FDA Grants Accelerated Approval to Regeneron's Blood Cancer Drug
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.
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Regeneron Pharmaceuticals, Inc. (REGN): Free Stock Analysis Report
Novartis AG (NVS): Free Stock Analysis Report
Roche Holding AG (RHHBY): Free Stock Analysis Report
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For more information on Ketchum, a part of Omnicom PR Group, visit Forward Looking Statements This press release contains forward-looking statements within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the timing and nature of cytisinicline clinical development and regulatory review and approval, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the development and effectiveness of new treatments, and the successful commercialization of cytisinicline. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development and commercialization of cytisinicline; the risk that cytisinicline will not receive regulatory approval in a timely manner or at all, or be successfully commercialized; the risk that new developments in the smoking and vaping cessation landscapes require changes in business strategy or clinical development plans; the risk that Achieve's intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of macroeconomic and geopolitical conditions, including fluctuating inflation, interest and tariff rates, volatility in the debt and equity markets, actual or perceived instability in the global banking system, global health crises and pandemics and geopolitical conflict and the other factors described in the risk factors set forth in Achieve's filings with the Securities and Exchange Commission from time to time, including Achieve's Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable. Achieve Contact Nicole Jones ir@ 425-686-1510 References 1 VanFrank B, Malarcher A, Cornelius ME, Schecter A, Jamal A, Tynan M. Adult Smoking Cessation — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:633–641. 2 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017. 3 U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014. 4 Vahratian A, Briones EM, Jamal A, Marynak KL. Electronic cigarette use among adults in the United States, 2019–2023. NCHS Data Brief, no 524. Hyattsville, MD: National Center for Health Statistics. 2025. DOI: 10.15620/cdc/174583. 5 Jamal A, Park-Lee E, Birdsey J, et al. Tobacco Product Use Among Middle and High School Students — National Youth Tobacco Survey, United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:917–924.
