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BioWorld - Friday, January 16, 2026
Home » Topics » Clinical, BioWorld

Clinical, BioWorld
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Natural killer cell attacking cancer cell

Immunitybio’s CAR-NK shows complete responses in Waldenström’s

Jan. 16, 2026
By Karen Carey
No Comments
Early data of Waldenström’s non-Hodgkin lymphoma patients enrolled in a trial testing Immunitybio Inc.’s off-the-shelf allogeneic CD19 chimeric antigen receptor natural killer cell therapy (CAR-NK), used in combination with anti-CD20 drug rituximab, led to durable complete responses without lymphodepletion.
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EMA icons

EMA marks 2025 2nd busiest year, says pace will continue in 2026

Jan. 15, 2026
By Nuala Moran
No Comments
The EMA had its second busiest year ever in 2025, approving 104 drugs, of which 38 had a new active substance. Sixteen of these are for treating rare diseases, and four are advanced therapy medicinal products.
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Pill with British pound sign

Enterobiotix seeks new funds to advance microbiome pill in IBS

Jan. 14, 2026
By Nuala Moran
No Comments
Microbiome specialist Enterobiotix Ltd. is in the throes of raising a new round of funding for a phase IIb trial after reporting positive results from the phase IIa study of EBX-102-02, an oral therapy for irritable bowel syndrome (IBS).
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Stomach and esophagus

Early data lift Immunofoco’s solid tumor CAR T program

Jan. 14, 2026
By Tamra Sami
No Comments
Immunofoco Biotechnology Co. Ltd. reported encouraging early clinical data for its CLDN18.2-targeted CAR T therapy, IMC-002, in heavily pretreated gastric and gastroesophageal junction cancer, adding momentum to the push to extend cellular immunotherapy into solid tumors.
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Heart, DNA and ECG

Heart-disease gene therapy race heating up as Lexeo posts data

Jan. 14, 2026
By Randy Osborne
No Comments
Lexeo Therapeutics Inc.’s phase I/II data – characterized by Oppenheimer analyst Leland Gershell as “heroic” – this week with gene therapy LX-2020 in PKP2-associated arrhythmogenic cardiomyopathy pushed the New York-based firm’s shares (NASDAQ:LXEO) down 35% to a low of $6.90 Jan. 12, following a $10.54 close the previous trading day.
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Electroencephalogram

Phase III update Stokes hope; Dravet game-change Encoded?

Jan. 12, 2026
By Randy Osborne
No Comments
Stoke Therapeutics Inc.’s speeded-up timeline for zorevunersen, the antisense oligonucleotide in development with Biogen Inc. as a first-in-class potential disease-modifying treatment for Dravet syndrome, put the rare, severe form of lifelong epilepsy in the spotlight. The news involved completion of enrollment and a phase III data readout from the Emperor study, as officials said signups of 150 patients are expected in the second quarter of the year, which puts the study on track for data in mid-2027.
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Close up of man's eye

Going Ollin on AMD, DME: Vabysmo in phase Ib crosshairs

Jan. 9, 2026
By Randy Osborne
No Comments
Ollin Biosciences Inc. is gearing up for global phase III trials this year after disclosing favorable top-line results from its randomized, head-to-head phase Ib Jade study comparing OLN-324, a next-generation VEGF/Ang2 bispecific antibody, to Vabysmo (faricimab, Roche AG), which takes aim at the same targets. The drugs were tested in more than 160 patients with diabetic macular edema (DME) or wet age-related macular degeneration (AMD).
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Hutchmed plans China NDA filing of sovleplenib in rare anemia

Jan. 8, 2026
By Marian (YoonJee) Chu
No Comments
Hutchmed Ltd. plans to file a second NDA in China for sovleplenib, a novel spleen tyrosine kinase inhibitor, based on positive phase II/III findings in warm antibody autoimmune hemolytic anemia.
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Hand holding elbow

Takeda’s zasocitinib meets phase III psoriasis endpoints

Jan. 8, 2026
By Tamra Sami
No Comments
Takeda Pharmaceuticals Co. Ltd.’s oral tyrosine kinase 2 inhibitor, zasocitinib (TAK-279), met the co-primary endpoints and all ranked secondary endpoints in two pivotal phase III studies in patients with moderate to severe plaque psoriasis.
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Illustration for yo-yo diet

Obesity meta-analysis provides important steer for next-gen drugs

Jan. 8, 2026
By Nuala Moran
No Comments
There are two significant messages for companies developing and profiting from obesity drugs in a meta-analysis of clinical trials examining the extent of weight regain after treatment stops. First, people taking obesity medication regain weight four times faster on average than those who lose weight through behavioral diet and exercise programs; and second, poor tolerability leads to poor adherence.
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