Regeneron Pharmaceuticals (REGN) Stock News

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.

Regeneron (NASDAQ: REGN) will report its Q2 2026 financial and operating results on Thursday, July 30, 2026, before U.S. markets open. The company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time, with replay and transcript available for at least 30 days.

Regeneron (NASDAQ: REGN) announced that the FDA and EMA accepted regulatory submissions for cemdisiran to treat adult, anti-AChR antibody-positive generalized myasthenia gravis (gMG). The FDA granted Priority Review with a target action date in November 2026, and an EU decision is expected in 2H 2027.

Submissions are backed by the Phase 3 NIMBLE trial of subcutaneous cemdisiran given every 12 weeks. Full NIMBLE data were published in The Lancet and presented at AAN 2026. A Japan filing is planned for early 2027. Cemdisiran remains investigational and is not yet approved.

Regeneron (NASDAQ: REGN) will present new clinical and preclinical data from its metabolic disease, ophthalmology and rare disease pipelines at ADA 2026 (June 5-8) and ENDO 2026 (June 13-16).

Highlights include Phase 2 COURAGE data on trevogrumab, Phase 3 OPTIMA FOP results for garetosmab, and early Graves’/thyroid eye disease antibody research.

Regeneron (NASDAQ: REGN) announced that maftivimab, the most potent antibody in Inmazeb, has been recommended by the WHO Therapeutics Advisory Group for prioritized evaluation in clinical trials of investigational treatments for the current Bundibugyo ebolavirus outbreak in the DRC and Uganda.

Maftivimab has shown broad in vitro activity against multiple Ebola species, including Bundibugyo. Inmazeb is FDA‑approved for Orthoebolavirus zairense, has been given to hundreds of patients, and supplied through donations, stockpiles and compassionate use programs in at‑risk countries.

Regeneron (NASDAQ: REGN) announced that the European Medicines Agency accepted for review, under Accelerated Assessment, the Marketing Authorization Application for Otarmeni (lunsotogene parvec), an in vivo AAV gene therapy for biallelic OTOF variant-associated hearing loss.

The filing is backed by the pivotal CHORD trial, where 24 children (10 months–16 years) received a single intracochlear dose (10 unilateral, 14 bilateral). An earlier CHORD data cut (n=20) supported Otarmeni’s U.S. FDA accelerated approval in April 2026. If approved, it would be the first gene therapy for OTOF-related hearing loss in the EU. The condition affects about 46 newborns per year in the EU. Otarmeni is approved in the U.S.; outside the U.S., safety and efficacy have not been fully evaluated. Regulatory submissions are planned in additional markets, including Japan.