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BioWorld - Monday, February 23, 2026
Home » Topics » Clinical, BioWorld

Clinical, BioWorld
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Man using walker with assistance

Perseus phase III fails to head off MS, review delayed: Sanofi

Dec. 15, 2025
By Randy Osborne
No Comments
Sanofi SA reported more hitches in the development of Bruton’s tyrosine kinase inhibitor tolebrutinib, saying the phase III Perseus study failed to meet its primary endpoint in primary progressive multiple sclerosis (MS) and that the ongoing U.S. regulatory review in non-relapsing secondary progressive MS likely will extend beyond the targeted PDUFA date of Dec. 28.
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Chalkboard with straight arrow erased, drawing a turning arrow

Arcus shifts effort, bears down on would-be ‘anchor’ in RCC

Dec. 12, 2025
By Randy Osborne
No Comments
Arcus Biosciences Inc. and partner Gilead Sciences Inc. are scrapping phase III work with anti-TIGIT antibody domvanalimab after an independent data monitoring committee said the drug will fail in gastric and esophageal cancers.
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Arrow missing target

Rezolute’s lone drug misses a phase III

Dec. 11, 2025
By Lee Landenberger
No Comments
Rezolute Inc.’s phase III Sunrize study of its only candidate, ersodetug, a fully human monoclonal antibody that binds to allosteric site on insulin receptors, missed its primary and secondary endpoints in treating the ultra-rare disease congenital hyperinsulinism.
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Parkinson's disease illustration showing neurons containing alpha-synuclein

AC puts the chill on Parkinson’s in vaccine phase II

Dec. 11, 2025
By Randy Osborne
No Comments
AC Immune SA plans talks with regulators based on positive interim safety and efficacy results from the phase II Vacsyn trial of its wholly owned anti-alpha-synuclein (a-syn) active immunotherapy ACI-7104.056 in early Parkinson’s disease (PD). The firm said that for the first time, data support targeting a-syn pathology via such a strategy. Disease-related biomarker results that suggest PD slowing include a-syn cerebrospinal fluid (CSF) levels and neurofilament light (NfL).
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Illustration of leg anatomy with target around knee

Lilly’s retatrutide shows solid weight loss, reduced knee pain

Dec. 11, 2025
By Karen Carey
No Comments
Eli Lilly and Co.’s latest phase III results for the obesity and overweight populations suggest its triple agonist, retatrutide, can deliver significant weight loss that, in turn, leads to reduced osteoarthritis knee pain.
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Platelets and red blood cells

ASH 2025: Ianalumab data offer break from chronic ITP therapy

Dec. 10, 2025
By Karen Carey
No Comments
Novartis AG’s monoclonal antibody, ianalumab (VAY-736), when added to standard-of-care eltrombopag, extended disease control of primary immune thrombocytopenia (ITP) by 45%, according to data presented Dec. 9 during a late-breaker abstract session at the 67th American Society of Hematology’s annual meeting in Orlando, Fla.
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Multiple myeloma illustration

ASH 2025: Tec-dara shines on ‘functional cure’ Majestec-3 MM data

Dec. 9, 2025
By Karen Carey
Impressive results of a potential second-line combination treatment for multiple myeloma from the Majestec-3 trial of teclistamab plus daratumumab raised eyebrows at the American Society of Hematology’s 67th annual meeting, with the combination showing an 83.4% rate of progression-free survival at three years vs. 29.7% for standard of care.
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Pills, bottle, scale and-measuring tape

Wave Life, Structure and Ascletis post wins in obesity management

Dec. 8, 2025
By Lee Landenberger
No Comments
With new results from Wave Life Sciences Ltd., Structure Therapeutics Inc. and Ascletis Pharma Inc., obesity management drugs continue to move forward in producing weight loss and move the market.
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Positive phase Ib SCD data perk Fulcrum stock

Dec. 8, 2025
By Randy Osborne
No Comments
On the heels of mixed phase III data from Agios Pharmaceuticals Inc. with mitapivat to treat sickle cell disease (SCD), Fulcrum Therapeutics Inc. wowed investors by way of initial results from the ongoing 20-mg dose cohort in the phase Ib Pioneer trial testing oral, once-daily fetal hemoglobin inducer pociredir.
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IV drips

ASH 2025: New blood cancer therapies trump chemo, older drugs

Dec. 8, 2025
By Karen Carey
No Comments
Targeted therapies and immunotherapies continue to show better results than chemotherapy in investigator-initiated and company-sponsored cancer trials, and newer options demonstrate improvements over older ones, supporting potential shifts in how patients are treated.
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