The novel coronavirus has wiped out trillions of dollars in global output with more than 1 million deaths worldwide in 2020. With cases rising rapidly in the United States and in Europe, more lockdowns are becoming a significant concern after France and Germany issued new lockdown efforts. There is also no fiscal stimulus package coming to keep the U.S. economic recovery going strong. And now the economy and stock market have been dealing with less enthusiastic reporting about the safety and efficacy of coronavirus vaccines.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) may have just changed the narrative in its efforts to help the world deal with COVID-19. The company has now announced positive prospective results from an ongoing Phase 2/3 COVID-19 outpatient trial. Its investigational antibody cocktail REGN-COV2 was shown to have met its primary and key secondary endpoints.
According to Regeneron’s press release, REGN-COV2 significantly reduced viral load and patient medical visits. These are defined as hospitalizations, emergency room visits, urgent care visits, physician office visits and telemedicine virtual visits.
Regeneron further indicated that initial data in 275 patients (strongly) suggested that the REGN-COV2 antibody cocktail could lower viral load, potentially improving clinical outcomes against COVID-19. The analysis was also said to involve more than 500 additional patients.
The end result is that the company believes REGN-COV2 significantly reduces viral load and that the observed viral reductions are associated with a much lower need for further medical attention. Perhaps most important in this study is that Regeneron is seeing the strongest effects in patients who are most at risk for poor outcomes. Those are the patients with high viral loads, ineffective antibody immune responses at baseline, or those with pre-existing risk factors.
On the primary endpoint, REGN-COV2 patients showed on average greater than a ten-fold reduction in viral load versus placebo by day 5 in treatment.
Regeneron also announced after Wednesday’s close that the company has shared the data with the U.S. Food and Drug Administration (FDA) as part of its review of its Emergency Use Authorization submission. The company continues to focus on completing ongoing trials evaluating REGN-COV2.
There was disappointing news that still has not been seen in a U.S. and European partnership, and speculation has grown that the data may not come until November. Pfizer Inc. (NYSE: PFE) was down over 5% at $35.45 in regular trading and BioNTech SE (NASDAQ: BNTX) was down 7.6% at $77.54 on Wednesday. One reason this has been a disappointment is that BioNTech’s CEO recently referred to initial data suggesting its vaccine candidate was “nearly perfect.”
Regeneron has many other efforts and products outside of its COVID-19 candidate. Its market cap was close to $60 billion as of Wednesday, it generated more than $7.8 billion in 2019 revenue, and Refinitiv’s consensus revenue estimates are looking for $8.1 billion in 2020 and $9.5 billion in 2021.
After closing down 2.6% at $567.04 on a day where its drop was less than the broader market indexes, Regeneron’s stock was up about 2.3% at $580.00 in Wednesday’s after-hours trading session.