aibioRegeneron Pharmaceuticals
Top story · Oct 6, 2026 · SEC filing 8-K
Regeneron Pharmaceuticals signs a material agreement
- Ticker
- REGN
- Listing
- NASDAQ, United States
- Next date
- October 30, 2026
- Chief executive
- Leonard S. Schleifer, M.D., Ph.D.
Desk view · Opinion · Updated Oct 22, 2026
Regeneron leans on Dupixent while it looks for the next one
Regeneron is a profitable antibody maker carried by Dupixent while its EYLEA business shrinks. The settled Sanofi dispute helps, but the successors to Dupixent are early, and the oncology pipeline took a setback with the fianlimab miss.
Read the full desk viewaibio.space Investor Rank · Opinion
7/10 Positive view
Very strong cash and a Dupixent-led profit base, but EYLEA sales are falling, fianlimab missed in phase 3 and Dupixent successors are early.
- Technology
- 2/2
- Odds
- 1/2
- Balance sheet
- 2/2
- Risk
- 1/2
- Momentum
- 1/2
Opinion only. The Investor Rank is aibio.space's opinion of the company's business position, drawn from the public sources on this page. It is not a recommendation to buy, sell or hold any security and it is not investment advice. It does not consider the share price, valuation or your circumstances, and it can change at any time. Payments from companies never affect it. How the rank works.
- Technology
- Proven antibody engine. VelocImmune antibodies include Dupixent, EYLEA and Libtayo, with about 50 clinical assets behind them.
- Odds
- Mixed this year. Pasatru won approval and cemdisiran is under priority review, but fianlimab missed in phase 3.
- Balance sheet
- Very strong. Regeneron held $17.82 billion in cash and securities against $1.99 billion of debt at June 30.
- Main risk
- Dependence on Dupixent. Its patents begin to expire in 2031 while US EYLEA sales are falling.
- Watch next
- Third-quarter results. Regeneron reports on October 30, the first quarter after the Sanofi development balance was repaid.
Top news on Regeneron
Questions investors ask
What is aibio.space's Investor Rank for Regeneron Pharmaceuticals?
7 out of 10, our positive view. Very strong cash and a Dupixent-led profit base, but EYLEA sales are falling, fianlimab missed in phase 3 and Dupixent successors are early. This is opinion only, not a recommendation to buy, sell or hold, and it does not consider the share price or valuation. Source
When does Regeneron report third quarter 2026 earnings?
Regeneron will report third-quarter 2026 results on Friday, October 30, 2026, before US markets open. It will host a conference call at 8:30 AM Eastern Time. Source
What is the 2026 Sanofi Regeneron deal?
Sanofi will pay Regeneron $1 billion upfront and up to $7 billion in milestones to co-develop four long-acting type 2 inflammation antibodies. Costs and global profits are split 50:50, and the companies settled earlier litigation. Source
Did Regeneron's fianlimab melanoma trial fail?
Yes. The phase 3 trial of fianlimab plus cemiplimab against pembrolizumab missed statistical significance on progression-free survival, with a hazard ratio of 0.845 and p=0.0627. A head-to-head trial against Opdualag is ongoing. Source
What is Pasatru and when was it approved?
Pasatru (garetosmab-grts) is an Activin A antibody approved by the FDA, as announced on August 19, 2026, for adults with fibrodysplasia ossificans progressiva. In the phase 3 OPTIMA trial it cut new bone lesions by 90% or more against placebo. Source
How much cash does Regeneron have?
Regeneron had $17.82 billion in cash and marketable securities at June 30, 2026, and $1.99 billion of long-term debt. It bought back $2.0 billion of stock in the first half of 2026. Source
What is Regeneron Pharmaceuticals's market cap?
We do not publish live share prices. In its annual report, Regeneron Pharmaceuticals, Inc. put the market value of shares held by non-affiliates (public float) at $54.80 billion as of Jun 30, 2025. Source
Is Regeneron Pharmaceuticals a smaller reporting company?
SEC records list Regeneron Pharmaceuticals, Inc.'s filer category as: Large accelerated filer. Source
Where is Regeneron Pharmaceuticals headquartered?
SEC records list its business address as 777 OLD SAW MILL RIVER ROAD, TARRYTOWN, NY, 10591. Source
When does Regeneron Pharmaceuticals's fiscal year end?
Regeneron Pharmaceuticals, Inc.'s fiscal year ends on December 31, per SEC records. Source
What did Regeneron Pharmaceuticals last file with the SEC?
Its most recent filing in our record is an 8-K filed 2026-10-06. All of its filings are on SEC EDGAR. Source
What was Regeneron Pharmaceuticals called before?
