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.

The FDA has accepted for review Amicus Therapeutics Inc's (NASDAQ: FOLD) Biologics License Application (BLA) for cipaglucosidase alfa and the New Drug Application (NDA) for miglustat for AT-GAA. Also Read:   Amicus's Fabry Disease Medicine Gets European Approval For Use In Adolescents

Why Are Amicus Therapeutics Shares Trading Higher Today?

FDA Sets PDUFA Target Action Date of May 29, 2022 for the New Drug Application and  July 29, 2022 for the Biologics License Application

U.S. FDA Accepts Filings for Amicus' AT-GAA for the Treatment of Pompe Disease

Business Combination of Amicus Gene Therapy Business with ARYA IV to Result  in the Launch of Caritas Therapeutics, a New Independent, Publicly Traded Company  with Expected ~$400M in Initial Funding

Amicus Therapeutics and ARYA Sciences Acquisition Corp IV Announce Formation of a Next-Generation Genetic Medicine Company: “Caritas Therapeutics”

PHILADELPHIA, Sept. 03, 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 September:

Amicus Therapeutics to Present at Upcoming Investor Conferences in September 2021

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Amicus (FOLD) reports narrower-than-expected Q2 loss. The sales figure also beat estimates.

Amicus (FOLD) Q2 Earnings & Revenues Top Estimates, Stock Up

Amicus Therapeutics, Inc. (FOLD) CEO John Crowley on Q2 2021 Results - Earnings Call Transcript

2Q21 Total Galafold ® (migalastat) Revenue of $77.4M, a 24% increase over 2Q20

Amicus Therapeutics Announces Second Quarter 2021 Financial Results and Corporate Updates

PHILADELPHIA, Aug. 04, 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 BTIG Virtual Biotechnology Conference on Monday, August 9, 2021 at 9:00 a.m. E.T.

Amicus Therapeutics to Present at the BTIG Virtual Biotechnology Conference

The European Commission has approved Amicus Therapeutics Inc (NASDAQ: FOLD) Galafold (migalastat) for use in adolescents with Fabry disease who have an amenable mutation.  Galafold is already approved in the U.S., EU, and Japan for adults who have an amenable variant or mutation.

Amicus's Fabry Disease Medicine Gets European Approval For Use In Adolescents

Galafold® is the First and Only Oral Therapy Approved in the EU for the Long-term Treatment of Adolescents with Fabry Disease Aged 12 years and older with an Amenable Mutation Galafold® is the First and Only Oral Therapy Approved in the EU for the Long-term Treatment of Adolescents with Fabry Disease Aged 12 years and older with an Amenable Mutation

Amicus Therapeutics Announces European Commission Approval of Galafold® (migalastat) for Adolescents with Fabry Disease

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.

Analysts Estimate Amicus Therapeutics (FOLD) to Report a Decline in Earnings: What to Look Out for

PHILADELPHIA, July 27, 2021 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that the Company will host a conference call and live audio webcast on Thursday, August 5, 2021 at 8:30 a.m. ET to discuss financial results for the second quarter ended June 30, 2021.

Amicus Therapeutics to Announce Second Quarter 2021 Financial Results on August 5, 2021

Amicus produced mixed results in the PROPEL trial.

Amicus Therapeutics: The Pompe Data Slump Was An Overreaction

PHILADELPHIA, June 14, 2021 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), today announced the election and appointment of Eiry W. Roberts, M.D. to its Board of Directors. Dr. Roberts is an esteemed drug developer who brings approximately 30 years of pharmaceutical industry experience to the Company's Board of Directors, having served in various leadership positions throughout her career and bringing extensive experience advancing therapies across all phases of drug development.

Amicus Therapeutics Appoints Eiry W. Roberts, M.D.

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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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

News for Amicus Therapeutics Stock (FOLD)