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.

Amicus Therapeutics (FOLD) posts a narrower-than-expected loss in the third quarter. FOLD's sole marketed drug Galafold's solid sales drive the top line.

Amicus (FOLD) Q3 Earnings Beat, Galafold Sales Miss Estimates

Amicus Therapeutics Inc. (NASDAQ:FOLD ) Q3 2022 Earnings Conference Call November 7, 2022 8:30 AM ET Company Participants Bradley Campbell - President, Chief Executive Officer Sébastien Martel - Chief Business Officer Jeff Castelli - Chief Development Officer Daphne Quimi - Chief Financial Officer Andrew Faughnan - Executive Director, Investor Relations Conference Call Participants Ritu Baral - Cowen Anupam Rama - JP Morgan Joseph Schwartz - SVB Securities Tazeen Ahmad - Bank of America Sarah - UBS Dae Gon Ha - Stifel Salveen Richter - Goldman Sachs Yun Zhong - BTIG Gil Blum - Needham & Co. Operator Good morning ladies and gentlemen and welcome to the Amicus Therapeutics third quarter 2022 financial results conference call and webcast. At this time, all participants are in a listen-only mode.

Amicus Therapeutics (FOLD) Q3 2022 Earnings Call Transcript

PHILADELPHIA, Nov. 07, 2022 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, today provided an EU regulatory update for AT-GAA. Earlier this morning, the Committee for Medicinal Products for Human Use (CHMP) issued the agenda for their November meeting indicating possible oral explanations for miglustat and for cipaglucosidase alfa on November 9th. The Company has now been informed that oral explanations will not take place as originally anticipated. The Company continues to prepare for a CHMP opinion on AT-GAA as early as December 2022 and will assess any potential change in timelines.

Amicus Therapeutics Provides EU Regulatory Update for AT-GAA

Amicus Therapeutics (FOLD) delivered earnings and revenue surprises of 36.84% and 3.38%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?

Amicus Therapeutics (FOLD) Reports Q3 Loss, Misses Revenue Estimates

Year-to-Date 2022 Reported Revenue Growth of 8% (16% at CER)

Amicus Therapeutics Announces Third Quarter 2022 Financial Results and Corporate Updates

Amicus approval gets delayed again because the FDA cannot inspect a Chinese facility. China's zero COVID policy is to blame.

Amicus: Another Day, Another Delay, Pretty Much The Same Silly Reason

FDA Issues Deferred Action Letter on AT-GAA Regulatory Filing Due to the Inability  to Conduct Required Manufacturing Site Inspection Prior to the PDUFA Action Date

U.S. FDA Defers Action on Filing for AT-GAA in Late-onset Pompe Disease

PHILADELPHIA, Oct. 27, 2022 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that the Company will host a conference call and live audio webcast on Monday, November 7, 2022 at 8:30 a.m. ET to discuss financial results for the third quarter ended September 30, 2022.

Amicus Therapeutics to Announce Third Quarter 2022 Financial Results on November 7, 2022

PHILADELPHIA, Oct. 11, 2022 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), today announced four poster presentations highlighting its development program for Pompe disease will be included at the 27th International Hybrid Annual Congress of the World Muscle Society, being held October 11-15, 2022 both virtually and in Halifax, Canada.

Amicus Therapeutics Announces Participation at World Muscle Society 2022

PHILADELPHIA, Sept. 21, 2022 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), today announced three poster presentations highlighting its development program for Pompe disease will be included at the 2022 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting, being held September 21-24, 2022 in Nashville, TN and virtually.

Amicus Therapeutics Announces Participation at the 2022 AANEM Annual Meeting

PHILADELPHIA, Sept. 08, 2022 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that management will participate in a fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference in New York, NY on Wednesday, September 14, 2022 at 12:20 p.m. E.T.

Amicus Therapeutics to Present at the Morgan Stanley 20th Annual Global Healthcare Conference

Amicus Therapeutics' AT-GAA approval in Pompe Disease has been pushed back by 3 months. However, the stock seems buoyant enough.

Amicus Therapeutics: AT-GAA Approval Delayed, I Will Continue Holding

Amicus Therapeutics (FOLD) posts a narrower-than-expected loss for the second quarter. FOLD's sole marketed drug Galafold's solid sales drive the top line.

