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BioWorld - Friday, January 16, 2026
Home » Topics » Clinical

Clinical
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Chris Lai, cofounder and CEO, Metis at Nanoforge launch

Metis plans China NDA submission for orally dissolving PBA drug

Oct. 28, 2025
By Marian (YoonJee) Chu
No Comments
Based on positive phase III study results, Metis Techbio is planning to file an NDA for its AI-derived orally disintegrating tablet drug candidate for pseudobulbar affect, MTS-004, in China next year.
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Man measuring waist

Hanmi’s efpeglenatide hits phase III endpoints in obesity

Oct. 28, 2025
By Marian (YoonJee) Chu
No Comments

Hanmi Pharmaceutical Co. Ltd. announced Oct. 27 that its glucagon-like peptide-1 receptor agonist, efpeglenatide (HM-11260C), met the co-primary endpoints in a phase III study of obese adults without diabetes.


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Illustration of leg anatomy with target around knee

Levicept data show neurotrophin inhibitor may be disease modifying in osteoarthritis

Oct. 28, 2025
By Nuala Moran
No Comments
An examination of X-ray and MRI scans of 518 patients before and after treatment with Levicept Ltd.’s Levi-04 has shown that, in addition to providing significant analgesia, the selective neurotrophin-3 inhibitor may have a disease-modifying effect in osteoarthritis of the knee.
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Penumbra STORM PE
TCT 2025

Penumbra takes TCT by STORM

Oct. 27, 2025
By Annette Boyle
Penumbra Inc.’s 'resoundingly positive' results from its STORM-PE trial could see current guidelines for anticoagulant use in pulmonary embolism swept away in favor of mechanical thrombectomy. A deluge of favorable comments by experts and analysts followed the presentation during a late-breaking session at Transcatheter Cardiovascular Therapeutics, the annual scientific symposium of the Cardiovascular Research Foundation, which showed more than 50% improvement in treatment effect from Penumbra’s computer-assisted vacuum thrombectomy system plus anticoagulation compared to anticoagulation alone within two days with no increase in major adverse events.
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Golden Gate Bridge, San Francisco, Calif.
TCT 2025

Reimbursement seen as a block on device-drug-AI convergence

Oct. 27, 2025
By Mark McCarty
In San Francisco, the first day of Transcatheter Cardiovascular Therapeutics 2025 annual meeting offered presentations on the future of the convergence of devices, drugs and AI. The takeaway from the session seems to be that while the future is bright, it will become the present only when payers can find an economic argument to pay for the advances formed by this convergence.
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Memed - Key - Cartridge

NHS trials Memed’s 15-minute blood test in children

Oct. 27, 2025
By Shani Alexander
Trials are being conducted at three pediatric emergency departments in England of the Memed BV rapid blood test, designed to help health care providers distinguish between bacterial and viral infections. The test developed by Memed Diagnostics Ltd. can deliver results in as little as 15 minutes, speeding up the diagnosis of serious conditions such as sepsis or meningitis in children.
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Chris Lai, cofounder and CEO, Metis at Nanoforge launch

Metis plans China NDA submission for orally dissolving PBA drug

Oct. 27, 2025
By Marian (YoonJee) Chu
No Comments
Based on positive phase III study results, Metis Techbio is planning to file an NDA for its AI-derived orally disintegrating tablet drug candidate for pseudobulbar affect, MTS-004, in China next year.
Read More
Ischemic stroke

Argenica’s stroke drug shows positive trends in functional outcomes

Oct. 27, 2025
By Tamra Sami
No Comments
Although Argenica Therapeutics Ltd.’s stroke drug, ARG-007, saw mixed results in top-line phase II data, new data in functional outcomes studies showed signs the drug helped patients think more clearly, regain independence, and enjoy a better quality of life after stroke.
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Nex-z less sexy with second liver case; Intellia phase III paused

Oct. 27, 2025
By Randy Osborne
No Comments
Intellia Therapeutics Inc. followed up troubling news in May with a similar, and worse, update regarding the Magnitude and Magnitude-2 phase III trials with nexiguran ziclumeran, also known as nex-z, for patients with transthyretin amyloidosis with cardiomyopathy and polyneuropathy, respectively.
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‘Home run scenario’ for Bridgebio’s BBP-418 in limb-girdle phase III

Oct. 27, 2025
By Jennifer Boggs
No Comments
Impressive data from an interim readout of Bridgebio Pharma Inc.’s BBP-418 in limb-girdle muscular dystrophy type 2I/R9 has the company prepping to meet with the U.S. FDA to discuss plans for the upcoming NDA filing, including the possibility for seeking full approval for what could be the first therapy for the rare muscular disease.
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