therapeutic benefits. A CHMP opinion for miglustat is expected in Q2 2023, marking a potential advance in treatment options for this rare condition.

Amicus Therapeutics (FOLD) reported a 16% revenue growth in 2022, totaling $329.2M, with projected Galafold revenue growth of 12-17% for 2023. The company expects non-GAAP profitability in the second half of 2023, driven by robust demand for Galafold and successful launches of AT-GAA for Pompe disease. A U.S. FDA pre-approval inspection for AT-GAA is scheduled with approvals anticipated in Q3 2023. Financials show a net loss of $236.6M in 2022, an improvement from $250.5M in 2021. Despite challenges, Amicus is focused on sustaining growth and expanding its product offerings.

Amicus Therapeutics (Nasdaq: FOLD) will participate in a fireside chat at the Cowen 43rd Annual Health Care Conference in Boston on March 6, 2023, at 9:50 a.m. E.T. Investors can access a live audio webcast of the presentation via the company’s investors section on its website. Amicus Therapeutics is dedicated to developing high-quality medicines for rare diseases, showcasing a strong patient focus and commitment to innovation. For more information, interested parties can visit the corporate website or follow the company on social media platforms.

Amicus Therapeutics (Nasdaq: FOLD) announced positive results from its Phase 3 OLE study (ATB200-07) for AT-GAA, targeting late-onset Pompe disease. Patients showed significant improvements in six-minute walk distance (6MWD) and stable pulmonary function after 104 weeks. Biomarker reductions indicate a beneficial effect on muscle tissue. The safety profile of AT-GAA remains consistent with prior data, showing mostly mild to moderate adverse events. The findings will be presented at the 2023 WORLD Symposium. This data fosters optimism that AT-GAA could set a new standard of care for Pompe disease.

Amicus Therapeutics (Nasdaq: FOLD) has announced a conference call and live audio webcast scheduled for March 1, 2023, at 8:30 a.m. ET to discuss its financial results for the year ended December 31, 2022. Investors can register for the call through an online form and will receive details for dial-in access. A live audio webcast and presentation materials will also be available on the company’s investor website. An archived version of the webcast will be accessible shortly after the event. Amicus Therapeutics is focused on developing novel medicines for rare diseases.

Amicus Therapeutics (Nasdaq: FOLD) announced its participation in the 19th Annual WORLDSymposium™ 2023 from February 22-26 in Orlando, FL. The company will present two oral presentations and showcase 11 posters related to its Pompe and Fabry disease programs. Key presentations include long-term studies on cipaglucosidase alfa/miglustat's efficacy and safety for Pompe disease. Notable presenters include Barry Byrne and Benedikt Schoser, highlighting ongoing research and development in rare diseases. The event aims to share advancements in lysosomal disease management and foster interdisciplinary collaboration among researchers and clinicians.