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BioWorld - Saturday, June 20, 2026
Home » Topics » Clinical

Clinical
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China approves Innovent’s picankibart as first domestic IL-23p19

Dec. 1, 2025
By Tamra Sami
No Comments
China’s National Medical Products Administration gave the nod to Innovent Biologics Inc.’s picankibart (IBI-112), branded as Pecondle, for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
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Skin irritation

Inflarx flexes; HS, CSU continue to percolate

Dec. 1, 2025
By Randy Osborne
No Comments
The data from Inflarx NV that took Wall Street by surprise also served to heighten attention for the hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU) spaces, where other news has been bubbling lately on the industry as well as scientific fronts.
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Eye with blue graphic overlays

Belite cements Stargardt position with phase III tinlarebant win

Dec. 1, 2025
By Randy Osborne
No Comments
Attention has turned to the regulatory path worldwide after Belite Bio Inc. unveiled positive top-line data from the phase III Dragon study with oral, daily tinlarebant in Stargardt disease type 1, the most common form of the rare affliction.
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Illustration of cancer tumor
Drug design, drug delivery & technologies

Myrio first to develop binders with high affinity/specificity

Nov. 26, 2025
By Tamra Sami
No Comments
Myrio Therapeutics Pty Ltd. has been able to accomplish something no other company has yet been able to crack: to develop binders where both the affinity and the specificity can be increased.
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Lab vials and dropper
Biopharma clinical updates October 2025

Merck’s Keytruda and Welireg power October’s phase III oncology wins

Nov. 26, 2025
By Amanda Lanier
No Comments
In October 2025, BioWorld tracked 252 clinical trial updates across phases I-III, roughly in line with September’s 230 but markedly higher than the 95 logged in August. Of those, 27 phase III studies reported positive results, while four disclosed failures. Clinical trial updates logged by BioWorld in October comprised 91 phase I reports, 75 from phase II, and 87 from phase III studies.
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Illustration of cancer tumor

Myrio first to develop binders with high affinity/specificity

Nov. 26, 2025
By Tamra Sami
No Comments
Myrio Therapeutics Pty Ltd. has been able to accomplish something no other company has yet been able to crack: to develop binders where both the affinity and the specificity can be increased.
Read More

Vigencell’s cell therapy for lymphoma meets phase II endpoint

Nov. 26, 2025
By Marian (YoonJee) Chu
No Comments
Vigencell Inc. plans to seek conditional approval in South Korea for VT-EBV-N, an antigen-specific killer T-cell therapy for natural killer T-cell lymphoma, after gaining positive top-line data from a phase II study Nov. 25.
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Edwards SAPIEN 3 transcatheter heart valve

Edwards shows benefits of early TAVR in asymptomatic severe AS

Nov. 26, 2025
By Shani Alexander
Edwards Lifesciences Corp. released data from a health economics study done across nine countries in Europe which showed that early transcatheter aortic valve replacement in patients with asymptomatic severe aortic stenosis can deliver significant economic benefits alongside improved clinical outcomes.
Read More
Lymph nodes and lymphatic vessels

Protara sees Chugai blue sky in LMs as phase II data strong

Nov. 25, 2025
By Randy Osborne
No Comments
Success in Japan may further bolster Protara Therapeutics Inc. in its push with TARA-002 in pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs), for which the New York-based firm disclosed interim results from an ongoing phase II trial.
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Otsuka submits NDA for new non-stimulant ADHD therapy

Nov. 25, 2025
By Tamra Sami
No Comments
Otsuka Pharmaceutical Co. Ltd. filed an NDA with the U.S. FDA for centanafadine (formerly EB-1020), a new nonstimulant therapy for treating attention-deficit hyperactivity disorder (ADHD) in children, adolescents and adults. Centanafadine is a norepinephrine, dopamine and serotonin reuptake inhibito formulated as a once-daily extended-release capsule.
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