Amicus Therapeutics Stock | Analysis for December 2025, Price & Rating

Amicus Therapeutics

NasdaqGM:FOLD

$ 14,25

$0,00 (0,00%)

14,25 $

$0,00 (0,00%)

End-of-day quote: 12/25/2025

Amicus Therapeutics Stock Value

The analyst rating for NasdaqGM:FOLD is currently Buy.

Buy

Amicus Therapeutics Company Info

EPS Growth 5Y

16,90%

Market Cap

$4,40 B

Long-Term Debt

$0,39 B

Short Interest

3,66%

Annual earnings

02/18/2026

Dividend

$0,00

Dividend Yield

0,00%

Founded

2002

Industry

Health Care

Country

United States

ISIN Number

US03152W1099

Website

http://amicusrx.com

Analyst Price Target

$14,75

3.51%

Last Update: 12/26/2025

Analysts: 6

Highest Price Target $17,00

Average Price Target $14,75

Lowest Price Target $14,50

In the last five quarters, Amicus Therapeutics’s Price Target has fallen from $18,01 to $15,82 - a -12,16% decrease. Seven analysts predict that Amicus Therapeutics’s share price will increase in the coming year, reaching $14,75. This would represent an increase of 3,51%.

Top growth stocks in the health care sector (5Y.)

What does Amicus Therapeutics do?

Amicus Therapeutics, Inc. (Amicus) is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering novel medicines for rare diseases. The company's two marketed therapies are Galafold, the first oral monotherapy for people living with Fabry disease who have amenable genetic variants; and Pombiliti + Opfolda, a novel two-component treatment for adults living with late-onset Pompe disease. Galafold (also referred to as ‘migalastat’) is approved in over 40...

Amicus Therapeutics, Inc. (Amicus) is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering novel medicines for rare diseases.

The company's two marketed therapies are Galafold, the first oral monotherapy for people living with Fabry disease who have amenable genetic variants; and Pombiliti + Opfolda, a novel two-component treatment for adults living with late-onset Pompe disease.

Galafold (also referred to as ‘migalastat’) is approved in over 40 countries around the world, including the United States (‘U.S.’), European Union (‘E.U.’), the United Kingdom (‘U.K.’), and Japan. Additionally, Galafold has been granted orphan drug designation in the U.S., E.U., the U.K., Japan, and several other countries.

Pombiliti + Opfolda (also referred to as ‘cipaglucosidase alfa-atga/miglustat’) is approved in the U.S., the E.U., the U.K., and Switzerland. Multiple regulatory submissions and reimbursement processes with global health authorities are underway. Additionally, Pombiliti + Opfolda has been granted orphan drug designation or status in the U.S., the U.K., Switzerland, and Japan; and data exclusivity in the E.U.

Strategy

The company's strategy is to create, manufacture, test, and deliver the highest quality medicines for people living with rare diseases through internally developed, jointly developed, acquired, or in-licensed products and product candidates. The company is leveraging its global capabilities to develop and broaden its franchises in Fabry and Pompe disease, with focused discovery work on next-generation therapies and novel technologies.

Highlights of the company's progress include:

Commercial and Regulatory Success in Pompe Disease: Pombiliti + Opfolda were approved by the European Commission (‘EC’), the Medicines and Healthcare products Regulatory Agency (‘MHRA’) of the United Kingdom, and the U.S. Food and Drug Administration (‘FDA’) in 2023, and the Swissmedic of Switzerland in 2024. Additionally, in 2024, the company established reimbursement agreements in multiple E.U. countries, including Spain, Czechia, Italy, Switzerland, and Sweden.

Pipeline Advancement and Growth: The company is leveraging its global capabilities to develop and broaden its franchises in Fabry and Pompe disease, with focused discovery work on next-generation therapies and novel technologies.

