Regeneron Pharmaceuticals, Inc. REGN obtained positive opinion for its pipeline candidate linvoseltamab from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

The CHMP recommended conditional marketing authorization of linvoseltamab to treat adults with relapsed and refractory (R/R) multiple myeloma (MM). The recommendation is specific to those who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.

A final decision is expected in the coming months.

Regeneron’s shares have lost 30.5% in the past year compared with the medical-biomedical genetics industry’s decline of 6.7%.

Image Source: Zacks Investment Research

More on REGN’s linvoseltamab

Linvoseltamab is an investigational BCMAxCD3 bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on MM cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.

The positive CHMP opinion is supported by data from the pivotal LINKER-MM1 trial, which evaluated linvoseltamab in adults with R/R MM.

Last month, the FDA accepted the biologics license application (BLA) for linvoseltamab for review and set a target action date of July 10, 2025.

A potential approval will diversify REGN’s portfolio.

We note that the FDA had earlier issued a CRL for the BLA for linvoseltamab in R/R multiple myeloma. The sole approvability issue identified was related to findings from a pre-approval inspection at a third-party fill/finish manufacturer.

The FDA’s acceptance of the BLA resubmission followed the resolution of third-party fill/finish manufacturing issues.

Linvoseltamab is being evaluated in a broad clinical development program that explores its use as a monotherapy and in combination regimens across different lines of therapy in MM, including earlier lines of treatment and plasma cell precursor disorders.

The program includes evaluating linvoseltamab in a phase Ib study (LINKER-MM2) in combination with other cancer treatments in R/R MM and a phase III confirmatory study (LINKER-MM3) as a monotherapy in R/R MM.

REGN’s Efforts to Broaden Oncology Portfolio

REGN is currently looking to strengthen its oncology franchise, which currently comprises Libtayo (cemiplimab-rwlc), indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer.

REGN’s oncology franchise got a boost with the European Commission's approval of odronextamab in 2024 for treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The drug has been approved under the brand name Ordspono.

However, the company’s efforts to get odronextamab approved in the United States suffered a setback. The regulatory body issued CRLs for its BLA for odronextamab in 2024.

Last week, Regeneron announced that the FDA has accepted for review the resubmission of the BLA for odronextamab in R/R FL after two or more lines of systemic therapy. The target action date for the FDA decision is July 30, 2025.

The BLA resubmission has been accepted following the achievement of an FDA-mandated enrollment target for the phase III confirmatory trial in R/R FL (OLYMPIA -1). The FDA identified this as the sole approvability issue in the CRL associated with the previous submission.

This BLA resubmission is supported by data from the phase I and pivotal phase II studies (ELM-1 and ELM-2), which demonstrated an overall response rate of 80%, with 74% achieving a complete response.

The successful development of these oncology drugs should be a great boost for REGN.

Headwinds for Regeneron: Decline of Eylea Sales

Last month, Regeneron reported better-than-expected results for the fourth quarter, but the decline in lead drug Eylea sales is a concern.

Eylea sales were under pressure in 2024 due to competition from Roche’s RHHBY Vabysmo. We note that the uptake of Vabysmo has been outstanding. Roche designed Vabysmo to block pathways involving Ang-2 and VEGF-A. On strong demand in all regions, Roche’s Vabysmo sales skyrocketed 68% to CHF 3.9 billion in 2024.

Nonetheless, the uptake of Eylea HD is encouraging as Eylea patients transition to the higher dose.

Regeneron’s efforts to broaden its oncology portfolio and foray into the lucrative obesity space are encouraging, even though it faced a few regulatory setbacks in 2024.

REGN’s Zacks Rank, Other Stocks to Consider

REGN currently carries a Zacks Rank #3 (Hold). A couple of top-ranked stocks in the biotech sector are Gilead Sciences GILD and BioMarin Pharmaceutical BMRN, each carrying a Zacks Rank of 2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 30 days, Gilead Sciences’ EPS estimate for 2025 has increased from $7.56 to $7.85. In the past 30 days, Gilead Sciences’ EPS estimate for 2025 has increased from $7.56 to $7.85. During the same timeframe, the figure for 2026 has increased to $8.17 from $7.82.

GILD’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.47%.

In the past 30 days, estimates for BioMarin Pharmaceutical’s 2025 EPS have increased from $4.01 to $4.19. Estimate for 2026 EPS has decreased from $5.21 to $5.20 during the same timeframe. BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 32.36%.
 

 

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report

Roche Holding AG (RHHBY) : Free Stock Analysis Report

BioMarin Pharmaceutical Inc. (BMRN) : Free Stock Analysis Report

Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research