Amicus Therapeutics Provides EU Regulatory Update for AT-GAA

Rhea-AI Summary

Amicus Therapeutics (Nasdaq: FOLD) announced an update regarding its investigational therapy AT-GAA. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has altered its agenda for its November meeting, indicating that oral explanations for miglustat and cipaglucosidase alfa will not occur as previously expected on November 9. Despite this setback, Amicus remains focused on preparing for a potential CHMP opinion on AT-GAA by December 2022 and will evaluate any changes to the anticipated timelines.

Positive

• Amicus is preparing for a potential CHMP opinion on AT-GAA by December 2022.

Negative

• Oral explanations for miglustat and cipaglucosidase alfa were canceled, indicating possible delays in regulatory timeline.

PHILADELPHIA, Nov. 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 provided an EU regulatory update for AT-GAA. Earlier this morning, the Committee for Medicinal Products for Human Use (CHMP) issued the agenda for their November meeting indicating possible oral explanations for miglustat and for cipaglucosidase alfa on November 9^th. The Company has now been informed that oral explanations will not take place as originally anticipated. The Company continues to prepare for a CHMP opinion on AT-GAA as early as December 2022 and will assess any potential change in timelines.

About AT-GAA
AT-GAA is an investigational two-component therapy that consists of cipaglucosidase alfa (ATB200), a unique recombinant human acid alpha-glucosidase (rhGAA) enzyme with optimized carbohydrate structures, particularly bis-phosphorylated mannose-6 phosphate (bis-M6P) glycans, to enhance uptake into cells, administered in conjunction with miglustat (AT2221), a stabilizer of cipaglucosidase alfa.

Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating timing of the potential regulatory approval of AT-GAA. The inclusion of forward-looking statements should not be regarded as a representation by us that any of our plans will be achieved. Any or all of the forward-looking statements in this press release may turn out to be wrong and can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and we undertake no obligation to revise or update this news release to reflect events or circumstances after the date hereof.

CONTACTS:

Investors:
Amicus Therapeutics
Andrew Faughnan
Executive Director, Investor Relations
afaughnan@amicusrx.com
(609) 662-3809

Media:
Amicus Therapeutics
Diana Moore
Head of Global Corporate Communications
dmoore@amicusrx.com
(609) 662-5079

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FAQ

What is the latest update from Amicus Therapeutics regarding AT-GAA?

Amicus Therapeutics announced that the CHMP canceled the oral explanations for miglustat and cipaglucosidase alfa originally scheduled for November 9.

When is the expected CHMP opinion on AT-GAA?

The potential CHMP opinion on AT-GAA is anticipated by December 2022.

What was the reason for the cancellation of oral explanations by CHMP?

The press release did not specify the reason for the cancellation of oral explanations by CHMP.

How does the cancellation of oral explanations affect FOLD stock?

The cancellation may indicate potential delays in the regulatory process, which could impact investor sentiment and stock performance.