ORION Biotech Catalyst Calendar
Menu
Skip to company dates

Regeneron Pharmaceuticals (REGN) pipeline and stated timing

Name in SEC filings: REGENERON PHARMACEUTICALS, INC.

Pipeline at a glance

ProgramEventStageStated timingFiling
Dupixent submission—fourth quarter 20248-K ·
dupilumab target date (company stated)PDUFAApril 18, 2025SEC filing ·
aflibercept 8 mgPDUFA target date (company stated)PDUFAApril 20, 2025SEC filing ·
dupilumabPDUFA target date (company stated)PDUFAJune 20, 2025SEC filing ·
linvoseltamabPDUFA target date (company stated)PDUFAJuly 10, 2025SEC filing ·
odronextamabPDUFA target date (company stated)PDUFAJuly 30, 2025SEC filing ·
cemiplimabPDUFA target date (company stated)PDUFAOctober 2025SEC filing ·
dupilumabPDUFA target date (company stated)PDUFAFebruary 2026SEC filing ·
cemdisiranPDUFA target date (company stated)PDUFANovember 20268-K ·

Source: ORION, orionbiotechai.com/company/REGN, data as of Oct 14, 2026
https://www.orionbiotechai.com/company/REGN

Nearest upcoming stated timing: cemdisiran · PDUFA target date (company stated) · November 2026

SEC sources last checked .

Programs and stated timing

○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.

aflibercept 8 mg

wet age-related macular degeneration and diabetic macular edema; two-year data label

Matched

PDUFA target date (company stated)April 20, 2025

Stage: PDUFASEC filing · “target action date”

Public float: $54,800,000,000 · as of · SEC filing

target action date of April 20, 2025

SEC filing · Filed · Last checked

Source details

Accession 0001804220-25-000011

Resolution filing: · SEC filing

Alert me · Calendar: same stage and window-end month (2025-04)

cemdisiran

generalized myasthenia gravis

Matched

PDUFA target date (company stated)November 2026

Stage: PDUFASEC filing · “target action date”

Public float: $54,800,000,000 · as of · SEC filing

The FDA will review the New Drug Application (NDA) under priority review with a target action date in November 2026, following use of a Priority Review Voucher.

8-K · Filed · Last checked

Source details

Accession 0000872589-26-000023

SEC accepted the filing

Alert me · Calendar: same stage and window-end month (2026-11)

How this date was described over time

Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .

Program / eventStated period and SEC wordingDisclosure in stated period
cemdisiranFDA decisionNovember 2026
“The FDA will review the New Drug Application (NDA) under priority review with a target action date in November 2026, following use of a Priority Review Voucher.”

Filed · EX-99.1

Period not started

The stated period has not started yet, so there is nothing to compare.

dupilumabFDA decisionFebruary 2026
“target action date in February 2026”

Filed · SEC original

Not compared

The stated period has ended. ORION has no record of a complete search of SEC filings from that period.

dupilumabFDA decisionFebruary 2026
“FDA decision on sBLA for Dupixent in AFRS (February 2026”

Filed · SEC original

Not compared

The stated period has ended. ORION has no record of a complete search of SEC filings from that period.

cemiplimabFDA decisionOctober 2025
“target action date in October 2025”

Filed · SEC original

Disclosure present

SEC filing date within the stated period

Filed · SEC original

“In October 2025, the FDA approved an sBLA for Libtayo as an adjuvant treatment for adults with CSCC at high risk of recurrence after surgery and radiation”
cemiplimabFDA decisionOctober 2025
“FDA decision on sBLA (October 2025”

Filed · SEC original

Disclosure present

SEC filing date within the stated period

Filed · SEC original

“In October 2025, the FDA approved an sBLA for Libtayo as an adjuvant treatment for adults with CSCC at high risk of recurrence after surgery and radiation”
dupilumabFDA decisionJune 20, 2025
“target action date of June 20, 2025”

Filed · SEC original

Not compared

The stated period has ended. ORION has no record of a complete search of SEC filings from that period.

dupilumabFDA decisionJune 20, 2025
“target action date of June 20, 2025”

Filed · SEC original

Not compared

The stated period has ended. ORION has no record of a complete search of SEC filings from that period.

