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Regeneron's (REGN) sBLA for Libtayo Gets Priority Review
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) recently announced that the FDA has accepted and granted Priority Review to its supplemental biologics license application (sBLA) for PD-1 inhibitor, Libtayo (cemiplimab-rwlc).
The sBLA is seeking label expansion of the drug for the treatment of patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy.
The regulatory body has set a target action date of Jan 30, 2022.
The application is based on results from the phase III study which investigated evaluated monotherapy versus an investigator's choice of chemotherapy in the targeted patient population. Libtayo demonstrated a significant improvement in overall survival in women with advanced cervical cancer after progression on chemotherapy, reducing the risk of death by 31% compared to chemotherapy in the overall population.
The sBLA is also being reviewed under the FDA's Project Orbis initiative, which will allow for concurrent review by participating health authorities in Australia, Brazil, Canada, and Switzerland.
Additional global regulatory submissions are planned, including in the European Union by the end of 2021.
Regeneron has a collaboration agreement with Sanofi (SNY - Free Report) for Libtayo.
Libtayo is already approved for the treatment of a type of skin cancer called cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma, and non-small cell lung cancer (NSCLC) in the United States.
Approval in other indications will boost the drug's sales, which totaled $217.7 million in the first half of 2021.
Cervical cancer is the fourth leading cause of cancer death in women worldwide. It is estimated that approximately 570,000 people are diagnosed with cervical cancer globally each year. Hence, the target market represents potential for growth.
Regeneron is looking to build a portfolio in the oncology space and diversify its revenue base.
The company's shares have gained 25.3% in the year so far against the industry’s decline of 5.4%.
Image Source: Zacks Investment Research
Demand for Regeneron’s lead drug, Eylea, has revived significantly after a slowdown last year. Eylea, approved for various ophthalmology indications, has been developed in collaboration with Bayer AG (BAYRY - Free Report) .
Asthma drug, Dupixent, developed in partnership with Sanofi, maintains its stellar performance on consistent label expansions. Moreover, an incremental contribution from REGEN-COV, its antibody cocktail for COVID-19, has significantly boosted the top line in the last couple of quarters and should propel sales as the pandemic continues.
Regeneron currently sports a Zacks Rank #1 (Strong Buy). Another top-ranked stock in the biotech sector is Horizon Therapeutics Public Limited Company , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Horizon’s earnings estimates have been revised upward by 27.3% for 2021 and 17.4% for 2022 over the past 60 days. The stock has surged 46.5% year to date.
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Regeneron's (REGN) sBLA for Libtayo Gets Priority Review
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) recently announced that the FDA has accepted and granted Priority Review to its supplemental biologics license application (sBLA) for PD-1 inhibitor, Libtayo (cemiplimab-rwlc).
The sBLA is seeking label expansion of the drug for the treatment of patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy.
The regulatory body has set a target action date of Jan 30, 2022.
The application is based on results from the phase III study which investigated evaluated monotherapy versus an investigator's choice of chemotherapy in the targeted patient population. Libtayo demonstrated a significant improvement in overall survival in women with advanced cervical cancer after progression on chemotherapy, reducing the risk of death by 31% compared to chemotherapy in the overall population.
The sBLA is also being reviewed under the FDA's Project Orbis initiative, which will allow for concurrent review by participating health authorities in Australia, Brazil, Canada, and Switzerland.
Additional global regulatory submissions are planned, including in the European Union by the end of 2021.
Regeneron has a collaboration agreement with Sanofi (SNY - Free Report) for Libtayo.
Libtayo is already approved for the treatment of a type of skin cancer called cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma, and non-small cell lung cancer (NSCLC) in the United States.
Approval in other indications will boost the drug's sales, which totaled $217.7 million in the first half of 2021.
Cervical cancer is the fourth leading cause of cancer death in women worldwide. It is estimated that approximately 570,000 people are diagnosed with cervical cancer globally each year. Hence, the target market represents potential for growth.
Regeneron is looking to build a portfolio in the oncology space and diversify its revenue base.
The company's shares have gained 25.3% in the year so far against the industry’s decline of 5.4%.
Demand for Regeneron’s lead drug, Eylea, has revived significantly after a slowdown last year. Eylea, approved for various ophthalmology indications, has been developed in collaboration with Bayer AG (BAYRY - Free Report) .
Asthma drug, Dupixent, developed in partnership with Sanofi, maintains its stellar performance on consistent label expansions. Moreover, an incremental contribution from REGEN-COV, its antibody cocktail for COVID-19, has significantly boosted the top line in the last couple of quarters and should propel sales as the pandemic continues.
Regeneron currently sports a Zacks Rank #1 (Strong Buy). Another top-ranked stock in the biotech sector is Horizon Therapeutics Public Limited Company , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Horizon’s earnings estimates have been revised upward by 27.3% for 2021 and 17.4% for 2022 over the past 60 days. The stock has surged 46.5% year to date.