argenx SE ARGX and Halozyme Therapeutics HALO announced that a phase III study — ADAPT-SC — evaluating a subcutaneous (‘SC”) formulation of argenx’s generalized myasthenia gravis therapy, Vyvgart (efgartigimod), met its primary endpoint of reduction in IgG, the most common type of antibody found in blood circulation. The myasthenia gravis disease is an autoimmune disorder of the musculoskeletal system caused by IgG autoantibodies.
Based on the positive data from the ADAPT-SC study, argenx is planning to submit a biologics license application (“BLA”) seeking approval for SC efgartigimod to the FDA by the end of this year. We note that intravenous (“IV”) administration of efgartigimod received FDA approval for treating generalized myasthenia gravis in December 2021 with the trade name of Vyvgart.
Shares of argenx gained 6.3% on Mar 22, following the ADAPT-SC study data readout. However, shares of the company have declined 9.4% so far this year compared with the industry’s decrease of 13.7%.
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Data from the late-stage study demonstrated that SC efgartigimod was statistically noninferior to Vyvgart in reducing IgG levels in generalized myasthenia gravis patients from baseline, at day 29. The SC efgartigimod reduced IgG levels by 66.4% compared to 62.2% for Vyvgart. The reduction in IgG levels results in clinical benefit in generalized myasthenia gravis patients as established in previously completed phase III and phase II studies on Vyvgart. The safety profile of IV and SC formulations of efgartigimod were similar in clinical studies.
Please note that argenx is using Halozyme’s ENHANZE drug-delivery technology for the development of the SC formulation of efgartigimod. Halozyme is eligible to receive royalties on potential sales of SC efgartigimod following regulatory approval. The SC formulation of efgartigimod will provide additional treatment options to patients based on individual preferences.
Halozyme and argenx entered into a collaboration agreement in 2019 for developing multiple subcutaneous product formulations for three targets, which were expanded to six targets in 2020. argenx is developing SC efgartigimod under this collaboration for different indications, which include myasthenia gravis, immune thrombocytopenia, rare autoimmune disease — pemphigus vulgaris and foliaceus — and chronic inflammatory demyelinating polyneuropathy. Apart from myasthenia gravis, argenx is evaluating SC efgartigimod in late-stage studies for the other three indications as well.
argenx has several other candidates in its pipeline in different stages of development for multiple indications.
argenex price | argenex Quote
Zacks Rank & Stocks to Consider
Argenx and Halozyme both currently carry a Zacks Rank #3 (Hold).
A couple of better-ranked stocks from the same sector include Voyager Therapeutics VYGR, and Trevi Therapeutics TRVI, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Estimates for Voyager’s 2022 bottom line have improved from a loss per share of $2.20 to $1.35 in the past 30 days. VYGR has surged 215.5% so far this year.
Voyager delivered an earnings surprise of 41.00%, on average, in the last four quarters.
Estimates for Trevi’s 2022 bottom line have narrowed from a loss per share of 98 cents to 71 cents in the past 30 days. TRVI has risen 185.1% so far this year.
Trevi delivered an earnings surprise of 5.09%, on average, in the last four quarters.
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