KEY TAKEAWAYS:
- Regeneron (#20 by revenue in FY2024) became the third company to launch a BCMAxCD3 bispecific for myeloma, following J&J (#3) and Pfizer (#2).
- Company spends 36.1% of revenue on R&D—highest in pharma—growing at 19.5% annually
- Patent portfolio shows 652 antibody patents (50.3% of total) with 31 bispecific-specific filings
Entrance to Regeneron Pharmaceuticals, a biotech company involved with a cocktail therapy of monoclonal antibodies to Covid-19 and other biologic drugs, Tarrytown, New York, March 21, 2020. Regeneron is also working with Sanofi on other biologic drugs.
Tarrytown, New York–based Regeneron may be a Big Pharma company, but it’s also a relative David compared to the likes of Merck & Co., Pfizer and J&J’s pharma business, which each bring in about four times more revenue overall. But despite its relatively small size and #20 global ranking, the company won its first FDA approval in blood cancer, where it will face competition from J&J (with teclistamab) and Pfizer (with elranatamab).
FDA’s accelerated approval of Lynozyfic (linvoseltamab-gcpt) on July 2, 2025, makes it the third BCMAxCD3 bispecific antibody for multiple myeloma, but the first with response-adapted monthly dosing. The approval validates Regeneron’s strategy of maintaining the industry’s highest R&D intensity at 36.1% of revenue while growing R&D spending at a 19.5% clip annually (looking at data from FY2022 to 2024).
The approval came after an initial FDA rejection in August 2024 due to third-party manufacturing issues, which were subsequently resolved.
The approval details
FDA’s accelerated approval for Lynozyfic (linvoseltamab-gcpt) covers adults with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy. The indication for the bispecific antibody directing T cells to kill multiple myeloma cancer cells is also limited to patients who have received a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody before commencing treatment.
The approval was based on positive results from the pivotal Phase 1/2 LINKER-MM1 trial. In a cohort of 80 patients who matched the indicated criteria, the treatment demonstrated a 70% overall response rate (ORR), with 46.9% of patients achieving a complete response (CR) or better. The responses also proved to be durable; at a median follow-up of 11.3 months, the median duration of response had not been reached, with an estimated 72% of responders maintaining their response at the 12-month mark.
Lynozyfic’s FDA win comes with a boxed warning and REMS
Lynozyfic represents a powerful therapeutic option for patients who have historically faced dismal outcomes. These heavily pre-treated patients, having failed a median of five prior therapies, typically have a life expectancy measured in months, not years. For this traditionally treatment-resistant population, the risk-benefit calculation shifts dramatically, although for many of these patients covered by the indication, the benefit-risk equation could favor Lynozyfic.
The safety profile, assessed in 117 patients receiving the 200 mg dose, showed that Cytokine Release Syndrome (CRS) occurred in 46% of patients. Most of these events were low-grade, with a median onset of approximately 11 hours and a median duration of about 16 hours. Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), was reported in 54% of patients, with 8% experiencing severe events.
Like other T-cell engaging bispecifics, Lynozyfic is available only through a Risk Evaluation and Mitigation Strategy (REMS) program. As such it requires specialized centers and monitoring protocols. Yet the response-adapted dosing could reduce the burden of frequent hospital visits over time.
Like other T-cell engaging bispecifics, Lynozyfic carries a Boxed Warning for cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).
The David vs. Goliath numbers: How being third became an advantage
Despite being the third BCMAxCD3 bispecific to market (after J&J’s Tecvayli in October 2022 and Pfizer’s Elrexfio in August 2023), Regeneron leveraged learnings from competitors to optimize Lynozyfic’s dosing regimen, achieving the first response-adapted monthly dosing schedule in this class.
In all, Regeneron invests about 36 cents of every revenue dollar into R&D, nearly double the industry average and significantly higher than its BCMAxCD3 competitors.
| Company | 2024 Revenue | R&D Spend | R&D Intensity | Global Rank |
|---|---|---|---|---|
| Regeneron | $14.2B | $5.1B | 36.1% | #20 |
| Johnson & Johnson (Pharma) | $57.1B | $13.5B | 23.7% | #3 |
| Pfizer | $63.6B | $10.8B | 17.0% | #2 |
| Merck & Co. | $64.2B | $17.9B | 27.9% | #1 |
The R&D investment story
Regeneron’s R&D spending has surged at nearly three times the industry average. The company’s research and development expenditures grew from $3.59 billion in 2022 to $4.44 billion in 2023 (a 23.6% increase), and then to $5.13 billion in 2024 (a 15.6% increase). This represents a two-year compound annual growth rate (CAGR) of 19.5%.
Patent portfolio: built for bispecifics
Regeneron’s patent strategy reveals a laser focus on antibody technologies that enabled Lynozyfic’s success:
U.S. patent portfolio analysis (1,296 patents) based on PatentsView dataset downloaded in late June 2025:
| Technology Area | Patents | % of Portfolio |
|---|---|---|
| Antibodies/Peptides | 652 | 50.3% |
| Pharmaceutical Preparations | 275 | 21.2% |
| Microorganisms/Enzymes | 156 | 12.0% |
The bispecific focus depth reveals significant activity in this therapeutic area, with 31 of Regeneron’s USPTO patents in the sample specifically mentioning bispecific antibodies. Among these, 19 patents reference CD3 targeting for T-cell engagement, while 4 patents focus on BCMA targeting. The portfolio demonstrates accelerating innovation, with 768 patents filed since 2019, representing 59.3% of the total portfolio.
Competitive landscape
While Regeneron was third to market with a BCMA-targeting bispecific, Lynozyfic offers the most flexible dosing regimen with key differentiators. Teclistamab by J&J, targeting BCMAxCD3, received FDA approval in October 2022 and had the advantage of being first to market. Pfizer’s Elranatamab, also targeting BCMAxCD3, was approved in August 2023 and offers a subcutaneous option as its key advantage. Regeneron’s Lynozyfic, targeting BCMAxCD3, received FDA approval in July 2025 and distinguishes itself with response-adapted dosing as its key advantage.
Lynozyfic’s differentiation:
- Regeneron describes the drug as the first BCMAxCD3 bispecific that can extend to monthly dosing (every 4 weeks)
- Response-adapted regimen: Weekly → Biweekly → Monthly based on patient response
- Competitors remain on fixed weekly/biweekly schedules
- Potential for reduced treatment burden and healthcare visits
Lynozyfic’s response-adapted dosing addresses one of the biggest challenges in bispecific therapy: treatment burden. For heavily pre-treated myeloma patients who already face frequent medical appointments, the ability to extend to monthly dosing could significantly improve quality of life. This advantage becomes even more meaningful when considering the size of the patient population that could benefit as multiple myeloma remains the second most common blood cancer in the United States.
Lynozyfic’s target population:
- ~8,000 US patients have received 3+ prior therapies
- ~2,000-2,500 have received 4+ prior therapies (Lynozyfic’s specific indication)
- Median 5 prior lines of therapy in the LINKER-MM1 trial
For these heavily pre-treated patients who have exhausted standard options, Lynozyfic’s 70% response rate and flexible dosing schedule offer new hope and potentially improved quality of life.
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