https://www.bioworld.com/rss en-us As expected, and following impressive phase III data released last September, Ionis Pharmaceuticals Inc. won U.S. FDA approval of Tryngolza (olezarsen) for adults with severe hypertriglyceridemia, unlocking a larger indication and one that held both priority review and breakthrough therapy designations. http://www.bioworld.com/articles/732162 Fri, 26 Jun 2026 08:00:00 -0400 https://www.bioworld.com/articles/732162-ionis-wins-wider-tryngolza-approval-for-hypertriglyceridemia Tryngolza pen and packaging Credit: Ionis Pharmaceuticals Inc. Fortvita Biologics Inc. and Innovent Biologics (Suzhou) Co. Ltd. have identified new calcitonin receptor (CALCR; CT-R) and amylin receptor dual agonists potentially useful for the treatment of metabolic dysfunction-associated steatohepatitis (MASH; NASH), overweight, dyslipidemia, cognitive and cardiovascular disorders. http://www.bioworld.com/articles/732142 Thu, 25 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732142-fortvita-biologics-innovent-biologics-discover-new-calcitonin-and-amylin-receptor-dual-agonists Merck KGaA has entered into a strategic research-stage collaboration with Saturnus Bio, a biotech founded by Versant Ventures, to establish a foundational portfolio in the field of rare genetic cardiomyopathies. http://www.bioworld.com/articles/732137 Thu, 25 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732137-merck-kgaa-announces-cardio-partnership-with-saturnus-bio Female hands holding heart on cardiogram Chinese peptide therapeutics developer Shaanxi Micot Pharmaceutical Technology Co. Ltd. is seeking up to HK$1.22 billion (US$155 million) in a Hong Kong IPO to advance its lead phase III chronic kidney disease candidate, MT-1013, and next-generation obesity therapies. http://www.bioworld.com/articles/732154 Tue, 23 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732154-chinas-micot-targets-hk12b-ipo-to-advance-metabolic-portfolio IPO, coins, upward arrow Croívalve Ltd. secured a further $20 million in series B financing for its Duo Adapt system, a transcatheter device that treats tricuspid regurgitation. The company also received $7 million from the European Innovation Council and the Disruptive Technologies Innovation Fund in grant financing. Croívalve will use the funds to expand its clinical study, which is evaluating the safety and performance of the Duo Adapt system in patients with severe or greater symptomatic tricuspid regurgitation. http://www.bioworld.com/articles/732061 Tue, 23 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732061-croivalve-secures-27m-for-duo-adapt-tricuspid-device Croívalve Duo System The Duo system is a novel transcatheter heart valve designed to preserve the patient’s native anatomy while treating tricuspid regurgitation. Credit: Croívalve Ltd. Europe must focus on prevention and innovation to ensure its health care systems are sustainable in the long term, said Olivér Várhelyi, European commissioner for health and animal welfare. With an aging population, rising chronic diseases, a stretched workforce and geopolitical tensions, the universal health coverage that Europeans enjoy is under threat, he told delegates at the HLTH Europe conference in Amsterdam last week. http://www.bioworld.com/articles/732049 Mon, 22 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732049-europes-health-system-under-threat-prevention-and-innovation-key Female healthcare professional holding health icon Scribe Therapeutics Inc. has been awarded more than $25 million by California Institute for Regenerative Medicine (CIRM) across two preclinical programs for CRISPR-based gene editing therapies targeting cardiovascular and metabolic disease. http://www.bioworld.com/articles/732028 Fri, 19 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732028-scribes-cardiometabolic-programs-gain-cirm-boost Artery and plaque Cardiovascular-focused Kardigan Inc. is the latest biopharma firm to take advantage of the wide open IPO window, pricing an upsized offering of 25 million shares at $16 per share, the high end of its proposed range, to rake in gross proceeds of about $400 million. http://www.bioworld.com/articles/731920 Thu, 18 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731920-biopharma-ipos-stay-strong-as-kardigan-prices-upsized-400m-offering Chinese peptide therapeutics developer Shaanxi Micot Pharmaceutical Technology Co. Ltd. is seeking up to HK$1.22 billion (US$155 million) in a Hong Kong IPO to advance its lead phase III chronic kidney disease candidate, MT-1013, and next-generation obesity therapies. http://www.bioworld.com/articles/731909 Wed, 17 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731909-chinas-micot-targets-hk12b-ipo-to-advance-metabolic-portfolio IPO, coins, upward arrow Fresh off a deal with Travere Therapeutics Inc. for civorebrutinib worth more than $1.14 billion, Everest Medicines Ltd. went on a shopping spree, striking three deals in six days to expand its pipeline and geographic reach across Asia Pacific. http://www.bioworld.com/articles/731982 Tue, 16 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731982-three-deals-in-six-days-everest-builds-late-stage-apac-portfolio Hands holding gears Demonstrating better tolerability and safety in comparison with standard of care, Edgewise Therapeutics Inc.’s EDG-7500 is moving toward a phase III trial for both obstructive and nonobstructive hypertrophic cardiomyopathy (HCM), the most common form of genetic heart disease. Boulder, Colo.