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BioWorld - Wednesday, December 24, 2025
Home » Topics » Clinical

Clinical
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Illustration of nerve cells

Amen at AANEM: Kyverna makes good on MG phase II promise

Oct. 29, 2025
By Randy Osborne
No Comments
Shooting for further proof of durable, drug-free, disease-free remission with a single dose of KYV-101 in generalized myasthenia gravis, Kyverna Therapeutics Inc. plans to start phase III work by the end of this year. The Emeryville, Calif.-based firm rolled out positive interim results from the phase II portion of the registrational Kysa-6 clinical trial testing the drug, a fully human, autologous, CD19 CAR T-cell therapy with CD28 costimulation.
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3D illustration of thyroid in human body with parathyroid glands highlighted

Bridgebio wows again, this time in genetic hypoparathyroidism

Oct. 29, 2025
By Jennifer Boggs
No Comments
Only two days after Bridgebio Pharma Inc. impressed investors with data from BBP-418 in limb-girdle muscular dystrophy type 2I/R9, the company was back at it again, this time reporting positive top-line results from its global phase III study of encaleret in autosomal dominant hypocalcemia type 1, a genetic form of hypoparathyroidism.
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Edwards Lifesciences Sapien M3

Data from Partner 3 low-risk affirms TAVR even with SAVR

Oct. 28, 2025
By Mark McCarty
Stakeholders of all stripes have wondered whether transcatheter aortic valve replacement devices could match their surgically implanted cousins for device durability, but seven-year data from the Partner 3 trial seems to suggest that patients, physicians, payers and regulators need not fret as the topline numbers showed no statistically significant difference for outcomes such as mortality and morbidity.
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Medtronic - Symplicty Spyral HTN
TCT 2025

Will Medtronic’s RDN study drive Spyral-ing growth?

Oct. 28, 2025
By Annette Boyle
Medtronic plc’s SPYRAL HTN-ON MED trial demonstrated significantly greater reduction in blood pressure with the Symplicity Spyral renal denervation procedure at three years than a sham procedure in a study presented as featured clinical research at the 2025 Transcatheter Cardiovascular Therapeutics conference in San Francisco.
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Selution SLR
TCT 2025

Cordis rings up twin wins for Selution SLR at TCT

Oct. 28, 2025
By Mark McCarty
Cordis Corp. has quite a bit to crow about in this latter part of October 2025 with the unveiling of results of two studies that back the Miami Lakes, Fla.-based company’s Selution SLR drug-eluting balloon (DEB) for both de novo coronary artery stenosis and in-stent restenosis.
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Health professional holding stethoscope with health icons
Biopharma clinical updates September 2025

Clinical trial activity jumps as BioWorld tracks 230 updates in September

Oct. 28, 2025
By Amanda Lanier
No Comments
In September 2025, BioWorld recorded 230 clinical trial updates spanning phases I through III, up sharply from 95 in August, 140 in July and just below 254 in June. Among these, 22 phase III trials reported positive outcomes, while four ended in failure and another three produced mixed results.
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Ischemic stroke

Argenica’s stroke drug shows positive trends in functional outcomes

Oct. 28, 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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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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