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BioWorld - Sunday, May 22, 2022
Home » Topics » Clinical

Clinical
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In the clinic for April 7, 2020

April 7, 2020
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB Science, Bellus, Bicycle, Boston, Can-Fite, Crinetics, Inventiva, Kalvista, Kazia, Precision, Quantum, Seneca, Vaccinex.
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Millendo quits Prader-Willi syndrome program after pivotal miss

April 6, 2020
By Michael Fitzhugh
No Comments
Shares of Millendo Therapeutics Inc. (NASDAQ:MLND) fell 70.1% to $1.45 on April 6 after a pivotal study of its experimental Prader-Willi syndrome (PWS) therapy, livoletide, failed to show a statistically significant improvement in hyperphagia, or insatiable hunger, and food-related behaviors vs. placebo.
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In a second successful phase III, Axsome’s oral migraine treatment hits primary endpoints

April 6, 2020
By Lee Landenberger
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With positive top-line data reported for Axsome Therapeutics Inc.’s oral migraine candidate, AXS-07, in its INTERCEPT trial, the company and the candidate have notched two successful phase III trials in little more than three months.
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Menlo's serlopitant whiffs in two phase III studies

April 6, 2020
By Brian Orelli
No Comments
Menlo Therapeutics Inc. announced a double dose of bad news with negative results for two phase III trials testing its NK1 receptor antagonist, serlopitant, as a treatment for pruritus (itch) associated with prurigo nodularis, a skin disease characterized by hard, itchy nodules.
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Immunomedics stock soars as efficacy signal prompts early halt of phase III TNBC trial

April 6, 2020
By Cormac Sheridan
No Comments
DUBLIN – Immunomedics Inc. is stopping the phase III Ascent trial of its antibody-drug conjugate, sacituzumab govitecan, in triple-negative breast cancer (TNBC) on the unanimous recommendation of the study’s independent data safety monitoring committee, after a scheduled look at the study data uncovered what the company called “compelling efficacy.”
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GM-CSF

Izana’s namilumab joins testing for COVID-19 arsenal as data point to GM-CSF as target for severe disease

April 6, 2020
By Nuala Moran
No Comments
LONDON – Izana Bioscience Ltd. has become the third company to supply an anti-GM-CSF antibody for compassionate use against COVID-19, announcing namilumab, currently in phase IIb testing in the treatment of rheumatoid arthritis and ankylosing spondylitis, will be used to treat 20 patients with severe respiratory symptoms.
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Ansun Biopharma reveals positive results for novel COVID-19 candidate

April 6, 2020
By David Ho
No Comments
HONG KONG – Another promising candidate has emerged in the race to find a treatment for the COVID-19 coronavirus. San Diego-based Ansun Biopharma Inc. released positive results from a four-patient study of its DAS-181 candidate, which is being developed for the treatment of severe COVID-19 infection. 
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In the clinic for April 6, 2020

April 6, 2020
No Comments
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aeterna Zentaris, American Brivision, Auris, Axsome, Bryn Pharma, Catalyst, Compugen, Cytodyn, Immunomedics, Incyte, Inovio, Janssen, Menlo, Millendo, Oxthera, Sun Biopharma, Windtree, Yiviva.
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Mirum, Albireo go final mile in bile; which is nonpareil in Alagille?

April 3, 2020
By Randy Osborne
No Comments
During its recent fourth-quarter and full-year earnings report, Foster City, Calif.-based Mirum Pharmaceuticals Inc. provided an update on the apical sodium dependent bile acid transporter (ASBT) inhibitor maralixibat for Alagille syndrome (ALGS), which will be the subject of a rolling NDA starting in the third quarter of 2020.
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In the clinic for April 3, 2020

April 3, 2020
No Comments
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Axon, Denali, Neurocrine, Novan, Oryzon, Regeneron, Restorbio, Sanofi, Umecrine, Urogen, Voyager.
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