Amicus Therapeutics

Amicus Therapeutics, Inc. operates as a biotechnology company. The firm focuses on discovering, developing and delivering medicines for people living with metabolic diseases. Its product portfolio includes first and only approved oral precision medicine for people living with Fabry disease who have amenable genetic variants, a novel, clinical-stage, treatment paradigm for Pompe disease and a rare disease gene therapy portfolio. The company was founded by John Francis Crowley on February 4, 2002 and is headquartered in Philadelphia, PA.

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Amicus Therapeutics reports robust revenue growth and eyes AT-GAA launch

Amicus Therapeutics showcased strong performance and growth prospects for Galafold and AT-GAA therapy.
The company aims for non-GAAP profitability in 2023, focusing on key strategic priorities and market expansion.
Challenges include profitability targets, regulatory approvals, and managing production costs for new therapies.
Opportunities lie in the anticipated AT-GAA launch, geographic market expansion, and continued revenue growth.

Amicus Therapeutics reports robust Q1 performance and eyes AT-GAA FDA approval

Amicus Therapeutics delivered strong Q1 results, focusing on revenue growth, regulatory milestones, and financial stability. The company's strengths lie in Galafold sales growth, positive patient outcomes with AT-GAA, and market opportunities in Pompe disease treatment. Challenges include scaling up patient numbers and transitioning manufacturing facilities, while opportunities exist in market expansion and physician engagement.

Amicus Therapeutics excels in Q2, eyes global expansion and profitability

Amicus Therapeutics demonstrates strong financial growth, focusing on expanding market presence and achieving non-GAAP profitability. The company's performance with Galafold and progress on regulatory filings position it well for future success, despite facing challenges in patient transitions and leadership changes.

Amicus Therapeutics reports robust Q3 earnings and growth opportunities

Amicus Therapeutics delivered strong financial results in Q3 2023, with revenue growth and profitability on track, supported by strategic investments and market expansion efforts.
The company's focus on patient-centric approaches, physician engagement, and global market penetration positions it well for future growth and success.
While facing challenges in gene therapy programs and revenue dynamics, Amicus is actively addressing these issues and leveraging opportunities in expanding markets and innovative therapies.
Overall, Amicus Therapeutics remains well-positioned in the biopharmaceutical industry, with a strong foundation for continued growth and impact in treating rare diseases.

Amicus Therapeutics reports strong Q4 earnings and growth opportunities

Amicus Therapeutics delivered strong financial results in Q4 2023, aiming for sustained growth and profitability in 2024 through strategic priorities and successful product launches.
The company faces challenges in forecasting seasonal trends and expanding payer coverage, yet opportunities lie in maximizing patient therapy, leveraging AI advancements, and broadening market reach.
With a focus on rare disease treatments and market penetration, Amicus is poised for growth and intervention strategies to address patient variability and drive revenue in 2024.

Amicus Therapeutics reports strong Q1 performance and growth opportunities

Amicus Therapeutics delivered strong Q1 2024 results, driven by Galafold's performance and a focus on expanding patient numbers for Pombiliti and Opfolda.
While facing challenges such as increased operating expenses and potential manufacturing issues, the company remains confident in its growth trajectory and supply capabilities.
Opportunities lie in revenue expansion, leveraging positive feedback for Pombiliti and Opfolda, and enhancing real-world evidence generation through registries.
Efforts to streamline treatment processes and establish new standards of care position Amicus for continued growth and impact in the rare disease space.

Amicus Therapeutics (FOLD) reports robust Q3 earnings and growth strategies

Amicus Therapeutics (FOLD) delivered strong financial performance in Q3 2024, driven by robust Galafold revenue and strategic focus on patient access.
While facing competitive pressures and regulatory challenges, the company aims to sustain growth through pipeline development and expense management.
Raising financial guidance and exploring accelerated approval opportunities position Amicus for continued success in the genetic medicine market.

