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BioWorld - Monday, July 6, 2026
Breaking News: Science fiction realized: BCI tech is hereBreaking News: Science fiction realized: BCI tech is here
Home » Topics » BioWorld, Clinical

BioWorld, Clinical
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Kidneys

Dimerix raises AU$20M on positive phase III kidney disease data

March 12, 2024
By Tamra Sami
Dimerix Ltd. announced a AU$20 million ($US13.22 million) capital raise following the news that its lead candidate, DMX-200, was successful in a prespecified interim analysis of the efficacy endpoint in its pivotal phase III trial in focal segmental glomerulosclerosis, a rare kidney disease.
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Ear illustration

Sound approach? Sensorion phase IIa wins in hearing loss

March 11, 2024
By Randy Osborne
After a disappointment with the same product in another indication about two years ago, Sensorion SA met the primary endpoint in its proof-of-concept phase IIa trial with SENS-401 for residual hearing preservation after cochlear implant.
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Arrow missing target

Centaur doesn’t hold as Amylyx’s Relyvrio phase III fails in ALS

March 8, 2024
By Randy Osborne
Tweaks made to the design of the phase III trial called Phoenix (vs. the narrowly positive phase II Centaur study) with Amylyx Pharmaceuticals Inc.’s amyotrophic lateral sclerosis (ALS) drug Relyvrio (sodium phenylbutyrate plus taurursodiol) didn’t work. Now, the Cambridge, Mass.-based firm is facing possible withdrawal of the treatment from the U.S. and Canada, where it’s known as Albrioza. Shares of Amylyx (NASDAQ: AMLX) closed March 8 at $3.36, down $15.61, or 82.3%, after the firm disclosed top-line results from Phoenix, a global, 48-week, randomized, placebo-controlled phase III effort with Relyvrio, also known as AMX-0035.
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3D pancreas illustration

Radiopharm explores αvβ6 integrin target for pancreatic cancer

March 8, 2024
By Tamra Sami
After spending 20 years at Novartis, Radiopharm Theranostics Ltd. CEO Riccardo Canevari told BioWorld that when he joined Radiopharm he wanted to focus on something different within radiopharmaceuticals where no one was playing. “I believe these new modalities are at the beginning of their potential, much like in the immuno-oncology space years ago. That’s a nice place to be,” he said, but it’s not only about competition, it’s also about understanding what other companies are doing and if there is a disease area or a mechanism of action that is not being explored, he said.
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Ultimovacs UV-1 cancer vaccine fails a phase II

March 7, 2024
By Lee Landenberger
The phase II Initium study of Ultimovacs ASA’s therapeutic cancer vaccine in treating unresectable or metastatic malignant melanoma did not meet the primary endpoint. The company framed the loss by saying the UV-1 vaccine still has other indications where it could succeed.
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Man measuring waist

Obesity data stir excitement for Novo Nordisk’s oral amycretin

March 7, 2024
By Karen Carey
Phase I data of oral amycretin, a co-agonist of GLP-1 and amylin receptors from Novo Nordisk A/S, showed a 13.1% reduction in body weight at 12 weeks vs. 1.1% for placebo, pushing shares of the Bagsvaerd, Denmark-based company to their highest levels to date.
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Face with digital focus on eye

Exonate’s topical retinal disease drug to advance on early data

March 5, 2024
By Caroline Richards
Exonate Ltd. is preparing to advance its eye drop candidate to treat retinal vascular diseases, EXN-407, into a phase IIb study following promising tolerability and early signs of efficacy in a phase Ib/IIa study. A small-molecule SRPK1 inhibitor, EXN-407 is designed to be administered twice daily and works by selectively targeting specific (proangiogenic) isoforms of VEGF that lead to vascular retinal disease progression via aberrant growth of leaky blood vessels within the eye.
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Line graph arrow trending upward

Apogee peaks with phase I atopic dermatitis data

March 5, 2024
By Randy Osborne
Apogee Therapeutics Inc.’s phase I home run put IL-13-targeting antibody APG-777 on an accelerated development path in atopic dermatitis, and the company touted its similarity to further-along IL-13 competitor lebrikizumab, from Eli Lilly and Co., as a likely indicator of further success.
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Blood pressure cuff

Kardia-2 prods Alnylam’s zilebesiran forward, hypertension back

March 5, 2024
By Karen Carey
The RNAi therapeutic zilebesiran, which was the focus of a 2023 $2.8 billion deal between Alnylam Pharmaceuticals Inc. and Roche Holding AG, demonstrated significant systolic blood pressure reductions in patients with mild to moderate hypertension who were part of the Kardia-2 phase II study.
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Cross section illustration of Helix device in heart

Biocardia phase III bolsters cell therapy data in heart failure

March 4, 2024
By Lee Landenberger
While preparing a follow-on phase III study of its Cardiamp cell therapy, Biocardia Inc. has mined positive interim data at a mean 20-month follow-up of all patients in the original Cardiamp HF Trial.
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