Day: November 8, 2025

Deep, stable and durable reductions in kallikrein observed  Among 32 patients who received a 50 mg dose of lonvo-z as of data cutoff:31 (97%) were attack-free and long-term prophylaxis (LTP)-free 24 (75%) were attack-free and LTP-free for at least seven months (up to 32 months) Among the 11 patients who originally received a 50 mg dose in Phase 2, 10 were attack-free and LTP-freeContinue to observe a well-tolerated safety profile with up to three years of patient follow-up and no new long-term risks identifiedCAMBRIDGE, Mass., Nov. 08, 2025 (GLOBE NEWSWIRE) — Intellia Therapeutics, Inc. (NASDAQ: NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today presented positive clinical data from a pooled analysis of all patients who received a 50 milligram (mg)...

Oral presentation highlights sotagliflozin’s unique benefits to HFpEF patients in significantly improving cardiac and physical performance, and quality of life THE WOODLANDS, Texas, Nov. 08, 2025 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that new sotagliflozin clinical data was presented at the AHA Annual Scientific Sessions 2025. The data highlighted benefits observed from sotagliflozin treatment in heart failure patients with preserved ejection fraction (HFpEF), and without diabetes, across a range of measures, including cardiac structure and function, quality of life and functional capacity. Conducted under the direction of Dr. Juan J Badimon, PhD, FACC, FAHA, director, Atherothrombosis Research Unit, professor of Medicine/Cardiology at Mount Sinai Medical Center in New York City,...

Data support NEK7 as a potential novel and differentiated therapeutic approach to modulate the NLRP3 inflammasome in multiple cardiovascular and cardiometabolic diseases, including pericarditis and atherosclerosis Initial data from a Phase 1 study of MRT-8102 in healthy volunteers and elevated CVD-risk subjects on track for first half of 2026 Poster presentation on November 8 at 10:30 a.m. CST BOSTON, Nov. 08, 2025 (GLOBE NEWSWIRE) — Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced the company will present preclinical data on the potential of MRT-8102, a first-in-class, NEK7-directed MGD for inflammatory diseases driven by the NLRP3 inflammasome, at the American Heart Association’s Scientific Sessions 2025, held November...

Treatment with telitacicept for 39 weeks resulted in a rapid, clinically meaningful, and statistically significant reduction in proteinuria, with a favorable safety profile Telitacicept demonstrated a 55% reduction in 24-hour urine protein-to-creatinine ratio (24h-UPCR) at 39 weeks compared with placebo; statistically significant benefits also achieved across all key secondary endpoints Data presented as late-breaking oral presentation at American Society of Nephrology’s Kidney Week 2025 BOSTON, Nov. 08, 2025 (GLOBE NEWSWIRE) — Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that the primary endpoint was achieved in Stage A of a Phase 3 clinical study in China evaluating telitacicept in adults with IgA nephropathy (IgAN). In addition, statistically...

MyPEAK-1 Data Presented During Late-Breaking Session at AHA Scientific Sessions 2025 with Simultaneous Publication in Cardiovascular Research TN-201 Has Been Generally Well Tolerated at Both Doses Longer-term Follow Up of Cohort 1 Patients Showed Consistent, Deeper, and Durable Improvement in Measures of Hypertrophy Initial Cohort 2 Data Demonstrated Early Dose Responsive Increases in TN-201 Transduction and MyBP-C Protein Expression Tenaya Management to Host Webcast Call for Analysts and Investors on Monday, November 10 at 8:00 a.m. EST NEW ORLEANS and SOUTH SAN FRANCISCO, Calif., Nov. 08, 2025 (GLOBE NEWSWIRE) — Tenaya Therapeutics, Inc. (NASDAQ: TNYA) announced that new interim safety and efficacy data from the company’s MyPEAK™-1 Phase 1b/2a clinical trial of TN-201 were presented today during the Late-Breaking Science:...

