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BioWorld - Wednesday, April 1, 2026
Home » Topics » Clinical

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Illustration of sickle-cell and normal red blood cells

Agios planning sNDA on mixed sickle cell data for mitapivat

Nov. 19, 2025
By Jennifer Boggs
No Comments
“Our goal is that by the end of this call, you’ll share our conviction in the totality of the data.” So said Agios Pharmaceuticals Inc. CEO Brian Goff as the company reported top-line data from its 52-week Rise Up trial testing mitapivat in sickle cell disease showing the oral pyruvate kinase activator hit statistical significance on one of two primary endpoints and two of three key secondary endpoints.
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Jingsong Wang, CEO, Harbour Biomed
Cancer

Harbour Biomed launches AI-based antibody development platform

Nov. 19, 2025
By Tamra Sami
No Comments
Harbour Biomed is stepping up its antibody discovery process by using AI to develop innovative therapeutics. “We have done great through the traditional way of generating leads and designing molecules, but there’s a major gap as some therapeutics cannot reach the desired location or common targets,” Harbour Biomed founder, chairman and CEO Jingsong Wang told BioWorld.
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Doctor-patient consultation

J&J pushes to elevate patient voices in Asia

Nov. 18, 2025
By Tamra Sami
No Comments
Up to 77% of patients with non-small-cell lung cancer in Asia-Pacific rely almost entirely on their physicians to decide their treatment, even though 69% of physicians say they encourage shared decision-making. That disconnect remains one of the region’s biggest obstacles to improving outcomes, Anthony Elgamal, vice president of Oncology Asia Pacific at Johnson & Johnson Innovative Medicine, told BioWorld.
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FDA Approved stamp

Henlius, Organon win US FDA approval of first Perjeta biosimilar

Nov. 18, 2025
By Marian (YoonJee) Chu
No Comments
Shanghai Henlius Biotech Inc. and Organon & Co. announced Nov. 17 that the U.S. FDA cleared Poherdy (pertuzumab-dpzb) as the first and only interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc./Roche Holding AG).
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Jingsong Wang, CEO, Harbour Biomed

Harbour Biomed launches AI-based antibody development platform

Nov. 18, 2025
By Tamra Sami
No Comments
Harbour Biomed is stepping up its antibody discovery process by using AI to develop innovative therapeutics. “We have done great through the traditional way of generating leads and designing molecules, but there’s a major gap as some therapeutics cannot reach the desired location or common targets,” Harbour Biomed founder, chairman and CEO Jingsong Wang told BioWorld.
Read More
3D illustration of human digestive system

Agomab heads for phase IIb on positive Crohn’s fibrosis data

Nov. 18, 2025
By Nuala Moran
No Comments
Growth factor specialist Agomab Therapeutics NV is now preparing to move into phase IIb development after delivering positive phase IIa results for its lead program, ontunisertib, an orally available treatment for fibrostenosing Crohn’s disease.
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Oral medication

Vanda’s tradipitant has phase II success but a court setback

Nov. 18, 2025
By Lee Landenberger
No Comments
Top-line results from a midstage study of Vanda Pharmaceuticals Inc.’s tradipitant hit its primary endpoint by preventing the nausea and vomiting that can be caused by the GLP-1 receptor agonist Wegovy (tirzepatide, Eli Lilly and Co.) in overweight and obese adults. The positive phase II study data prompted Vanda to look at a phase III study of the oral neurokinin-1 receptor antagonist next year.
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Mammogram

CERAN wrap: Roche phase III BC win seals thesis, boosts Olema

Nov. 18, 2025
By Randy Osborne
No Comments
Roche AG’s Genentech unit landed another clinical victory with giredestrant that provided a major stock boost for competitor Olema Pharmaceuticals Inc. Made public were positive phase III data from the Lidera study testing selective estrogen receptor degrader and complete estrogen receptor antagonist (CERAN) as an adjuvant endocrine treatment for people with ER-positive, HER2-negative, early stage breast cancer (BC).
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Cancer cell, DNA illustration

Artios raises $115M series D for potential first-in-class programs

Nov. 17, 2025
By Nuala Moran
No Comments
DNA damage response specialist Artios Ltd. has closed an oversubscribed $115 million series D after delivering positive phase I/IIa data for its two lead programs.
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Illustration of cancer on the esophagus

Jazz, Zymeworks unveil positive zanidatamab phase III data

Nov. 17, 2025
By Lee Landenberger
No Comments
A potentially $1.76 billion oncology deal created a little more than three years ago between partners Jazz Pharmaceuticals plc and Zymeworks Inc. now has a more solid direction. New and positive top-line results for the phase III Herizon-GEA-01 study of the HER2-targeted bispecific antibody zanidatamab in locally advanced or metastatic gastroesophageal adenocarcinoma (GEA) moved the stock and expectations for both companies.
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