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Regeneron Pharmaceuticals, Inc.REGN

ImmunologyOncology80 cited findings ยท profile updated 2026-08-25

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About Regeneron Pharmaceuticals, Inc.

Regeneron Pharmaceuticals, Inc. (REGN) has a therapeutic focus in oncology. The company's oncology portfolio includes LIBTAYO (cemiplimab-rwlc), which has been associated with various immune-mediated adverse reactions. For instance, Grade 3 immune-mediated dermatologic adverse reactions occurred at an incidence of 1.0% with LIBTAYO (cemiplimab-rwlc), while Grade 2 immune-mediated pneumonitis incidence was 1.9% with LIBTAYO (cemiplimab-rwlc). Other notable adverse reactions include Grade 4 immune-mediated hepatitis at 0.2% incidence and Grade 3 hypophysitis at 0.2% incidence with LIBTAYO (cemiplimab-rwlc).

Another oncology drug, linvoseltamab (REGN5458), is being studied. In Study 1826, 72.6% of all 200 mg patients experienced Grade 3 or 4 TEAEs, and 12.0% experienced Grade 5 TEAEs. Grade 3 or 4 infections were observed in 36% of patients, and Grade โ‰ฅ3 neutropenia occurred in 40.2% of patients. The median time to not getting grade โ‰ฅ3 infection for linvoseltamab (REGN5458) ranged from 15 weeks (Q1 CMAXWKE) to >176 weeks (Q4 CMAXWKE).

Compiled from the cited findings below โ€” figures are as stated in each company's published technical reports and filings.

Key figures โ€” cited

Grade 3 immune-mediated dermatologic adverse reactions incidence1.0 %Regeneron Pharmaceuticals, Inc. โ€” Libtayo FDA Review (NDA/BLA 761097,, p.16
Grade 2 immune-mediated pneumonitis incidence1.9 %Regeneron Pharmaceuticals, Inc. โ€” Libtayo FDA Review (NDA/BLA 761097,, p.13
Grade 4 immune-mediated hepatitis incidence0.2 %Regeneron Pharmaceuticals, Inc. โ€” Libtayo FDA Review (NDA/BLA 761097,, p.14
Grade 3 hypophysitis incidence0.2 %Regeneron Pharmaceuticals, Inc. โ€” Libtayo FDA Review (NDA/BLA 761097,, p.14
patients experienced Grade 3 or 4 TEAEs72.6 %Regeneron Pharmaceuticals, Inc. โ€” Lynozyfic EMA EPAR public assessment, p.92
Grade 3 or 4 infections36 %Regeneron Pharmaceuticals, Inc. โ€” Lynozyfic EMA EPAR public assessment, p.123

Key projects

  • LIBTAYO (cemiplimab-rwlc)

    Grade 3 immune-mediated dermatologic adverse reactions incidence was 1.0% with LIBTAYO (cemiplimab-rwlc).

  • linvoseltamab (REGN5458)

    The median time to not getting grade โ‰ฅ3 infection (Q1 CMAXWKE) was 15 weeks for linvoseltamab (REGN5458).

Every figure cites its source document. Prices refresh daily, not live. Informational only โ€” not investment advice. Explore the Immunology research library โ†’

Regeneron Pharmaceuticals, Inc. (REGN) โ€” Immunology Company Profile, Projects & Data | BioPharmaPT