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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has given positive opinions for oncology drug, Libtayo (cemiplimab), as monotherapy in two advanced cancers.
The drug is being developed in collaboration with Sanofi (SNY - Free Report) .
The CHMP recommended the approval of the drug for the first-line treatment of adults with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥50% of tumor cells with no EGFR, ALK or ROS1 aberrations. Patients must have metastatic disease or locally advanced disease that is not a candidate for definitive chemoradiation. The drug was recommended for approval in adults with locally advanced or metastatic basal cell carcinoma (BCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI).
A decision on the same by the European Commission is expected in the coming months.
The positive CHMP opinion for Libtayo in advanced NSCLC is based on results from a phase III study, which allowed for the enrollment of patients with disease characteristics frequently underrepresented in advanced NSCLC pivotal trials, including those with pre-treated and clinically stable brain metastases or locally advanced NSCLC and who were not candidates for definitive chemoradiation.
The positive opinion for Libtayo in locally advanced and metastatic BCC is based on results from the largest, prospective clinical trial in these patients previously treated with an HHI.
We remind investors that Libtayo is currently approved in the European Union (EU) and other countries for the treatment of certain patients with advanced cutaneous squamous cell carcinoma (CSCC). Its label was recently expanded with the approval of monotherapy for certain patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression in the United States.
The FDA also recently approved the use of Libtayo as the first immunotherapy indicated for patients with BCC, previously treated with an HHI or for whom an HHI is not appropriate.
Approval for additional indications will boost the growth potential of the drug. The uptake of the drug has been encouraging since its approval in 2018.
The company is looking to build a portfolio in the oncology space and diversify its revenue base.
The company's shares have gained 4.9% in the year so far against the industry’s decline of 4.4%.
Regeneron’s first-quarter results were strong with broad-based growth. Demand for lead drug, Eylea, in collaboration with Bayer (BAYRY - Free Report) , revived. Dupixent maintained its strong performance. Incremental contribution from REGEN-COV boosted the top line and should propel sales as the pandemic continues.
Repligen’s earnings estimates for 2021 have increased to $2.21 from $1.66 in the past 90 days
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Regeneron (REGN)-Sanofi's Libtayo Gets Positive CHMP Opinion
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has given positive opinions for oncology drug, Libtayo (cemiplimab), as monotherapy in two advanced cancers.
The drug is being developed in collaboration with Sanofi (SNY - Free Report) .
The CHMP recommended the approval of the drug for the first-line treatment of adults with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥50% of tumor cells with no EGFR, ALK or ROS1 aberrations. Patients must have metastatic disease or locally advanced disease that is not a candidate for definitive chemoradiation. The drug was recommended for approval in adults with locally advanced or metastatic basal cell carcinoma (BCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI).
A decision on the same by the European Commission is expected in the coming months.
The positive CHMP opinion for Libtayo in advanced NSCLC is based on results from a phase III study, which allowed for the enrollment of patients with disease characteristics frequently underrepresented in advanced NSCLC pivotal trials, including those with pre-treated and clinically stable brain metastases or locally advanced NSCLC and who were not candidates for definitive chemoradiation.
The positive opinion for Libtayo in locally advanced and metastatic BCC is based on results from the largest, prospective clinical trial in these patients previously treated with an HHI.
We remind investors that Libtayo is currently approved in the European Union (EU) and other countries for the treatment of certain patients with advanced cutaneous squamous cell carcinoma (CSCC). Its label was recently expanded with the approval of monotherapy for certain patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression in the United States.
The FDA also recently approved the use of Libtayo as the first immunotherapy indicated for patients with BCC, previously treated with an HHI or for whom an HHI is not appropriate.
Approval for additional indications will boost the growth potential of the drug. The uptake of the drug has been encouraging since its approval in 2018.
The company is looking to build a portfolio in the oncology space and diversify its revenue base.
The company's shares have gained 4.9% in the year so far against the industry’s decline of 4.4%.
Regeneron’s first-quarter results were strong with broad-based growth. Demand for lead drug, Eylea, in collaboration with Bayer (BAYRY - Free Report) , revived. Dupixent maintained its strong performance. Incremental contribution from REGEN-COV boosted the top line and should propel sales as the pandemic continues.
Regeneron currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Repligen Corporation (RGEN - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Repligen’s earnings estimates for 2021 have increased to $2.21 from $1.66 in the past 90 days
Infrastructure Stock Boom to Sweep America
A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made.
The only question is “Will you get into the right stocks early when their growth potential is greatest?”
Zacks has released a Special Report to help you do just that, and today it’s free. Discover 7 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.
Download FREE: How to Profit from Trillions on Spending for Infrastructure >>