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Amicus Therapeutics Inc (FOLD.OQ)

FOLD.OQ on NASDAQ Stock Exchange Global Market

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Latest Key Developments (Source: Significant Developments)

Amicus Therapeutics Q3 loss per share $0.84
Monday, 5 Nov 2018 07:00am EST 

Nov 5 (Reuters) - Amicus Therapeutics Inc ::AMICUS THERAPEUTICS ANNOUNCES THIRD QUARTER 2018 FINANCIAL RESULTS AND CORPORATE UPDATES.Q3 LOSS PER SHARE $0.84.Q3 REVENUE $20.6 MILLION VERSUS I/B/E/S VIEW $23.6 MILLION.Q3 EARNINGS PER SHARE VIEW $-0.28 -- THOMSON REUTERS I/B/E/S.REAFFIRMING HIGHER END OF FY18 REVENUE GUIDANCE OF $80M-$90M.BALANCE SHEET STRENGTH SUFFICIENT TO FUND OPERATIONS INTO AT LEAST 2021.REDUCED NET CASH SPEND GUIDANCE FOR 2018.QTRLY REVENUE WAS IMPACTED BY UNEVEN ORDERING PATTERNS OVER SUMMER MONTHS IN EUROPE.CASH, CASH EQUIVALENTS, AND MARKETABLE SECURITIES TOTALED $564.4 MILLION AT SEPT 30 VERSUS $358.6 MILLION AT DEC 31, 2017.LOWERING ITS FULL-YEAR 2018 NET CASH SPEND TO $190 TO $210 MILLION.  Full Article

Amicus Acquires Gene Therapy Portfolio Of Ten AAV Programs In Neurologic Lysosomal Storage Disorders
Thursday, 20 Sep 2018 06:00am EDT 

Sept 20 (Reuters) - Amicus Therapeutics Inc ::AMICUS THERAPEUTICS ACQUIRES GENE THERAPY PORTFOLIO OF TEN CLINICAL AND PRE-CLINICAL STAGE AAV PROGRAMS IN NEUROLOGIC LYSOSOMAL STORAGE DISORDERS.AMICUS THERAPEUTICS INC - BALANCE SHEET STRENGTHENED WITH $150 MILLION IN NON-DILUTIVE DEBT FINANCING.AMICUS THERAPEUTICS INC - UNDER TERMS OF AGREEMENT, AMICUS WILL PAY $100 MILLION IN AN UPFRONT CASH PAYMENT TO ACQUIRE ALL OF THESE ASSETS.AMICUS THERAPEUTICS INC - CELENEX SHAREHOLDERS ARE ALSO ELIGIBLE FOR UP TO $15 MILLION IN DEVELOPMENT MILESTONES.AMICUS THERAPEUTICS INC - CLOSED A FIVE-YEAR, SENIOR CREDIT FACILITY WITH BIOPHARMA CREDIT.AMICUS THERAPEUTICS - CELENEX SHAREHOLDERS ARE ALSO ELIGIBLE FOR UP TO $262 MILLION IN BLA/MAA SUBMISSION AND APPROVAL MILESTONES ACROSS MULTIPLE PROGRAMS.AMICUS THERAPEUTICS INC - NEW CREDIT FACILITY CONSISTS OF A $150 MILLION NON-DILUTIVE TERM LOAN.AMICUS THERAPEUTICS INC - AMICUS EXPECTS TO PAY NO MORE THAN $75 MILLION OVER NEXT 4 YEARS IN THESE MILESTONES.AMICUS THERAPEUTICS INC - PROCEEDS FROM LOAN FINANCING WILL BE USED TO SUPPORT COST OF ACQUISITION AND SEVERAL YEARS OF RELATED DEVELOPMENT COSTS.AMICUS THERAPEUTICS INC - TRANSACTION WAS APPROVED BY BOARD OF DIRECTORS OF BOTH COMPANIES AND CLOSED IMMEDIATELY.AMICUS THERAPEUTICS INC - CELENEX SHAREHOLDERS MAY ALSO BE ELIGIBLE FOR UP TO $75 MILLION IN TIERED SALES ($500 MILLION/$750 MILLION) MILESTONE PAYMENTS.  Full Article

Amicus Therapeutics Announces Clinical Updates For AT-GAA
Monday, 10 Sep 2018 07:00am EDT 

Sept 10 (Reuters) - Amicus Therapeutics Inc ::AMICUS THERAPEUTICS ANNOUNCES REGULATORY AND CLINICAL UPDATES FOR AT-GAA IN POMPE DISEASE.AMICUS THERAPEUTICS INC - REGULATORY & CLINICAL ADVANCEMENTS IN ITS DEVELOPMENT PROGRAM AT-GAA FOR POMPE DISEASE.AMICUS THERAPEUTICS INC - AMICUS INTENDS TO INITIATE STUDIES IN ADDITIONAL PATIENT POPULATIONS, INCLUDING PEDIATRIC POMPE PATIENTS, IN 2019.AMICUS THERAPEUTICS INC - DURING Q3, AMICUS HELD A TYPE C MEETING WITH FDA IN ORDER TO DISCUSS REGULATORY PATH FOR AT-GAA.AMICUS THERAPEUTICS - AMICUS SOUGHT INPUT ON DESIGN OF PIVOTAL STUDY FOR APPROVAL FOR AT-GAA, OTHER SUPPLEMENTAL CLINICAL STUDIES IN POMPE DISEASE PATIENTS.AMICUS THERAPEUTICS INC - AMICUS INCORPORATED KEY ELEMENTS OF FEEDBACK FROM FDA, INCLUDING TYPE C MEETING.AMICUS THERAPEUTICS INC - INTENDS TO INCLUDE ERT-SWITCH PATIENTS & ERT TREATMENT-NAÏVE PATIENTS IN THIS SINGLE PIVOTAL STUDY TO SUPPORT FULL APPROVAL.AMICUS THERAPEUTICS INC - PATIENTS CURRENTLY ENROLLED IN STUDY POM-003 WILL BE ELIGIBLE FOR PIVOTAL STUDY AS WELL.AMICUS THERAPEUTICS INC - FDA ALSO INDICATED THAT CURRENT CLINICAL PACKAGE IS NOT SUFFICIENT TO SUPPORT ACCELERATED APPROVAL.AMICUS THERAPEUTICS - INTENDS TO CONTINUE TO GENERATE DATA TO SUPPORT FURTHER DISCUSSIONS ON POTENTIAL PATHWAY FOR ACCELERATED APPROVAL WITH FDA IN 2019.  Full Article

