Regeneron to ask FDA for antibody drug approval


Top financial figures, such as Federal Reserve Chairman Jerome Powell, have said that the rise in vaccinations and COVID-19 treatments is one reason why he expects the economy to do well in 2021. While a few major treatments have already been approved, primarily antivirals and vaccines, there are a number of other promising options that are still in the works. Regeneron Pharmaceuticals (NASDAQ: REGN) has its own antibody therapy that it’s hoping to receive approval for. Over the weekend, the company said it would ask the Food and Drug Administration (FDA) for the use of its REGEN-COV antibody cocktail as a preventative treatment.

The announcement follows another piece of news, in which Regeneron’s phase 3 trial for REGEN-COV showed 81% reduced symptoms in COVID-19 patients. This study, which was run jointly with the National Institute of Health (NIH) and other government organizations, met both its primary and secondary endpoints for reducing symptoms in patients. Having passed this recent trial with flying colors, Regeneron’s hoping that the FDA will quickly approve its antibody treatment, which was first used on former President Trump in 2020.

These findings are very encouraging and suggest that REGEN-COV is highly effective at preventing symptomatic COVID-19 in household contacts of SARS-CoV-2 infected individuals,” said Dan H. Barouch, M.D. and trial investigator. “With more than 60,000 Americans continuing to be diagnosed with Covid-19 every day, the REGEN-COV antibody cocktail may help provide immediate protection to unvaccinated people who are exposed to the virus,” added George D. Yancopoulos, Regeron’s CEO.

The new study involved over 1,500 patients that lived with someone recently diagnosed with COVID-19. This group was then split up between those that received a placebo and those that received Regeneron’s shot. After one month, only 1.5% of tested patients had any symptoms compared to the 7.8% of those who received the placebo. The results still haven’t been peer-reviewed in a scientific journal yet, but are quite optimistic at this point in time.

Expect shares of Regeneron to surge in response to the news. While it’s never certain when it comes to the FDA, there’s a very high chance that the regulatory body will approve this drug. While there already are a number of vaccines out there, there are fewer antibody-based treatments available, which makes it more likely the FDA will approve it.

Unlike most other COVID-involved pharmaceutical stocks, Regeneron has been steadily falling over the past few months. Shares have tumbled from around $600 in October to just $470 in April. Most analysts still are optimistic about the company, despite these losses.

Regeneron Pharmaceuticals Company Profile

Regeneron Pharmaceuticals discovers, develops, and commercializes products that fight eye disease, cardiovascular disease, cancer, and inflammation. The company has several marketed products including: Eylea, approved for wet age-related macular degeneration and other eye diseases; Praluent for LDL cholesterol lowering; Dupixent in atopic dermatitis, asthma, and nasal polyposis; Libtayo in cutaneous squamous cell carcinoma; and Kevzara in rheumatoid arthritis. Regeneron is also developing monoclonal antibodies with Sanofi in immunology and cancer, and bispecific antibodies and antibody cocktails with other collaborators and independently. – Warrior Trading News