Regeneron Pharmaceuticals, Inc (REGN) said Monday it started late-stage trials to evaluate the effectiveness of REGN-COV2, its investigational dual antibody cocktail for the prevention and treatment of COVID-19 lifting shares by almost 5% in pre-market trading.
The stock rose to $649.96 in Monday’s pre-market trading. The Phase 3 trial, run jointly with the National Institute of Allergy and Infectious Diseases (NIAID), will assess REGN-COV2’s capacity to prevent infection among uninfected people who have had close exposure to a COVID-19 patient.
Regeneron added that REGN-COV2 has also moved into the Phase 2/3 portion of two adaptive Phase 1/2/3 trials testing the cocktail’s ability to treat hospitalized and non-hospitalized patients with COVID-19.
This progress to the clinical trials follows a “positive” review from the Independent Data Monitoring Committee of REGN-COV2 Phase 1 safety results in an initial cohort of 30 hospitalized and non-hospitalized patients with COVID-19, the company said.
“We are running simultaneous adaptive trials in order to move as quickly as possible to provide a potential solution to prevent and treat COVID-19 infections, even in the midst of an ongoing global pandemic,” said Regeneron CEO George D. Yancopoulos. “We are pleased to collaborate with NIAID to study REGN-COV2 in our quest to further prevent the spread of the virus with an anti-viral antibody cocktail that could be available much sooner than a vaccine.”
The Phase 3 trial will be conducted at about 100 sites with the enrollment of about 2,000 patients in the U.S. The two Phase 2/3 treatment trials are planned to be conducted at about 150 sites in the U.S., Brazil, Mexico and Chile, and will evaluate virologic and clinical endpoints, with preliminary data expected later this summer.
In the run-up to finding a treatment against COVID-19, shares in Regeneron have ballooned 66% so far this year. In view of the stock’s recent rally, the $590.38 average price target now indicates 5.2% downside potential in the coming 12 months.
Five-star analyst Alethia Young at Cantor Fitzgerald last month raised the stock’s price target to $624 from $400 and maintained a Hold rating, saying the company’s drug pipeline faces stiff competition in the generics market.
“Potential upside may come from a sustainable commercial COVID-19 franchise, where studies should begin soon,” Young wrote in a note to investors.
Overall, the rest of the Street is slightly more optimistic on the stock. The Moderate Buy consensus breaks down evenly between 9 Holds and 9 Buys. (See Regeneron stock analysis on TipRanks).
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