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BioWorld - Thursday, May 28, 2026
Home » Topics » Clinical

Clinical
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More Chinese ADCs enter the clinic as biotech race heats up

July 9, 2025
By Tamra Sami
No Comments
China has proved to be a fertile ground for innovation as evidenced by some big deals in the antibody-drug conjugate (ADC) space, and the number of candidates entering clinical trials in China or being advanced in the U.S. by Chinese companies.
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Up-tempo phase II Rhythm data in obesity sweeten bivamelagon

July 9, 2025
By Randy Osborne
No Comments
Rhythm Pharmaceuticals Inc. will be sitting down with regulators in the U.S. and Europe to discuss phase III plans in the wake of positive phase II data from the study testing bivamelagon (formerly LB5-4640), an oral melanocortin-4 receptor agonist, in patients with acquired hypothalamic obesity.
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Glucomodicum-CGM-8july25.jpg

Glucomodicum reports positive data from its needle-free CGM

July 8, 2025
By Shani Alexander
Glucomodicum Oy reported positive results from a clinical study in which its needle-free continuous glucose monitor, Talisman, was tested in participants across both standard multi-hour glucose tolerance and ambulatory conditions involving exercise and meals.
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Digital lungs illustration

Bioversys, Shionogi in CHF529M lung infection collaboration

July 8, 2025
By Nuala Moran
No Comments
Antibiotics specialist Bioversys AG has sealed a potential CHF529 million (US$667.5 million) deal with Shionogi Co. Ltd., in which they will work together on novel ansamycins for treating multidrug-resistant lung infections caused by non-tuberculous mycobacteria.
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Rare disease illustration

UK industry encourages renewal of rare disease framework

July 8, 2025
By Nuala Moran
No Comments
Representatives of patients’ groups, industry bodies and venture philanthropy funders are calling for a renewal of the U.K. Rare Diseases Framework, to put fresh momentum behind translational research and clinical trials, streamline regulatory oversight and improve access to therapies.
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Man using walker with assistance

Taiho’s pizuglanstat fails in phase III DMD trial

July 8, 2025
By Tamra Sami
No Comments
In yet another fail for the Duchenne muscular dystrophy (DMD) field, Taiho Pharmaceutical Co. Ltd.’s pizuglanstat (TAS-205) did not meet the primary endpoint in a phase III trial. The phase III Reach-DMD trial, a randomized, placebo-controlled, double-blind and open-label, extension study of pizuglanstat in patients with DMD showed no significant difference in the mean change from baseline to 52 weeks in the primary endpoint of time to rise from the floor in the ambulatory cohort of the study.
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B cell-activating factor (BAFF)

Wheat from chaff in BAFF: APRIL’s advent for Aurinia?

July 8, 2025
By Randy Osborne
No Comments
Tickling Wall Street’s already strong interest in the mechanism of action was Aurinia Pharmaceuticals Inc., which June 30 made public positive results from the phase I single ascending-dose study with aritinercept (AUR-200), the company’s dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL).
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Kidney disease illustration

Prokidney produces positive phase II CKD data, thunderous stock surge

July 8, 2025
By Lee Landenberger
No Comments
A mixed bag of top-line phase II data prompted stellar stock results for Prokidney Corp. and its chronic kidney disease (CKD) and diabetes therapy, rilparencel. The results came from two arms of the study, each with its own treatment regime. The market heartily took to the results as the company’s stock (NASDAQ:PROK) closed 515% upward at $3.73 per share after starting the day under $1 each.
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Accunea monitoring device

Accunea’s Renosure device can save kidneys from being discarded

July 7, 2025
By Shani Alexander
Accunea Ltd.’s bioanalysis technology, Renosure, can measure creatinine clearance in machine perfused kidneys, according to data presented at the recent European Society of Organ Transplantation 2025.
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Apogee’s Apex phase II reads out for APG-777 in atopic dermatitis

July 7, 2025
By Brian Orelli
No Comments
Apogee Therapeutics Inc. plans to enter a crowded atopic dermatitis market with established drugs, such as Dupixent (dupilumab, Regeneron Pharmaceuticals Inc. and Sanofi SA) and Ebglyss (lebrikizumab-lbkz, Eli Lilly and Co.), which are sold by much larger competitors. But the company thinks it can compete with its anti-IL-13 antibody, APG-777, thanks to the drug’s 77 day half-life that may allow it to be dosed only two to four times a year in the maintenance phase, compared to 13 to 26 injections per year for the established competitors.
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