Commercial Products and Product Candidates

Galafold (migalastat HCl) for Fabry Disease

The company's oral precision medicine Galafold was granted accelerated approval by the FDA in August 2018 for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (‘GLA’) variant based on in vitro assay data. Galafold was approved in the E.U. and the U.K. in May 2016 as a first-line therapy for long-term treatment of adults and adolescents, aged 16 years and older, with a confirmed diagnosis of Fabry disease and who have an amenable variant. Marketing authorization approvals, as well as approvals for adolescents aged 12 years and older weighing 45 kg or more, have been granted in over 40 countries around the world. The company plans to continue to launch Galafold in additional countries, upon receipt of marketing authorization.

As an orally administered monotherapy, Galafold is designed to bind to and stabilize an endogenous alpha-galactosidase A (‘alpha-Gal A’) enzyme in those patients with genetic variants identified as amenable in a Good Laboratory Practice (‘GLP’) cell-based amenability assay.

Next-Generation for Fabry Disease

The company is committed to continued innovation for all people living with Fabry disease. As part of its long-term commitment, the company is also continuing discovery for next-generation genetic medicines.

Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) for Pompe Disease

The company has leveraged its biologics capabilities to develop Pombiliti + Opfolda, a novel two-component treatment paradigm for Pompe disease. Pombiliti + Opfolda was approved by the EC, the MHRA, and the FDA in 2023, and the Swissmedic in 2024 for adult late-onset Pompe disease (‘LOPD’) patients. Additional regulatory submissions and reimbursement processes with global health authorities are underway.

Pombiliti + Opfolda consists of a uniquely engineered rhGAA enzyme, cipaglucosidase alfa-atga, with an optimized carbohydrate structure to enhance cellular uptake, administered intravenously in combination with orally administered miglustat. Miglustat binds to and stabilizes the cipaglucosidase alfa-atga in circulation, reducing inactivation of rhGAA in circulation to improve the uptake of active enzyme into key disease-relevant tissues. Miglustat is not an active ingredient that contributes directly to glycogen reduction.

In addition, clinical studies are ongoing in pediatric patients for both the LOPD and infantile-onset Pompe disease (‘IOPD’) populations.

Next-Generation for Pompe Disease

The company is committed to continued innovation for all people living with Pompe disease. As part of its long-term commitment, the company is also continuing discovery for next-generation genetic medicines for Pompe disease.

Intellectual Property

Patents and Trade Secrets

The company owns or holds license rights to several issued patents and numerous pending and issued applications, filed in the U.S., Europe, Japan, and other jurisdictions that are related to Galafold and its ongoing clinical programs:

The company owns issued U.S. patents that cover the use of migalastat, the active pharmaceutical ingredient in Galafold, in the treatment of Fabry disease, which expire between 2027 and 2042 and are listed in the FDA Orange Book. Foreign counterparts of the U.S. patents are pending or issued in Europe, Japan, and certain other jurisdictions. Further, the company has pending U.S. patent applications, as well as their foreign counterparts covering various aspects of Galafold, including composition-of-matter, methods of treating a patient diagnosed with Fabry disease, and methods of manufacturing. Any patents issuing from these applications will expire between 2036 and 2043. The company anticipates listing these patents in the FDA Orange Book if issued.

The company owns several issued U.S. patents that cover various aspects of Opfolda and Pombiliti, a pharmacological chaperon/ERT combination in the treatment of Pompe disease, which expire between 2033 and 2037. Several of the issued U.S. patents are listed in the FDA Orange Book for Opfolda. Foreign counterparts to the issued patents are pending or issued in Europe, Japan, and certain other jurisdictions. The company also has pending U.S. patent applications, as well as foreign counterpart applications, covering various aspects of compositions, methods of treatment, methods of manufacture, and formulations. Any patents issuing from these pending applications will expire between 2033 and 2043. The company also filed a Patent Term Extension application at the U.S. Patent and Trademark Office (‘USPTO’), requesting that the term of certain issued U.S. patent covering cipaglucosidase alfa, the active pharmaceutical ingredient in Pombiliti, be extended pursuant to 35 U.S.C. § 156.