Amicus (FOLD) Q2 Earnings Beat, Galafold Sales Miss Estimates

Amicus Therapeutics, Inc. (NASDAQ:FOLD ) Q2 2022 Earnings Conference Call August 4, 2022 8:30 AM ET Company Participants Andrew Faughnan - Senior Director, IR Bradley Campbell - CEO, President & Director Sebastien Martel - Chief Business Officer Jeffrey Castelli - Chief Development Officer Daphne Quimi - CFO Conference Call Participants Anupam Rama - JPMorgan Chase & Co. Ritu Baral - Cowen and Company Joseph Schwartz - SVB Securities Dae Gon Ha - Stifel Zhiqiang Shu - Berenberg Ellie Merle - UBS Operator Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics Second Quarter 2022 Financial Results Conference Call and Webcast. [Operator Instructions].

Amicus Therapeutics, Inc. (FOLD) CEO Bradley Campbell on Q2 2022 Results - Earnings Call Transcript

Amicus Therapeutics (FOLD) delivered earnings and revenue surprises of 8.70% and 5.16%, respectively, for the quarter ended June 2022. Do the numbers hold clues to what lies ahead for the stock?

Amicus Therapeutics (FOLD) Reports Q2 Loss, Lags Revenue Estimates

1H22 Galafold ® Revenue of $159.4M, reflecting 11% Sales Growth  with Operational Growth of 18%, Partly Offset by Currency Headwinds of 7%

Amicus Therapeutics Announces Second Quarter 2022 Financial Results

Amicus Therapeutics (FOLD) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Amicus Therapeutics (FOLD) Expected to Beat Earnings Estimates: Should You Buy?

PHILADELPHIA, July 26, 2022 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that the Company will host a conference call and live audio webcast on Thursday, August 4, 2022 at 8:30 a.m. ET to discuss financial results for the second quarter ended June 30, 2022.

Amicus Therapeutics to Announce Second Quarter 2022 Financial Results on August 4, 2022

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

Why Is Amicus Therapeutics (FOLD) Up 25.1% Since Last Earnings Report?

PHILADELPHIA, June 08, 2022 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that management will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference in Rancho Palos Verdes, CA on Wednesday, June 15, 2022 at 11:20 a.m. P.T.

Amicus Therapeutics to Present at the Goldman Sachs 43rd Annual Global Healthcare Conference

Currently, Amicus Therapeutics (FOLD) has only one marketed product in its portfolio, the Fabry disease drug Galafold. The FDA is reviewing FOLD's filings that seek approval for Pompe disease.

Amicus' (FOLD) Galafold Aids Growth, Overdependence a Woe

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PHILADELPHIA, May 10, 2022 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by 90 days for the Biologics License Application (BLA) for cipaglucosidase alfa and the New Drug Application (NDA) for miglustat, the two components of AT-GAA. The revised PDUFA action dates for miglustat and cipaglucosidase alfa are August 29, 2022 and October 29, 2022, respectively. The Company continues to expect the FDA to approve the applications together.

Amicus Therapeutics Receives Notification of PDUFA Date Extensions for AT-GAA

Amicus Therapeutics (FOLD) posts a wider-than-expected loss for the first quarter. FOLD's sole marketed drug Galafold's solid sales drive the top line.

Amicus (FOLD) Q1 Earnings Miss, Galafold Sales Top Estimates

Amicus Therapeutics, Inc. (NASDAQ:FOLD ) Q1 2022 Earnings Conference Call May 9, 2022 8:30 AM ET Company Participants Andrew Faughnan - Executive Director-Investor Relations John Crowley - Chairman and Chief Executive Officer Bradley Campbell - President and Chief Operating Officer Daphne Quimi - Chief Financial Officer Jeffrey Castelli - Chief Development Officer Conference Call Participants Ritu Baral - Cowen Anupam Rama - JPMorgan Ellie Merle - UBS Beth Feindt-Scott - SVB Leerink Kristen Kluska - Cantor Fitzgerald Dae Gon Ha - Stifel Salveen Richter - Goldman Sachs Yun Zhong - BTIG Operator Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics' First Quarter 2022 Financial Results Conference Call and Webcast. At this time, all participants are in a listen-only mode.

News for Amicus Therapeutics Stock (FOLD)