Biotech Stock Roundup: REGN Gets EC Nod for Cocktail, BIIB's Drug Approval & More

It has been a busy week for the biotech sector with drug approvals and other regular pipeline updates. The development of coronavirus treatments and subsequent progress also continue to be in the spotlight.

Recap of the Week’s Most Important Stories:

Regeneron (NASDAQ:REGN) Cocktail Gets EC Nod: Regeneron Pharmaceuticals REGN and partner Roche announced that the European Commission (“EC”) has approved the casirivimab and imdevimab antibody cocktail for people aged 12 years and older. It will be used for the treatment of non-hospitalized patients (outpatients) with confirmed COVID-19 who do not require oxygen supplementation and are at an increased risk of progressing to severe COVID-19, and to prevent the disease.

The cocktail is known as REGEN-COV in the United States and Ronapreve in the European Union and other countries. The approval comes close on the heels of a positive opinion by the European Medicines Agency's (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”).

The EC approval is based on positive data from two phase III studies involving more than 6,000 individuals that evaluated the efficacy and safety of the antibody cocktail to treat non-hospitalized patients already infected with SARS-CoV-2, and to prevent symptomatic infection in asymptomatic household contacts of SARS-CoV-2 infected individuals.

Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Biogen’s MS Drug Gets Approval: Biogen BIIB announced that the EC has granted marketing authorization to Vumerity (diroximel fumarate) for the treatment of adults with relapsing-remitting multiple sclerosis (MS). The drug is an oral fumarate with a distinct chemical structure from the older MS drug Tecfidera (dimethyl fumarate). The approval was based on data from pharmacokinetic bridging studies that compared Vumerity withTecfidera to establish bioequivalent exposure of monomethyl fumarate, the active metabolite for both drugs and also partly backed by the established long-term efficacy and safety profile of Tecfidera. The approval was also based on findings from EVOLVE-MS-2, a large, randomized, double-blind, five-week, multi-center phase III study to evaluate the gastrointestinal tolerability of Vumerity compared to Tecfidera in patients with relapsing-remitting MS.

It is already approved in the United States for the treatment of relapsing forms of MS in adults to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Regulatory Update From Amgen: Amgen AMGN announced that CHMP gave a positive opinion for Lumykras (sotorasib). The CHMP recommended conditional marketing authorization of Lumykras for the treatment of adults with advanced non-small-cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy. A potential approval by the EC will make Lumykras the first targeted therapy available in the European Union (EU) for the KRAS G12C mutation, one of the most prevalent biomarkers in NSCLC.

The positive CHMP opinion was based on data from the phase II CodeBreaK 100 study that evaluated patients with the KRAS G12C mutation.

Valneva Surges on EC Purchase Agreement: Shares of Valneva SE VALN surged after it entered into an advance purchase agreement with the EC. Per the agreement, Valneva would supply up to 60 million doses of VLA2001, its inactivated COVID-19 vaccine candidate, over two years, including approximately 27 million doses in 2022.

Additionally, the EC has the option to increase its initial purchase, in 2022, of VLA2001 up to a total of 60 million doses by the end of 2023. The agreement is under final review, including volumes required, by each of the EU member states. The delivery of the vaccine is currently expected to begin in April 2022.

Performance

The Nasdaq Biotechnology Index has lost 1.85% in the past five trading sessions. Among the biotech giants, Regeneron has gained 4.29% during the period. Over the past six months, shares of Moderna (NASDAQ:MRNA) have soared 46.03%. (See the last biotech stock roundup here: Biotech Stock Roundup: REGN, MRNA Post Q3 Earnings, SAVA Gains on AD Review Data).

Image Source: Zacks Investment Research

What's Next in Biotech?

Stay tuned for more pipeline, and regulatory updates.

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