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.

Permits All Eligible Individuals with Late-Onset Pompe Disease Access to AT-GAA Prior to Marketing Authorization in the UK

Amicus Therapeutics Announces United Kingdom's MHRA Grants Early Access to AT-GAA

PHILADELPHIA, May 28, 2021 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that members of the Amicus senior leadership team will participate in a fireside chat at the Goldman Sachs 42nd Annual Global Healthcare Conference, being held virtually on Wednesday, June 9, 2021 at 5:30 p.m. E.T.

Amicus Therapeutics to Present at the Goldman Sachs 42nd Annual Global Healthcare Conference

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Amicus, Bloomin' Brands, Seagate and More Friday Afternoon Analyst Calls

PHILADELPHIA, May 21, 2021 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), today announced two posters for presentation highlighting its development program for Pompe disease at the 16th International Congress on Neuromuscular Diseases (ICNMD) being held virtually, May 21-22 and 28-29, 2021.

Amicus Therapeutics Announces Upcoming Presentations at the 16th International Congress on Neuromuscular Diseases

Amicus (FOLD) reports a wider Q1 loss and sales miss estimates.

Amicus' (FOLD) Q1 Loss Wider Than Expected, Sales Up Y/Y

Amicus Therapeutics, Inc. (FOLD) CEO John Crowley on Q1 2021 Results - Earnings Call Transcript

Shares of Amicus Therapeutics (NASDAQ:FOLD) rose 0.6% in pre-market trading after the company reported Q1 results. Quarterly Results Earnings per share were up 28.57% over the past year to ($0.25), which missed the estimate of ($0.24).

Recap: Amicus Therapeutics Q1 Earnings

Galafold ® (migalastat) Performance Reflects Continued Strong Adoption in All Key Global Regions; On-Track to Achieve Revenue Guidance of $300M-$315M

Amicus Therapeutics Announces First Quarter 2021 Financial Results and Corporate Updates

PHILADELPHIA, May 07, 2021 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that members of the Amicus senior leadership team will participate in upcoming presentations at the following virtual investor conferences in May:

Amicus Therapeutics to Present at Upcoming Investor Conferences in May 2021

Most Recently Served as Global Head of Rare Diseases at Sanofi Genzyme

Amicus Therapeutics Appoints Sébastien Martel as Senior Vice President of Strategy and Business Development

Amicus Therapeutics (FOLD) doesn't possess 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) May Report Negative Earnings: Know the Trend Ahead of Next Week's Release

Amicus Therapeutics Inc (NASDAQ: FOLD) has completed a Type B Pre-Biologics License Application (BLA) meeting with the FDA for AT-GAA (cipaglucosidase alfa co-administered with miglustat) for Pompe disease. Based on this formal pre-BLA meeting and the final written communication received from the FDA, Amicus intends to complete the rolling submission for cipaglucosidase alfa and submit a marketing application for miglustat.

Amicus Therapeutics Concludes Pre-BLA Meeting With FDA For AT-GAA In Pompe Disease

Great Place to Work® Certification in the United Kingdom, Spain, Italy and Germany Great Place to Work® Certification in the United Kingdom, Spain, Italy and Germany

Amicus Therapeutics Recognized as a Great Place to Work® in Europe

PHILADELPHIA, April 26, 2021 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that the Company will host a conference call and live audio webcast on Monday, May 10, 2021 at 8:30 a.m. ET to discuss financial results for the first quarter ended March 31, 2021.

Amicus Therapeutics to Announce First Quarter 2021 Financial Results on May 10, 2021

Investors cheered an analyst's upgrade of the biotech stock.

Why Amicus Therapeutics Stock Is Soaring Today

Amicus (FOLD) reports a wider-than-expected Q4 loss but sales beat estimates.

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

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With the trading day more than halfway over, the broad markets pulled back from their impressive start to the week.

Carnival, Royal Caribbean, Switch and More Tuesday Afternoon Analyst Calls

Amicus Therapeutics' (FOLD) CEO John Crowley on Q4 2020 Results - Earnings Call Transcript

Shares of Amicus Therapeutics (NASDAQ:FOLD) moved higher by 0.2% in pre-market trading after the company reported Q4 results. Quarterly Results Earnings per share rose 22.86% over the past year to ($0.27), which missed the estimate of ($0.23).

Amicus Therapeutics: Q4 Earnings Insights

Amicus Therapeutics (NASDAQ:FOLD) unveils its next round of earnings this Monday, March 01. Get prepared with Benzinga's ultimate preview for Amicus Therapeutics's Q4 earnings.

Earnings Preview for Amicus Therapeutics

Will Amicus Therapeutics (FOLD) Report Negative Earnings Next Week? What You Should Know

Amicus Therapeutics said Thursday its rare-disease treatment failed to outperform a standard drug on one key measure in a Phase 3 test. In response, FOLD stock plunged on Friday.

Why This Rare-Disease Biotech Stock Just Lost A Third Of Its Value

Amicus Stock Plunges After Rare-Disease Drug Misses In Key Study

Shares of Amicus Therapeutics Inc. were down 23.1% in premarket trading on Friday, the day after the company said an experimental rare disease drug failed to perform better than the standard of care in a late-stage trial. The investigational drug, AT-GAA, is a treatment for Pompe disease, a rare, genetic disease that causes severe muscle weakness.

SVB Leerink, J.P. Morgan downgrade Amicus stock after Phase 3 data for rare disease drug comes out

Rolling BLA submission for AT-GAA planned for completion in Q2 and other global regulatory submissions for approval expected throughout 2021

Amicus' AT-GAA Shows Clinically Meaningful & Significant Improvements in Both Musculoskeletal and Respiratory Measures in Late-Onset Pompe Disease Compared to Standard of Care in Pivotal Phase 3 PROPEL Study

News for Amicus Therapeutics Stock (FOLD)