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 Inc. ( FOLD , Financial) is the poster child for the malaise affecting small biotechs, especially those working on gene and cell therapy. Owners of the stock are hoping the company's symbol isn't a portent of things to come.

Amicus Therapeutics Among Small Biotechs Cutting Back

Amicus Therapeutics Inc (NASDAQ: FOLD) has announced additional results from a Phase 1/2 clinical study of AT-GAA in adult patients with Pompe disease. Study participants treated with AT-GAA for up to 36 months showed persistent and durable effects on six-minute walk test (6MWT).

Amicus Shares Encouraging Long-Term Data Of AT-GAA Study In Pompe Disease

Meaningful and Durable Responses in Key Endpoints of Six-Minute Walk and Forced Vital Capacity

Amicus Therapeutics Announces Positive Long-Term Data from Phase 1/2 Study of AT-GAA in Pompe Disease at the 2022 MDA Clinical & Scientific Conference

PHILADELPHIA, March 10, 2022 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), today announced one oral presentation and two posters highlighting its development program for Pompe disease will be included at the 2022 MDA Clinical & Scientific Conference, being held March 13-16, 2022 in Nashville, TN and virtually.

Amicus Therapeutics Announces Presentation and Posters at the 2022 MDA Clinical & Scientific Conference

PHILADELPHIA, March 01, 2022 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that members of the Amicus senior leadership team will participate in a fireside chat at the Cowen 42nd Annual Health Care Conference on Tuesday, March 8, 2022 at 9:10 a.m. E.T.

Amicus Therapeutics to Present at the Cowen 42nd Annual Health Care Conference

Amicus Therapeutics' (FOLD) CEO John Crowley on Q4 2021 Results - Earnings Call Transcript

Galafold ®  Revenue Growth of 17% YoY to $306M in 2021

Amicus Therapeutics Announces Full-Year 2021 Financial Results and Corporate Updates

Amicus Therapeutics Inc (NASDAQ: FOLD) has terminated its plans to spin off its gene therapy assets, citing 'existing market conditions.' With "market conditions" sinking the planned merger with ARYA Sciences Acquisition Corp IV (NASDAQ: ARYD), Amicus plans to.

Gene Therapy Player Amicus Therapeutics Terminates SPAC Merger, Shares Fall

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: What to Know Ahead of Q4 Release

PHILADELPHIA, Feb. 10, 2022 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that the Company will host a conference call and live audio webcast on Thursday, February 24, 2022 at 8:30 a.m. ET to discuss financial results for the full year ended December 31, 2021.

Amicus Therapeutics to Announce Full-Year 2021 Financial Results on February 24, 2022

PHILADELPHIA, Feb. 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 announced that two oral presentations and 11 posters across its development programs will be included at the 18th Annual WORLDSymposium™ 2022, being held February 7-11, 2022 in San Diego, CA.

Amicus Therapeutics Announces Presentations and Posters at the 18th Annual WORLDSymposium™ 2022

The Pompe data doesn't give 100% confidence for approval. However, there are positive aspects to the data, as we discuss here.

Amicus Therapeutics: PDUFA In 6 Months

Amicus Therapeutics (FOLD) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.

Amicus Therapeutics (FOLD) Stock Jumps 6.4%: Will It Continue to Soar?

Full-Year 2021 Galafold ® Revenue of ~$306M, Representing 17% YoY Growth

Amicus Therapeutics Reports Preliminary 2021 Revenue and Provides 2022 Strategic Outlook and Revenue Guidance

PHILADELPHIA, Jan. 05, 2022 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that management will present at the 40th Annual J.P. Morgan Healthcare Conference, being held virtually on Wednesday, January 12, 2022 at 3:45 p.m. E.T.

Amicus Therapeutics to Present at the 40th Annual J.P. Morgan Healthcare Conference

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The European Medicines Agency accepts Amicus Therapeutics' (FOLD) MAA for AT-GAA, a potential treatment for Pompe disease.

Amicus (FOLD) Filings for AT-GAA in Pompe Disease Accepted by EMA

PHILADELPHIA, Dec. 03, 2021 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that the European Medicines Agency (EMA) validated the Marketing Authorization Applications (MAA) for AT-GAA, the Company's investigational two-component therapy for the treatment of Pompe disease. Validation of the application confirms the submission is accepted, and the EMA's centralized procedure with Committee for Medicinal Products for Human Use (CHMP)'s assessment begins.

European Medicines Agency Validates Amicus Therapeutics Marketing Authorization Applications for AT-GAA for the Treatment of Pompe Disease

PHILADELPHIA, Nov. 24, 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 4th Annual Evercore ISI HealthCONx Virtual Conference on Wednesday, December 1, 2021 at 8:50 a.m. E.T.

Amicus Therapeutics to Present at the 4th Annual Evercore ISI HealthCONx Virtual Conference

PHILADELPHIA, Nov. 22, 2021 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), today announced two digital posters for presentation at the 14th International Congress of Inborn Errors of Metabolism (ICIEM) being held virtually and in Sydney, Australia, November 21-23, 2021.

Amicus Therapeutics Announces Presentations at the 14th International Congress of Inborn Errors of Metabolism

Peer Reviewed Results from PROPEL Show Treatment with AT-GAA Provided Clinically Meaningful Improvements Over Standard of Care, including ERT Experienced Patients with High Unmet Need

The Lancet Neurology Publishes Pivotal Phase 3 PROPEL Study Results of AT-GAA in Late-Onset Pompe Disease

PHILADELPHIA, Nov. 11, 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 Stifel 2021 Virtual Healthcare Conference on Tuesday, November 16, 2021 at 8:00 a.m. E.T.

Amicus Therapeutics to Present at the Stifel 2021 Virtual Healthcare Conference

Amicus (FOLD) misses both Q3 earnings and revenue estimates. Resultantly, the stock price falls.

Amicus (FOLD) Stock Down on Q3 Earnings and Revenue Miss

Amicus Therapeutics' (FOLD) CEO John Crowley on Q3 2021 Results - Earnings Call Transcript

Amicus Therapeutics (FOLD) delivered earnings and revenue surprises of -5.56% and -2.30%, respectively, for the quarter ended September 2021. Do the numbers hold clues to what lies ahead for the stock?

News for Amicus Therapeutics Stock (FOLD)