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Home » Topics » Clinical

Clinical
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Celldex’s urticaria candidate impresses in post-treatment findings

June 13, 2025
By Jennifer Boggs
No Comments
Celldex Inc.’s KIT inhibitor, barzolvolimab, which hit its phase II endpoints in late 2023, kicking off phase III development in chronic spontaneous urticaria, offered up some impressive long-term findings at the EAACI Congress 2025, including complete responses in patients for as long as seven months after the cessation of therapy, which analysts said could position the drug as a potentially best-in-class option.
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Fineheart Flowmaker

Fineheart pursues FIH study of Flowmaker fully implanted heart pump

June 11, 2025
By Shani Alexander
Fineheart SA will soon begin a first-in-human study of Flowmaker, its fully implantable left ventricular assist device, in France, after receiving authorization from the French National Agency for the Safety of Medicines and Health Products to initiate the trial.
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Red and blue bispecific antibodies

3Sbio revs on with phase II data in tight PD-1/VEGF bispecific race

June 11, 2025
By Marian (YoonJee) Chu
No Comments
3Sbio Inc. reported interim phase II study results of its PD-1/VEGF bispecific antibody, SSGJ-707 – a “fabulous” asset, according to Pfizer Inc. CEO Albert Bourla, that landed in Pfizer’s cancer arsenal via a potential $6 billion deal in May, of which $1.2 billion was paid up front.
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Neuronata-R

Corestemchemon preps US BLA filing for stem cell ALS therapy

June 10, 2025
By Marian (YoonJee) Chu
No Comments
Corestemchemon Inc. is planning to file a BLA for Neuronata-R (lenzumestrocel) by the end of 2025 to gain accelerated approval from the U.S. FDA, company officials confirmed to BioWorld during a June 2 interview. Neuronata-R is an autologous bone marrow-derived mesenchymal stem cell therapy that first gained approval in South Korea in 2014 to delay the progression of amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disorder also known as Lou Gehrig’s disease.
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Ascletis’ denifanstat meets phase III endpoints in acne

June 10, 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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Xiaolin Zhang, CEO, Dizal
ASCO 2025

Dizal's new chemical entities for lung, blood cancers

June 10, 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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Lung illustration

Phase II home run: Insmed’s TPIP hits hypertension endpoints

June 10, 2025
By Karen Carey
No Comments
Insmed Inc.’s chair and CEO, Will Lewis, called the phase IIb trial of TPIP in pulmonary arterial hypertension a “clear and unequivocal success,” with analysts and investors wholeheartedly agreeing, as the company’s shares surged 28.7% June 10.
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Smartphone on nightstand, woman sleeping in bed

Newel Health secures CE mark under MDR for BP app

June 9, 2025
By Shani Alexander
Newel Health srl received CE mark certification under the European Medical Device Regulation for Amicomed, its digital therapeutic solution for hypertension management. The app, which was cleared as a class IIa medical device, provides clinical insights and behavioral tools to help individuals manage their blood pressure.
Read More
Neuronata-R

Corestemchemon preps US BLA filing for stem cell ALS therapy

June 9, 2025
By Marian (YoonJee) Chu
No Comments
Corestemchemon Inc. is planning to file a BLA for Neuronata-R (lenzumestrocel) by the end of 2025 to gain accelerated approval from the U.S. FDA, company officials confirmed to BioWorld during a June 2 interview. Neuronata-R is an autologous bone marrow-derived mesenchymal stem cell therapy that first gained approval in South Korea in 2014 to delay the progression of amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disorder also known as Lou Gehrig’s disease.
Read More

Metsera’s long-acting amylin analogue delivers in phase I

June 9, 2025
By Jennifer Boggs
No Comments
One of the big questions going into the phase I readout for Metsera Inc.’s amylin analogue, MET-233i, was whether findings would support once-monthly dosing for the potential obesity candidate. They did. Results also indicated solid and dose-dependent weight loss activity, and Metsera was able to identify well-tolerated starting doses for subsequent studies, said Steve Marso, chief medical officer. “So we exceeded expectations on all three scientific objectives.”
Read More
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