Regeneron (REGN) Gets FDA Nod for Libtayo's Label Expansion

Regeneron Pharmaceuticals, Inc. REGN announced that the FDA has approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) for another indication.

The drug has been approved in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations. The drug has been approved for patients who either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation. Patients may be treated with this combination irrespective of PD-L1 expression or histology.

The approval was based on data from the global phase III trial, EMPOWER-Lung 3, which evaluated Libtayo in combination with a physician's choice of platinum-doublet chemotherapy (Libtayo combination), compared to platinum-doublet chemotherapy alone.

The drug is already approved for advanced cutaneous squamous cell carcinoma and adults with NSCLC. It is also approved for advanced cutaneous squamous cell carcinoma and basal cell carcinoma.

The latest approval is the second advanced NSCLC indication that expands the patient population eligible for a Libtayo-based regimen to include the combination treatment with chemotherapy, irrespective of PD-L1 expression levels. Libtayo is now approved for extending the survival of patients with advanced non-small cell lung cancer as both a monotherapy in high PD-L1 expressors and in combination with chemotherapy, irrespective of PD-L1 expression levels.

Libtayo sales came in at $143.2 million in the third quarter of 2022, up 20% year over year.

Regeneron’s shares have gained 19.1% in the year so far against the industry’s decline of 20.6%.

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Please note that prior to Jul 1, 2022, Regeneron recorded net product sales of Libtayo in the United States and Sanofi SNY recorded net product sales of Libtayo outside the United States.

Effective Jul 1, 2022, Regeneron records global net product sales of Libtayo outside the United States and pays a royalty to Sanofi on such sales.

Regeneron’s third-quarter results were strong, reflecting broad-based growth. Solid demand for Eylea and Dupixent maintained momentum for the company.

Growth in Eylea and Dupixent through further penetration in existing indications and a promising late-stage pipeline set the momentum for growth. The company’s progress with Libtayo will enable it to further diversify its revenue base.

Regeneron currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the healthcare sector are Puma Biotechnology PBYI and Dynavax DVAX. While Puma sports a Zacks Rank #1 (Strong Buy), Dynavax carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, loss estimates for Puma have narrowed to 6 cents from 16 cents. Puma also surpassed estimates in three of the trailing four quarters, with the average being 201.37%.

Earnings estimates for Dynavax have increased to $1.74 from $1.15 for 2022 over the past 90 days. Earnings of Dynavax surpassed estimates in two of the trailing four quarters.


 

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