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REGENERON PHARMACEUTICALS (REGN)

Earnings summaries and quarterly performance for REGENERON PHARMACEUTICALS.

Research analysts who have asked questions during REGENERON PHARMACEUTICALS earnings calls.

Brian Abrahams

RBC Capital Markets

7 questions for REGN

Also covers: ACAD, ATAI, BCRX +17 more

Salveen Richter

Goldman Sachs

7 questions for REGN

Also covers: ACAD, AGIO, ALLO +20 more

Tyler Van Buren

TD Cowen

7 questions for REGN

Also covers: ADVM, ALLO, ARQT +12 more

Akash Tewari

Jefferies

6 questions for REGN

Also covers: ALKS, APLS, ARGX +15 more

Carter L. Gould

Barclays

6 questions for REGN

Also covers: ABBV, ALEC, AMGN +7 more

Cory Kasimov

Evercore ISI

6 questions for REGN

Also covers: BBIO, BMRN, BNTX +5 more

Evan Seigerman

BMO Capital Markets

6 questions for REGN

Also covers: ABBV, AMGN, ARVN +15 more

Terence Flynn

Morgan Stanley

6 questions for REGN

Also covers: ABBV, AMGN, ARVN +17 more

Alexandria Hammond

Wolfe Research

5 questions for REGN

Also covers: ABBV, AMGN, BMRN +6 more

Christopher Schott

JPMorgan Chase & Co.

5 questions for REGN

Also covers: ABBV, AMGN, AMRX +15 more

David Risinger

Leerink Partners

5 questions for REGN

Also covers: ABBV, AMGN, BMY +9 more

Christopher Raymond

Piper Sandler

3 questions for REGN

Also covers: ABBV, AGIO, AMGN +7 more

William Pickering

Sanford C. Bernstein & Co.

3 questions for REGN

Also covers: ALLO, ARWR, NTLA +1 more

Geoff Meacham

Citigroup Inc.

2 questions for REGN

Also covers: ABBV, AMGN, BMY +8 more

Jeffrey Meacham

Citi

2 questions for REGN

Mohit Bansal

Wells Fargo & Company

2 questions for REGN

Also covers: ABBV, AMGN, BMRN +16 more

Simon Goodwin

Rothschild & Co. Redburn

2 questions for REGN

Taylor Hanley

JPMorgan Chase & Co.

2 questions for REGN

Tim Anderson

Bank of America

2 questions for REGN

Also covers: ABBV, AMLX, BIIB +4 more

Alice Natelton

Bank of America

1 question for REGN

Chris

Morgan Stanley

1 question for REGN

Also covers: GILD, MRNA, VRTX

Trung Huynh

UBS Group AG

1 question for REGN

Also covers: ABBV, ABOS, AMGN +5 more

Recent press releases and 8-K filings for REGN.

