We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
Amicus Therapeutics Inc | NASDAQ:FOLD | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.12 | -1.15% | 10.30 | 10.19 | 10.75 | 10.79 | 10.36 | 10.74 | 1,360,422 | 01:00:00 |
310+ People with Fabry Disease Treated with Reimbursed Galafold® at YE17
Key 2017 Accomplishments
John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics, Inc. stated, “During 2017 we continued to build a leading global rare disease biotech company while advancing our vision to maximize the impact of our medicines for people living with rare diseases. We exceeded our EU launch and regulatory objectives for our Fabry precision medicine Galafold, and we reported clinical data from our Pompe clinical study that lays the foundation for a potential new treatment paradigm for this muscle disease. Throughout 2018 we are poised to create significant additional value for patients and shareholders across our key programs in Fabry and Pompe, and through our focused commitment to advancing and expanding a pipeline of novel medicines for rare metabolic diseases.”
Amicus is focused on five key strategic priorities in 2018:
Mr. Crowley will discuss Amicus' corporate objectives and key milestones in a presentation at the 36th Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2018 at 8:00 a.m. PT (11:00 a.m. ET). A live webcast of the presentation can be accessed through the Investors section of the Amicus Therapeutics corporate web site at http://ir.amicusrx.com/events.cfm, and will be archived for 90 days.
Full-Year 2017 Financial Summary and 2018 Guidance
Amicus recorded approximately $36 million in full-year 2017 revenue from commercial sales and reimbursed expanded access programs for Galafold. For the full-year 2018 the Company anticipates total Galafold revenue of $75 million to $85 million.
Cash, cash equivalents, and marketable securities totaled approximately $359 million at December 31, 2017. As previously announced, the Company strengthened the balance sheet during 2017 with a $243.0 million in net proceeds from a follow on public offering in July 2017. The Company expects full-year 2018 net cash spend of between $230 million and $260 million. The current cash position is anticipated to fund ongoing operations into at least the second half of 2019.
Program Highlights
Migalastat for Fabry DiseaseMigalastat is an oral precision medicine intended to treat Fabry disease in patients who have amenable genetic mutations. Regulatory authorities in the European Union, Switzerland, Israel, Canada, Australia, and South Korea have granted full approval for migalastat under the trade name Galafold. The EU approval may serve as the basis for regulatory approvals in more than two-thirds of the global Fabry market that is outside the U.S. In the U.S., Amicus submitted a new drug application (NDA) to the FDA in December 2017 to seek approval of migalastat.
Amicus is committed to advancing the highest quality therapies for all people living with Fabry disease. For people with non-amenable mutations who are not eligible for migalastat as an oral precision medicine, the Company has established initial preclinical proof-of-concept for a novel Fabry ERT (ATB101) co-formulated with migalastat as part of our CHART® platform.
Global Fabry Updates:
Anticipated Milestones:
ATB200/AT2221 for Pompe Disease
ATB200/AT2221 is a novel treatment paradigm that consists of ATB200, a unique recombinant human acid alpha-glucosidase (rhGAA) enzyme with optimized carbohydrate structures, particularly mannose-6 phosphate (M6P), to enhance uptake, co-administered with AT2221, a pharmacological chaperone. Throughout 2017, Amicus presented a cascade of positive data from an ongoing global Phase 1/2 clinical study (ATB200-02) to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ATB200/AT2221 across ambulatory ERT-switch patients (Cohort 1), non-ambulatory ERT-switch patients (Cohort 2), and ERT-naïve patients (Cohort 3).
Amicus continues to assemble the highest quality data package and to scale up manufacturing to meet the needs of the Pompe community. The Company is in the midst of a series of collaborative discussions with U.S. and EU regulators regarding the best and fastest pathway forward for this novel treatment option, and continues to anticipate a Pompe regulatory pathway update in the first half of 2018.
Pompe Program Updates:
Anticipated Upcoming Pompe Program Milestones:
EU Important Safety InformationTreatment with GALAFOLD should be initiated and supervised by specialists experienced in the diagnosis and treatment of Fabry disease. GALAFOLD is not recommended for use in patients with a nonamenable mutation.
For further important safety information for Galafold, including posology and method of administration, special warnings, drug interactions and adverse drug reactions, please see the European SmPC for Galafold available from the EMA website at www.ema.europa.eu.
About Amicus Therapeutics Amicus Therapeutics (Nasdaq:FOLD) is a global, patient-centric biotechnology company focused on discovering, developing and delivering novel high-quality medicines for people living with rare metabolic diseases. The cornerstone of the Amicus portfolio is migalastat, an oral precision medicine for people living with Fabry disease who have amenable genetic mutations. Migalastat is currently approved under the trade name Galafold™ in the European Union, with additional approvals granted and pending in several geographies. The future value driver of the Amicus pipeline is ATB200/AT2221, a novel, late-stage, potential best-in-class treatment paradigm for Pompe disease. The Company is committed to advancing and expanding a robust pipeline of cutting-edge, first- or best-in-class medicines for rare metabolic diseases.
Forward-Looking StatementsThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to preclinical and clinical development of our product candidates, the timing and reporting of results from preclinical studies and clinical trials, the prospects and timing of the potential regulatory approval of our product candidates, commercialization plans, manufacturing and supply plans, financing plans, and the projected revenues and cash position for the Company. 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. For example, with respect to statements regarding the goals, progress, timing, and outcomes of discussions with regulatory authorities, and in particular the potential goals, progress, timing, and results of preclinical studies and clinical trials, actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in our business, including, without limitation: the potential that results of clinical or preclinical studies indicate that the product candidates are unsafe or ineffective; the potential that it may be difficult to enroll patients in our clinical trials; the potential that regulatory authorities, including the FDA, EMA, and PMDA, may not grant or may delay approval for our product candidates; the potential that we may not be successful in commercializing Galafold in Europe and other geographies or our other product candidates if and when approved; the potential that preclinical and clinical studies could be delayed because we identify serious side effects or other safety issues; the potential that we may not be able to manufacture or supply sufficient clinical or commercial products; and the potential that we will need additional funding to complete all of our studies and manufacturing. Further, the results of earlier preclinical studies and/or clinical trials may not be predictive of future results. With respect to statements regarding projections of the Company's revenue and cash position, actual results may differ based on market factors and the Company's ability to execute its operational and budget plans. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2016 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2017. 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/Media:Amicus TherapeuticsSara Pellegrino, IRCSenior Director, Investor Relationsspellegrino@amicusrx.com (609) 662-5044
Media:Pure CommunicationsJennifer Paganelli jpaganelli@purecommunications.com (347) 658-8290
FOLD–G
1 Year Amicus Therapeutics Chart |
1 Month Amicus Therapeutics Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions