Latest news with #linvoseltamab
Yahoo
6 days ago
- Business
- Yahoo
Regeneron's Lynozyfic Gains Accelerated FDA Approval for Multiple Myeloma
Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) is one of the most undervalued large cap stocks to buy according to analysts. On July 2, the US FDA) granted accelerate approval to Regeneron Pharmaceuticals's linvoseltamab-gcpt, which is marketed under the brand name Lynozyfic. This bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager is approved for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least 4 prior lines of therapy, including a proteasome inhibitor, which is an immunomodulatory agent, and an anti-CD38 monoclonal antibody. A pharmacist in a lab coat carefully analyzing a vial of medicine for its quality. The accelerated approval for Lynozyfic was based on positive results from the Phase 1/2 LINKER-MM1 trial. In the efficacy population of 80 patients who had received at least four prior lines of therapy, Lynozyfic demonstrated an objective response rate of 70% and a complete response rate of 45%. The FDA had previously issued a Complete Response Letter (CRL) for linvoseltamab due to findings from a pre-approval inspection at a third-party fill/finish manufacturer. Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) discovers, invents, develops, manufactures, and commercializes medicines for treating various diseases worldwide. While we acknowledge the potential of REGN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey.
Yahoo
03-07-2025
- Business
- Yahoo
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. Image Source: Zacks Investment Research 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 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. Regeneron Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Regeneron Pharmaceuticals, Inc. Quote 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 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%. 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 Novartis AG (NVS) : Free Stock Analysis Report Roche Holding AG (RHHBY) : Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Globe and Mail
03-07-2025
- Business
- Globe and Mail
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%. 5 Stocks Set to Double Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in the coming year. While not all picks can be winners, previous recommendations have soared +112%, +171%, +209% and +232%. Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor. Today, See These 5 Potential Home Runs >> 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 Novartis AG (NVS): Free Stock Analysis Report Roche Holding AG (RHHBY): Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY): Free Stock Analysis Report
Medscape
02-07-2025
- Business
- Medscape
Linvoseltamab Approved for R/R Multiple Myeloma
The FDA has granted accelerated approval to linvoseltamab (Lynozyfic, Regeneron) for relapsed or refractory multiple myeloma (MM) after at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody. The bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager joins two others already on the US market for the same indication, teclistamab (Tecvayli, Johnson & Johnson) and elranatamab (Elrexfio, Pfizer). The approval of linvoseltamab was based on 80 patients treated with 200 mg intravenously in the phase 1/2 LINKER-MM1 trial who had received at least 4 prior lines of therapy but not a previous BCMA-directed bispecific antibody. The objective response rate was 70%, with 45% of patients achieving a complete response. The estimated duration of response was 89% at 9 months and 72% at 12 months. The outcomes are among the best reported so far for a bispecific antibody in heavily pretreated MM. Linvoseltamab is also the only one that can be dosed every 4 weeks in patients who are doing well after at least 24 weeks of treatment, according to a Regeneron press release. Because of that, 'we believe Lynozyfic is poised to potentially become a new standard of care for multiple myeloma. Furthermore, given the strength of the data, we are rapidly advancing our broad clinical development program for Lynozyfic — exploring its use in earlier lines of therapy as monotherapy and in novel combinations,' a company executive said in the release. Regeneron has a phase 3 trial in the works to confirm clinical benefit. It is also testing subcutaneous administration, which is the route of administration for teclistamab and elranatamab. Like both of those agents, linvoseltamab carries a boxed warning of life-threatening cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). All three agents are available only through a Risk Evaluation and Mitigation Strategy program. The rate of CRS in LINKER-MM1 was 46%, with grade 3 CRS occurring in less than 1% of patients. ICANS occurred in 54%, with grade 3/4 neurologic toxicity in 8%. Other warnings and precautions include infections, neutropenia, hepatotoxicity, and embryo-fetal toxicity. Linvoseltamab is administered with an initial step-up dosing regimen followed by the full 200 mg dose weekly. At week 14, patients transition to every 2-week dosing. Patients who achieve and maintain a very good partial response or better shift to monthly dosing after 24 weeks. Linvoseltamab requires a 24-hour hospitalization for safety after the first and second step-up doses. M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@