From its agreement with the University of Pennsylvania (‘Penn’), the company has a license to Penn’s patent portfolio pertaining to vector and other platform technologies for treating Pompe disease and Fabry disease.

In the fourth quarter of 2022, the company received Paragraph IV Certification Notice Letters from Teva Pharmaceuticals USA, Inc. (‘Teva’), Aurobindo Pharma Limited (‘Aurobindo’), and Lupin Limited (‘Lupin’) in connection with Abbreviated New Drug Applications (‘ANDA’) filed with the FDA requesting approval to market generic Galafold. Lupin, Aurobindo, and Teva supplemented their Paragraph IV Certifications in 2023. In the fourth quarter of 2023, a stipulation order to stay litigation with respect to Lupin was ordered. Additionally, in the first quarter of 2024, a stipulation was filed with the court and approved by the presiding judge, whereby the parties agreed to accept the company's definition of the terms that were in dispute. As such, the scheduled Markman hearing was deemed unneeded and cancelled. In October 2024, the company entered into a non-exclusive, non-transferable, royalty-free, fully paid-up license with Teva, which will allow Teva to market its generic version of Galafold in the United States beginning on January 30, 2037, or earlier in certain circumstances. In accordance with the license agreement, a consent judgment and permanent injunction was entered with the Court, and all Hatch-Waxman litigation between Amicus and Teva has been terminated. As required by law, Amicus and Teva have submitted the confidential license agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice.

The company has filed applications to register certain trademarks in the United States and abroad, including AMICUS THERAPEUTICS and design, Galafold and design, Pombiliti and design, Opfolda and design.

Collaboration and License Agreements

GlaxoSmithKline

In July 2012, as amended in November 2013, the company entered into an agreement with GlaxoSmithKline (‘GSK’), pursuant to which Amicus obtained global rights to develop and commercialize Galafold as a monotherapy and in combination with ERT for Fabry disease.

Manufacturing

The company continues to rely on contract manufacturers to supply the active biopharmaceutical ingredients and finished goods for its products and product candidates. The active biopharmaceutical ingredients and final formulations for these products are manufactured under current Good Manufacturing Practice (‘cGMP’).

Competition

The company's principal competitors are Sanofi, Takeda, Chiesi, Eleva, Idorsia, AceLink, Sangamo, UniQure, 4DMT, Bayer, Astellas, Roche, GeneCradle, Aro, and Maze.

Government Regulation

The company's activities are subject to various federal and state fraud and abuse laws, including without limitation, the federal Anti-Kickback Statute, the federal civil False Claims Act, and laws and regulations pertaining to limitations on and reporting of healthcare provider payments (physician sunshine laws). These laws and regulations are interpreted and enforced by various federal, state, and local authorities, including CMS, the Office of Inspector General for the U.S. Department of Health and Human Services, the U.S. Department of Justice, individual U.S. Attorney offices within the Department of Justice, and state and local governments. These laws include:

The U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving, or paying any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order, or arranging for or recommending the purchase, lease, or order of, any good or service, for which payment may be made, in whole or in part, under federal healthcare programs, such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

The U.S. civil False Claims Act (which can be enforced through ‘qui tam,’ or whistleblower actions, by private citizens on behalf of the federal government), prohibits any person from, among other things, knowingly presenting, or causing to be presented false or fraudulent claims for payment of government funds or knowingly making, using, or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay money to the U.S. federal government;

The U.S. federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal liability and amends provisions on the reporting, investigation, enforcement, and penalizing of civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing, or covering up a material fact or making any materially false statement, in connection with the delivery of or payment for healthcare benefits, items, or services by a healthcare benefit program, which includes both government and privately funded benefits programs; similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

State laws and regulations, including state anti-kickback and false claims laws including but not limited to, research, distribution, sales, and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payer, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; and state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals and entities; and

The Physician Payments Sunshine Act, implemented as the Open Payments program, and its implementing regulations, requires certain manufacturers of drugs, devices, biologics, and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to CMS information related to certain payments made in the preceding calendar year and other transfers of value to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; beginning in 2022, applicable manufacturers are required to report such information regarding payments and transfers of value provided, as well as ownership and investment interests held, during the previous year to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives.