-based Edgewise reported top-line phase II results from part D of the Cirrus-HCM trial, showing meaningful responses in terms of hemodynamics, biomarkers and patient-reported measures. http://www.bioworld.com/articles/731889 Tue, 16 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731889-edgewise-heads-to-phase-iii-with-solid-edg-7500-data-in-hcm Abstract blue human heart with red cardio pulse line and red circle Chengdu Shibeikang Biological Medicine Technology Co. Ltd. has patented new platelet adhesion inhibitors reported to be useful for the treatment of cardiovascular and cerebrovascular disorders. http://www.bioworld.com/articles/731973 Tue, 16 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731973-chengdu-shibeikang-synthesizes-new-platelet-adhesion-inhibitors Thryv Therapeutics Inc. has divulged new crystalline forms of serum/glucocorticoid-regulated kinase 1 (SGK1) inhibitors and maleic acid potentially useful for the treatment of atrial fibrillation, heart failure and inflammatory disorders. http://www.bioworld.com/articles/731867 Fri, 12 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731867-thryv-therapeutics-synthesizes-sgk1-inhibitors Shenzhen Salubris Pharmaceuticals Co. Ltd. has synthesized relaxin family peptide receptor 1 (RXFP1) receptor agonists reported to be potentially useful for the treatment of heart failure. http://www.bioworld.com/articles/731848 Thu, 11 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731848-salubris-pharma-reports-new-rxfp1-receptor-agonists Leto Laboratories Co. Ltd. has identified macro cyclic peptides acting as calcitonin receptor (CALCR; CT-R) and amylin dual receptor agonists reported to be potentially useful for the treatment of atherosclerosis, type 1 diabetes, dyspepsia, myocardial infarction, obesity and more. http://www.bioworld.com/articles/731845 Thu, 11 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731845-leto-laboratories-presents-long-acting-amylin-receptor-agonists Fresh off a deal with Travere Therapeutics Inc. for civorebrutinib worth more than $1.14 billion, Everest Medicines Ltd. went on a shopping spree, striking three deals in six days to expand its pipeline and geographic reach across Asia Pacific. http://www.bioworld.com/articles/731721 Wed, 10 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731721-three-deals-in-six-days-everest-builds-late-stage-apac-portfolio Hands holding gears The U.S. Supreme Court handed Hikma Pharmaceuticals and the entire generic industry a big victory June 4 with its 9-0 opinion ensuring the future of skinny labels and correcting the Federal Circuit’s flawed understanding of infringed inducement. http://www.bioworld.com/articles/731619 Thu, 04 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731619-scotus-breathes-new-life-into-skinny-labels Generic drugs and bottle Bristol Myers Squibb Co. (BMS) has disclosed new 1H-benzo[d]imidazole derivatives acting as calcium/calmodulin-dependent protein kinase type II (CAMK2) inhibitors potentially useful for the treatment of anxiety disorders, asthma, cardiomyopathy, diabetes, fibrosis, heart failure, hypertension and allergy, among others. http://www.bioworld.com/articles/731605 Wed, 03 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731605-bms-patents-new-camk2-inhibitors D&D Pharmatech Inc. announced May 27 positive top-line tissue biopsy results of zabopegdutide (DD-01) from a 48-week phase II study of metabolic dysfunction-associated steatohepatitis (MASH), pushing company shares up 30% on the day. http://www.bioworld.com/articles/731650 Tue, 02 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731650-d-and-ds-zabopegdutide-shows-more-upbeat-top-line-phase-ii-mash-data Art concept for liver damage, such as fatty liver, fibrosis or cirrhosis Protuoso Biosciences has announced the close of an oversubscribed $9.5 million seed financing round, the proceeds of which will be used to advance its multifunctional protein engineering platform and broad pipeline across cardiometabolic, oncology and autoimmune diseases. http://www.bioworld.com/articles/731477 Thu, 28 May 2026 09:00:00 -0400 https://www.bioworld.com/articles/731477-protuoso-biosciences-building-multifunctional-protein-engineering-platform Drug R&D concept image. D&D Pharmatech Inc. announced May 27 positive top-line tissue biopsy results of zabopegdutide (DD-01) from a 48-week phase II study of metabolic dysfunction-associated steatohepatitis (MASH), pushing company shares up 30% on the day. http://www.bioworld.com/articles/731423 Wed, 27 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731423-d-and-ds-zabopegdutide-shows-more-upbeat-top-line-phase-ii-mash-data Art concept for liver damage, such as fatty liver, fibrosis or cirrhosis Circio Holding ASA and Aavigen GmbH have entered a research collaboration focused on developing circVec-enhanced AAV vectors engineered for targeted, low-dose gene therapies for heart diseases. http://www.bioworld.com/articles/731292 Wed, 27 May 2026 09:00:00 -0400 https://www.bioworld.com/articles/731292-circio-and-aavigen-to-collaborate-on-targeted-cardiac-aavs Heart and DNA As the most active biopharma acquirer of 2026, Eli Lilly and Co. offered to buy three vaccine companies for up to $3.8 billion combined, while it simultaneously released positive early clinical results of a gene editing medicine brought into the fold last year through its buyout of Verve Therapeutics Inc. http://www.bioworld.com/articles/731401 Tue, 26 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731401-lilly-buys-three-vaccine-makers-pcsk9-base-editor-shows-promise Syringes in virus cell; Lilly, Curevo, Limmatech, Vaccine Company logos Scribe Therapeutics Inc. has obtained clearance from Australia’s Therapeutic Goods Administration (TGA) to initiate a first-in-human study of STX-1150 for the treatment of hypercholesterolemia, a major driver of atherosclerotic cardiovascular disease (ASCVD). The phase I study will enroll adults with elevated LDL-C at increased cardiovascular risk at sites in Australia and New Zealand. http://www.bioworld.com/articles/731249 Fri, 22 May 2026 09:00:00 -0400 https://www.bioworld.com/articles/731249-scribes-stx-1150-for-hypercholesterolemia-cleared-for-clinic Nanjing Reju Therapeutics Inc. has reported new nicotinamide phosphoribosyltransferase (NAmPRTase; Nampt) activators potentially useful for the treatment of atherosclerosis, Duchenne muscular dystrophy, heart failure, multiple sclerosis, obesity, cardiomyopathy, Alzheimer’s and Parkinson’s disease, among others. http://www.bioworld.com/articles/731246 Thu, 21 May 2026 09:00:00 -0400 https://www.bioworld.com/articles/731246-nampt-activators-disclosed-in-nanjing-reju-therapeutics-patent As interests and competition in the intravascular lithotripsy (IVL) market heats up, Shockwave Medical Inc. said it believes that its latest coronary IVL catheter, the C2 Aero, and other projects in the pipeline, will help it to maintain its leadership in calcium modification. http://www.bioworld.com/articles/731372 Thu, 21 May 2026 08:00:00 -0400 https://www.bioworld.com/articles/731372-as-ivl-technologies-advance-shockwave-looks-to-defend-its-lead Shockwave Medical - C2 Aero coronary IVL C2 Aero coronary IVL catheter. Credit: Shockwave Medical Inc. A subgroup analysis of data from Boston Scientific Corp.’s Champion-AF trial, which looked at the outcomes for patients with atrial fibrillation treated with a left atrial appendage closure (LAAC) device compared to direct oral anticoagulants (DOACs), found that the efficacy and safety of LAAC compared to DOAC are not affected by age. The data were presented at the EuroPCR conference in Paris. http://www.bioworld.com/articles/731344 Wed, 20 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731344-subgroup-analysis-of-the-champion-af-trial-shows-age-not-a-factor Boston Scientific Watchman FLX Watchman FLX left atrial appendage closure device. Credit: Boston Scientific Corp. Data from the All Women clinical trial, which looked at the Allegra transcatheter aortic valve replacement (TAVR) system compared to balloon-expandable valves (BEV) in women with aortic stenosis, showed that Allegra delivered lower mean gradients and less prosthesis-patient mismatch than BEVs. The data presented at the EuroPCR conference in Paris was the first randomized head-to-head comparison of different TAVR platforms conducted exclusively in women. http://www.bioworld.com/articles/731340 Wed, 20 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731340-all-women-data-show-allegra-edge-in-female-tavr-patients Biosensors International Allegra transcatheter heart valve Allegra transcatheter heart valve. Credit: Biosensors International A new strategy aims to improve gene therapy for Pompe disease by optimizing both the genetic component that restores the function of a deficient lysosomal enzyme and the vector that delivers it to the target tissue while avoiding the liver. The findings suggest that combining an optimized transgene with a targeted capsid could significantly enhance the effectiveness of gene therapy for Pompe disease. http://www.bioworld.com/articles/731174 Wed, 20 May 2026 09:00:00 -0400 https://www.bioworld.com/articles/731174-detargeted-targeted-gene-therapy-improves-activity-in-pompe Acid alpha-glucosidase molecular structure isolated on black The convergence of robotics, sensors and AI is reshaping how medical devices interact with patients, clinicians and healthcare systems. Across the field, from oncology to cardiology and women’s health, companies are integrating software, connectivity, data analytics and biological information into their products. And although traditional devices, such as screws for orthopedics or valves for cardiology, remain essential, the shift underway is leading to much more personalized medicine, which is more effective and safer, Eran Lerer, managing partner, at Shoni Health Ventures, told BioWorld. BioWorld.]]> http://www.bioworld.com/articles/731366 Tue, 19 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731366-medical-devices-evolving-into-intelligent-adaptive-systems Feminai patch and app Feminai Ltd. combines a disposable wearable patch with an app to help women screen for breast cancer at home. Credit: Feminai Ltd.