Abbott announced that its Volt Pulsed Field Ablation System was used for the first time in Canada at the McGill University Health Centre in Montreal to treat patients with atrial fibrillation. The system, which received Health Canada authorization in April 2026, is designed to deliver more precise, targeted energy with fewer catheter exchanges and reduced radiation exposure than earlier-generation systems, and is also approved and available in the United States, Europe and Australia. Health Canada authorization was based on results from Abbott's VOLT-AF IDE study, a clinical trial of 392 patients conducted at 40 centres in the United States, Europe, Canada and Australia, which demonstrated clinically meaningful performance in both safety and effectiveness in treating paroxysmal AFib and persistent AFib. Dr. Atul Verma, director of cardiology at the McGill University Health Centre, said innovations like Volt are notable for combining real-time feedback with a distinctive catheter design that may help optimize contact and energy delivery during procedures. Christopher Piorkowski, chief medical officer of Abbott's electrophysiology business, said the system's introduction in Canada enables an approach that can support conscious sedation and may help make procedures more efficient while supporting quicker recovery. AFib affects between 500,000 to nearly one million Canadians, and people with the condition have 3 to 5 times greater risk for ischemic stroke.
Abbott's Volt Pulsed Field Ablation System was used for the first time in Canada after Health Canada authorization, advancing its electrophysiology product adoption.
Novartis Acquires Tourmaline Bio for $1.4 Billion, Adding Phase III-Ready IL-6 Therapy Pacibekitug
Novartis agreed in September 2025 to acquire Tourmaline Bio, Inc. for approximately $1.4 billion, with the IL-6 inhibitor pacibekitug as the central strategic asset. Novartis described pacibekitug as Phase III-ready and positioned it as a complement to its cardiovascular portfolio, gaining access to its global cardiovascular infrastructure, development capabilities, payer relationships and launch expertise. The deal follows positive topline results from the Phase II TRANQUILITY trial reported by Tourmaline Bio in May 2025, in which monthly dosing at 15 mg produced an hs-CRP reduction of more than 85% and 50 mg quarterly dosing achieved a reduction of more than 86%, with all treatment arms reaching p< 0.0001 compared with placebo and adverse event rates comparable to placebo. Pacibekitug is an investigational, long-acting fully human IgG2 monoclonal antibody that selectively binds to and neutralizes IL-6 signaling, designed for low-volume subcutaneous administration with an extended half-life that may support quarterly dosing. Originally developed by Pfizer Inc. for autoimmune diseases including Crohn's Disease and Systemic Lupus Erythematosus, the asset has since been repositioned for atherosclerotic cardiovascular disease, Chronic Kidney Disease with elevated inflammation, Thyroid Eye Disease and other inflammatory conditions. A new ResearchAndMarkets.com report forecasts pacibekitug sales and market size through 2034 across the seven major markets of the United States, EU4, the United Kingdom and Japan, covering cardiovascular disorders, Graves ophthalmopathy, kidney disorders and abdominal aortic aneurysm.
FDA Expands CAMZYOS Approval to Pediatric Obstructive HCM Patients
The U.S. Food and Drug Administration has approved an expanded indication for Bristol Myers Squibb's CAMZYOS (mavacamten) to treat symptomatic obstructive hypertrophic cardiomyopathy in adults and pediatric patients weighing 30 kg (66 lbs) or more, making it the only FDA-approved therapy for oHCM in a pediatric population and giving it the broadest indication of any cardiac myosin inhibitor. The approval is based on positive results from the Phase 3 SCOUT-HCM trial, which evaluated CAMZYOS (n=23) versus placebo (n=21) in patients aged 12 to under 18 years with symptomatic NYHA Class II-III oHCM. CAMZYOS met the trial's primary endpoint, showing a statistically significant reduction in Valsalva left ventricular outflow tract gradient at Week 28 compared with placebo, with a least-squares mean difference from placebo of minus 48.0 mm Hg (95% CI, minus 67.7 to minus 28.3; P<0.0001). No patients in SCOUT-HCM experienced left ventricular ejection fraction below 50%, no adverse events led to treatment discontinuation, and no new adverse reactions were identified beyond the safety profile observed in adults. CAMZYOS was first approved by the FDA in 2022 for adults with symptomatic NYHA class II-III oHCM and has been prescribed by more than 5,000 healthcare providers to over 25,000 patients in the U.S. alone; the pediatric data is now being discussed with multiple global regulatory authorities for potential pediatric indications.
Biotech & Genomic Medicine › Cardiovascular & Heart-Failure Therapeutics ▲Regulation
BMY · Regulation · Positive FDA expanded CAMZYOS approval to pediatric oHCM patients, broadening the label and making it the only approved pediatric oHCM therapy.
Cantor Fitzgerald Starts Lexicon at Overweight on Inpefa HCM Optimism
Cantor Fitzgerald initiated coverage of Lexicon Pharmaceuticals at overweight, citing optimism over upcoming phase 3 data for the SGLT1/2 inhibitor Inpefa, also known as sotagliflozin, as a treatment for hypertrophic cardiomyopathy, with results expected in the first quarter of 2027. The firm set a price target of $8, which it said represents roughly 344% upside based on the September 27 close. Analyst Steve Seedhouse wrote that Inpefa is completely orthogonal to cardiac myosin inhibitors, where most of the recent innovation in HCM has come from, so it will complement rather than compete with those drugs, examples of which include Bristol Myers Squibb's Camzyos, or mavacamten, and Cytokinetics' Myqorto, or aficamten. Seedhouse added that background cardiac myosin inhibitors are allowed in the phase 3 study SONATA-HCM, so if SONATA-HCM works, sotagliflozin is essentially unencumbered competitively in a proven blockbuster market. He noted several potential ways SGLT and SGLT2 are involved in HCM, including reducing epicardial adipose tissue and mitochondrial oxidative stress and restoring glucose levels and ATP homeostasis. Inpefa is already approved to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure in adults with heart failure, or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.
