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BioWorld - Friday, January 9, 2026
Home » Topics » Clinical

Clinical
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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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MEK specs re-checked in Immuneering pancreatic phase II

Jan. 8, 2026
By Randy Osborne
No Comments
Having nailed down alignment with the U.S. FDA in December on a phase III trial that will start in the middle of this year, Immuneering Corp. updated the overall survival and safety data from an ongoing phase IIa trial testing atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer patients (n=34), with more than 13 months median follow-up time.
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3D print imagery of hepatitis B virus

GSK’s hep B approach hits functional cure goal in pivotal trials

Jan. 7, 2026
By Jennifer Boggs
No Comments
As widely expected, GSK plc and Ionis Pharmaceuticals Inc. reported positive findings from two pivotal trials testing bepirovirsen in chronic hepatitis B, showing the antisense oligonucleotide therapy achieved a statistically and clinically meaningful functional cure rate, indicating a potential transition in CHB treatment beyond the current viral suppression-focused standard of care.
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Cardiovascular illustration

Cardio works out for Monte Rosa in NEK7 phase I

Jan. 7, 2026
By Randy Osborne
No Comments
Monte Rosa Therapeutics Inc. followed up December’s positive prostate cancer data with strong interim findings from a phase I study with MRT-8102, a NEK7-directed molecular glue degrader in the works for inflammatory conditions driven by the NLRP3 inflammasome, IL-1, and IL-6.
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Oculis eyes MS as privosegtor gets FDA breakthrough status in AON

Jan. 6, 2026
By Nuala Moran
No Comments
Eye disease specialist Oculis SA is laying plans to branch out into multiple sclerosis (MS) after the phase II trials of its acute optic neuritis (AON) drug, privosegtor, showed it reduced levels of neurofilament release, a key biomarker of neuronal damage and neurodegeneration.
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Obesity rings in New Year with Lilly-Nimbus $1.3B deal, RNAi data

Jan. 6, 2026
By Karen Carey
No Comments
Biopharma industry zeal for obesity therapeutics does not appear to be dying down any time soon, with Eli Lilly and Co. entering a $1.3 billion deal with Nimbus Therapeutics LLC for a new small molecule, and Arrowhead Pharmaceuticals Inc. rolling out phase I/IIa data of its RNAi therapeutics used in combination with Lilly’s GLP-1/GIP receptor agonist tirzepatide.
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Man scratching arm

Alumis’ TYK2 envu in view as standout in psoriasis phase III

Jan. 6, 2026
By Randy Osborne
No Comments
A would-be psoriasis winner began taking more distinct shape in the competitive oral tyrosine kinase 2 (TYK2) inhibitor space, and shares of Alumis Inc. (NASDAQ:ALMS) closed Jan. 6 at $16.23, up $7.92, or 95% – having traded as high as $22.30 – after unveiling positive top-line results from the phase III Onward1 and Onward2 trials with envudeucitinib (envu). Alumis CEO Martin Babler called 2026 “a value-inflection year. It starts today.”
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