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Amicus Therapeutics, Inc. operates as a biotechnology company. The firm focuses on discovering, developing and delivering medicines for people living with metabolic diseases. Its product portfolio includes first and only approved oral precision medicine for people living with Fabry disease who have amenable genetic variants, a novel, clinical-stage, treatment paradigm for Pompe disease and a rare disease gene therapy portfolio. The company was founded by John Francis Crowley on February 4, 2002 and is headquartered in Princeton, NJ.

PHILADELPHIA, May 02, 2023 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that management will participate in a fireside chat at the Bank of America 2023 Health Care Conference in Las Vegas, NV on Thursday, May 11, 2023, at 8:40 a.m. PT.

Amicus Therapeutics to Present at the Bank of America 2023 Health Care Conference

PHILADELPHIA, May 01, 2023 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that the Company will host a conference call and live audio webcast on Wednesday, May 10, 2023, at 8:30 a.m. ET to discuss financial results for the first quarter ended March 31, 2023.

Amicus Therapeutics to Announce First Quarter 2023 Financial Results on May 10, 2023

European Commission Approval of Opfolda and Commercial Launch of Pombiliti ® + Opfolda ® Anticipated in 3Q 2023

Amicus Therapeutics Receives Positive CHMP Opinion for Opfolda® (miglustat) for Late-Onset Pompe Disease

PARIS--(BUSINESS WIRE)-- #FreseniusKabi--Fresenius Kabi today announced the availability of a single-needle venous access option for the Amicus® Extracorporeal Photopheresis (ECP) System at the 49th annual meeting of the European Society for Blood and Marrow Transplantation (EBMT). Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The Amicus Blue System with online ECP was launched in Europe in 2019 with double-needle.

Fresenius Kabi Launches Single-Needle Option for the Amicus® Extracorporeal Photopheresis Protocol

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China's pandemic-era travel restrictions paused approvals on some new drugs. The end of Zero Covid means the pipeline will reopen.

The FDA Is Resuming Drug Lab Inspections in China. These Biotechs Could Benefit.

Amicus (FOLD) receives approval from the European Commission to treat the adult late-onset Pompe disease with Pombiliti (cipaglucosidase alfa).

Amicus (FOLD) Gets Pompe Disease Treatment Approval in Europe

WUXI, China , March 28, 2023 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), congratulates its strategic partner Amicus Therapeutics ("Amicus") (Nasdaq: FOLD) on receiving European Commission's approval for Pombiliti™ (cipaglucosidase alfa), a long-term enzyme replacement therapy (ERT) used in combination with miglustat for adults with late-onset Pompe disease (LOPD). Pombiliti™ was started at WuXi Biologics in 2012 with just an initial concept and now realizes commercialization enabled by WuXi Biologics' proprietary integrated technology platform and unparalleled manufacturing capacity.

WuXi Biologics Congratulates Amicus Therapeutics on European Commission Approval for Pombiliti™ in Patients with Late-Onset Pompe Disease

Approved as a Long-Term Enzyme Replacement Therapy  in Combination with Miglustat for All Adults Living with Late-Onset Pompe Disease

Amicus Therapeutics Announces European Commission Approval for Pombiliti™ in Patients with Late-Onset Pompe Disease

Amicus (FOLD) posts a wider-than-expected fourth-quarter loss but strong sales of its solely marketed drug Galafold drive the top line.

Amicus (FOLD) Q4 Earnings Miss, Galafold Sales Beat Estimates

Amicus Therapeutics. (NASDAQ:FOLD ) Q4 2022 Earnings Conference Call March 1, 2023 8:30 AM ET Company Participants Andrew Faughnan - Vice President, Investor Relations Bradley Campbell - President, Chief Executive Officer Sébastien Martel - Chief Business Officer Jeff Castelli - Chief Development Officer Daphne Quimi - Chief Financial Officer Conference Call Participants Anupam Rama - JPMorgan Ritu Baral - Cowen Tazeen Ahmad - Bank of America Ellie Merle - UBS Joseph Schwartz - SVB Securities Dae Gon Ha - Stifel Yun Zhong - BTIG Gil Blum - Needham Company Zhiqiang Shu - Berenberg Operator Good morning ladies and gentlemen and welcome to the Amicus Therapeutics Full Year 2022 financial results conference call and webcast.

