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BioWorld - Monday, April 6, 2026
Home » Topics » Clinical

Clinical
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Phase HPV urine test

Phase launches largest urine-based HPV screening study

Sep. 26, 2025
By Tamra Sami
Phase Scientific International Ltd. launched China’s largest clinical study for urine-based cervical cancer screening. If successful, the blood-based test could be the first non-invasive test for HPV.
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Head and neck anatomy

Real-world data illuminates Rakuten's Alluminox solid tumor platform

Sep. 26, 2025
By Marian (YoonJee) Chu
No Comments
Rakuten Medical Inc. is advancing a pipeline of solid tumor therapeutics built on its Alluminox platform worldwide, having gained conditional early approval of ASP-1929, an Alluminox-derived photoimmunotherapy, in Japan in 2020.
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3D illustration of pancreatic cancer

To vanquish pancreatic at last? Immuneering scores in phase II

Sep. 25, 2025
By Randy Osborne
No Comments
Nailing down what Oppenheimer analyst Jay Olson characterized as “a trifecta,” Immuneering Corp. unveiled positive updated survival and safety data from the ongoing phase IIa trial testing oral, once-daily MEK inhibitor atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxe in first-line pancreatic cancer patients.
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Kidneys

Hansa’s imlifidase enables transplants for advanced kidney disease

Sep. 25, 2025
By Nuala Moran
No Comments
Hansa Biopharma A/S has turned in positive data from a pivotal U.S. phase III trial of imlifidase, an enzyme that speedily removes antibodies from the bloodstream, enabling highly sensitized kidney patients to have transplants.
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Vibrant DNA double helix

Billiontoone’s Unity screen IDs cystic fibrosis, enables in utero treatment

Sep. 24, 2025
By Annette Boyle
Billiontoone Inc.’s Unity Fetal Risk screen identifies fetuses at high risk for cystic fibrosis (CF), a study published in Journal of Cystic Fibrosis found.
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Child feet

Acadia, with a failed phase III, drops Prader-Willi candidate

Sep. 24, 2025
By Lee Landenberger
No Comments
After a phase III stumble, Acadia Pharmaceuticals Inc. will drop development of ACP-101, intranasal carbetocin, to treat hyperphagia in patients with the rare genetic disorder Prader-Willi syndrome. Top-line data from the 12-week, double-blind, randomized phase III study missed its primary endpoint by not producing a statistically significant improvement over placebo.
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AI-generated art of brain connections

Hunting down Huntington’s: Uniqure’s pivotal win

Sep. 24, 2025
By Randy Osborne
No Comments
Uniqure NV rang the bell with a best-case scenario in the pivotal phase I/II study with AMT-130 for the treatment of Huntington’s disease, and shares of the Amsterdam-based firm (NASDAQ:QURE) closed Sept. 24 at $47.50, up $33.84, or 248%. The study met its prespecified primary endpoint, with high-dose AMT-130 turning up a statistically significant slowing of disease progression as measured by the composite Unified Huntington’s Disease Rating Scale at 36 months compared to a propensity score-matched external control.
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Brain-DNA illustration
Rare Genetic Disease Symposium

More stem cell, gene therapies progressing in clinic for ALS

Sep. 23, 2025
By Marian (YoonJee) Chu
No Comments
Amyotrophic lateral sclerosis (ALS), formerly known as Lou Gehrig’s disease, is a progressive and fatal neurodegenerative disorder with no known cure. While three therapies have gained U.S. FDA approvals to date, including Rilutek (riluzole), Radicava/Radicava ORS (edaravone) and tofersen (BIIB-067, the lack of a disease-modifying drug has spurred the continual search for novel therapies.
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Multiple myeloma illustration

Carsgen’s zevor-cel CAR T shows long-term survival in MM

Sep. 23, 2025
By Tamra Sami
No Comments
Patients with relapsed/refractory multiple myeloma (r/r MM) treated with Carsgen Therapeutics Holdings Ltd.’s CAR T therapy, zevorcabtagene autoleucel (zevor-cel, CT-053), have shown durable responses lasting nearly five years.
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Person injecting medicine into abdomen

QL Biopharm’s monthly GLP-1 meets phase II endpoints

Sep. 23, 2025
By Tamra Sami
No Comments
Beijing QL Biopharmaceutical Co. Ltd.’s once-monthly GLP-1 receptor agonist, zovaglutide (ZT-002), met its primary and secondary endpoints in a phase II obesity trial, and QL Biopharm will now advance the GLP-1 to a pivotal phase III study.
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