argenx (ARGX) Tanks on Top-Line Data From Pemphigus Study
Shares of argenx SE ARGX were down 25.1% on Dec 20 after the company announced top-line data from the phase III ADDRESS study, which evaluated efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with pemphigus vulgaris (PV) and pemphigus foliaceus.
Pemphigus is a chronic autoimmune disease that usually affects the skin and mucous membranes.
The ADDRESS study evaluated efgartigimod SC (efgartigimod alfa and hyaluronidase-qvfc) in adult patients with newly diagnosed or relapsing moderate-to-severe PV. Data from the study showed that treatment with efgartigimod SC led to complete remission on a minimal dose of steroids (CRmin) in 35% of patients compared with 30.3% of patients who received placebo.
Notably, the proportion of PV patients who achieved CRmin did not demonstrate a significant difference between treatment with efgartigimod SC and placebo, thereby failing to meet the primary endpoint.
The study also failed to meet the secondary endpoints.
Shares of argenx have plunged 11.6% in the past year compared with the industry’s decline of 18.7%.
Image Source: Zacks Investment Research
Owing to the disappointing data from the ADDRESS study, argenx decided to stop further development of efgartigimod in pemphigus. The company remains focused on the ongoing clinical development of efgartigimod in other severe autoimmune indications.
Per the company, in light of the data from the ADDRESS study, argenx is reviewing the BALLAD study, which is evaluating the safety and efficacy of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adult patients with bullous pemphigoid.
The company is not willing to make a GO/NO GO decision on this study.
Vyvgart Hytrulo has been developed using Halozyme’s proprietary Enhanze technology for treating generalized myasthenia gravis.
Zacks Rank & Stocks to Consider
argenx currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Journey Medical Corporation DERM, Entrada Therapeutics, Inc. TRDA and Puma Biotechnology, Inc. PBYI, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Journey Medical’s 2023 loss per share have narrowed from $1.28 to 16 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 41 cents to 35 cents. In the past year, shares of DERM have surged 539.7%.
Earnings of Journey Medical beat estimates in one of the last four quarters while missing the same on the remaining three occasions. DERM delivered a four-quarter earnings surprise of 118.25%, on average.
In the past 60 days, estimates for Entrada Therapeutics’ 2023 loss per share have narrowed from $2.07 to 9 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $2.35 to $2.04. In the past year, shares of TRDA have decreased 2.4%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 56 cents to 64 cents. In the past year, shares of PBYI have lost 21.6%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Puma Biotechnology, Inc. (PBYI) : Free Stock Analysis Report
Journey Medical Corporation (DERM) : Free Stock Analysis Report
argenex SE (ARGX) : Free Stock Analysis Report
Entrada Therapeutics, Inc. (TRDA) : Free Stock Analysis Report
