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Regeneron's (REGN) Libtayo Gets EC Nod for Cervical Cancer
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the European Commission (EC) approved PD-1 inhibitor Libtayo (cemiplimab-rwlc) for another indication.
The drug has been approved as a monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.
The EC approval was based on data from the phase III EMPOWER-Cervical 1 study. The study evaluated Libtayo in comparison to an investigator's choice of chemotherapy and enrolled 608 patients across 14 countries, irrespective of PD-L1 expression status or histology. We remind investors that the trial was stopped early in March 2021 based on the highly significant effect of Libtayo on overall survival among squamous cell carcinoma patients following a unanimous recommendation by the Independent Data Monitoring Committee.
Libtayo is already approved in the European Union for the treatment of certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer (NSCLC).
Libtayo’s sales came in at $143.2 million in the third quarter of 2022, up 20% year over year. Additional label expansion of the drug will boost its sales.
Earlier in the month, the FDA approved Libtayo in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced 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.
Regeneron’s shares have gained 18.7% in the year so far against the industry’s decline of 19.6%.
Image Source: Zacks Investment Research
Prior to Jul 1, 2022, Regeneron recorded net product sales of Libtayo in the United States and Sanofi (SNY - Free Report) 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 is looking to diversify into the lucrative oncology space with Libtayo. Regeneron’s strong portfolio boasts of leading ophthalmology drug Eylea and asthma drug Dupixent
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 biotech space include Syndax Pharmaceuticals (SNDX - Free Report) and Biogen (BIIB - Free Report) . While Syndax sports a Zacks Rank #1 (Strong Buy), Biogen 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 Syndax have narrowed to $2.59 from $2.68. Syndax also surpassed estimates in each of the trailing four quarters, with the average being 95.39%.
Over the past 30 days, earnings estimates for Biogen have increased by 30 cents to $16.98. Biogen also surpassed estimates in three of the trailing four quarters, with the average being 7.02%.
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Regeneron's (REGN) Libtayo Gets EC Nod for Cervical Cancer
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the European Commission (EC) approved PD-1 inhibitor Libtayo (cemiplimab-rwlc) for another indication.
The drug has been approved as a monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.
The EC approval was based on data from the phase III EMPOWER-Cervical 1 study. The study evaluated Libtayo in comparison to an investigator's choice of chemotherapy and enrolled 608 patients across 14 countries, irrespective of PD-L1 expression status or histology. We remind investors that the trial was stopped early in March 2021 based on the highly significant effect of Libtayo on overall survival among squamous cell carcinoma patients following a unanimous recommendation by the Independent Data Monitoring Committee.
Libtayo is already approved in the European Union for the treatment of certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer (NSCLC).
Libtayo’s sales came in at $143.2 million in the third quarter of 2022, up 20% year over year. Additional label expansion of the drug will boost its sales.
Earlier in the month, the FDA approved Libtayo in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced 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.
Regeneron’s shares have gained 18.7% in the year so far against the industry’s decline of 19.6%.
Image Source: Zacks Investment Research
Prior to Jul 1, 2022, Regeneron recorded net product sales of Libtayo in the United States and Sanofi (SNY - Free Report) 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 is looking to diversify into the lucrative oncology space with Libtayo. Regeneron’s strong portfolio boasts of leading ophthalmology drug Eylea and asthma drug Dupixent
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 biotech space include Syndax Pharmaceuticals (SNDX - Free Report) and Biogen (BIIB - Free Report) . While Syndax sports a Zacks Rank #1 (Strong Buy), Biogen 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 Syndax have narrowed to $2.59 from $2.68. Syndax also surpassed estimates in each of the trailing four quarters, with the average being 95.39%.
Over the past 30 days, earnings estimates for Biogen have increased by 30 cents to $16.98. Biogen also surpassed estimates in three of the trailing four quarters, with the average being 7.02%.