Amicus Therapeutics (FOLD) Q4 2022 Earnings Call Transcript

Amicus Therapeutics (FOLD) delivered earnings and revenue surprises of -46.15% and 1.44%, respectively, for the quarter ended December 2022. Do the numbers hold clues to what lies ahead for the stock?

Amicus Therapeutics (FOLD) Reports Q4 Loss, Tops Revenue Estimates

2022 Revenue Growth of 16% at CER to $329M

Amicus Therapeutics Announces Full-Year 2022 Financial Results and Corporate Updates

PHILADELPHIA, Feb. 27, 2023 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that management will participate in a fireside chat at the Cowen 43rd Annual Health Care Conference in Boston, MA on Monday, March 6, 2023 at 9:50 a.m. E.T.

Amicus Therapeutics to Present at the Cowen 43rd Annual Health Care Conference

Meaningful and Durable Responses in Key Endpoints of Six-Minute Walk, Forced Vital Capacity for ERT-Naïve and ERT-Experienced Participants Out to Two Years

Amicus Therapeutics Announces Positive Long-Term Data from Phase 3 Open-label Extension Study of AT-GAA in Late-Onset Pompe Disease at the 19th Annual WORLDSymposium™ 2023

PHILADELPHIA, Feb. 14, 2023 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that the Company will host a conference call and live audio webcast on Wednesday, March 1, 2023 at 8:30 a.m. ET to discuss financial results for the full-year ended December 31, 2022.

Amicus Therapeutics to Announce Full-Year 2022 Financial Results on March 1, 2023

PHILADELPHIA, Feb. 13, 2023 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), today announced that two oral presentations and 11 posters across its development programs will be included at the 19th Annual WORLDSymposium™ 2023, being held February 22-26, 2023 in Orlando, FL.

Amicus Therapeutics Announces Presentations and Posters at the 19th Annual WORLDSymposium™ 2023

PHILADELPHIA, Feb. 08, 2023 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that management will participate in a fireside chat at the SVB Securities Global Biopharma Conference, being held virtually, on Wednesday, February 15, 2023 at 10:40 a.m. E.T.

Amicus Therapeutics to Present at the SVB Securities Global Biopharma Conference

AT-GAA's US approval is still held up by the China delay. Meanwhile, the company faces the risk of appearing overvalued.

Amicus: While AT-GAA For Pompe Faces Delay, Troubles Slowly Raise Their Heads

Significant Growth in Demand with More Than 2,000 People Living with Fabry Disease on Galafold by End of 2022

Amicus Therapeutics Reports Preliminary 2022 Revenue and Provides 2023 Strategic Outlook

PHILADELPHIA, Jan. 03, 2023 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that Bradley Campbell, President and Chief Executive Officer, will present at the 41st Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Monday, January 9, 2023 at 2:15 p.m. PT.

Amicus Therapeutics to Present at the 41st Annual J.P. Morgan Healthcare Conference

CHMP Adopts Positive Opinion Based Upon Complete Review of all Pre-Clinical, Clinical Studies and CMC Data

Amicus Therapeutics Receives Positive CHMP Opinion for Pombiliti™ (cipaglucosidase alfa) for Late-Onset Pompe Disease

Amicus Therapeutics (FOLD) reported earnings 30 days ago. What's next for the stock?

Why Is Amicus Therapeutics (FOLD) Up 13.7% Since Last Earnings Report?

PHILADELPHIA, Nov. 15, 2022 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that management will participate in a fireside chat at the Stifel 2022 Healthcare Conference in New York, NY on Wednesday, November 16, 2022 at 9:45 a.m. E.T.

Amicus Therapeutics to Present at the Stifel 2022 Healthcare Conference

NEW YORK , Nov. 14, 2022 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Amicus Therapeutics, Inc. ("Amicus" or the "Company") (NASDAQ: FOLD). Such investors are advised to contact Robert S.

News for Amicus Therapeutics Stock (FOLD)