September 26, 2022 (Investorideas.com Newswire) Argenx SE has “several upcoming catalysts,” noted a Wedbush report.
Argenx SE’s (ARGX:NASDAQ) drug for generalized myasthenia gravis, efgartigimod (Vyvgart), in subcutaneous form, “is coming soon to a clinic near you,” reported Wedbush analyst Dr. David Nierengarten in a September 21, 2022 research note. The company just submitted to the U.S. Food and Drug Administration a biologics license application (BLA) for the subcutaneous (SC) formulation of efgartigimod to complement the intravenous (IV) version already on the market.
“We continue to believe that Argenx should be able to capitalize on its first mover advantage,” Nierengarten added.
The Netherlands-based company’s BLA package included positive data from the Phase 3 ADAPT-SC trial, which showed SC efgartigimod’s “noninferiority” to IV Vyvgart, noted Nierengarten. On Day 29, SC efgartigimod 100 milligrams per kilogram (100 mg/kg) lowered total immunoglobulin G by 66.4% compared to 62.2% with 10 mg/kg of IV Vyvgart.
Additionally, SC efgartigimod showed equal or better efficacy than intravenous Vyvgart in the secondary endpoints of Myasthenia Gravis Activities of Daily Living scale score, 69.1% SC versus 69.1% IV, and Quantitative Myasthenia Gravis score, 65.5% SC vs. 51.9% IV.
“An approval of SC efgartigimod would improve dosing convenience for both patients and physicians alike, further enhancing its competitive profile compared with Ultomiris (C5 inhibitor, IV), which requires less frequent dosing than IV Vyvgart,” Nierengarten noted.
Other potential competitors are UCB’s clinical-stage zilucoplan and rozanolixizumab, but, Nierengarten wrote, “we believe Vyvgart has the most competitive profile from a benefit-risk perspective based on cross-trial comparisons.”
The analyst pointed out that the immunology solutions firm has several upcoming catalysts outside of its myasthenia gravis program. The include topline results from three clinical trials evaluating subcutaneous efgartigimod in different indications:
ADHERE, chronic inflammatory demyelinating polyneuropathy, data due out in Q1/23
ADVANCE, primary immune thrombocytopenia, data expected in H2/23
ADDRESS, pemphigus vulgaris, and foliaceus, data anticipated in H2/23
“We would be buyers ahead of these data,” recommended Nierengarten.
Wedbush has an Outperform rating and a US$410 per share price target on Argenx, the stock of which is currently trading at about US$351.76 per share.
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Disclosures For Wedbush Securities, arGEN-X N.V, September 21, 2022
Analyst Certification: We, David Nierengarten and Dennis Pak, certify that the views expressed in this report accurately reflect our personal opinions and that we have not and will not, directly or indirectly, receive compensation or other payments in connection with our specific recommendations or views contained in this report.
Company Specific Disclosures:
1. WS makes a market in the securities of arGEN-X N.V..
3. WS co-managed a public offering of securities for arGEN-X N.V. within the last 12 months.
4. WS has received compensation for investment banking services from arGEN-X N.V. within the last 12 months.
5. WS provided arGEN-X N.V. with investment banking services within the last 12 months.
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