FDA Grants Accelerated Approval to Regeneron's Blood Cancer Drug

Regeneron Pharmaceuticals, Inc. REGN obtained FDA approval for linvoseltamab-gcpt for the treatment of relapsed or refractory (R/R) multiple myeloma (MM).

The regulatory body granted accelerated approval to linvoseltamab under the brand name Lynozyfic for the treatment of R/R MM who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti CD38 monoclonal antibody.

Lynozyfic is a fully human 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.

Year to date, REGN’s shares have lost 22.9% compared with the industry’s 0.6% decline.

More on REGN’s MM Drug

The approval was based on positive results from the phase I/II LINKER-MM1 trial, wherein Lynozyfic demonstrated one of the highest objective response rates (70%) and complete response rates (45%) among bispecific antibodies for this challenging patient population.

With the FDA approval, Lynozyfic is the first FDA-approved BCMAxCD3 bispecific antibody that can be dosed every two weeks starting at week 14, and every four weeks if a very good partial response (VGPR) or better is achieved following completion of at least 24 weeks of therapy.

MM remains the second most common blood cancer, with more than 36,000 new cases expected in the US in 2025 alone.
Lynozyfic is tailored for patients who have undergone at least four prior treatment regimens, addressing a critical unmet need in late-stage MM.

The approval strengthens REGN’s oncology portfolio.

Lynozyfic 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, and have demonstrated disease progression on the last therapy.

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.

REGN’s Efforts to Strengthen Oncology Portfolio

REGN is currently looking to strengthen its oncology franchise, which currently comprises Libtayo, 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 received a boost with the European Commission's approval of odronextamab in 2024 for treating adult patients with 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.

The FDA has accepted for review the resubmission of the BLA for odronextamab in R/R follicular lymphoma with a target action date of July 30, 2025.

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

The decline in lead drug Eylea sales is a concern for REGN.

Eylea sales are under pressure due to competition from Roche’s RHHBY Vabysmo. Roche designed Vabysmo to block pathways involving Ang-2 and VEGF-A.

The uptake of Vabysmo has been outstanding, causing a loss of market share for Eylea.

REGN’s Zacks Rank and Stocks to Consider

REGN currently carries a Zacks Rank #3 (Hold).  A couple of better-ranked stocks in the pharma/biotech sector are Novartis NVS and Bayer BAYRY, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

The Zacks Consensus Estimate for Novartis’ 2025 earnings per share (EPS) has risen from $8.69 to $8.81 over the past 60 days. EPS estimates for 2026 have jumped 12 cents to $9.12 during this time frame. The stock has risen 30.2% so far this year.

BAYRY’s 2025 EPS estimate has increased from $1.19 to $1.25 over the past 90 days, while that for 2026 has gone up from $1.28 to $1.31 over the same time frame. Year to date, shares of Bayer have surged 60%.

BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.

 

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