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BioWorld - Tuesday, June 2, 2026
Home » Topics » Clinical

Clinical
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Elderly woman and jigsaw puzzle

Alzheon’s lead candidate misses a phase III in early Alzheimer’s

April 10, 2025
By Lee Landenberger
Alzheon Inc.’s oral treatment for people in the early stages of Alzheimer’s disease missed its phase III primary endpoint, adding yet another therapy to a long list by many developers that can’t beat dementia. The study also received grant money, which is in increasingly short supply.
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Neurosense phase II combo to hail new Paradigm in ALS?

April 9, 2025
By Randy Osborne
As developers continue to search for better amyotrophic lateral sclerosis (ALS) therapies, Neurosense Therapeutics Ltd. turned up some hopeful findings from its phase IIb Paradigm trial with PrimeC. The drug, a combination therapy (ciprofloxacin and celecoxib) designed to target multiple ALS pathways, is having salutary effects on microRNA modulation (miRNA), Neurosense said, with the study showing a “profound and consistent” downregulation of 161 mature miRNAs across all time points in the double-blind period of the experiment.
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Telitacicept packaging

Remegen’s lupus drug surfaces with phase III myasthenia gravis data

April 9, 2025
By Marian (YoonJee) Chu
Remegen Co. Ltd. emerged as a surprise challenger in the generalized myasthenia gravis space, unveiling positive phase III data of its China-approved lupus drug, telitacicept (RCT-18; Tai’ai), in the rare autoimmune neuromuscular disorder at the 2025 American Academy of Neurology conference.
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Radiopharma AMC

Radiopharmaceuticals stake more territory in breast cancer care

April 8, 2025
By Marian (YoonJee) Chu
Radiopharmaceuticals, including 16α-18F-fluoro-17β-estradiol (18F-FES) PET/CT, are emerging as powerful tools with new diagnostic and therapeutic potential in breast cancer diagnosis and treatment, Han Sang-won, professor from the department of nuclear medicine at Asan Medical Center, recently told BioWorld.
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More failures for TIGIT: Beigene shutters phase III lung cancer trial

April 8, 2025
By Tamra Sami
Beigene Ltd. said it is shutting down development of its anti-TIGIT antibody, ociperlimab (BGB-A1217), after the humanized IgG1-variant monoclonal antibody failed a phase III trial in lung cancer. The move is one of many in a string of anti-TIGIT immunotherapy failures.
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3D rendering of CAR T therapy in cell

Cartesian math works out nicely in phase IIb MG trial

April 8, 2025
By Randy Osborne
Cartesian Therapeutics Inc. followed up December’s phase IIb data with more good news regarding Descartes-08, offering 12-month efficacy and safety results that whetted Wall Street’s appetite for the phase III Aurora effort ahead. Milos Miljkovic, chief medical officer, told BioWorld that minimum symptom expression – among the areas where Descartes-08 shone, providing relief for “months and months after the last dose of treatment” – is especially important to patients.
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Boston Scientific Farapulse PFS system

PFA non-inferior, even superior, to cryoablation for paroxysmal AF

April 7, 2025
By Shani Alexander
Pulsed field ablation using Boston Scientific Corp.’s Farapulse system was non-inferior and even superior, slightly, to Medtronic plc’s Artic Front Advance cardiac cryoablation system in treating patients with paroxysmal atrial fibrillation.
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More Lexeo data in Friedreich ataxia sees stock slump

April 7, 2025
By Lee Landenberger
Lexeo Therapeutics Inc. produced more positive interim data from early stage studies of its gene therapy to treat Friedreich’s ataxia cardiomyopathy. The results have prompted the company to continue their ongoing dialogue with U.S. FDA regulators to finalize a registrational study protocol and launch that study by early 2026 with data the following year.
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Easier row to HO with Imcivree as Rhythm phase III grooves

April 7, 2025
By Randy Osborne
Rhythm Pharmaceuticals Inc.’s sales with Imcivree (setmelanotide) in weight management could exceed $1 billion by 2028 if hypothalamic obesity (HO) is added to the label of the drug, Oppenheimer analyst Leland Gershell said in a report. Boston-based Rhythm rolled out positive top-line data from the pivotal phase III study called Transcend with the melanocortin-4 receptor agonist in HO. The global trial met its primary endpoint with a statistically significant and highly clinically meaningful reduction in body mass index in adult and pediatric HO patients vs. placebo.
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Women's health

Women’s health needs a ‘GLP-1 moment’ to attract investors

April 7, 2025
By Nuala Moran
“Men in general have been playing golf for a longer time – in those old boy networks we still haven’t tapped into.” It may seem far-fetched, but that is put forward as a reason for underinvestment in women’s health companies. The argument goes that women heading women’s health startups find it hard to raise money because their networks are weaker, making it harder to tap into investment networks.
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