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BioWorld - Thursday, June 19, 2025
Home » Topics » Clinical

Clinical
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Ascletis’ denifanstat meets phase III endpoints in acne

June 5, 2025
By Tamra Sami
No Comments
Ascletis Pharma Inc.’s once-daily oral fatty acid synthase inhibitor, denifanstat, demonstrated statistically significant and clinically meaningful improvements compared to placebo, meeting all primary and secondary endpoints in a phase III trial for moderate to severe acne vulgaris.
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DNA mutations or genetic disorder concept art

Regenxbio’s Duchenne gene therapy data positive as shares falter

June 5, 2025
By Lee Landenberger
No Comments
Regenxbio Inc.’s gene therapy in treating Duchenne muscular dystrophy (DMD) produced positive initial phase I/II results from its first five patients. However, the company’s stock (NASDAQ:RGNX) shuddered on June 5 as shares closed at $8.36 each, a drop of 17% on the day.
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Illustration of head with circuit board brain

Paradromics joins BCI in-human race

June 4, 2025
By Shani Alexander
Paradromics Inc. became the latest company developing a brain-computer interface (BCI) system to implant its technology, Connexus, into a human. The device was safely implanted, it recorded electrical brain signals and was removed intact in less than 20 minutes. Paradromics hopes to begin clinical trials later this year.
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Xiaolin Zhang, CEO, Dizal

ASCO 2025: Dizal's new chemical entities for lung, blood cancers

June 4, 2025
By Tamra Sami
No Comments
Dizal (Jiangsu) Pharmaceutical Co. Ltd.’s LYN/BTK dual inhibitor, DZD-8586, saw tumor shrinkage in 94.1% of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma following Bruton's tyrosine kinase inhibitors, the company reported during an oral presentation at the American Society of Clinical Oncology (ASCO) 2025 conference.
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Kymera’s phase I data lead big week for STAT6 space

June 4, 2025
By Jennifer Boggs
No Comments
It’s a good week to be working on drugs targeting STAT6. Kymera Therapeutics Inc.’s, KT-621, the first oral STAT6 degrader candidate to enter the clinic, surpassed expectations with impressive safety, pharmacokinetic and biomarker data from a phase I trial, while potential fast-followers from Nurix Therapeutics Inc. and Recludix Pharma Inc. advanced via respective partnerships with Sanofi SA.
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Amber Implants VCFix Spinal System

Amber Vcfix spinal system shows promising data

June 3, 2025
By Shani Alexander
Amber Implants BV reported no device-related adverse events were seen in any of the patients fitted with its Vcfix spinal system, which treats vertebral compression fractures, at one-year. Data from the first-in-human trial of the device also showed patients experienced a significant reduction in their pain levels.
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Daiichi and Merck pull accelerated approval BLA for ADC

June 3, 2025
By Lee Landenberger
No Comments
Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. have voluntarily pulled the BLA for accelerated approval tied to their HER3-directed antibody-drug conjugate (ADC) in treating EGFR-mutated non-small-cell lung cancer. The partnership in the expanding ADC space began nearly two years ago in a $22 billion deal.
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Anatara takes a second look at Garp after phase II IBS miss

June 3, 2025
By Tamra Sami
No Comments
After reporting in April that its gastrointestinal reprogramming product (Garp) failed to meet the primary efficacy endpoint in a phase II trial in irritable bowel syndrome (IBS), Anatara Lifesciences Ltd. conducted a further analysis that shows a positive trend toward efficacy.
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Handshake with DNA, molecules

Regeneron boosts obesity pipeline with Hansoh’s GLP-1/GIP for $2B

June 3, 2025
By Tamra Sami
No Comments
Regeneron Pharmaceuticals Inc. is adding to its obesity pipeline by in-licensing Hansoh Biomedical Co. Ltd.’s phase III dual glucagon-like peptide 1 (GLP-1)/gastric inhibitory polypeptide (GIP) receptor agonist, HS-20094, for up to $2 billion.
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Next IgAN contenders line up; Vera preps a BLA for atacicept

June 3, 2025
By Karen Carey
No Comments
With a 42% placebo-adjusted reduction in proteinuria at week 36, Vera Therapeutics Inc. met its primary endpoint in the Origin phase III trial with BAFF and APRIL dual inhibitor atacicept in treating immunoglobulin A nephropathy (IgAN) in adults.
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