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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.
Regeneron Announces New Results from COURAGE Trial
Regeneron Pharmaceuticals announced new results from the Phase 2 COURAGE trial evaluating trevogrumab for its potential to prevent lean mass and muscle loss during GLP-1 receptor agonist-induced weight loss in people living with obesity. The results of the trial were presented during a Scientific Symposium at the European Association for the Study of Diabetes Annual Meeting and is in press with The Lancet. Building on these positive findings, Regeneron is planning to initiate a Phase 2 trial evaluating trevogrumab in combination with GLP-1 receptor agonist-based therapies in older adults with obesity and decreased muscle mass and/or strength. COURAGE investigated the quality of weight loss in people living with obesity in two independent portions over 52 weeks. A higher-dose portion evaluated trevogrumab in combination with semaglutide 2.4 mg for 26 weeks compared to semaglutide alone, and then trevogrumab compared to placebo alone for an additional 26 weeks after semaglutide was discontinued. The trial also included a treatment arm with semaglutide, trevogrumab and an Activin-A inhibitor for which the results were previously presented. A lower-dose portion evaluated trevogrumab in combination with semaglutide 2.4 mg compared to semaglutide monotherapy for 52 weeks. The results in this portion replicated the findings of the higher-dose portion, with the greatest reduction in lean mass occurring during the period of most rapid weight loss that was observed in the first six months of treatment. While lower-dose trevogrumab did not meaningfully enhance the weight loss achieved with semaglutide alone, it preserved lean mass at both 26 and 52 weeks. Among participants with evaluable MRI data, lower dose trevogrumab preserved almost 70% of the thigh muscle that would have been otherwise lost with semaglutide treatment alone. The lower doses of trevogrumab were generally well tolerated, with 77% of participants experiencing at least one adverse event compared with 82% of those who were treated with placebo. The most common AEs occurring in greater than or equal to10% of patients were nausea, constipation, diarrhea and vomiting. Also presented at EASD was a pre-specified subgroup analysis of participants with low lean mass at baseline. Compared to patients without LLM at baseline, these patients experienced a greater loss of lean mass with semaglutide alone and numerically more preservation of lean mass in combination with trevogrumab. LLM was defined using the imaging component of the sarcopenia definition established by the Foundation for the National Institutes of Health.
Regeneron Announces Preliminary Results for Ubamatamab in Low-Grade Ovarian Cancer
Regeneron Pharmaceuticals announced the first results for the investigational ubamatamab in patients with low-grade serous ovarian cancer. The data are from an ongoing Phase 1/2 trial in recurrent platinum-resistant high- or low-grade serous ovarian cancer that were presented in a late-breaking plenary oral session at the International Gynecologic Cancer Society 2026 Annual Global Meeting. Ubamatamab is a MUC16xCD3 bispecific antibody designed to bridge MUC16 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation. Based on these preliminary trial results, Regeneron has been enrolling a single-arm, potentially registrational LGSOC trial and will be discussing the data with the U.S. Food and Drug Administration in the coming months. Regeneron is also planning to initiate a confirmatory, randomized, controlled Phase 3 trial to support the use of ubamatamab in LGSOC. LGSOC is a biologically distinct variant from the more common high-grade serous ovarian cancer, comprising up to 10% of serous ovarian cancer, with typically uniformly high MUC16 expression and limited treatment options. The disease often affects younger women and is characterized by slower-growing tumors than those seen in HGSOC, but frequently recurs and is less responsive to conventional chemotherapy with few treatment options. LGSOC has a median overall survival of approximately seven years from initial diagnosis, compared to approximately four years for HGSOC. In recurrent advanced LGSOC, historical trial data have shown that objective response rates generally remain below 15% with chemotherapy and endocrine therapy, while the only approved therapy has an ORR of 44% in biomarker-selected patient populations. Data presented at IGCS focused on the LGSOC subset of 19 patients who had received a median of four prior lines of therapy and were dosed with intravenous ubamatamab ranging from 3 to 800 mg weekly or every three weeks. Ubamatamab was given either as monotherapy or in combination with Libtayo. Included in the presentation were 11 patients treated with 800 mg of ubamatamab monotherapy, eight treated weekly and three treated every three weeks. Results at the 800 mg doses showed a: 73% ORR, with all responses being partial responses; 9-month median duration of response, per Kaplan-Meier estimate; 11-month median progression-free survival, per Kaplan-Meier estimate. Safety was assessed across all 19 patients in the LGSOC subset. Treatment-emergent adverse events occurred in 100% of participants. Cytokine release syndrome occurred in 90% of participants, all of which were Grade 1 or 2. Serious TEAEs grade 3 or higher occurred in 21% of participants and treatment-related adverse events occurred in 74% of participants. Grade 3 or higher TRAEs included neutropenia , anemia, increased alanine aminotransferase, increased aspartate aminotransferase, abdominal pain and ileus. Most adverse events occurred during the step-up dosing period. One participant discontinued treatment due to a stroke considered unrelated to ubamatamab treatment; no TEAEs resulted in death.
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