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Regeneron Initial Data on Multiple Myeloma Drug Encouraging
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced encouraging initial results from two cohorts of the early-stage study on oncology drug linvoseltamab.
LINKER-MM2 is a phase Ib, open-label clinical trial evaluating linvoseltamab in combination with other cancer treatments in patients with relapsed/refractory (R/R) multiple myeloma (MM).
Results presented that linvoseltamab in combination with carfilzomib or bortezomib showed promising results in earlier lines of treatment for relapsed/refractory multiple myeloma. Data in both combinations demonstrate high response rates.
The data will be featured in two oral presentations at the American Society of Clinical Oncology (“ASCO”) 2025 Annual Meeting on June 2.
Year to date, REGN shares have lost 17.3% compared with the industry’s 4.9% decline.
Image Source: Zacks Investment Research
More on REGN’s Linvoseltamab
LINKER-MM2 included patients who had progressed after at least two lines of therapy and were either double-class refractory (immunomodulatory drug [IMiD] and proteasome inhibitor [PI]) or triple-class exposed (IMiD, PI and anti-CD38 monoclonal antibody).
The treated patients had previous exposure to PIs and more than half were refractory to at least one PI. Among the enrolled patients, 48% had baseline soft tissue plasmacytomas, and 39% were over 75 years old, representing a patient population with high-risk features. Of the 21 patients evaluable for efficacy, 11 received linvoseltamab 100 mg, and five received linvoseltamab 150 mg or 200 mg prior to initiation of carfilzomib.
The initial results were promising. Efficacy results across all dose levels showed a 90% objective response rate (ORR) with 76% achieving a complete response (CR), at a median follow-up of 15 months. At 12 months, the estimated probability of maintaining a response was 87% and being progression-free was 83%. Regeneron has planned a registrational, randomized phase III study investigating this combination against standard-of-care in the same setting.
Meanwhile, among enrolled patients (n=24), six received linvoseltamab at 100 mg and 18 at 200 mg before initiating bortezomib. More than half were refractory to PIs, including 58% to carfilzomib and 13% to bortezomib. Of the 20 patients evaluable for efficacy and with a median duration of follow-up of nine months, results across dose levels showed an 85% ORR with 50% achieving a CR.
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Last month, the European Commission granted conditional marketing approval to linvoseltamab under the brand name Lynozyfic to treat adults with R/R MM. The indication 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.
The FDA has accepted for review the resubmission of the BLA for linvoseltamab with a target action date of July 10, 2025.
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 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, a 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 - Free Report) 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.
The Zacks Consensus Estimate Novartis’ 2025 earnings per share (EPS) has risen from $8.47 to $8.74 over the past 60 days. EPS estimates for 2026 have jumped 20 cents to $9.02 during this timeframe. The stock has risen 18.3% so far this year.
Pfizer’s 2025 EPS estimate has risen from $2.99 to $3.08 in the past 60 days, while that for 2026 has gone up from $2.99 to $3.09 over the same timeframe.
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Regeneron Initial Data on Multiple Myeloma Drug Encouraging
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced encouraging initial results from two cohorts of the early-stage study on oncology drug linvoseltamab.
LINKER-MM2 is a phase Ib, open-label clinical trial evaluating linvoseltamab in combination with other cancer treatments in patients with relapsed/refractory (R/R) multiple myeloma (MM).
Results presented that linvoseltamab in combination with carfilzomib or bortezomib showed promising results in earlier lines of treatment for relapsed/refractory multiple myeloma. Data in both combinations demonstrate high response rates.
The data will be featured in two oral presentations at the American Society of Clinical Oncology (“ASCO”) 2025 Annual Meeting on June 2.
Year to date, REGN shares have lost 17.3% compared with the industry’s 4.9% decline.
Image Source: Zacks Investment Research
More on REGN’s Linvoseltamab
LINKER-MM2 included patients who had progressed after at least two lines of therapy and were either double-class refractory (immunomodulatory drug [IMiD] and proteasome inhibitor [PI]) or triple-class exposed (IMiD, PI and anti-CD38 monoclonal antibody).
The treated patients had previous exposure to PIs and more than half were refractory to at least one PI. Among the enrolled patients, 48% had baseline soft tissue plasmacytomas, and 39% were over 75 years old, representing a patient population with high-risk features. Of the 21 patients evaluable for efficacy, 11 received linvoseltamab 100 mg, and five received linvoseltamab 150 mg or 200 mg prior to initiation of carfilzomib.
The initial results were promising. Efficacy results across all dose levels showed a 90% objective response rate (ORR) with 76% achieving a complete response (CR), at a median follow-up of 15 months. At 12 months, the estimated probability of maintaining a response was 87% and being progression-free was 83%. Regeneron has planned a registrational, randomized phase III study investigating this combination against standard-of-care in the same setting.
Meanwhile, among enrolled patients (n=24), six received linvoseltamab at 100 mg and 18 at 200 mg before initiating bortezomib. More than half were refractory to PIs, including 58% to carfilzomib and 13% to bortezomib. Of the 20 patients evaluable for efficacy and with a median duration of follow-up of nine months, results across dose levels showed an 85% ORR with 50% achieving a CR.
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Regeneron Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Regeneron Pharmaceuticals, Inc. Quote
REGN Looks to Ramp Up Oncology Portfolio
Last month, the European Commission granted conditional marketing approval to linvoseltamab under the brand name Lynozyfic to treat adults with R/R MM. The indication 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.
The FDA has accepted for review the resubmission of the BLA for linvoseltamab with a target action date of July 10, 2025.
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 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, a 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 - Free Report) 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 - Free Report) and Pfizer (PFE - Free Report) , 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 Novartis’ 2025 earnings per share (EPS) has risen from $8.47 to $8.74 over the past 60 days. EPS estimates for 2026 have jumped 20 cents to $9.02 during this timeframe. The stock has risen 18.3% so far this year.
Pfizer’s 2025 EPS estimate has risen from $2.99 to $3.08 in the past 60 days, while that for 2026 has gone up from $2.99 to $3.09 over the same timeframe.