Lupin Wins Tentative U.S. FDA Approval for Apixaban Oral Suspension
Lupin Limited has received tentative approval from the United States Food and Drug Administration for its New Drug Application for Apixaban Oral Suspension 1.25mg/mL, cleared via the 505(b)(2) pathway. The oral liquid formulation uses apixaban, the active ingredient in Eliquis of Bristol Myers Squibb, and offers an alternative administration option for adult patients requiring anticoagulation therapy, including those who may have difficulty swallowing tablets. CEO Vinita Gupta said the tentative approval reflects Lupin's continued focus on developing differentiated medicines that address meaningful patient needs. Upon final approval, the product will be manufactured at Lupin's Somerset, New Jersey facility, leveraging the company's U.S.-based manufacturing expertise to support high-quality standards and supply reliability. Lupin Limited is headquartered in Mumbai, India, and distributes products in over 100 markets.
Biotech & Genomic Medicine › Cardiovascular & Heart-Failure Therapeutics Competition
BMY · Competition · Negative Lupin's tentative FDA approval of a generic apixaban oral suspension introduces a competing alternative to BMS's Eliquis, whose active ingredient it uses.
Novo Nordisk Lifts 2026 Guidance as Lilly's Zepbound Pulls Ahead
Novo Nordisk raised its 2026 sales and operating-profit growth outlook to a range of 0% to negative 6% at constant exchange rates, up from a prior negative 4% to negative 12%. The Danish drugmaker faces renewed investor pressure over what comes after its weight-loss franchise, with analysts projecting Eli Lilly's Zepbound will outsell Novo's Wegovy by more than $7 billion this year. CEO Mike Doustdar has cut costs, ended weak programs, and pursued targeted acquisitions and partnerships, while Novo has five oral candidates in development and expects pills could capture as much as half of the obesity market by 2030. The company halted trials of heart drug ziltivekimab and CagriSema disappointed investors, and semaglutide already faces generic competition in markets including India, Canada, and Brazil after 2026 patent expiries, even though protection in major Western markets holds into the early 2030s. Hedge fund holdings in Novo rose to 59 funds with $2.00 billion in position value in the second quarter of 2026 from 55 funds and $1.79 billion in the first, while Eli Lilly's holders rose to 152 from 132 and position value jumped to $17.24 billion from $12.58 billion.
Biotech & Genomic Medicine › Metabolic, Diabetes & Obesity Competition
Biotech & Genomic Medicine › Cardiovascular & Heart-Failure Therapeutics ▼Technology
NVO · Capital · Neutral Novo Nordisk raised its 2026 sales and operating-profit growth outlook to 0% to negative 6% from negative 4% to negative 12%.
NVO · Competition · Negative Eli Lilly's Zepbound is projected to outsell Novo's Wegovy by more than $7 billion this year, and CagriSema disappointed investors.
LLY · Competition · Positive Analysts project Eli Lilly's Zepbound will outsell Novo's Wegovy by more than $7 billion this year, and Lilly's hedge-fund position value jumped to $17.24 billion.
Novo Nordisk Targets Over DKK 150 Billion in Pipeline Sales by 2035 in Diversification Push
Novo Nordisk is pursuing deals to build growth beyond its core weight-loss franchise, with CEO Mike Doustdar signaling willingness to diversify as obesity and diabetes accounted for more than 90% of the company's 2025 sales. At its September 2026 Capital Markets Day, Novo said it aims to launch more than five multi-blockbuster medicines by 2030 and generate more than DKK 150 billion, or $23 billion, in pipeline sales by 2035, alongside at least five Phase 3 programs in obesity and diabetes and at least five in other therapeutic areas. Obesity sales reached DKK 82.3 billion in 2025, up 31% at constant exchange rates, but in the second quarter of 2026 U.S. Wegovy injectable sales fell 22% at constant exchange rates on lower realized prices, even as combined injectable and pill sales rose 4%. Novo is expanding its portfolio with oral Wegovy, CagriSema and zenagamtide while pursuing cardiovascular, kidney, liver and rare disease opportunities, and recent CagriSema data showed 12.4% average weight loss versus 9.1% for tirzepatide 5 mg in the REIMAGINE 5 trial. The company's diabetes value market share fell 3.6 percentage points to 30.1% in 2025, and Eli Lilly's Zepbound is expected to generate roughly $7 billion more in sales than Wegovy in 2026, according to Reuters, which also noted expected R&D returns across the industry have fallen toward roughly 9%, only modestly above an estimated 8% cost of capital.
Biotech & Genomic Medicine › Metabolic, Diabetes & Obesity Competition
Biotech & Genomic Medicine › Cardiovascular & Heart-Failure Therapeutics Demand
NVO · Capital · Neutral Novo targets over DKK 150 billion in pipeline sales by 2035 and five-plus multi-blockbuster launches, but faces falling diabetes share and declining U.S. Wegovy injectable sales.
LLY · Competition · Positive Eli Lilly's Zepbound is expected to generate roughly $7 billion more in sales than Wegovy in 2026, a competitive gain versus Novo.