Regeneron Scores FDA Nod For Ebola Treatment

Regeneron announced that the US Food and Drug Administration (FDA) has approved its Inmazeb anti-viral antibody as a first-of-its-kind treatment for Ebola virus infection in adult and pediatric patients.

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Regeneron (REGN) said that the approval followed a large clinical trial, which showed Inmazeb’s superiority with respect to mortality compared to other investigational agents (ZMapp and remdesivir). The treatment was most effective when given early in the outbreak of the disease, the company added.

Inmazeb is an anti-viral antibody medicine, which was developed using the same “rapid response” technologies as Regeneron’s investigational COVID-19 antibody combination, the drugmaker said. The treatment consists of 3 monoclonal antibodies of similar structure that bind to different, non-overlapping epitopes on Zaire ebolavirus glycoprotein. The 3 antibodies help neutralize the Ebola virus by blocking its ability to invade patients’ and/or enlisting other immune cells to target infected cells and remove them from the body.

“This is the first time the FDA has approved a treatment specifically for Ebola, which has caused a number of deadly outbreaks,” said Regeneron President George D. Yancopoulos. “Decades of investment in our VelociSuite rapid response technologies, the dedication of world-class scientists, and the courageous contributions of healthcare providers and patients, together with remarkable cooperation between leading international health organizations and governments, have led to this important moment.”

“As we apply the same sophisticated technologies and manufacturing capabilities against COVID-19, we hope this will be one of many demonstrations of how the power of science can be successfully deployed against dangerous infectious diseases,” Yancopoulos added.

As part of an agreement announced in July this year, Regeneron will deliver a number of Inmazeb treatment doses over the course of 6 years to the Biomedical Advanced Research and Development Authority (BARDA), as part of the US Department of Health and Human Services’ (HHS) goal of building national preparedness for public health emergencies.

Shares in Regeneron have soared a stellar 60% year-to-date, and analysts have a cautiously optimistic Moderate Buy consensus on the stock. That’s alongside an average analyst price target of $668.21 indicating upside potential of another 11% lies ahead.

Earlier this month, Regeneron filed a request for emergency use authorization from the FDA for its investigational coronavirus antibody cocktail REGN-COV2, which was also given to US President Donald Trump.

Following the announcement, Cantor Fitzgerald analyst Alethia Young 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).