Amicus is about to receive European approval for the first oral therapy to treat Fabry disease. Amicus Therapeutics) is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases. Amicus acquired Scioderm in a cash and stock transaction. Important factors that could cause or contribute to such differences include risks relating to: the possibility that the expected benefits of the transaction will not be fully realized by us or may take longer to realize than expected; future results of on-going or later clinical trials for SD-101; our ability to obtain regulatory approvals and commercialize SD-101 following the closing; and market acceptance of SD-101. Please confirm you are a US healthcare professional. Amicus completed its IPO on NASDAQ in 2007. With respect to statements regarding projections of the Company's cash position, actual results may differ based on market factors and the Company's ability to execute its operational and budget plans. Today we believe that Amicus is stronger than ever and has the potential to create significant near- and long-term value for patients as well as our shareholders." Amicus Therapeutics, Inc. (Nasdaq:FOLD) is a biotechnology company at the forefront of therapies for rare and orphan diseases. The regulatory path for Galafold approval in the U.S. is also still unclear.Amicus has a pipeline of additional orphan disease drugs, but their future is still tied to ongoing and risky clinical trials.There are good reasons for investors to like Amicus. EB affects all races, ethnicities and genders equally. Amicus Therapeutics Buys Celenex for $100 Million up Front . If Galafold, Amicus' Fabry disease drug, secures European approval in the next two or three months, the company must still figure out pricing and marketing. by September 2-3, 2020 Live, Online Course: Biopharma Revenue Forecasting that Drives Decision Making and InvestmentsBecome fluent in the core elements of revenue forecasting including epidemiology, competitive assessments, market share assignment and pricing. Amicus has agreed to pay up to an additional $361 million to Scioderm shareholders, option holders and warrant holders upon achievement of certain clinical and regulatory milestones and $257 million to Scioderm shareholders, option holders and warrant holders upon achievement of certain sales milestones. As a result, the company has an EPS growth of 32.1% for the approaching year. They can be affected by inaccurate assumptions Amicus might make or by known or unknown risks and uncertainties. Investors are giving the side eye to a prediction from Chardan analyst Gbola Amusa that Amusa, in a note published Tuesday, makes a case for Amicus, with a new rare-disease therapy nearing approval in Europe, as an attractive $3 billion takeout target for either In response, Amicus shares have barely budged, trading up just 1.4% to $7.93. Chief Medical Officer: Exercise or conversion of derivative security exempted pursuant to Rule 16b-3 : 30,000: $6.10: Jul 27, 2020 An estimated 30,000 to 40,000+ people are currently diagnosed with EB in major markets. Earnings per share increased 44.44% … By Mark Terry . This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.Advances Amicus Vision to Create One of the World's Leading Rare Disease Biotechnology Companies While that means the value of the deal could swell over time, Amicus expects to pay $75 million, at most, over the next four years.The financial commitments have bought Amicus a spot in the blossoming gene therapy sector. exclude terms. Amicus Therapeutics has paid $100 million to buy Celenex. A Phase 3 multi-center, randomized, double-blind, placebo-controlled study (SD-005) in the U.S. and Europe is currently underway and expected to support registration globally. It has one approved product, "Galafold," in Europe that targets Fabry Disease and is … Amicus Therapeutics, Amarin, and CRISPR Therapeutics are all way oversold. Secondary outcome measures include 1) median time to complete target wound closure; 2) change in lesional skin at Month 2; 3) change in itching at Day 7; and 4) change in pain at Day 7. Cranbury, NJ. "The successful closing of the Scioderm acquisition is another important step forward toward fulfilling our patient-centric vision to build one of the world's leading rare disease biotechnology companies," said John F. Crowley, Chairman and Chief Executive Officer of Amicus. Action Alerts PLUS is a registered trademark of TheStreet, Inc. Amicus, for its part, appears particularly ripe for a buyout, especially with the company bolstering its presence in the highly coveted field of gene therapy. If SD-101 is approved, EB qualifies as a rare pediatric disease and Amicus will request a Priority Review Voucher. Amicus' lead programs in development include the small molecule pharmacological chaperone migalastat as a monotherapy for Fabry disease, SD-101 for Epidermolysis Bullosa (EB), as well as next-generation enzyme replacement therapy (ERT) products for Fabry disease, Pompe disease, and MPS I. Amicus estimates that EB represents a potential $1 billion+ global market opportunity, based on third party market research. If the Priority Review voucher is obtained and subsequently sold, Amicus will pay Scioderm shareholders, option holders and warrant holders the lesser of $100 million in the aggregate or 50% of the proceeds of such sale.

SD-101 is currently being investigated in a Phase 3 study to support global regulatory submissions and was the first-ever treatment in EB clinical studies to show improvements in wound closure across all major EB subtypes. There is currently no FDA approved treatment for EB. The average price we get from analysts is $18.79 which is $3.67 above current price.


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