SEC records list these former names: REGENERON PHARMACEUTICALS INC. Source
What industry is Regeneron Pharmaceuticals in?
Its SEC industry code (SIC 2834) is Pharmaceutical Preparations. Source
Legal and investor matters
- Financing
Regeneron and Sanofi sign sixth amendment with $1.0 billion upfront
On 2026-10-01 Regeneron and Sanofi signed the Sixth Amendment to their 2009 collaboration agreement, under which they will co-develop and co-commercialize four new long-acting Regeneron antibodies. Sanofi will pay Regeneron $1.0 billion upfront, and Regeneron can receive up to $7.0 billion more on development, regulatory and commercial milestones. Global profits on the new products will be shared equally. Regeneron disclosed the terms in an 8-K filed 2026-10-06.
- Governance
Regeneron grants one-time 10-year performance awards to CEO and CSO
Effective 2026-09-24, Regeneron's compensation committee, with approval of the independent directors, granted one-time performance share units to CEO Leonard Schleifer and Chief Scientific Officer George Yancopoulos. The 8-K says the awards are fully performance-based over a ten-year period and replace annual equity awards for both executives until 2036. Shares cannot be sold until February 2036 except in cases of death, disability or change in control.
- Litigation
Putative class action filed over Dupixent and lymphoma warning
The 10-Q says two plaintiffs filed a putative class action on 2026-07-17 in the U.S. District Court for the District of Maryland, alleging that Regeneron failed to warn that Dupixent allegedly causes or is linked to cutaneous T-cell lymphoma. The complaint seeks damages and a fund for medical monitoring. Separately, the JPML on 2026-06-04 transferred federal Dupixent product liability suits to the District of New Jersey for pretrial proceedings.
- Class action
Securities class action filed over fianlimab program disclosures
The 10-Q reports that on 2026-07-16 a purported shareholder filed a putative class action in the U.S. District Court for the Southern District of New York against Regeneron and certain employees. The complaint asserts violations of federal securities laws in connection with statements or disclosures purportedly related to the fianlimab clinical development program. The 10-Q gives no further procedural detail.
- Litigation
Court grants Regeneron motion to dismiss challenged Amgen defenses and counterclaims in EYLEA patent case
In Regeneron's 2025 patent suit against Amgen over an aflibercept 2 mg biosimilar, Amgen counterclaimed that Regeneron obtained patents fraudulently and violated Section 2 of the Sherman Act. On 2026-07-07 the court granted Regeneron's motion to dismiss the challenged defenses and counterclaims, except for Amgen's prosecution delay defense and counterclaim. Regeneron's separate 2024 suit against Amgen remains pending, with a motion to dismiss filed 2026-04-20.
- Class action
Hearing held on motion to dismiss securities class action over EYLEA HD
A purported shareholder sued Regeneron and certain current and former executives on 2025-01-07 in the Southern District of New York. The second amended complaint asserts federal securities law violations tied to the DOJ conduct alleged in the March 2024 complaint and to the EYLEA HD launch. The court appointed a lead plaintiff on 2025-07-10, Regeneron moved to dismiss on 2025-11-17, and the court heard argument on 2026-06-25.
- Litigation
Qui tam complaint against Regeneron unsealed after government declines
A qui tam plaintiff filed a sealed complaint on 2026-01-20 against Regeneron and other pharmaceutical companies, alleging violations of the federal Anti-Kickback Statute and asserting False Claims Act and state-law claims relating to allegedly unlawful remuneration and assistance provided to prescribers. The United States and the applicable states notified the court on 2026-05-22 and 2026-06-17 that they declined to intervene. The U.S. District Court for the Central District of California unsealed the complaint on 2026-06-18, and the plaintiff filed an amended complaint on 2026-07-20.
- Litigation
European Patent Office invalidates Regeneron EYLEA patent; appeal hearing set
The 10-Q says the European Patent Office Opposition Division invalidated Regeneron's European Patent No. 3,384,049 on 2026-04-21, after revoking the '306 patent on 2024-11-26. Regeneron's appeal on the '306 patent has an oral hearing scheduled for October 2026. The Division upheld the '992 patent in amended form on 2025-10-22, and Amgen has appealed. In Germany, Regeneron sued Sandoz and Sam Chun Dang over aflibercept 2 mg biosimilars from March to June 2026.
- Litigation
Court denies Sanofi motion to dismiss Regeneron collaboration lawsuit
Regeneron sued Sanofi in the Southern District of New York on 2024-11-18, alleging breach of the 2009 collaboration agreement by limiting Regeneron's access to information on Dupixent commercialization and its audit rights. The suit seeks declaratory and injunctive relief and damages. On 2026-03-17 the court denied Sanofi's motion to dismiss. On 2026-10-01 the companies signed a separate amendment to the collaboration agreement.
