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Regeneron Gets FDA Nod for Label Expansion of Oncology Drug Libtayo
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Key Takeaways
Regeneron gained FDA approval to expand Libtayo as adjuvant therapy for high-risk CSCC.
Libtayo cut disease recurrence or death risk by 68% in the late-stage C-POST study.
Strong Libtayo sales and new oncology drugs help offset Eylea's competition-driven decline.
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has approved the label expansion of PD-1 inhibitor Libtayo (cemiplimab-rwlc).
Libtayo is now approved as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (“CSCC”) at high risk of recurrence after surgery and radiation.
Please note that the drug is already approved in several countries for certain adult patients with advanced basal cell carcinoma, advanced CSCC, advanced non-small cell lung cancer and advanced cervical cancer.
REGN stock has lost 20.5% year to date against the industry’s growth of 10.5%.
Image Source: Zacks Investment Research
More on Latest Approval of REGN’s Libtayo
The FDA evaluated Libtayo for CSCC under Priority Review. An additional regulatory application is also under review in the European Union and a decision on the same is expected by the first half of 2026.
The approval is based on data from the late-stage C-POST study evaluating adjuvant Libtayo versus placebo in patients with CSCC at high risk of recurrence after surgery and radiation. Results from this study showed that Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death compared with placebo in patients with CSCC at high risk of recurrence after surgery and radiation.
Per REGN, the latest approval provides patients with CSCC at high risk of disease recurrence following surgery and radiation a much-needed option, as Libtayo is the only immunotherapy to demonstrate efficacy in this setting.
Libtayo’s performance has been good so far, as sales totaled $661.6 million in the first half of 2025, up 18% year over year. Regeneron records global net product sales of Libtayo and pays Sanofi (SNY - Free Report) a royalty on such sales.
REGN 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.
REGN Makes Efforts to Diversify Portfolio
REGN’s oncology franchise received a boost with the recent FDA approval of linvoseltamab-gcpt for the treatment of relapsed or refractory (R/R) multiple myeloma (“MM”). The drug was granted accelerated approval by the FDA under the brand name Lynozyfic. It is also approved in the European Union to treat adults with R/R MM after at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
The approval of Ordspono (odronextamab) for treating adult patients with R/R follicular lymphoma or R/R diffuse large B-cell lymphoma after two or more lines of systemic therapy has also strengthened its oncology franchise.
However, the company’s efforts to get odronextamab approved in the United States suffered a setback. The FDA recently issued a complete response letter for the BLA for odronextamab.
REGN is making efforts to diversify its portfolio as the lead drug Eylea is under pressure due to competition from Roche’s (RHHBY - Free Report) Vabysmo.
Eylea, an anti-vascular endothelial growth factor inhibitor (“VEGF”), is approved for various ophthalmology indications. The drug is the biggest contributor to the top line.
The uptake of Roche’s Vabysmo has been phenomenal. Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A.
Since Eylea accounts for a majority of REGN’s sales, a rapid decline in sales has adversely impacted its top line.
To counter the decline in Eylea sales, Regeneron has developed a higher dose of the drug. Eylea HD sales in the United States surged 29% in the second quarter due to higher sales volumes driven by increased demand.
REGN’s top line also comprises its share of profits/losses in connection with the global sales of Dupixent. Partner Sanofi records global net product sales of Dupixent.
Solid sales of Dupixent (approved for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis) have fueled the top line for Sanofi and Regeneron.
Image: Bigstock
Regeneron Gets FDA Nod for Label Expansion of Oncology Drug Libtayo
Key Takeaways
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has approved the label expansion of PD-1 inhibitor Libtayo (cemiplimab-rwlc).
Libtayo is now approved as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (“CSCC”) at high risk of recurrence after surgery and radiation.
Please note that the drug is already approved in several countries for certain adult patients with advanced basal cell carcinoma, advanced CSCC, advanced non-small cell lung cancer and advanced cervical cancer.
REGN stock has lost 20.5% year to date against the industry’s growth of 10.5%.
Image Source: Zacks Investment Research
More on Latest Approval of REGN’s Libtayo
The FDA evaluated Libtayo for CSCC under Priority Review. An additional regulatory application is also under review in the European Union and a decision on the same is expected by the first half of 2026.
The approval is based on data from the late-stage C-POST study evaluating adjuvant Libtayo versus placebo in patients with CSCC at high risk of recurrence after surgery and radiation. Results from this study showed that Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death compared with placebo in patients with CSCC at high risk of recurrence after surgery and radiation.
Per REGN, the latest approval provides patients with CSCC at high risk of disease recurrence following surgery and radiation a much-needed option, as Libtayo is the only immunotherapy to demonstrate efficacy in this setting.
Libtayo’s performance has been good so far, as sales totaled $661.6 million in the first half of 2025, up 18% year over year. Regeneron records global net product sales of Libtayo and pays Sanofi (SNY - Free Report) a royalty on such sales.
REGN 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.
REGN Makes Efforts to Diversify Portfolio
REGN’s oncology franchise received a boost with the recent FDA approval of linvoseltamab-gcpt for the treatment of relapsed or refractory (R/R) multiple myeloma (“MM”). The drug was granted accelerated approval by the FDA under the brand name Lynozyfic. It is also approved in the European Union to treat adults with R/R MM after at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
The approval of Ordspono (odronextamab) for treating adult patients with R/R follicular lymphoma or R/R diffuse large B-cell lymphoma after two or more lines of systemic therapy has also strengthened its oncology franchise.
However, the company’s efforts to get odronextamab approved in the United States suffered a setback. The FDA recently issued a complete response letter for the BLA for odronextamab.
REGN is making efforts to diversify its portfolio as the lead drug Eylea is under pressure due to competition from Roche’s (RHHBY - Free Report) Vabysmo.
Eylea, an anti-vascular endothelial growth factor inhibitor (“VEGF”), is approved for various ophthalmology indications. The drug is the biggest contributor to the top line.
The uptake of Roche’s Vabysmo has been phenomenal. Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A.
Since Eylea accounts for a majority of REGN’s sales, a rapid decline in sales has adversely impacted its top line.
To counter the decline in Eylea sales, Regeneron has developed a higher dose of the drug. Eylea HD sales in the United States surged 29% in the second quarter due to higher sales volumes driven by increased demand.
REGN’s top line also comprises its share of profits/losses in connection with the global sales of Dupixent. Partner Sanofi records global net product sales of Dupixent.
Solid sales of Dupixent (approved for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis) have fueled the top line for Sanofi and Regeneron.
REGN currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.