Regeneron Pharmaceuticals Inc. develops and commercializes biotechnology medicines for serious diseases across eye disease, allergic and inflammatory conditions, cancer, cardiovascular and metabolic disease, neurological disease, hematologic conditions, infectious disease and rare disease. News about REGN commonly covers marketed products and pipeline programs such as EYLEA, EYLEA HD, Dupixent, Praluent, Libtayo, Kevzara, Otarmeni and investigational therapies developed through antibody, genetic medicine and RNA-based approaches.
Recurring company updates include financial results, FDA and European regulatory approvals, clinical trial data, label expansions, collaboration and licensing activity, product-access and pricing arrangements, share repurchase authorizations and corporate responsibility recognition. Regeneron's disclosures also frequently address its Sanofi collaboration around Dupixent and its use of proprietary technologies such as VelocImmune in drug discovery.
Regeneron Pharmaceuticals (REGN) will present cancer research at the ESMO Congress in Madrid, Spain, from October 23–27, 2026.
The 10 abstracts include a Phase 3 C-POST overall survival update at approximately 3.5 years’ median follow-up for Libtayo after surgery and radiation in high-risk cutaneous squamous cell carcinoma, and a final Phase 2 analysis of Libtayo before surgery. Other presentations cover lung cancer, ovarian cancer and melanoma. Cancer-associated blood clot research includes a Phase 2 sub-analysis of amrecibart and cenvacibart, modeling data and an update on the ongoing Phase 3 ROXI-CAT-II trial.
Regeneron Pharmaceuticals (REGN) reported a 73% objective response rate with investigational ubamatamab in an initial study of recurrent low-grade serous ovarian cancer. Among 11 patients receiving 800 mg monotherapy, all responses were partial; median response duration was 9 months and median progression-free survival, the time before disease worsens or death, was 11 months.
Safety results covered 19 patients receiving different doses, alone or with Libtayo. All experienced treatment-emergent adverse events; 90% experienced cytokine release syndrome, all Grade 1 or 2. Serious events of Grade 3 or higher occurred in 21%, with no treatment-emergent deaths. Regeneron is enrolling a potentially registrational cohort of up to 100 patients receiving 800 mg every three weeks. The company plans FDA discussions in the coming months and a confirmatory randomized, controlled Phase 3 trial. Results remain preliminary.
Regeneron Pharmaceuticals (NASDAQ: REGN) reported Phase 2 COURAGE results showing trevogrumab preserved muscle during semaglutide-induced weight loss in people with obesity. At the 52-week primary endpoint, lean mass fell 5.8% with 25 mg trevogrumab and 4.2% with 75 mg, versus 7.3% with placebo, all combined with semaglutide. Relative lean mass preservation was 20.5% and 42.5%, respectively.
Among participants with evaluable MRI scans, thigh muscle preservation at 52 weeks was 71.8% and 68.9%, respectively, relative to placebo plus semaglutide. Lower-dose trevogrumab did not meaningfully enhance weight loss. Adverse events occurred in 77% of trevogrumab participants versus 82% with placebo. Participants with low baseline lean mass showed numerically greater preservation with trevogrumab. Regeneron plans another Phase 2 trial in older adults with obesity and decreased muscle mass and/or strength.
Regeneron (REGN) expanded its antibody alliance with Sanofi, adding four long-acting candidates and securing an agreement for a $1 billion upfront payment. Regeneron may receive up to an additional $7 billion in development, regulatory and commercial milestones. The companies will equally share development and commercialization costs and split future global profits 50:50.
REGN20423, targeting IL-13, is in Phase 1 testing for atopic dermatitis. The companies expect the other three antibodies to enter clinical studies in 2027. Regeneron also has an option to add Sanofi’s investigational lunsekimig after completion of its Phase 3 trials for chronic obstructive pulmonary disease.
Regeneron Pharmaceuticals (REGN) will report third-quarter 2026 financial and operating results before U.S. markets open on October 30, 2026.
A conference call and live webcast are scheduled for 8:30 a.m. Eastern Time that day. A replay and transcript will be archived on the company’s website for at least 30 days.
Regeneron (NASDAQ: REGN) announced that it will webcast management presentations at three upcoming healthcare investor conferences in September 2026: the Wells Fargo Healthcare Conference on September 9 at 8:45 a.m. ET, the Morgan Stanley 24th Annual Global Healthcare Conference on September 14 at 1:05 p.m. ET, and the Bernstein Insights 3rd Annual Healthcare Forum on September 23 at 10:30 a.m. ET.
According to Regeneron, live webcasts, replays and transcripts will be available for at least 30 days on the "Investors & Media" section of its website.