Regeneron provides linvoseltamab clinical development update
REGN
Product Launch
New Projects/Investments
  • Regeneron highlighted the complex multiple myeloma treatment paradigm and its strategy to simplify care with linvoseltamab, now approved in the late-line setting and launched with over 300 REMS-certified institutions and 35 formulary wins.
  • Phase II data for linvoseltamab + carfilzomib in second-line patients showed a 90% overall response rate and 76% complete response rate, with 87% of responses durable at 12 months.
  • In newly diagnosed first-line multiple myeloma (LINKER-MM4), linvoseltamab monotherapy at 200 mg achieved an 86% overall response rate and 43% complete response rate at nine months, with all evaluable patients achieving MRD negativity at 10^-5 sensitivity.
  • Early data in high-risk smoldering multiple myeloma (LINKER-SMM1) reported a 100% overall response rate and ~40% complete response rate at four months, leading to a pivotal LINKER-SMM2 study planned for H1 2026.
  • Regeneron plans to initiate eight registrational studies across multiple myeloma lines and related conditions by mid-2026, with key readouts through 2029 to establish linvoseltamab as a BCMA bispecific backbone.
3 days ago
Regeneron outlines linvoseltamab development program update
REGN
Product Launch
New Projects/Investments
  • Late-line LINKER-MM1 showed ORR 71%, CR 52%, and median DOR 29 months (median follow-up 20 months); received accelerated approval in July 2025 and confirmatory phase III LINKER-MM3 is fully enrolled (~410 pts; data expected 2027).
  • Second-line Linvoseltamab + Carfilzomib achieved ORR 90%, CR 76%, with 87% of patients maintaining response at 12 months; phase III LINKER-MM5 will start in early 2026 (readout 2028).
  • First-line monotherapy (LINKER-MM4) in newly diagnosed MM yielded ORR 86%, CR 43%, and MRD negativity in all nine evaluable patients at 200 mg (9 months follow-up); supports three phase III first-line trials to initiate in 2026.
  • Precursor MM (high-risk SMM) saw ORR 100% and CR ~40% at <4 months follow-up; pivotal LINKER-SMM2 begins H1 2026; amyloidosis patients achieved normalization of involved free light chain in 15 days.
3 days ago
Regeneron presents linvoseltamab study update
REGN
Product Launch
New Projects/Investments
  • In late-line relapsed/refractory multiple myeloma, linvoseltamab achieved 71% ORR and 52% CR at 20-month median follow-up, with median DOR of 29 months and time to response <1 month.
  • The U.S. FDA granted accelerated approval in July 2025 for LINKER-MM1 trial data; confirmatory phase III LINKER-MM3 (≈410 patients) versus EloPd is fully enrolled, with results expected in 2027.
  • Emerging first- and second-line data show 95% MRD negativity and rapid median time to PR (~1 month); safety remains manageable with only grade I CRS during step-up dosing.
  • Eight registrational studies are underway or initiating by H1 2026 across front-line (LINKER-MM6/7/8), precursor conditions (LINKER-SMM1/2, MGUS), and amyloidosis (LINKER-AL2), with pivotal readouts through 2029.
  • Commercial launch momentum includes >300 REMS-certified centers and addition to 35+ formularies; first- and second-line markets each represent >$10 billion opportunities.
3 days ago
Regeneron details manufacturing expansion and pipeline updates
REGN
New Projects/Investments
Product Launch
  • Leveraged $7 billion domestic manufacturing and R&D investment commitment in 2025, partnering with FUJIFILM Diosynth to expand capacities in Tarrytown and Saratoga, NY, while in active MFN drug‐pricing negotiations with the administration.
  • Prioritized internal R&D and selective external collaborations, exemplified by the Tessera contract announced in early December, and remains open to strategic M&A for late‐stage assets.
  • Eylea HD received FDA approvals for RVO and four-week dosing ahead of the 2026 commercial inflection, with a prefilled syringe NDA submission in Q1 2026 and anticipated Q2 2026 approval.
  • Dupixent continues robust growth in atopic dermatitis (20–25% biologic penetration vs. ~40% in psoriasis), leads new-to-brand share in asthma, and has launched in COPD with highest new-to-brand share and superior exacerbation reduction; CSU and BP indications drive further market expansion.
  • Late-stage pipeline milestones include the Phase III fianlimab+Libtayo melanoma PFS readout in H1 2026 , Linvoseltamab’s BCMA bispecific with ~70% ORR in rrMM and favorable CRS profile , and obesity programs on a Hansoh GIP/GLP-1 backbone with myostatin combo data expected in 2026.
Dec 3, 2025, 3:30 PM
Regeneron discusses FY 2025 strategy and pipeline at Citi Global Healthcare Conference
REGN
New Projects/Investments
Product Launch
M&A
  • Regeneron announced a $7 billion commitment to expand U.S. R&D and manufacturing, including new facilities in New York and a contract manufacturing arrangement with FUJIFILM Diosynth Biotechnologies.
  • The company remains open to M&A and external collaborations, but prioritizes internal investment and evaluates opportunities based on scientific and commercial potential.
