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argenx : Positive Topline Phase 3 ADAPT Trial Results

06/24/2020 | 10:26am

Efgartigimod in Generalized Myasthenia Gravis

Forward-Looking Statements

This presentation has been prepared by argenx se ("argenx" or the "company") for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter or the company or any director, employee, agent, or adviser of the company. This presentation does not purport to be all-inclusive or to contain all of the information you may desire. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates.

Safe Harbor: Certain statements contained in this presentation, other than present and historical facts and conditions independently verifiable at the date hereof, may constitute forward-looking statements. Examples of such forward-looking statements include those regarding our investigational product candidates and preclinical studies and clinical trials, and the status, the safety, tolerability and efficacy of efgartigimod and the results of the ADAPT trial; the timing of presentation of detailed results from the ADAPT trial, planned regulatory submissions with the FDA and PSMA and, if approved, launch in the U.S.; and the therapeutic and commercial potential of efgartigimod, as well as those regarding plans, timing of expected data readouts and related presentations and related results thereof, including the design of our trials and the availability of data from them, the timing and achievement of our product candidate development activities, our ability to obtain regulatory approval of our product candidates, the expected size of the markets for our product candidates, future results of operations and financial positions, including potential milestones, business strategy, plans and our objectives for future operations. When used in this presentation, the words "anticipate," "believe," "can," "could," "estimate," "expect," "intend," "is designed to," "may," "might," "will," "plan," "potential," "predict," "objective," "should," or the negative of these and similar expressions identify forward-looking statements. Such statements, based as they are on the current analysis and expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond the Company's control. Such risks include, but are not limited to: the impact of the COVID-19 pandemic on our business, the impact of general economic conditions, general conditions in the biopharmaceutical industries, changes in the global and regional regulatory environments in the jurisdictions in which the Company does or plans to do business, market volatility, fluctuations in costs and changes tothe competitive environment. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. In the case of forward-looking statements regarding investigational product candidates and continuing further development efforts, specific risks which could cause actual results to differ materially from the Company's current analysis and expectations include: failure to demonstrate the safety, tolerability and efficacy of our product candidates; final and quality controlled verification of data and the related analyses; the expense and uncertainty of obtaining regulatory approval, including from the U.S. Food and Drug Administration and European Medicines Agency; the possibility of having to conduct additional clinical trials; our ability to obtain and maintain intellectual property protection for our product candidates; and our reliance on third parties such as our licensors and collaboration partners regarding our suite of technologies and product candidates. Further, even if regulatory approval is obtained, biopharmaceutical products are generally subject to stringent on-going governmental regulation, challenges in gaining market acceptance and competition. These statements are also subject to a number of material risks and uncertainties that are described in the Company's filings with the U.S. Securities and Exchange Commission ("SEC"), including in argenx's most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. The reader should not place undue reliance on any forward-looking statements included in this presentation. These statements speak only as of the date made and the Company is under no obligation and disavows any obligation to update or revise such statements as a result of any event, circumstances or otherwise, unless required by applicable legislation.

Efgartigimod Showed Robust Benefit For Patients With gMG

  • Statistically significant and clinically meaningfulimprovement in MG-ADL

  • Fast and deep responses

  • Potential for individualized dosing

  • Safety & tolerability profile comparable to placebo

gMG is a Chronic and Debilitating Autoimmune Disease

*Progression to gMG may be less with early immunosuppressive treatment

85% of people with MG progress* to generalized MG within 18 months

Up to 20% of patients experience a life-threatening myasthenic crisis (severe respiratory failure)

High need for safe & efficacious medication

1. Grob et al. Muscle Nerve 2008;37:141-9; 2. Jacob. Eur Neurol Rev 2018;13:18−20; 3. Wendell. Neurohospitalist 2011;1:16-22, 4. Gilhus. N Engl J Med 2016;375:2570-81

IgG Auto-Antibodies Drive Myasthenia Gravis

Efgartigimod is Designed to Eliminate Auto-Antibodies


arGEN-X SE published this content on 26 May 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 24 June 2020 14:23:39 UTC

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