Regeneron Pharmaceuticals Inc. (REGN - Free Report) announced that its study evaluating four investigational therapies for Ebola virus infection was stopped early as itscandidate, REGN-EB3, was superior to Mapp Biopharmaceutical Inc.'s ZMapp in preventing death.
ZMapp served as the control arm of the study because it was considered the standard-of-care based on the previous PREVAIL II clinical study.
Shares of the company have lost 20.8% year to date compared with the industry’s decline of 1.7%.
The PAmoja TuLinde Maisha (PALM) study evaluated the safety and efficacy of four investigational agents for the treatment of patients with Ebola virus infection, including three antibody-based therapies — REGN-EB3, ZMapp and a single monoclonal antibodymAb114 — and one small molecule antiviral, remdesivir. The primary objective of the study was to compare mortality in patients with Ebola, who received either REGN-EB3, mAb114 or remdesivir to those who received ZMapp in the control arm.
Per the company, the study was concluded early because its therapy, REGN-EB3, demonstrated a highly statistically significant result compared to ZMapp, which was considered a standard-of-care treatment. The independent data safety monitoring board decided to stop the study after reviewing interim mortality data from 499 patients. The study was conducted in the Democratic Republic of Congo (DRC), the center of the current outbreak.
With the preliminary findings in 499 trial participants, REGN-EB3 and mAb114 will be the two investigational treatments given as part of an Extension Phase to further evaluate safety until the final results of the clinical trial are known. Then, an Expanded Access phase will be initiated using the lead therapeutics from the study. The candidates were superior to the other two therapies — ZMapp andremdesivir — in preventing death.
We note that REGN-EB3 was invented by Regeneron using its VelociSuite technologies. The therapy combines three fully-human monoclonal antibodies. REGN-EB3 has received Orphan Drug designation from both the FDA and the European Medicines Agency.
Zacks Rank and Stocks to Consider
Regeneron currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks are Acorda Therapeutics Inc. (ACOR - Free Report) , Celldex Therapeutics, Inc. (CLDX - Free Report) and Eton Pharmaceuticals, Inc. (ETON - Free Report) . While Acorda and Celldex carry Zacks Rank #1 (Strong Buy), Eton carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Acorda’s loss per share estimates have narrowed from $3.59 to $2.74 for 2019 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, the average being 69.68%.
Celldex’s loss per share estimates have narrowed from $4.80 to $3.98 for 2019 and from $3.69 to $3.37 for 2020 in the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters, the average being 24.15%.
Eton Pharmaceuticals’ loss per share estimates have narrowed from $1.41 to $1.04 for 2019 and from $1.03 to 50 cents for 2020 in the past 60 days.
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