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BioWorld - Tuesday, February 17, 2026
Home » Topics » Clinical, BioWorld

Clinical, BioWorld
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In the clinic for Dec. 9, 2021

Dec. 9, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Affimed, Amphera, Biogen, Celldex, Eisai, Glaxosmithkline, Henlius, I-Mab, Index, LB, Lexaria, Medicago, Merck, Monopar, MRM, Neurocrine, Novabiotics, Novartis, Radius, Sage, Sorrento, Takeda, Tranquis, Treadwell.
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Mesoblast’s new subgroup analysis brings needed jolt to revive heart failure study

Dec. 8, 2021
By Tamra Sami
PERTH, Australia – Stem cell therapy company Mesoblast Ltd. provided new subgroup analyses from its phase III advanced chronic heart failure trial showing a greater treatment benefit from rexlemestrocel-L in high-risk patients with chronic heart failure and low ejection fraction (HFrEF) with diabetes or ischemia. The company had reported in December 2020 that the allogeneic mesenchymal cell therapy failed to meet the primary endpoint of a reduction in hospitalizations in its DREAM-HF phase III trial.
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Pfizer-Biontech vaccine and syringe

Omicron neutralized after 3rd dose of Pfizer-Biontech vaccine; Astrazeneca wins Evusheld EUA

Dec. 8, 2021
By Lee Landenberger
There is now more clarity on the Omicron variant of SARS-CoV-2, as serum antibodies produced by three doses of the Pfizer Inc.-Biontech SE COVID-19 vaccine have been shown to neutralize it. The data arrived a day after Glaxosmithkline plc and Vir Biotechnology Inc. said the monoclonal antibody sotrovimab retains activity against key mutations of the Omicron variant, including those found in sotrovimab’s binding site.
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In the clinic for Dec. 8, 2021

Dec. 8, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acadia, Aligos, Anthos, Astrazeneca, Blueprint, Can-Fite, Daiichi, Ideaya, Innovent, Inventiva, Janssen, Meiragtx, Noxxon, Prometheus, Puretech, Recce, Revalesio, Vaccitech.
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Stock chart, upward arrow

Neuren’s stock rockets 91% on positive phase III results for trofinetide in Rett syndrome

Dec. 7, 2021
By Tamra Sami
PERTH, Australia – Neuren Pharmaceuticals Ltd.’s stock nearly doubled on positive top-line phase III results for trofinetide in Rett syndrome, meeting all primary and secondary endpoints in the pivotal phase III trial run by partner Acadia Pharmaceuticals Inc.
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In the clinic for Dec. 7, 2021

Dec. 7, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Acurx, Aeglea, Bavarian Nordic, Biohaven, Catalyst, Citius, Cyxone, Dydo, Glycomimetics, Hutchmed, Implicit, J&J, Karyopharm, Kazia, Kronos, Mediwound, Mesoblast, Nrx, Ocular, PDS, Ventyx, Xenon, ZZ.
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Clinical data illustration

Aeglea posts positive phase III data but stock staggers

Dec. 6, 2021
By Lee Landenberger
Despite hitting the primary endpoint in its phase III study of pegzilarginase in treating arginase 1 deficiency, Aeglea Biotherapeutics Inc. had a tough go of it Dec. 6 as the price of its stock (NASDAQ:AGLE) plunged 36.5% to close at $3.81 per share. The study hit its primary endpoint with a statistically significant reduction in plasma arginine from baseline after 24 weeks of treatment with pegzilarginase (p<0.0001). The study results were positive enough to prompt Aeglea to say it planned to submit a BLA to the FDA in the first half of 2022.
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Cancer cells

Isofol stock drops 27% as PFS reporting issue emerges in phase III cancer trial

Dec. 6, 2021
By Cormac Sheridan
Shares in Isofol Medical AB dropped by 27% on Dec. 6 as the company informed investors that its ongoing phase III trial of arfolitixorin in metastatic colorectal cancer would not reach the predefined number of events needed to demonstrate a statistically significant effect on progression-free survival (PFS) based on the study’s present statistical plan.
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In the clinic for Dec. 6, 2021

Dec. 6, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adagene, Adicet, Astrazeneca, Bayer, Bellicum, Biofrontera, Bolt, Eupraxia, Fulcrum, Hummingbird, I-Mab, Immunicum, Immunocore, Janssen, Merus, Neurona, Revive, Scynexis, Springworks, Stoke, Surface Oncology, Viacyte.
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In the clinic for Dec. 3, 2021

Dec. 3, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 180 Life Sciences, Acasti, Amgen, Arbutus, Arca, Bonus, Hepagene, Humanigen, India Globalization, Immutep, Karyopharm, Redhill, Revelation, Spago, VBI, Ysopia.
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