  • Recent Eylea HD label enhancements (RVO and Q4 dosing) were approved, with commercial impact expected to begin in 2026; a prefilled syringe submission is planned for Q2 2026.
  • Dupixent continues robust growth, now treating over 1.3 million patients globally, with significant runway in atopic dermatitis and strong momentum in asthma and COPD indications.
  • Regeneron highlighted promising pipeline assets, including fianlimab plus Libtayo in melanoma (phase 3 data expected H1 2026) and Linvoseltamab in myeloma, with best-in-class efficacy and safety data.
Dec 3, 2025, 3:30 PM
Regeneron outlines manufacturing, commercial, and pipeline strategy at Citi Healthcare Conference
REGN
New Projects/Investments
M&A
Product Launch
  • Regeneron commits $7 billion to U.S. R&D and domestic manufacturing expansions, including partnerships with FUJIFILM Diosynth and new facilities in Tarrytown and Saratoga, NY.
  • Capital allocation will prioritize internal R&D, with an active BD group open to M&A or collaborations for late-stage assets despite high valuations.
  • Eylea HD enhancements (Q4 dosing and RVO approval) launched late 2025 with 2026 inflection expected; prefilled syringe submission planned for Q2 2026.
  • Dupixent treats 1.3 million patients globally, benefits from underpenetrated AD (20–25% biologic uptake) and a strong COPD launch (30–35% exacerbation reduction).
  • Pipeline updates include LAG-3/Libtayo combo Phase 3 melanoma PFS readout in H1 2026 and Phase 2 lung cancer results H1 2026, plus advancing bispecific oncology and obesity combination programs.
Dec 3, 2025, 3:30 PM
Regeneron details 2025 product performance and 2026 outlook at HealthCONx
REGN
  • Regeneron returned ~$4 billion to shareholders in 2025 via dividends and share repurchases and committed >$7 billion to U.S. manufacturing and R&D investment.
  • EYLEA HD secured label enhancements (weekly dosing and RVO indication, ~17–18% of the market) with a prefilled syringe submission planned for Jan 2026 and expected approval by Q2 2026, with uptake accelerating in 2026.
  • Dupixent expanded to eight indications, including COPD (~300k eligible patients), chronic spontaneous urticaria (~300k) and bullous pemphigoid (~27k), sustaining its trajectory toward $20 billion in sales.
  • Pipeline milestones include positive Phase 3 data for Cemdisiran in generalized myasthenia gravis, U.S. and EU approvals of Linvoseltamab, EU approval of Ordspono, DB-OTO gene therapy successes and garetosmab in FOP reducing lesions by 99%.
Dec 2, 2025, 6:20 PM
Regeneron highlights 2025 portfolio expansions and $4 billion capital return plan
REGN
Dividends
Share Buyback
New Projects/Investments
  • Expanded key products: Eylea HD secured weekly dosing and RVO label enhancements; Dupixent now covers 8 indications including COPD, CSU and bullous pemphigoid; Libtayo launched in adjuvant CSCC; Linvoseltamab approved in the US and Europe for relapsed/refractory multiple myeloma.
  • Advanced pipeline: positive phase 3 results for Cemdisiran in generalized myasthenia gravis; DB-OTO gene therapy restoring hearing; garetosmab achieved 99% reduction in FOP lesion formation; Odronextimab approved in Europe; birch and cat allergy programs progressing to phase 3.
  • Capital allocation: initiated a dividend and increased share repurchases by ~$1 billion (from $2.6 billion in 2024), targeting ~$4 billion in total shareholder returns in 2025.
  • US investments: committed >$7 billion to expand domestic manufacturing and R&D infrastructure.
Dec 2, 2025, 6:20 PM
Regeneron obtains EU approval for Dupixent in chronic spontaneous urticaria
REGN
Product Launch
  • The European Commission approved Dupixent (dupilumab) for moderate-to-severe chronic spontaneous urticaria in patients aged 12+ who are antihistamine-refractory and naïve to anti-IgE therapy, marking the first targeted CSU therapy in Europe in over a decade.
  • The approval expands Dupixent’s label to seven chronic inflammatory diseases within the EU, broadening its market opportunity.
  • Decision based on Phase 3 trials showing significant reductions in itch and hives at 24 weeks versus placebo.
  • Regeneron and Sanofi continue global marketing of Dupixent, which achieved over $14 billion in net sales last year.
Nov 25, 2025, 6:09 AM
Regeneron approves EYLEA HD for retinal vein occlusion
REGN
Product Launch
  • The FDA approved EYLEA HD (aflibercept) 8 mg for macular edema following retinal vein occlusion, with dosing every eight weeks after an initial monthly phase and an alternative monthly option.
  • Approval is based on Phase 3 QUASAR trial data showing non-inferior visual acuity gains with eight-week dosing compared to standard EYLEA 2 mg.
  • The flexible regimen may halve the number of injections versus existing therapies and offers a monthly dosing option across all four EYLEA HD indications.
  • Regeneron’s strong financials include a $73.86 billion market capitalization, 0.09 debt-to-equity ratio, 4.06 current ratio, and 90.44 interest coverage ratio.
Nov 20, 2025, 2:03 AM