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BioWorld - Tuesday, December 9, 2025
Home » Topics » Clinical

Clinical
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Illustration of antibodies flying around a kidney

Takeda’s mezagitamab shows lasting kidney function in IgA nephropathy

Nov. 11, 2025
By Tamra Sami
No Comments
Takeda Pharmaceutical Co. Ltd.’s anti-CD38 antibody, mezagitamab (TAK-079), sustained kidney function up to 18 months after treatment ended in patients with primary immunoglobulin A (IgA) nephropathy, showing early signs of disease modification in a phase Ib study presented at the American Society of Nephrology’s Kidney Week 2025 in Houston.
Read More
3D illustration showing presence of tumor inside prostate gland

Advancell sets new radiopharma standard in prostate cancer

Nov. 11, 2025
By Tamra Sami
No Comments
Aussie radiopharma company Advancell Co. Ltd. unveiled promising early clinical data that could redefine how advanced prostate cancer is treated by targeted alpha therapies in the radiopharmaceutical space.
Read More
Celltrion building and skyline

Celltrion signs $744M deal with Kaigene, $500M with Mustbio

Nov. 11, 2025
By Marian (YoonJee) Chu
No Comments
Celltrion Inc. scored a hat-trick of deals to license new antibody candidates, including a $744 million deal with Kaigene Inc. Nov. 3, and a near $500 million deal with Mustbio Co. Ltd. Oct. 31.
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Stomach cross-section on scientific background

A second win for Cogent pushes the company toward two NDAs

Nov. 10, 2025
By Lee Landenberger
No Comments
Cogent Biosciences Inc. is now lining up two NDA submissions for its tyrosine kinase inhibitor bezuclastinib in treating two forms of cancer. Cogent intends to submit an NDA for bezuclastinib, a tyrosine kinase inhibitor that targets and inhibits mutated KIT proteins, specifically KIT D816V, in the first half of 2026 to treat gastrointestinal stromal tumors. That will follow the company’s plans for an NDA submission for bezuclastinib in treating non-advanced systemic mastocytosis before the end of 2025.
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Heartflow FFRCT analysis Credit: Heartflow Inc.
AHA Scientific Sessions

FISH&CHIPS serves up appetizing news for Heartflow

Nov. 10, 2025
By Mark McCarty
Shares of Mountain View, Calif.-based Heartflow Inc. have oscillated significantly over the past three months, but the results of a study of the company’s plaque staging system have breathed new life into the company’s shares, boosting them by 7% in Nov. 10 trading.
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Symani system

MMI gets IDE for robotic microsurgical study in Alzheimer’s

Nov. 10, 2025
By Holland Johnson
Medical Microinstruments Inc., reported the U.S. FDA approval of an investigational device exemption for a study using its Symani surgical system for treating Alzheimer’s disease, one of its earliest forays into the brain.
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Liver over digital lens background

MASH prospects from Rivus, Metavia show promise in phase II

Nov. 7, 2025
By Karen Carey
No Comments
Phase II data being presented at the American Association for the Study of Liver Diseases annual meeting indicate drug development in the field of metabolic dysfunction-associated steatohepatitis (MASH) is making steady progress.
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Kidneys, pills and chart line

Eledon tego for phase III in transplant despite midstage miss

Nov. 7, 2025
By Randy Osborne
No Comments
A primary endpoint failure but with outstanding estimated glomerular filtration rates and impressive safety data in the phase II trial called Bestow are adding up to plans for later-stage work with Eledon Pharmaceuticals Inc.’s tegoprubart (tego) for preventing rejection in de novo kidney transplant.
Read More
3D illustration showing presence of tumor inside prostate gland

Advancell sets new radiopharma standard in prostate cancer

Nov. 7, 2025
By Tamra Sami
No Comments
Aussie radiopharma company Advancell Co. Ltd. unveiled promising early clinical data that could redefine how advanced prostate cancer is treated by targeted alpha therapies in the radiopharmaceutical space.
Read More
Illustration of antibodies flying around a kidney

Takeda’s mezagitamab shows lasting kidney function in IgA nephropathy

Nov. 7, 2025
By Tamra Sami
No Comments
Takeda Pharmaceutical Co. Ltd.’s anti-CD38 antibody, mezagitamab (TAK-079), sustained kidney function up to 18 months after treatment ended in patients with primary immunoglobulin A (IgA) nephropathy, showing early signs of disease modification in a phase Ib study presented at the American Society of Nephrology’s Kidney Week 2025 in Houston.
Read More
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