- Derivative suit
Shareholder derivative suits over DOJ allegations consolidated and stayed
Several purported shareholders sued Regeneron's directors and officers in 2025, with Regeneron as nominal defendant, alleging breach of fiduciary duty over oversight of the conduct alleged in the DOJ's March 2024 complaint. On 2026-03-16 the Southern District of New York denied motions to remand and consolidated the cases with other derivative suits, including a 2021 suit tied to the 2020 DOJ complaint. Those cases are stayed.
- Regulatory
DOJ charity-support case against Regeneron: second summary judgment motion filed
On 2020-06-24 the U.S. Attorney's Office for the District of Massachusetts filed a civil complaint alleging violations of the Anti-Kickback Statute and asserting False Claims Act and state-law claims relating to Regeneron's support of 501(c)(3) organizations that assist patients. The First Circuit affirmed the portion of a 2023 order certified for interlocutory appeal on 2025-02-18. On 2025-10-01 the government filed a second motion for partial summary judgment. The 10-Q describes no trial date or ruling in this case and says related payor suits are stayed pending it.
- Derivative suit
Derivative suit alleges excessive Regeneron director pay
On 2025-07-22 an alleged shareholder filed a derivative complaint in New York Supreme Court against Regeneron's non-employee directors and its two co-chairs, with Regeneron as nominal defendant. The complaint alleges breach of fiduciary duty, unjust enrichment and waste over allegedly excessive director compensation in 2024 and 2025. The court heard Regeneron's motion to dismiss on 2026-04-17, and plaintiff's counsel moved to substitute the named plaintiff on 2026-06-22.
- Regulatory
DOJ False Claims Act suit over alleged EYLEA reimbursement inflation proceeds; more states join
On 2024-03-28 the DOJ and the Massachusetts U.S. Attorney filed a complaint in partial intervention in a qui tam case, asserting False Claims Act and unjust enrichment claims over alleged inflated EYLEA reimbursement rates. The court denied Regeneron's motion to dismiss on 2025-04-29, and five more states intervened on 2025-06-18. Regeneron received a related civil investigative demand in June 2021. The 10-Q reports no ruling on liability.
- Litigation
Jury awards Regeneron $406.8 million against Amgen in Praluent antitrust case
At a trial in the District of Delaware, a jury on 2025-05-15 found for Regeneron on nine of ten counts in its antitrust suit against Amgen over alleged bundling that excluded Praluent. It awarded $135.6 million in compensatory and $271.2 million in punitive damages. Amgen filed a post-trial motion on 2025-06-20, and the court heard post-trial motions on 2025-08-27. The 10-Q reports no later ruling.
- Other
Regeneron starts quarterly dividend at $0.88 per share
On 2025-02-04 Regeneron announced that its board initiated a quarterly cash dividend program and declared a dividend of $0.88 per share on its common stock and Class A stock. The company disclosed the decision under Item 8.01 of a Form 8-K.
Pipeline
| Program | Indication | Stage |
|---|---|---|
| Cemdisiran | Generalized myasthenia gravis | FDA priority review, action date November 2026 Source |
| Fianlimab plus cemiplimab | First-line melanoma | Phase 3 head-to-head versus Opdualag ongoing Source |
| Trevogrumab | Muscle preservation with GLP-1 therapy in obesity | Phase 2 Source |
| Linvoseltamab (Lynozyfic) | AL amyloidosis | Phase 2 portion with registrational intent Source |
| Factor XI antibodies | Peripheral artery disease | Phase 3 Source |
| REGN20423 (with Sanofi) | Atopic dermatitis | Phase 1 Source |
Opinion · Devil's advocate
Fact-check-o-meter
Releases are plain about the fianlimab miss, but lead with the growth lines and leave litigation to the 10-Q
Regeneron's May fianlimab release states the missed primary endpoint in its first sentence, and the earnings release matches the 10-Q on the numbers. The gaps are about emphasis: the EYLEA franchise and GAAP earnings both fell while the headline bullets and CFO quote lead with what grew. The 10-Q also lists a large docket, including two putative shareholder class actions. The releases mention only Department of Justice proceedings and EYLEA patent litigation, and only in their general forward-looking statements.
