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Regeneron Pharmaceuticals (REGN) has revealed that the independent data monitoring committee (IDMC) has advised it to modify its current REGN-COV2 antibody cocktail treatment trials for COVID-19. Shares are falling 2.5% in Friday’s trading.
Specifically, based on a potential safety signal and an unfavorable risk/benefit profile, the IDMC recommended that Regeneron place on hold the further enrollment of patients requiring high-flow oxygen or mechanical ventilation while data on patients already enrolled is collected and analyzed.
The IDMC also recommended continuing enrollment of hospitalized patients requiring either no or low-flow oxygen “as the risk/benefit remains acceptable,” and continuing the outpatient trial without modification.
“Regeneron remains blinded to the data and is implementing the IDMC recommendations” the company stated.
It says it is also informing the U.S. Food and Drug Administration, which is currently evaluating REGN-COV2 for a potential Emergency Use Authorization in mild-to-moderate outpatients at high risk for poor outcomes.
Regeneron will also share the recommendation with the independent committee monitoring the RECOVERY trial in the UK, which is evaluating REGN-COV2 in hospitalized patients.
REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.
To develop REGN-COV2, Regeneron scientists evaluated thousands of fully-human antibodies produced by the company’s VelocImmune mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19.
Regeneron has also partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021. If REGN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. with Roche in charge of ex-U.S, the company says.
Shares in Regeneron have soared a 44% year-to-date, and analysts have a cautiously optimistic Moderate Buy consensus on the stock with 9 buys vs 7 holds. That’s alongside an average analyst price target of $668.21 indicating upside potential of another 23% lies ahead.
Cantor Fitzgerald analyst Alethia Young recently reiterated a Buy rating on the stock with a $690 price target, saying that she expects COVID-19 sales of $1.8 billion in 2021, assuming a 50% probability of success.
“Our positive thesis on REGN is more than REGN-COV2, but certainly we think commercial sales from REGN-COV2 could be a near-term positive earnings driver for 2021,” Young wrote in a note to investors. (See Regeneron stock analysis on TipRanks).
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