Amicus Therapeutics, Inc.

417 articles about Amicus Therapeutics, Inc.

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  FDA Decisions: First Treatment for Desmoid Tumors and a Dry Eye Rejection for...

  11/28/2023

  Keep up with the regulator’s latest rulings on novel drugs and expanded indications, as the second half of 2023 promises some major milestone FDA approvals.

• Amicus Therapeutics Announces Third Quarter 2023 Financial Results and Corporate Updates

  11/8/2023

  Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, today announced financial results for the third quarter ended September 30, 2023.

• Amicus Therapeutics to Present at Upcoming Investor Conferences in November 2023

  11/1/2023

  Amicus Therapeutics announced that management will participate in upcoming presentations at the following investor conferences in November.

• Amicus Therapeutics to Announce Third Quarter 2023 Financial Results on November 8, 2023

  10/27/2023

  Amicus Therapeutics (Nasdaq: FOLD) today announced that the Company will host a conference call and live audio webcast on Wednesday, November 8, 2023, at 8:30 a.m. ET to discuss financial results for the third quarter ended September 30, 2023.

• Amicus Therapeutics Announces Presentation and Posters at World Muscle Society 2023

  10/3/2023

  Amicus Therapeutics (Nasdaq: FOLD), today announced that one oral presentation and four posters highlighting its development program for Pompe disease will be included at the 28th Annual Congress of the World Muscle Society (WMS) , being held October 3-7, 2023 in Charleston, SC.

• Amicus Therapeutics and Blackstone Enter into $430 Million Strategic Financing Collaboration

  10/2/2023

  Amicus Therapeutics today announced that it has entered into a definitive agreement for a $430 million financing collaboration with funds managed by Blackstone Life Sciences and Blackstone Credit have agreed to provide Amicus with a $400 million senior secured term loan facilitating a refinancing of existing debt and a $30 million strategic investment in Amicus’s common stock.

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  Amicus Gets FDA Approval for Rare Muscle Disorder Treatment

  9/29/2023

  Thursday’s approval comes after the FDA pushed back the target action dates for Amicus’ Biologics License Application in May, allowing the regulator more time to review the company’s submitted data.

• Orsini Specialty Pharmacy Partners with Amicus Therapeutics to Dispense New Therapy for the Treatment of Late-Onset Pompe Disease

  9/28/2023

  Orsini Specialty Pharmacy has been selected by Amicus Therapeutics to dispense Pombiliti™ and Opfolda™, a two-component treatment approved for certain patients with late-onset Pompe disease.

• Amicus Therapeutics Announces FDA Approval and Launch of New Treatment for Pompe Disease

  9/28/2023

  Amicus Therapeutics (Nasdaq: FOLD) today announced that the U.S. Food and Drug Administration (FDA) has approved Pombiliti™ (cipaglucosidase alfa-atga) + Opfolda™ (miglustat) 65mg capsules.

• Amicus Therapeutics to Present at Upcoming Investor Conferences in September 2023

  9/1/2023

  Amicus Therapeutics (Nasdaq: FOLD) today announced that management will participate in upcoming presentations at the following investor conferences in September.

• Amicus Therapeutics Announces Presentation and Posters at the SSIEM Annual Symposium 2023

  8/29/2023

  Amicus Therapeutics (Nasdaq: FOLD), today announced that one oral presentation and five posters across its development programs will be included at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium 2023, being held August 29 – September 1, 2023 in Jerusalem, Israel.

• Amicus Therapeutics Appoints Simon Harford as Chief Financial Officer

  8/21/2023

  Amicus Therapeutics today announced that Simon Harford has been appointed Chief Financial Officer, effective immediately.

• Amicus Therapeutics Announces Approval and Launch of New Pompe Disease Therapy in the United Kingdom

  8/15/2023

  Amicus Therapeutics today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (U.K.) has granted marketing authorizations for Pombiliti® (cipaglucosidase alfa) + Opfolda® (miglustat) for adults living with late-onset Pompe disease (acid α-glucosidase [GAA] deficiency).

• Amicus Therapeutics Announces Second Quarter 2023 Financial Results and Corporate Updates

  8/8/2023

  Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, today announced financial results for the second quarter ended June 30, 2023.

• Amicus Therapeutics Announces Approval and Launch of New Pompe Disease Therapy in the European Union

  6/27/2023

  Amicus Therapeutics today announced that the European Commission (EC) has granted approval for Opfolda ® (miglustat) 65mg capsules, an enzyme stabilizer of cipaglucosidase alfa, a long-term enzyme replacement therapy for adults with late-onset Pompe disease.

• Amicus Therapeutics Announces First Quarter 2023 Financial Results and Corporate Updates

  5/10/2023

  Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, today announced financial results for the first quarter ended March 31, 2023.

• Amicus Therapeutics to Announce First Quarter 2023 Financial Results on May 10, 2023

  5/1/2023

  Amicus Therapeutics (Nasdaq: FOLD) today announced that the Company will host a conference call and live audio webcast on Wednesday, May 10, 2023, at 8:30 a.m. ET to discuss financial results for the first quarter ended March 31, 2023.

• Amicus Therapeutics Receives Positive CHMP Opinion for Opfolda® (miglustat) for Late-Onset Pompe Disease

  4/26/2023

  Amicus Therapeutics (Nasdaq: FOLD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorization of miglustat, the enzyme stabilizer component of AT-GAA.

• Amicus Therapeutics Announces European Commission Approval for Pombiliti™ in Patients with Late-Onset Pompe Disease

  3/27/2023

  Amicus Therapeutics today announced that the European Commission has granted approval for Pombiliti™ (cipaglucosidase alfa), a long-term enzyme replacement therapy (ERT) used in combination with miglustat for adults with late-onset Pompe disease (LOPD).

• Amicus Therapeutics Announces Full-Year 2022 Financial Results and Corporate Updates

  3/1/2023

  Amicus Therapeutics today announced financial results for the full-year ended December 31, 2022.