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Regeneron (REGN)/Sanofi's Libtayo sBLA Accepted by the FDA

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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) recently announced that the FDA has accepted for review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo (cemiplimab-rwlc).

The sBLA is seeking approval of the drug in combination with chemotherapy as first-line treatment in advanced non-small cell lung cancer (NSCLC).

The agency had set a target action date of Sep 19, 2022.

A regulatory filing has also been recently submitted to the European Medicines Agency.

The sBLA is supported by results from a randomized, multicenter phase III study that evaluated Libtayo in combination with a physician's choice of platinum-doublet chemotherapy (Libtayo combination) compared to platinum-doublet chemotherapy alone in the targeted population.

The study was stopped early after the Libtayo combination demonstrated a significant overall survival improvement compared to chemotherapy alone.

We remind investors that Libtayo was approved in the United States and European Union as a first-line monotherapy treatment for adult patients with advanced NSCLC whose tumors have high PD-L1 expression (tumor proportion score ≥50%), as determined by an FDA-approved test in 2021.

Libtayo is also indicated in certain patients with advanced basal cell carcinoma and advanced cutaneous squamous cell carcinoma in the United States.

Regeneron is currently evaluating Libtayo as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers.

Regeneron and Sanofi (SNY - Free Report) are jointly developing Libtayo under a global collaboration agreement.

Regeneron records net product sales of Libtayo in the United States and Sanofi records the drug’s net product sales outside the United States. The companies equally share profits/losses in connection with global sales of Libtayo.

Regeneron’s shares have gained 15.4% in the past year against the industry’s decline of 37.5%.

Zacks Investment ResearchImage Source: Zacks Investment Research

REGN’s performance has been outstanding in 2021. Strong demand for Eylea and Dupixent maintained momentum for the company. Incremental contribution from REGEN-COV has boosted the top line significantly.

REGEN-COV (casirivimab and imdevimab) is a cocktail of two monoclonal antibodies currently authorized for emergency use in the United States for the treatment and post-exposure prophylaxis in certain high-risk individuals. Earlier, the company announced that its currently authorized REGEN-COV antibodies have diminished potency versus Omicron.  With Omicron gaining steam rapidly, the diminished potency against the same does not bode well for Regeneron and might result in loss of revenues.

Continued growth in Eylea and Dupixent through further penetration in existing indications and a promising late-stage pipeline set the momentum for growth. The approval of Libtayo in the lucrative indication of lung cancer should further boost the drug’s sales in the upcoming quarters.

Regeneron currently has a Zacks Rank #2 (Buy). Other attractive stocks in the healthcare sector include Vir Biotechnology (VIR - Free Report) and Alkermes (ALKS - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Earnings estimates for Vir have moved up $6.81 in the past 30 days for 2022. VIR has gained 106.5% in the past two years.

Earnings estimates for Alkermes have moved up a cent for 2022 in the past 60 days. ALKS is up 16.4% in the past year.