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BioWorld - Wednesday, February 18, 2026
Home » Topics » Clinical

Clinical
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Person testing glucose level

Biomea’s ‘durable’ menin inhibitor advancing in hard-to-treat diabetes

Oct. 7, 2025
By Karen Carey
No Comments
Among severe insulin-deficient diabetes patients, 12 weeks of 100-mg, once-daily dosing of Biomea Fusion Inc.’s icovamenib lowered hemoglobin A1c by 1.8% from placebo at the 52-week timepoint, an increased benefit over and above what was seen at 26 weeks.
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Layer 7 Cortical Interface

Precision Neuro’s minimally invasive BCI effective in early studies

Oct. 6, 2025
By Shani Alexander
The brain-computer interface (BCI) system being developed by Precision Neuroscience Corp. is capable of capturing high-resolution brain signals and stimulating areas without damaging the cortical surface, according to a study published in Nature Biomedical Engineering.
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Pills, bottle, scale and-measuring tape

Skye hopeful on next steps for obesity drug despite phase II miss

Oct. 6, 2025
By Jennifer Boggs
No Comments
A top-line readout of the 26-week phase IIa Cbeyond trial showed nimacimab, Skye Bioscience Inc.’s peripherally restricted CB1 inhibitor antibody for weight loss, fell short of statistical significance as a monotherapy vs. placebo on the primary endpoint of weight loss, sending the company’s shares down 60%. Skye executives, however, offered a more optimistic outlook for the findings, which they said provide clear direction for moving forward.
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Medtronic Brainsense adaptive DBS

Medtronic’s adaptive DBS safe, effective in people with Parkinson’s

Oct. 2, 2025
By Shani Alexander
Medtronic plc’s Brainsense adaptive deep brain stimulation system has been shown to be tolerable, effective and safe for long-term use at home in people with Parkinson’s disease. A study published in the Journal of the American Medical Association (JAMA) Neurology found that the majority of participants who received aDBS with the Percept neurostimulator achieved good ‘on-time’ without troublesome dyskinesia compared to standard continuous DBS therapy.
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Natural killer cell attacking cancer cell

Takeda ditches cell therapy business

Oct. 2, 2025
By Tamra Sami
No Comments
Takeda Pharmaceutical Co. Ltd. is exiting all work in cell therapies and will seek an external partner to advance the company’s research and clinic-ready cell therapy programs, the company said, noting that it is not currently running any clinical trials using cell therapy technology.
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Brain illustration

Synendos poised for phase II trial of endocannabinoid modulator

Oct. 2, 2025
By Nuala Moran
No Comments
Synendos Therapeutics AG has delivered initial clinical data demonstrating the potential of its lead compound to selectively modulate the endocannabinoid system in the brain and to relieve anxiety symptoms without triggering a psychoactive response.
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Feet and scale

Pfizer M&A prospect Metsera heads to phase III with lead GLP-1

Sep. 30, 2025
By Karen Carey
No Comments
Phase IIb data of Metsera Inc.’s lead GLP-1 receptor agonist, MET-097i, showed significant weight loss and good tolerability, supporting a phase III start later this year, and validating Pfizer Inc.’s decision a week ago to buy the obesity-focused company for $7.3 billion.
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Eye chart and teen with laser over eye

Magnum Opus: Street drinks in LCA5 gene therapy phase I/II data

Sep. 30, 2025
By Randy Osborne
No Comments
Opus Genetics Inc. will be sitting down with the U.S. FDA to talk about positive three-month data from the pediatric cohort of its ongoing phase I/II trial called OPGx-LCA5-1001 – partially funded by the agency – evaluating OPGx-LCA5, a gene augmentation therapy for ultra-rare Leber congenital amaurosis type 5 (LCA5). The affliction is a severe form of retinal dystrophy that renders babies blind in the first year of life.
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Pacbio Revio sequencing plate

Pacbio’s Puretarget simplifies carrier screening

Sep. 29, 2025
By Annette Boyle
Up to 71% of people carry at least one pathogenic variant that could contribute to development of a heritable disorder in offspring, but until now, prospective parents often had to undergo multiple tests to understand their risks. Pacific Biosciences of California Inc. (Pacbio)’s expanded Puretarget portfolio provides a quicker and more streamlined solution as it covers all challenging tier 3 genes identified in the American College of Medical Genetics technical standard.
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Generic injection pens

Larimar above par in FA despite anaphylaxis penalty

Sep. 29, 2025
By Randy Osborne
No Comments
Anaphylaxis rates caused Larimar Therapeutics Inc.’s stock (NASDAQ:LRMR) to take a hit on the latest data from an open-label study with nomlabofusp in the neuromuscular disease Friedreich’s ataxia (FA), but the company is targeting a BLA submission to seek accelerated approval in the second quarter of next year.
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