argenx SE (NASDAQ: ARGX) rose mid-morning Monday after the company reported positive topline results from Phase 2 proof-of-concept trial of efgartigimod in primary immune thrombocytopenia.
The primary endpoint was safety and tolerability, with efgartigimod demonstrating a profile consistent with earlier studies.
In all, 46% of patients in each of the 5 mg/kg and 10 mg/kg dosing cohorts experienced increases in platelet count to at least 50x10(9)/L (normal range is 150 - 450 x10(9)/L) compared to 25% for placebo. The average duration of response in the responder group was 40 days versus 16 days for placebo.
The company plans to advance efgartigimod into Phase 3 development for ITP. It also plans to launch a Phase 2 study assessing a subcutaneous formulation. A Phase 3 study in myasthenia gravis and a Phase 2 in pemphigus vulgaris are ongoing.
Last month, argenx announced the exercise by AbbVie of its exclusive license option to develop and commercialize ARGX-115, an antibody targeting the novel immuno-oncology target glycoprotein A repetitions predominant (GARP).
argenx and AbbVie entered into an option and license agreement for ARGX-115 in April 2016. With the option exercise announced today, AbbVie obtains a worldwide, exclusive license to develop and commercialize ARGX-115-based products.
argenx is now eligible to potentially receive development, regulatory and commercial milestone payments of up to $625 million, as well as tiered royalties on ARGX-115-based product sales, if approved. argenx also has the right to co-promote ARGX-115-based products in the EU and Swiss Economic Area.
Shares in argenx popped $3.31, or 3.5%, to $97.09
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