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Amicus Therapeutics Inc (FOLD.OQ)

FOLD.OQ on NASDAQ Stock Exchange Global Market

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15 Dec 2017
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Latest Key Developments (Source: Significant Developments)

Amicus Therapeutics Submits New Drug Application To U.S. FDA For Migalastat
Thursday, 14 Dec 2017 07:30am EST 

Dec 14 (Reuters) - Amicus Therapeutics Inc ::AMICUS THERAPEUTICS SUBMITS NEW DRUG APPLICATION TO U.S. FDA FOR MIGALASTAT FOR TREATMENT OF FABRY DISEASE.AMICUS THERAPEUTICS INC - ‍LOOK FORWARD TO POTENTIAL U.S. APPROVAL OF MIGALASTAT IN 2018​.  Full Article

Amicus Therapeutics Q3 loss per share $0.69
Wednesday, 8 Nov 2017 07:00am EST 

Nov 8 (Reuters) - Amicus Therapeutics Inc ::Amicus therapeutics announces third quarter 2017 financial results and corporate updates.Q3 loss per share $0.69.Q3 revenue $10.9 million versus I/B/E/S view $9.5 million.Q3 adjusted loss per share $0.41 excluding items.Q3 earnings per share view $-0.31 -- Thomson Reuters I/B/E/S.Amicus Therapeutics Inc - ‍reiterated full-year 2017 financial guidance​.Amicus Therapeutics Inc - ‍current cash position anticipated to fund ongoing operations into at least H2 2019​.  Full Article

Amicus Therapeutics announces additional positive data in Pompe disease phase 1/2 study at World Muscle Society
Wednesday, 4 Oct 2017 06:00am EDT 

Oct 4 (Reuters) - Amicus Therapeutics Inc : :Amicus Therapeutics announces additional positive data in Pompe disease phase 1/2 study at World Muscle Society.Amicus Therapeutics Inc - ‍pulmonary function generally improved or remained stable at 6 and 9 months​.Amicus Therapeutics - plans to continue collaborative discussions with regulators in US and EU, expects to provide update in first half of 2018.  Full Article

Amicus Therapeutics says U.S. FDA granted orphan drug designation to ATB200/AT2221 for Pompe disease
Thursday, 21 Sep 2017 07:30am EDT 

Sept 21 (Reuters) - Amicus Therapeutics Inc :Says ‍U.S. FDA has granted orphan drug designation to ATB200/AT2221​ for Pompe disease​.Amicus Therapeutics - ‍look forward to announcing new clinical data in all patients from ATB200/AT2221​ study at World Muscle Society in early Oct.  Full Article

U.S. FDA grants fast track designation for Amicus Therapeutics’ migalastat for treatment of Fabry disease
Tuesday, 19 Sep 2017 07:30am EDT 

Sept 19 (Reuters) - Amicus Therapeutics Inc :U.S. FDA grants fast track designation for Amicus Therapeutics’ migalastat for treatment of Fabry disease.Amicus Therapeutics Inc - ‍company plans to submit a new drug application (NDA) for migalastat in Q4 of 2017​.  Full Article

Amicus Therapeutics announces approval for Galafold™ for treatment of Fabry disease in Canada
Thursday, 14 Sep 2017 04:01pm EDT 

Sept 15 (Reuters) - Amicus Therapeutics Inc :Amicus Therapeutics Inc announces approval for Galafold™ (Migalastat) for treatment of Fabry disease in Canada.Amicus Therapeutics Inc - ‍Amicus expects to make Galafold available to Canadian patients in coming weeks​.Amicus Therapeutics Inc says ‍following Health Canada approval, Amicus expects to make Galafold available to Canadian patients in coming weeks.​.  Full Article

Amicus Therapeutics reports Q2 loss per share of $0.34
Monday, 7 Aug 2017 07:00am EDT 

Aug 7 (Reuters) - Amicus Therapeutics Inc :Amicus Therapeutics announces second quarter 2017 financial results and corporate updates.Q2 loss per share $0.34.Q2 revenue $7.2 million versus I/B/E/S view $6.7 million.Q2 earnings per share view $-0.36 -- Thomson Reuters I/B/E/S.Amicus Therapeutics Inc - company also provided near-term program updates and reiterated full-year 2017 financial guidance.Amicus Therapeutics Inc - total revenue in Q2 2017 was approximately $7.2 million, a sequential increase of 71.4%.Amicus Therapeutics Inc - cash, cash equivalents, and marketable securities totaled $227.2 million at June 30, 2017 versus to $330.4 million at December 31, 2016.Amicus Therapeutics Inc - continues to expect full-year 2017 net operating cash spend of between $175 million to $200 million.Amicus Therapeutics Inc sees full-year 2017 total net cash spend of between $200 million and $225 million.Amicus Therapeutics Inc - current cash position is anticipated to fund ongoing operations into at least second half of 2019.  Full Article

Amicus Therapeutics says offering of 18.4 mln common shares priced at $12.25 per share
Wednesday, 12 Jul 2017 08:00pm EDT 

July 12 (Reuters) - Amicus Therapeutics Inc :Amicus therapeutics prices underwritten offering of common stock.Says offering of 18.4 million common shares priced at $12.25per share.Says gross proceeds from offering to amicus are expected to be $225 million.  Full Article

Amicus Therapeutics announces public offering of common stock
Wednesday, 12 Jul 2017 04:01pm EDT 

July 12 (Reuters) - Amicus Therapeutics Inc :Amicus Therapeutics announces public offering of common stock.Amicus Therapeutics Inc - ‍announced it has commenced a $225 million underwritten public offering of its common stock​.Amicus Therapeutics - expects to use net proceeds of offering for investment in U.S. and international commercial infrastructure for Migalastat HCL.Amicus Therapeutics Inc - also expects to use net proceeds of offering for investment in manufacturing capabilities for ATB200.  Full Article

Amicus Therapeutics' ‍NDA submission for Migalastat targeted for 4Q17​
Tuesday, 11 Jul 2017 06:00am EDT 

July 11 (Reuters) - Amicus Therapeutics Inc :U.S. FDA confirms Amicus Therapeutics may submit new drug application for Migalastat for fabry disease.‍NDA submission targeted for 4q17​.Additional phase 3 study previously requested by agency to assess gastrointestinal symptoms is no longer required prior to an nda submission.‍Based on series of discussions with, written communication from FDA, agency informed it may now submit an NDA for Migalastat​.Says ‍is preparing NDA submission under subpart H, which provides for accelerated approval​.  Full Article

BRIEF-Amicus Therapeutics Submits New Drug Application To U.S. FDA For Migalastat

* AMICUS THERAPEUTICS SUBMITS NEW DRUG APPLICATION TO U.S. FDA FOR MIGALASTAT FOR TREATMENT OF FABRY DISEASE