News & Events zu Regeneron Pharmaceuticals Inc (REGN)REGNRegeneron Pharmaceuticals Inc

Regeneron Libtayo New Dosing Schedule Recommended by EMA

Regeneron announced that the European Medicines Agency's, or EMA, Committee for Medicinal Products for Human Use, or CHMP, has adopted an opinion recommending the approval of an alternative dosing schedule for Libtayo across all approved indications. Specifically, the CHMP's recommendation supports an extended dosing regimen of higher-dose Libtayo administered as a 30-minute intravenous infusion every six weeks, after an initial 12-week regimen of Libtayo 350 mg administered as a 30-minute intravenous infusion every three weeks. Additionally, the positive opinion supports a 15- to 30-minute infusion option for patients receiving Libtayo 350 mg every three weeks, if their first infusion at this dose level was well tolerated when administered over 30 minutes, which could cut treatment time by up to half. The CHMP opinion is supported by comprehensive pharmacokinetic and pharmacodynamic modeling and simulation data, integrated with clinical safety and efficacy data from Libtayo's clinical development program. The European Commission, or EC, is expected to make a final decision on the application in the coming months, which would allow for this dosing regimen to be applied across all six approved indications in the European Union, or EU. The Libtayo 700 mg every six-week dosing option is already approved in the EU for use after an initial 12 weeks as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma, or CSCC, at high risk of recurrence after surgery and radiation. Across all other approved indications, an alternate dosing regimen remains including Libtayo 350 mg every three weeks administered as an intravenous infusion over 30 minutes.

Regeneron Pharmaceuticals Announces 84-Week Results for Pasatru

Regeneron Pharmaceuticals announced 84-week results from the Phase 3 OPTIMA trial evaluating Pasatru in adults with fibrodysplasia ossificans progressiva. These longer-term findings for Pasatru demonstrated sustained efficacy in halting new, rogue bone growth and in significantly reducing disease flare-ups, and were presented during a late-breaking oral session at the American Society for Bone and Mineral Research Annual Meeting. Pasatru was recently approved by the U.S. Food and Drug Administration based on a 56-week, placebo-controlled trial to reduce the formation of new heterotopic ossification lesions and clinician-assessed flare-ups in adults with FOP. Pasatru is a VelocImmune-derived, fully human monoclonal antibody that binds to and inhibits signaling by the Activin A protein, which Regeneron scientists discovered to be a critical protein involved in the development of HO lesions in people with FOP. OPTIMA, a global, multi-center, randomized, double-blind, placebo-controlled trial, enrolled 63 people with FOP aged 18 years and older. Trial participants were randomized to receive intravenously administered Pasatru 10 mg/kg, Pasatru 3 mg/kg, or placebo once every four weeks for 56 weeks. Following this, 58 participants completed the double-blind extension phase to at least 84 weeks. At 56 weeks, OPTIMA met its primary endpoint, demonstrating a 90% or greater reduction in new HO lesions, with a dramatic reduction in clinician-assessed flare-ups in adults with FOP. Detailed results on these 56-week data were recently published in The Lancet. The endpoints were then re-assessed at 84 weeks. From week 56, there were no new HO lesions observed at week 84 for Pasatru compared to 9 new lesions for placebo as assessed by computed tomography scan. Additionally, one new HO lesion previously detected at week 56 for Pasatru 3 mg/kg was no longer detectable at week 84. The number of new clinician-assessed flare-ups was also reduced compared to placebo, notably with 1 observed for Pasatru 10 mg/kg, 14 for Pasatru 3 mg/kg, and 17 for placebo. Through week 84, both doses of Pasatru had a generally well-tolerated safety profile, consistent with that observed at 56 weeks. At 56 weeks, the most common adverse reactions occurring in greater than or equal to10% of adults with FOP treated with Pasatru were abscess, acne, increased hair growth, madarosis, oral ulcers, epistaxis, folliculitis, paronychia, and rash. At 84 weeks, the most common treatment-emergent adverse events were acne in participants treated with Pasatru 10 mg/kg and epistaxis in participants treated with Pasatru 3 mg/kg. Treatment-emergent bleeding events were lower in participants treated with Pasatru 10 mg/kg than those treated with Pasatru 3 mg/kg or placebo. There was a dose-dependent increase in skin and soft tissue infections that were all resolved with further management, with no patients discontinuing treatment as a result of infection. No deaths were reported in the trial. A Phase 3 trial of Pasatru in adolescents and children with FOP, OPTIMA 2, is planned to begin later this year.

Major Averages Little Changed as Micron Reports Strong Q4 Earnings

The major averages were little changed to start the month as rising Treasury yields continue to weigh on markets even as Micron reported upbeat Q4 earnings and revenue. Also weighing on stocks was a jump in oil prices as traders await President Trump's next move in the war with Iran.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:Micronreported better-than-expected Q4 results and provided an upbeat earnings and revenue outlook for Q1Accenturereported upbeat Q4 results but provided conservative FY27 earnings guidanceMSG Sports'board of directors approved a spinoff of its Rangers business from its Knicks businessMattelhas drawn takeover interest from Authentic Brands, WSJ reportsGeneral Motorsreported a 6% drop in Q3 U.S. sales, while Toyotareported an 8.4% increase in September U.S. sales on a volume basis, and Stellantisreported "steady" U.S. sales for last quarter2. WALL STREET CALLS:Wells Fargo upgraded BP, downgraded Exxonon relative valuation callOccidentalupgraded to Buy at Goldman SachsBarclays reinstated Williamswith an Overweight, sees growth from behind-the-meter powerEthosdowngraded to Neutral from Overweight at JPMorganArgus upgraded Regeneron, sees attractive entry point after selloff3. AROUND THE WEB:BAE Systemsis weighing a bid for Robin Radar in a potential $2.3B deal, Reuters reportsMetaCEO Mark Zuckerberg helped initiate and draft the principles behind the White House's voluntary AI industry accord, working with Nvidia'sJensen Huang and other executives to address regulatory and safety concerns, Semafor reportsTencenthas signed an estimated $7B, five-year lease with Oracleacross Southeast Asian data centers, giving it access to roughly 100,000 advanced AI chips unavailable in China, FT saysBroadcomis emerging as a uniquely strategic Anthropic partner, spanning compute supply, equipment leasing, and up to $42B of infrastructure financing, Reuters reportsGoogleis paying roughly 100 digital publishers for how much their content contributes to AI Overviews, AI Mode, and Gemini in a pilot, The Information reports4. MOVERS:Synopsysgained after providing guidance for FY27 and announcing its intention to repurchase $1B sharesWave Life Sciencesincreased after announcing FDA feedback supported its pathway for WVE-006Infosyswas higher in New York after partnering with Columbia University to develop its AI R&D activitiesCortevafell after completing the spin-off of its seed and genetics businessNektarwas lower after announcing long-term data on rezpegaldesleukin5. EARNINGS/GUIDANCE:Lyftbacked its outlook for Q3McCormickreported Q3 results and reaffirmed its outlook for FY26Acuityreported Q4 results, with EPS beating consensusCardinal Healthreaffirmed its outlook for FY27Progress Softwarereported Q3 results and provided guidance for both Q4 and FY26INDEXES:The Dow rose 20.51, or 0.04%, to 50,926.56, the Nasdaq gained 10.53, or 0.04%, to 26,871.60, and the S&P 500 advanced 14.91, or 0.19%, to 7,666.45.