REGN Gets EC Nod for Libtayo Label Expansion, FDA Clears Monthly Eylea HD

Regeneron Pharmaceuticals, Inc. REGN announced that the European Commission (EC) has approved label expansion of its PD-1 inhibitor Libtayo (cemiplimab).

The EC approved Libtayo as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.

The recent label expansion by EC expands the existing approved indication for Libtayo in advanced CSCC to include patients at high risk of disease recurrence. Libtayo is also currently approved in the EU for the treatment of certain patients with advanced CSCC, advanced basal cell carcinoma (BCC, advanced non-small cell lung cancer (NSCLC) and recurrent or metastatic cervical cancer.

More on REGN’s Libtayo

The latest EC approval is supported by data from the global late-stage C-POST study, which evaluated adjuvant Libtayo versus placebo in patients with CSCC at high risk of recurrence following surgery and radiation.

Data from the study showed Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death compared to placebo.

The safety profile of the drug in this indication is consistent with the known safety profile for Libtayo monotherapy in advanced cancers.

CSCC is one of the fastest-growing forms of skin cancer. REGN stated that although CSCC is often managed effectively with surgery or radiation, some patients still face a significant risk of recurrence and serious outcomes. This highlights the urgent need for earlier intervention, even though immunotherapy has traditionally been reserved for advanced disease.

Since treatment with Libtayo has shown improvement in disease-free survival in this setting, it has the potential to improve outlook for these earlier-stage patients in need.

Libtayo’s performance has been good so far, as sales totaled $1.03 billion in the first nine months of 2025, up 21% year over year. Regeneron records global net product sales of Libtayo and pays Sanofi SNY 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 Wins FDA Approval for Monthly Dose of Eylea HD

Separately, Regeneron announced that the FDA has approved Eylea HD (aflibercept) Injection 8 mg for the treatment of patients with macular edema following retinal vein occlusion (RVO) with up to every eight-week dosing after an initial monthly dosing period.

The regulatory body also approved a monthly dosing option for some patients who may benefit from resuming this dosing schedule across approved indications — wet age-related macular degeneration (wAMD), diabetic macular edema (DME), diabetic retinopathy (DR) and RVO.

Regeneron’s lead drug Eylea is an anti-vascular endothelial growth factor inhibitor (“VEGF”). The drug, approved for various ophthalmology indications, is a major contributor to the top line.

However, Eylea is under pressure due to competition from Roche’s RHHBY Vabysmo.

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.

Eylea HD sales in the United States increased 10% in the third quarter of 2025 due to higher sales volumes driven by increased demand.

Additional label expansions of the drug should further boost sales.

Please note that Regeneron co-developed Eylea with the HealthCare unit of Bayer AG BAYRY. Regeneron records net product sales of Eylea and Eylea HD in the United States and Bayer does the same outside the country.

Meanwhile, the uptake of Roche’s Vabysmo has been phenomenal. Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A.

REGN’s Efforts to Diversify Portfolio

Regeneron is striving hard to diversify its portfolio, given the decline in Eylea sales.

REGN stock has lost 1.4% year to date against the industry’s growth of 16.5%.

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 EU 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 EU 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.

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.

Zacks Rank

Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

 

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