SAN FRANCISCO and VANCOUVER, British Columbia, Nov. 08, 2025 (GLOBE NEWSWIRE) — Jade Biosciences, Inc. (“the Company” or “Jade”), (Nasdaq: JBIO), a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases, today presented two posters for JADE101, its investigational anti-A PRoliferation-Inducing Ligand (APRIL) monoclonal antibody for the treatment of immunoglobulin A nephropathy (IgAN), at the American Society of Nephrology (ASN) Kidney Week 2025. JADE101 is designed to selectively inhibit APRIL, a key driver of pathogenic IgA production in IgAN, a progressive autoimmune disease that frequently leads to end-stage kidney disease over a patient’s lifetime. Jade has engineered JADE101 with properties intended to capture the full efficacy of APRIL pathway inhibition while enabling patient-friendly...

Proof-of-concept trials confirm robust anti-clotting effects for Regeneron’s two mechanistically-distinct antibodies against factor XI, in patients undergoing total knee replacement Trial results consistent with prospective design of these antibodies to have distinct profiles – one to provide stronger anticoagulation and the other to have a lower risk of bleeding – potentially allowing physicians to tailor anticoagulant therapy for patients with different risk profiles Phase 3 trials in patients undergoing total knee replacement initiated as part of broad factor XI program evaluating the two antibodies across a range of patient populations and clinical settings Regeneron to host virtual ‘Regeneron Roundtable’ investor event to discuss its factor XI development program on Monday, November 10 at 8:30 a.m. ET TARRYTOWN, N.Y., Nov. 08, 2025...

– Simultaneously published in JAMA Cardiology along with moderated posters at AHA, acoramidis demonstrated:59% risk reduction in ACM in the ATTR-CM variant population at Month 42 (p=0.032) compared to patients initially randomized to placebo in the ATTRibute-CM study 69% risk reduction in ACM/ first CVH through Month 30 compared to placebo (p=0.016) and a 69% risk reduction in ACM through Month 42 (p=0.045) in ATTR-CM participants with the genetic variant p.Val142Ile (V142I, V122I) compared to patients initially randomized to placebo in the ATTRibute-CM study– This is the first report of clinical benefit of this magnitude observed in this high-risk population with significant unmet need PALO ALTO, Calif., Nov. 08, 2025 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new...

-Data presented in a late-breaking presentation at the American Heart Association (AHA) Scientific Sessions 2025- -Phase 1 clinical data for CTX310® demonstrate robust, dose-dependent reductions in circulating ANGPTL3 with a mean reduction from baseline of -73% (maximum -89%), a mean reduction in triglycerides (TG) of -55% (maximum -84%), and a mean reduction of low-density lipoprotein (LDL) of -49% (maximum -87%) at the highest dose- -Among participants with elevated baseline TG (>150 mg/dL), a mean reduction of 60% in TG were observed at therapeutic doses- -CTX310 was well tolerated with no treatment-related serious adverse events and no ≥Grade 3 changes in liver transaminases- -Findings simultaneously published in The New England Journal of Medicine entitled “First-in-Human Phase 1 Trial of CRISPR-Cas9 Gene Editing Targeting ANGPTL3”-ZUG,...

Bagsværd, Denmark, 8 November 2025 – Novo Nordisk today confirms that it does not intend to make an increased offer to acquire Metsera.  On 30 October 2025, Novo Nordisk announced the submission of an unsolicited proposal to acquire Metsera, Inc. (Metsera) which was declared superior by Metsera’s board of directors.   On 4 November 2025, Novo Nordisk confirmed that it had submitted an updated unsolicited proposal to acquire Metsera price of 62.20 USD per share in cash (equal to an approximate aggregated equity value of 7.2 billion USD or approximate enterprise value of 6.7 billion USD) and contingent value rights (CVRs) for up to 24.00 USD per share in cash (or an approximate aggregated value of up to 2.8 billion USD) based on the achievement of certain clinical and regulatory milestones which was declared superior by Metsera’s board of...