Regeneron (NASDAQ: REGN) announced that the U.S. FDA has approved Pasatru (garetosmab-grts) as the first treatment to reduce new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP).
Approval is based on the Phase 3 OPTIMA trial in 63 adults, where monthly intravenous Pasatru at 10 mg/kg and 3 mg/kg achieved 90% (2 vs 19) and 94% (1 vs 19) reductions in new HO lesions versus placebo at 56 weeks, assessed by CT. Clinician-assessed flare-ups fell to 9 events with 10 mg/kg (an 88% reduction vs placebo) and 53 with 3 mg/kg (15% reduction) versus 66 on placebo. Serious treatment-emergent adverse events occurred in 2, 1 and 2 patients in the 10 mg/kg, 3 mg/kg and placebo arms, respectively. Pasatru carries important safety warnings, including harm to unborn babies, risk of serious skin infections and nosebleeds. A pediatric Phase 3 trial (OPTIMA 2) is planned, and a European regulatory submission is under EMA review.
Regeneron (NASDAQ: REGN) announced the winners of the 2026 Regeneron Prize for Creative Innovation, an annual award recognizing early‑career biomedical scientists for visionary “dream project” proposals. Three researchers from New York University, Stanford University and Rensselaer Polytechnic Institute received individual awards of $50,000 (postdoctoral) and $25,000 (graduate) each.
Their institutions received $5,000 apiece for seminar series, and seven additional finalists earned $5,000 each, bringing total 2026 awards to $150,000. According to Regeneron, the prize, launched in 2013, is part of its STEM-Fueled™ efforts to support the next generation of scientific leaders.
Regeneron (NASDAQ: REGN) reported second quarter 2026 total revenues of $4.291 billion, up 17% year over year. GAAP net income was $1.297 billion (down 7%), with GAAP diluted EPS of $12.23 including a $1.02 negative impact from acquired IPR&D. Non-GAAP net income was $1.543 billion, up 8%, and non-GAAP diluted EPS was $14.29, up 11%.
Key products delivered strong growth: Dupixent global net sales (recorded by Sanofi) rose 38% to $6.0 billion, EYLEA HD U.S. net sales rose 52% to $596 million, and Libtayo global net sales increased 30% to $489 million. Total U.S. EYLEA HD and EYLEA net product sales declined 12% to $1.008 billion amid patient transition and competitive pressure. Sanofi collaboration revenue increased 51% to $2.174 billion, driven by higher antibody profits, and the Sanofi Development Balance was fully repaid, removing this drag on collaboration revenue from Q3 2026 onward.
Regeneron highlighted pipeline and regulatory milestones, including FDA and European approvals for Dupixent in chronic spontaneous urticaria in children, extended dosing for EYLEA HD, EMA accelerated review of Otarmeni, and FDA/EMA acceptance of cemdisiran applications in generalized myasthenia gravis. The company also initiated a Phase 3 PAD study for two Factor XI antibodies and reported positive Phase 1/2 data for Lynozyfic in amyloid light chain amyloidosis.
Operating expenses rose with R&D increasing to $1.632 billion GAAP (up 15%) and IPR&D at $127 million, while GAAP gross margin on net product sales declined to 78% from 87% due to temporary unabsorbed manufacturing costs from a bulk production interruption in Limerick, which has now normalized without impacting product availability. Regeneron repurchased $1.2 billion of stock in Q2 and $2.0 billion year to date, with $2.5 billion remaining under repurchase programs, and declared a $0.94 per share dividend payable August 31, 2026.
The company updated 2026 guidance, modestly increasing expected R&D, raising projected GAAP and non-GAAP gross margins on net product sales to 78–79% and 84–85%, and slightly increasing projected GAAP and non-GAAP effective tax rates. Capital expenditure guidance was lowered to $1.03–$1.10 billion. According to Regeneron, these changes reflect continued investment in its late-stage pipeline, manufacturing expansion, and a stronger collaboration profit outlook following repayment of the Sanofi Development Balance.
Tessera Therapeutics appointed veteran pharmaceutical executive Joseph Romanelli as President and Chief Executive Officer, succeeding Michael Severino, and named him to its board and as a CEO-Partner at Flagship Pioneering. The transition occurs as Tessera advances its first in vivo gene editing program TSRA-196 into the clinic and builds a broader Gene Writing™ pipeline, including a sickle cell disease candidate and in vivo CAR-T efforts for oncology and autoimmune diseases.
TSRA-196 is being jointly developed and commercialized with Regeneron for alpha-1 antitrypsin deficiency, and Tessera has secured up to $50 million from the Gates Foundation to pursue a globally accessible in vivo gene editing therapy for sickle cell disease. Romanelli previously led Merck’s more than $25 billion international human health business and its fast-growing China business.