Regeneron (REGN), Sanofi Win EC Nod for Dupixent Label Expansion

Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. REGN and partner Sanofi (NASDAQ:SNY) SNY announced that the European Commission (EC) has extended the marketing authorization for asthma drug, Dupixent.

The drug is now approved in the European Union (EU) to include children 6 to 11 years of age with severe atopic dermatitis who are candidates for systemic therapy.

Per the company, Dupixent is the only systemic medicine approved in the EU to treat these patients.

Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins.

A pivotal study showed that more than four times as many children achieved itch reduction and more than three times as many children achieved clear or almost clear skin with Dupixent plus topical corticosteroids (TCS) compared to TCS alone. In addition, three in four children achieved a 75% improvement in disease extent and severity, with an average improvement of approximately 80%.

Approximately 80% of children experienced clinically meaningful improvements in a composite of health-related quality of life measures that include sleep, school, emotional well-being and relationships.

We note that Dupixent is approved for specific patients with atopic dermatitis, asthma and/or in adults with CRSwNP in several countries around the world, including the European Union, the United States and Japan.

Approval in additional indications will boost sales of the drug.

It is being evaluated further in pediatric atopic dermatitis, pediatric asthma, eosinophilic esophagitis, chronic obstructive pulmonary disease, bullous pemphigoid, prurigo nodularis, chronic spontaneous urticaria, and food and environmental allergies.

Regeneron’s shares have rallied 27.5% in the year so far compared with the industry’s growth of 2.1%.

Ophthalmology drug, Eylea, developed in collaboration with Bayer (OTC:BAYRY) BAYRY, and Dupixent maintain momentum for the company.

Moreover, the company has been in the news since the onset of the pandemic as it is developing an antibody cocktail for COVID-19.

The FDA has given Emergency Use Authorization (EUA) to its antibody cocktail, casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19. The antibody cocktail is authorized for the treatment of mild-to-moderate COVID-19 in adults, as well as pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.

Regeneron currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech space is Halozyme (NASDAQ:HALO) Therapeutics, Inc. HALO, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Halozyme’s earnings estimates are up 18 cents for 2020 in the past 30 days.

The Hottest Tech Mega-Trend of All

Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.

See Zacks' 3 Best Stocks to Play This Trend >>