linvoseltamabFDA decisionJuly 10, 2025
“target action date of July 10, 2025”

Filed · SEC original

Not compared

The stated period has ended. ORION has no record of a complete search of SEC filings from that period.

linvoseltamabFDA decisionJuly 10, 2025
“target action date of July 10, 2025”

Filed · SEC original

Not compared

The stated period has ended. ORION has no record of a complete search of SEC filings from that period.

odronextamabFDA decisionJuly 30, 2025
“target action date of July 30, 2025”

Filed · SEC original

Not compared

The stated period has ended. ORION has no record of a complete search of SEC filings from that period.

odronextamabFDA decisionJuly 30, 2025
“target action date of July 30, 2025”

Filed · SEC original

Not compared

The stated period has ended. ORION has no record of a complete search of SEC filings from that period.

aflibercept 8 mgFDA decisionApril 20, 2025
“target action date of April 20, 2025”

Filed · SEC original

Not compared

The stated period has ended. ORION has no record of a complete search of SEC filings from that period.

dupilumabFDA decisionApril 18, 2025
“target action date of April 18, 2025”

Filed · SEC original

Not compared

The stated period has ended. ORION has no record of a complete search of SEC filings from that period.

aflibercept 8 mgFDA decisionApril 20, 2025
“target action date of April 20, 2025”

Filed · SEC original

Not compared

The stated period has ended. ORION has no record of a complete search of SEC filings from that period.

dupilumabFDA decisionApril 18, 2025
“target action date of April 18, 2025”

Filed · SEC original

Not compared

The stated period has ended. ORION has no record of a complete search of SEC filings from that period.

aflibercept 8 mgFDA decisionApril 20, 2025
“PDUFA date of April 20, 2025”

Filed · SEC original

Not compared

The stated period has ended. ORION has no record of a complete search of SEC filings from that period.

dupilumabFDA decisionApril 18, 2025
“Food and Drug Administration (FDA) decision by April 18, 2025”

Filed · SEC original

Not compared

The stated period has ended. ORION has no record of a complete search of SEC filings from that period.

DupixentSubmissionfourth quarter 2024
“BP sBLA submission planned for fourth quarter 2024”

Filed · EX-99.1

Not compared

The stated period has ended. ORION has no record of a complete search of SEC filings from that period.

“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.

Retained company announcements

Historical summaries and source dates are retained separately from the SEC timing quotes above. Earlier publications were collected retrospectively.

Historical catalog checked .

No historical announcement trail is retained for this company in this catalog.

Selected registry record

Odronextamab · NCT06091865

Condition in the selected registry record
Diffuse Large B-cell Lymphoma (DLBCL)
Phase in the selected registry record
Phase 3
Identity checked

Original ClinicalTrials.gov record · Open the selected study

Retained company–study identity sources

Scope of retained company and registry evidence

These are selected linked records and dated source metadata, not a live registry recheck or the company’s full pipeline. Company announcements and the selected registry study are separate evidence sets. No stage or event timing is borrowed between them.

Coverage and identity checks

Watch REGN

Or email ORION to ask for this Watch.

Request another SEC timing statement

Suggest an SEC timing statement to add for REGN. You can include the original filing link in your note. The founder reads each request by hand.

Or email ORION.

Reading these records

First stated window
The timing wording in the earliest company statement located within the sources checked, quoted as written (for example “2H 2026”). An earlier statement may exist outside those sources.
Disclosure date
The date of the filing or company release that disclosed the readout. “None found” means no such disclosure was located in the sources checked. SEC filings were searched through the “SEC filings searched through” date shown.
1H, 2H, 1Q–4Q
First or second half, or first to fourth quarter, of the year named, as the company wrote it. Equivalent notations are compared together; the original wording stays visible.
SEC original
The filing as published on the SEC EDGAR system. “Company original” is the release on the company's own investor site.
Status
One of seven labels set by founder review of the original filings. Definitions: Methodology.

See REGN in the calendar · Review labels and methodology

A New Drug Application (NDA) or Biologics License Application (BLA) asks the FDA to approve a drug or biologic for sale.A PDUFA date is the target date by which the FDA aims to decide on a drug or biologic application.