The company has obtained a positive opinion for its pediatric investigation plan (‘PIP’) in the E.U. for Galafold for the treatment of Fabry disease as well.

The Foreign Corrupt Practices Act, or the FCPA, generally prohibits offering, promising, giving, or authorizing others to give anything of value, either directly or indirectly, to a non-U.S. government official in order to influence official action, or otherwise obtain or retain business. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the company and to devise and maintain an adequate system of internal accounting controls.

History

Amicus Therapeutics, Inc. was incorporated under the laws of the state of Delaware in 2002.

Amicus Therapeutics Questions and Answers

Which sectors generate sales and which are the top 3 markets?

Revenue distribution by industry: Biotechnology: 100% (2025) TOP 3 markets and their percentage shares: USA: 60% Europe: 25% Asia-Pacific: 10% Amicus Therapeutics, Inc. generates its revenues entirely from the biotechnology industry, particularly through the development and commercialization of...

At which locations are the company’s products manufactured?

Production Sites: Contract manufacturers in the USA and Europe Amicus Therapeutics, Inc. does not produce its products itself, but uses contract manufacturers. These are mainly located in the USA and Europe. The company focuses on the research and development of therapies for rare genetic diseases a...

What strategy does Amicus Therapeutics pursue for future growth?

Strategy for Future Growth: Focus on Rare Diseases: Amicus Therapeutics continues to focus on the development and commercialization of therapies for rare genetic diseases. This includes expanding their product pipeline, especially in the field of enzyme replacement therapies. Expansion of Produc...

Which raw materials are imported and from which countries?

Main raw materials: Enzymatic agents, Biotechnological materials Countries of origin: USA, Germany, Switzerland Amicus Therapeutics, Inc. is a biopharmaceutical company that focuses on developing therapies for rare diseases. The main raw materials imported by the company include enzymatic agents and...

How strong is the company’s competitive advantage?

Market share in the field of rare diseases: Estimated 5-10% (2025) Research & Development (R&D) expenses: $200 million (2024) Patent protection: Several patents until 2030 Amicus Therapeutics, Inc. specializes in developing therapies for rare genetic diseases, giving them a significant compe...

What is the share of institutional investors and insider buying/selling?

Institutional Investor Share: 95% (estimated, based on historical data from 2023) Insider Buys/Sells: No significant transactions in the last year (estimated, based on historical trends) Amicus Therapeutics, Inc. has traditionally had a high proportion of institutional investors, indicating the trus...

What percentage market share does Amicus Therapeutics have?

Market share of Amicus Therapeutics, Inc.: Estimate: 3-5% (2025) Top competitors and their market shares: Sanofi S.A.: 20-25% Pfizer Inc.: 15-20% Roche Holding AG: 10-15% Novartis AG: 10-15% Takeda Pharmaceutical Company Limited: 5-10% Amicus Therapeutics, Inc.: 3-5% Biogen Inc.: 3-5% Alexion Pharm...

Is Amicus Therapeutics stock currently a good investment?

Revenue Growth: 18% (2024) Research and Development Expenses: 35% of Revenue (2024) Market Share in Rare Diseases Sector: 10% (2024) Amicus Therapeutics, Inc. achieved an impressive revenue growth of 18% in 2024. This indicates strong demand for their products, especially in the rare diseases sector...

Does Amicus Therapeutics pay a dividend – and how reliable is the payout?

Dividend payment: None (as of 2025) Amicus Therapeutics, Inc. currently does not pay dividends to its shareholders. The company focuses on the development and commercialization of therapies for rare diseases and typically reinvests its profits into research and development as well as expanding its p...

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Amicus Therapeutics Stock Value

Amicus Therapeutics Company Info

Analyst Price Target

Top growth stocks in the health care sector (5Y.)

What does Amicus Therapeutics do?

Amicus Therapeutics Questions and Answers

Offer & Services

Service & Collaboration

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