REGN · Company research

Regeneron Pharmaceuticals, Inc.

2 upcoming catalysts · 0 phase 2+ trials on file

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Upcoming catalysts

FDA decisionREGNRegeneronNov 2026

The FDA is expected to decide in Nov 2026 (no exact date yet) whether to approve Regeneron’s cemdisiran (C5 siRNA) for Generalized myasthenia gravis (anti-AChR antibody-positive). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.

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Entry

PDUFA target action date for cemdisiran in generalized myasthenia gravis · FDA decision due (PDUFA date)

Drug

cemdisiran (C5 siRNA)

For

Generalized myasthenia gravis (anti-AChR antibody-positive)

Stage

Phase 3 · the last stage before a drug can be approved

When

Nov 2026 · the company gave a window, not a day

Source note

FDA accepted the NDA under Priority Review (priority review voucher used) with a target action date in November 2026; announced June 22, 2026. Would be the first siRNA approved in gMG, dosed subcutaneously every 12 weeks.

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Source: investor.regeneron.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
Drugs@FDA ↗ — search the drug name for approval letters
REGN headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ApprovalREGNRegeneronH2 2027

Regeneron expects European regulators to decide on cemdisiran (C5 siRNA) for Generalized myasthenia gravis in the second half of 2027 (no exact date yet). An approval lets the company start selling it in that market.

More details

Entry

European Commission decision on cemdisiran in gMG · Regulatory approval

Drug

cemdisiran (C5 siRNA)

For

Generalized myasthenia gravis

Stage

Phase 3 · the last stage before a drug can be approved

When

H2 2027 · the company gave a window, not a day

Source note

EMA accepted the MAA; Regeneron says a European Commission decision is anticipated in the second half of 2027. Japan filing planned for early 2027.

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Source: investor.regeneron.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
Drugs@FDA ↗ — search the drug name for approval letters
REGN headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Past catalysts

ApprovalREGNRegeneronAug 19, 2026

The FDA approved Regeneron’s Pasatru (garetosmab-grts) for Fibrodysplasia ossificans progressiva in adults on Aug 19, 2026. The company can now sell it in that market.

More details

Entry

FDA approves Pasatru (garetosmab) for fibrodysplasia ossificans progressiva · Regulatory approval

Drug

Pasatru (garetosmab-grts)

For

Fibrodysplasia ossificans progressiva in adults

Stage

Phase 3 · the last stage before a drug can be approved

When

Aug 19, 2026

Source note

FDA approved Pasatru (garetosmab-grts), an anti-Activin A antibody, to reduce new heterotopic ossification lesions and clinician-assessed flare-ups in adults with FOP, based on the Phase 3 OPTIMA trial showing roughly 90-94% reductions in new HO lesions at 56 weeks.

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Source: stocktitan.net ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
Drugs@FDA ↗ — search the drug name for approval letters
REGN headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

MilestoneREGNRegeneronJun 22, 2026

FDA accepts cemdisiran NDA under Priority Review in gMG; PDUFA Nov 2026, on Jun 22, 2026. A company milestone for Regeneron (Cemdisiran for Generalized myasthenia gravis (anti-AChR antibody positive)): a step in the program rather than a decision or a data readout.

More details

Entry

FDA accepts cemdisiran NDA under Priority Review in gMG; PDUFA Nov 2026 · Company milestone

Drug

Cemdisiran

For

Generalized myasthenia gravis (anti-AChR antibody positive)

Stage

Phase 3 · the last stage before a drug can be approved

When

Jun 22, 2026

Source note

FDA accepted the cemdisiran NDA under Priority Review with a November 2026 target action date, and EMA accepted the EU application, both supported by the Phase 3 NIMBLE trial in anti-AChR antibody-positive generalized myasthenia gravis.

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Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
REGN headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsREGNRegeneronMay 15, 2026

Regeneron reported results from its Phase 3 study of Fianlimab (LAG-3) plus cemiplimab (Libtayo) for First-line unresectable or metastatic melanoma on May 15, 2026. The study missed its main goal.

More details

Entry

Phase 3 fianlimab combo missed PFS primary endpoint in 1L metastatic melanoma · Clinical trial results (readout / topline data)

Drug

Fianlimab (LAG-3) plus cemiplimab (Libtayo)

For

First-line unresectable or metastatic melanoma

Stage

Phase 3 · the last stage before a drug can be approved

When

May 15, 2026

Source note

The 1,546-patient Phase 3 trial of fianlimab plus cemiplimab did not reach statistical significance for progression-free survival versus pembrolizumab, though median PFS was 11.5 months on high-dose combination versus 6.4 months (p=0.0627). No new safety signals were seen.

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Source: stocktitan.net ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
REGN headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ApprovalREGNRegeneronApr 23, 2026

The FDA approved Regeneron’s Otarmeni (lunsotogene parvec-cwha, DB-OTO) for OTOF-related genetic hearing loss on Apr 23, 2026. The company can now sell it in that market.

More details

Entry

FDA grants accelerated approval to Otarmeni for OTOF genetic hearing loss · Regulatory approval

Drug

Otarmeni (lunsotogene parvec-cwha, DB-OTO)

For

OTOF-related genetic hearing loss

Stage

Pivotal (CHORD) · a study designed to support approval

When

Apr 23, 2026

Source note

Otarmeni (lunsotogene parvec-cwha) became the first gene therapy approved under the FDA Commissioner's National Priority Voucher program, cleared for severe-to-profound sensorineural hearing loss from biallelic OTOF variants based on week-24 pure tone audiometry from the CHORD trial. Regeneron said it will provide the therapy free in the U.S.

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Source: stocktitan.net ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
Drugs@FDA ↗ — search the drug name for approval letters
REGN headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ApprovalREGNRegeneronApr 2, 2026

The FDA approved Regeneron’s EYLEA HD (aflibercept) 8 mg for Wet age-related macular degeneration and diabetic macular edema on Apr 2, 2026. The company can now sell it in that market.

More details

Entry

FDA approves EYLEA HD dosing intervals up to every 20 weeks in wAMD and DME · Regulatory approval

Drug

EYLEA HD (aflibercept) 8 mg

For

Wet age-related macular degeneration and diabetic macular edema

Stage

Phase 3 · the last stage before a drug can be approved

When

Apr 2, 2026

Source note

FDA approved extending EYLEA HD dosing to every 20 weeks (5 months) for wAMD and DME patients after one year of successful response, based on 96-week PULSAR and PHOTON data. It becomes the injectable anti-VEGF with the widest approved dosing range.

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Source: stocktitan.net ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
Drugs@FDA ↗ — search the drug name for approval letters
REGN headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Things of Interest

Explore reported politician transactions and public investor statements connected to REGN.

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Pipeline trials

ClinicalTrials.gov · phase 2 and later

No phase 2+ trials cached for this company.

Company news

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