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Regeneron (REGN) Withdraws sBLA for Libtayo in Cervical Cancer
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , along with partner Sanofi (SNY - Free Report) , announced that they have voluntarily withdrawn the supplemental biologics license application (sBLA) for PD-1 inhibitor, Libtayo (cemiplimab-rwlc), as a second-line treatment for patients with advanced cervical cancer.
The decision was taken after the two companies and the FDA could not align on certain post-marketing studies. Discussions with other regulatory bodies in ex-U.S. markets are currently ongoing.
In September 2021, the FDA accepted and granted Priority Review to the sBLA for Libtayo to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy. A decision from the regulatory body was due on Jan 30, 2022.
The application was based on data from the phase III study, which investigated Libtayo monotherapy versus an investigator's choice of chemotherapy in the given patient population.
Shares of Regeneron have rallied 23% in the past year against the industry’s decline of 38.8%.
Image Source: Zacks Investment Research
Libtayo is currently approved for the treatment of a type of skin cancer called cutaneous squamous cell carcinoma and basal cell carcinoma in the United States. Libtayo is also approved as a first-line monotherapy treatment for adult patients with advanced non-small-cell lung cancer ("NSCLC") whose tumors have high PD-L1 expression in the United States and European Union.
In January 2022, the FDA accepted for review the sBLA for Libtayo in combination with chemotherapy as first-line treatment in advanced NSCLC. The regulatory body had set an action date of Sep 19, 2022.
Regeneron has a collaboration agreement with Sanofi for Libtayo. The initial uptake of the drug has been strong so far. Approval in additional indications will boost Libtayo sales which totaled $337.2 million worldwide in the first nine months of 2021.
Regeneron records net product sales of Libtayo in the United States and Sanofi records the drug’s net product sales outside the country. The companies equally share profits/losses in connection with global sales of Libtayo.
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.
Image: Shutterstock
Regeneron (REGN) Withdraws sBLA for Libtayo in Cervical Cancer
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , along with partner Sanofi (SNY - Free Report) , announced that they have voluntarily withdrawn the supplemental biologics license application (sBLA) for PD-1 inhibitor, Libtayo (cemiplimab-rwlc), as a second-line treatment for patients with advanced cervical cancer.
The decision was taken after the two companies and the FDA could not align on certain post-marketing studies. Discussions with other regulatory bodies in ex-U.S. markets are currently ongoing.
In September 2021, the FDA accepted and granted Priority Review to the sBLA for Libtayo to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy. A decision from the regulatory body was due on Jan 30, 2022.
The application was based on data from the phase III study, which investigated Libtayo monotherapy versus an investigator's choice of chemotherapy in the given patient population.
Shares of Regeneron have rallied 23% in the past year against the industry’s decline of 38.8%.
Libtayo is currently approved for the treatment of a type of skin cancer called cutaneous squamous cell carcinoma and basal cell carcinoma in the United States. Libtayo is also approved as a first-line monotherapy treatment for adult patients with advanced non-small-cell lung cancer ("NSCLC") whose tumors have high PD-L1 expression in the United States and European Union.
In January 2022, the FDA accepted for review the sBLA for Libtayo in combination with chemotherapy as first-line treatment in advanced NSCLC. The regulatory body had set an action date of Sep 19, 2022.
Regeneron has a collaboration agreement with Sanofi for Libtayo. The initial uptake of the drug has been strong so far. Approval in additional indications will boost Libtayo sales which totaled $337.2 million worldwide in the first nine months of 2021.
Regeneron records net product sales of Libtayo in the United States and Sanofi records the drug’s net product sales outside the country. The companies equally share profits/losses in connection with global sales of Libtayo.
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.
Zacks Rank & Other Stocks to Consider
Regeneron currently carries a Zacks Rank #2 (Buy). Top-ranked stocks in the biotech sector include Vertex Pharmaceuticals Incorporated (VRTX - Free Report) and Cara Therapeutics, Inc. (CARA - Free Report) , both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Vertex’s earnings estimates have been revised 2.5% upward for 2022 over the past 60 days. The stock has increased 4.8% in the past year.
Vertex’s earnings have surpassed estimates in each of the trailing four quarters
Cara Therapeutics’ loss per share estimates have narrowed 1.3% for 2022, over the past 60 days.
Cara Therapeutics’ earnings surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.