Press release vs filing · weight medium
EYLEA HD record sales lead; the combined EYLEA franchise fell 12%
The company said: "EYLEA HD U.S. net sales increased 52% to a new all-time high of $596 million" source
The record says: The same release's revenue table shows total EYLEA HD and EYLEA in the U.S. at $1,008 million versus $1,147 million a year earlier, a 12% decline, with EYLEA alone down 45% and EYLEA HD growth "partly offset by a lower net selling price." The 10-Q states that "EYLEA net product sales have been, and are likely to continue to be, negatively impacted by increased competition from other anti-VEGF products, including biosimilars, as well as the transition of patients from EYLEA to EYLEA HD. The magnitude and duration of such impact is presently unknown." source
Our view: The bullet is accurate and the table discloses the decline, so this is emphasis rather than omission. A reader of the bullets alone would miss that the U.S. eye franchise shrank, and the 10-Q says the company cannot yet size the pressure.
Press release vs filing · weight low
Non-GAAP growth quoted; GAAP net income and EPS fell
The company said: "Second quarter revenues grew 17% and non-GAAP net income per share grew 11%" source
The record says: The financial highlights table in the same release shows GAAP net income of $1,297 million versus $1,392 million a year earlier (down 7%) and GAAP diluted EPS of $12.23 versus $12.81 (down 5%). Non-GAAP net income rose 8% to $1,543 million. The release attributes part of the gap to a lower net gain on marketable and other securities and a higher effective tax rate (15.1% versus 8.4%). source
Our view: Both sets of figures are printed and reconciled, so nothing is omitted. The CFO quote, though, picks the measure that grew. The tax-rate comparison flatters 2025, which included a one-time audit release.
Science · weight medium
Fianlimab phase 3: missed on the primary endpoint, no clear dose response
The company said: "A numeric improvement of 5.1 months in median PFS was observed for the high-dose fianlimab combination compared to pembrolizumab monotherapy" source
The record says: The same release opens with "The trial did not reach statistical significance for the primary endpoint of improvement in progression-free survival (PFS)". Its table gives a high-dose hazard ratio of 0.845 (0.709, 1.008), p=0.0627, and a low-dose hazard ratio of 0.931 (0.773, 1.122), p=0.4661. Median PFS was 11.5 months (95% CI 6.3, 16.8) for high dose versus 6.4 (4.4, 11.1) for pembrolizumab. The head-to-head trial against Opdualag is "ongoing". source
Our view: The release is candid, and the 5.1 month figure is labelled numeric. Still, the confidence intervals for median PFS overlap widely and the low dose did not separate from pembrolizumab (hazard ratio 0.931, p=0.4661), so the 5.1 months is weak support for the Opdualag comparison that follows.
Legal and disclosure record · weight high
Government, shareholder and product-liability matters listed in Note 12
The record says: The Q2 2026 10-Q lists, among other matters: a civil complaint filed June 24, 2020 by the U.S. Attorney's Office for the District of Massachusetts under the Anti-Kickback Statute and False Claims Act over support of patient assistance charities; a March 28, 2024 complaint in partial intervention by the DOJ in a qui tam action over EYLEA reimbursement reporting; a putative securities class action filed January 7, 2025 in the SDNY, with a motion to dismiss argued June 25, 2026; a second putative securities class action filed July 16, 2026 in the SDNY "in connection with statements or disclosures purportedly related to the Company's fianlimab clinical development program"; several shareholder derivative complaints; Dupixent product liability suits transferred by the JPML to the District of New Jersey on June 4, 2026 and a putative class action filed July 17, 2026 in the District of Maryland; and Regeneron's own suit against Sanofi (SDNY, filed November 18, 2024). These are allegations and unresolved claims as described by the filing. On October 1, 2026 the companies said they "have settled their prior collaboration-related litigation." source
Our view: The docket is long and several matters have been open for years. Both releases name only the Department of Justice proceedings and the EYLEA patent litigation, and only inside the general forward-looking statements. Neither mentions the class actions or the Dupixent product liability suits. The July 2026 class action concerns statements the 10-Q describes as related to the fianlimab program.
Stock chart
SEC filings and registration
- SEC name
- Regeneron Pharmaceuticals, Inc.
- CIK
- 872589
- Industry (SIC)
- Pharmaceutical Preparations (2834)
- US tickers
- REGN (Nasdaq)
- State or country of incorporation
- NY
- Fiscal year ends
- December 31
- Filer category
- Large accelerated filer
- Business address
- 777 OLD SAW MILL RIVER ROAD, TARRYTOWN, NY, 10591
- Phone
- 9148477000
- Shares outstanding
- 93,955,110 as of 2012-07-13 (10-Q filed 2012-07-25)
- Former names
- REGENERON PHARMACEUTICALS INC
Recent filings
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