Amicus Therapeutics Sees FY 2018 Revenue $75 Million To $85 Million
Wednesday, 28 Feb 2018 07:00am EST 

Feb 28 (Reuters) - Amicus Therapeutics Inc ::AMICUS THERAPEUTICS ANNOUNCES FULL-YEAR 2017 FINANCIAL RESULTS AND 2018 CORPORATE UPDATES.SEES FY 2018 REVENUE $75 MILLION TO $85 MILLION.DEVELOP AND EXPAND PRECLINICAL PIPELINE TO ENSURE AT LEAST ONE NEW CLINICAL PROGRAM IN 2019.ON TRACK TO ACHIEVE FY18 REVENUE GUIDANCE OF $75M-$85M.REITERATED FULL-YEAR 2018 REVENUE AND NET CASH SPEND GUIDANCE.CASH, CASH EQUIVALENTS, AND MARKETABLE SECURITIES TOTALED $358.6 MILLION AT DECEMBER 31, 2017.FY2018 REVENUE VIEW $86.8 MILLION -- THOMSON REUTERS I/B/E/S.  Full Article

Amicus Therapeutics Announces Closing Of Underwritten Offering Of Common Stock
Wednesday, 21 Feb 2018 04:30pm EST 

Feb 21 (Reuters) - Amicus Therapeutics Inc ::AMICUS THERAPEUTICS ANNOUNCES CLOSING OF UNDERWRITTEN OFFERING OF COMMON STOCK.  Full Article

Amicus Therapeutics Prices Underwritten Offering Of Common Stock
Thursday, 15 Feb 2018 07:00pm EST 

Feb 15 (Reuters) - Amicus Therapeutics Inc ::AMICUS THERAPEUTICS PRICES UNDERWRITTEN OFFERING OF COMMON STOCK.SAYS OFFERING OF 19.4 MILLION COMMON SHARES PRICED AT $15.50PER SHARE.  Full Article

Amicus Therapeutics Announces Public Offering Of Common Stock
Wednesday, 14 Feb 2018 04:01pm EST 

Feb 14 (Reuters) - Amicus Therapeutics Inc ::AMICUS THERAPEUTICS ANNOUNCES PUBLIC OFFERING OF COMMON STOCK.AMICUS THERAPEUTICS INC - COMMENCED A $250 MILLION UNDERWRITTEN PUBLIC OFFERING OF ITS COMMON STOCK.AMICUS THERAPEUTICS INC - EXPECTS TO USE NET PROCEEDS OF OFFERING FOR INVESTMENT IN U.S., INTERNATIONAL COMMERCIAL INFRASTRUCTURE FOR MIGALASTAT HCL.AMICUS THERAPEUTICS INC - TO ALSO USE NET PROCEEDS OF OFFERING FOR INVESTMENT IN MANUFACTURING CAPABILITIES FOR ATB200, AMONG OTHERS.  Full Article

U.S. FDA Files NDA Under Priority Review For Migalastat
Monday, 12 Feb 2018 07:30am EST 

Feb 12 (Reuters) - Amicus Therapeutics Inc ::U.S. FDA FILES NEW DRUG APPLICATION UNDER PRIORITY REVIEW FOR MIGALASTAT FOR TREATMENT OF FABRY DISEASE.AMICUS THERAPEUTICS INC - PRESCRIPTION DRUG USER FEE ACT GOAL DATE FOR FDA DECISION IS AUGUST 13, 2018.  Full Article

Amicus Therapeutics Expects 2018 Net Cash Spend Of $230 Mln To $260 Mln
Monday, 8 Jan 2018 07:30am EST 

Jan 8 (Reuters) - Amicus Therapeutics Inc ::AMICUS THERAPEUTICS PROVIDES FULL-YEAR 2018 STRATEGIC OUTLOOK AND FINANCIAL GUIDANCE.AMICUS THERAPEUTICS SEES GALAFOLD FY 2018 REVENUE $75 MILLION TO $85 MILLION.CASH, CASH EQUIVALENTS, AND MARKETABLE SECURITIES TOTALED ABOUT $359 MILLION AT DEC 31, 2017.EXPECTS FULL-YEAR 2018 NET CASH SPEND OF BETWEEN $230 MILLION AND $260 MILLION.CURRENT CASH POSITION IS ANTICIPATED TO FUND ONGOING OPERATIONS INTO AT LEAST SECOND HALF OF 2019.FY2018 REVENUE VIEW $88.9 MILLION -- THOMSON REUTERS I/B/E/S.  Full Article

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

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Amicus sets $315,000 price for new Fabry disease treatment

Amicus Therapeutics on Monday set an average price of $315,000 per year for its newly approved Fabry disease treatment, a price it believes is below that of the main existing treatment in the United States.