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REGN Gains 21.5% in a Month: Time to Buy, Sell or Hold the Stock?
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Key Takeaways
Regeneron shares have jumped 21.5% YTD on positive pipeline and regulatory updates.
Eylea HD approvals and rising demand help counter pressure from competing ophthalmology therapies.
Label expansions for Libtayo and strong Dupixent sales continue to support Regeneron's top-line growth.
Shares of Regeneron Pharmaceuticals (REGN - Free Report) have gained 21.5% year to date compared with the industry’s growth of 10.2%. The stock has also outperformed the sector and the S&P 500 Index during this time frame.
The rally can be attributed to recent positive pipeline and regulatory updates. The recent surge has also reversed the stock’s year-to-date performance trend.
REGN Outperforms Industry, Sector and S&P 500 Index
Image Source: Zacks Investment Research
Let us analyze the company’s strengths and weaknesses in such a scenario to make a prudent investment choice:
Positive Eylea HD Updates Fuel REGN
Regeneron recently 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 - Free Report) 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 - Free Report) . 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 Broadens Oncology Portfolio
REGN’s oncology franchise comprises PD-1 inhibitor Libtayo (cemiplimab-rwlc), indicated in certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer (NSCLC).
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 - Free Report) a royalty on such sales.
The European Commission (EC) recently approved a label expansion of Libtayo as an adjuvant treatment for adult patients with 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.
The drug was also approved by the FDA in October for the same indication.
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’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 who have received 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.
Strong Dupixent Sales Fuel REGN Profits
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.
Last week, the EC approved a label expansion of Dupixent for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in adult and adolescent patients 12 years and above with inadequate response to histamine-1 antihistamines (H1AH) and who are naïve to anti-immunoglobulin E (IgE) therapy for CSU.
REGN: Valuation & Estimates
Image Source: Zacks Investment Research
Going by the price/earnings ratio, REGN is expensive at this moment. Shares currently trade at 23.27X forward earnings, higher than its mean of 18.84X and the large-cap pharma industry’s value of 17.26X.
The bottom-line estimate for 2025 has moved up $3.23 to $43.29 over the past 60 days and the same for 2026 has increased $1.90.
Image Source: Zacks Investment Research
Final Thoughts on Regeneron
REGN is one of the largest biotechs in the sector that are considered safe havens for investors interested in this sector.
REGN’s progress with the oncology portfolio should enable diversification of top-line growth.
Consistent label expansions of Dupixent continue to fuel its sales and help REGN earn higher profits.
However, the decline in Eylea sales remains a headwind as it was the growth engine for REGN. Regulatory setbacks are worrisome as well.
We believe that the near-term pipeline setbacks and challenges with Eylea weigh on the stock for now. Hence, we would advise prospective investors to be on the sidelines for the time being as the valuation is pricey as well.
For investors already owning the stock, staying invested at current levels would be prudent.
Image: Bigstock
REGN Gains 21.5% in a Month: Time to Buy, Sell or Hold the Stock?
Key Takeaways
Shares of Regeneron Pharmaceuticals (REGN - Free Report) have gained 21.5% year to date compared with the industry’s growth of 10.2%. The stock has also outperformed the sector and the S&P 500 Index during this time frame.
The rally can be attributed to recent positive pipeline and regulatory updates. The recent surge has also reversed the stock’s year-to-date performance trend.
REGN Outperforms Industry, Sector and S&P 500 Index
Image Source: Zacks Investment Research
Let us analyze the company’s strengths and weaknesses in such a scenario to make a prudent investment choice:
Positive Eylea HD Updates Fuel REGN
Regeneron recently 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 - Free Report) 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 - Free Report) . 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 Broadens Oncology Portfolio
REGN’s oncology franchise comprises PD-1 inhibitor Libtayo (cemiplimab-rwlc), indicated in certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer (NSCLC).
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 - Free Report) a royalty on such sales.
The European Commission (EC) recently approved a label expansion of Libtayo as an adjuvant treatment for adult patients with 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.
The drug was also approved by the FDA in October for the same indication.
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’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 who have received 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.
Strong Dupixent Sales Fuel REGN Profits
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.
Last week, the EC approved a label expansion of Dupixent for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in adult and adolescent patients 12 years and above with inadequate response to histamine-1 antihistamines (H1AH) and who are naïve to anti-immunoglobulin E (IgE) therapy for CSU.
REGN: Valuation & Estimates
Image Source: Zacks Investment Research
Going by the price/earnings ratio, REGN is expensive at this moment. Shares currently trade at 23.27X forward earnings, higher than its mean of 18.84X and the large-cap pharma industry’s value of 17.26X.
The bottom-line estimate for 2025 has moved up $3.23 to $43.29 over the past 60 days and the same for 2026 has increased $1.90.
Image Source: Zacks Investment Research
Final Thoughts on Regeneron
REGN is one of the largest biotechs in the sector that are considered safe havens for investors interested in this sector.
REGN’s progress with the oncology portfolio should enable diversification of top-line growth.
Consistent label expansions of Dupixent continue to fuel its sales and help REGN earn higher profits.
However, the decline in Eylea sales remains a headwind as it was the growth engine for REGN. Regulatory setbacks are worrisome as well.
We believe that the near-term pipeline setbacks and challenges with Eylea weigh on the stock for now. Hence, we would advise prospective investors to be on the sidelines for the time being as the valuation is pricey as well.
For investors already owning the stock, staying invested at current levels would be prudent.
REGN currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.