VANCOUVER, British Columbia – Yiviva Inc., a pharmaceutical company focused on developing botanical drugs, has moved its lead candidate further into an international phase IIb trial for liver cancer and closer to an application through the FDA’s little-used botanicals pathway and a similar pathway in China. The company’s lead candidate, YIV-906, is intended for use in immunotherapy, chemotherapy and radiation therapy.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Annovis, Aurinia, Beigene, Immunitybio, J&J, Meiji Seika, Medivir, Onconova, Phosplatin, Poxel, Regulus.
CEO David Epstein said Black Diamond Therapeutics Inc. was “delighted” with phase I data testing BDTX-189 in advanced solid tumors harboring EGFR or HER2 alterations, but Wall Street seemed less so. Shares (NASDAQ:BDTX) closed at $13.93, down $8.30, or 37%.
Where Ilaris (canakinumab) failed, can Kineret (anakinra) succeed? Swedish Orphan Biovitrum AB is reporting that an investigator-initiated phase III study of its interleukin-1 (IL-1) blocker, Kineret, in 594 hospitalized COVID-19 patients with moderate or severe pneumonia, who had a poor prognosis, uncovered what appear to be dramatic benefits.
LONDON – The U.K. is launching a trial to investigate the potential use of seven different COVID-19 vaccines as boosters, to provide safety and immunogenicity data for if/when immune responses to initial vaccination wane and a revaccination campaign is needed later in the year. The trial, at 18 sites across the country, will recruit 2,886 participants who previously received two doses of either Astrazeneca plc or Pfizer Inc./Biontech SE’s COVID-19 vaccines.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acelrx, Annovis, Astellas, Black Diamond, Cantargia, Crescendo, Laurent, Merck, Obseva, Pyramid, Recardio, Seagen, Sensei, Transcenta, Xalud.
Reneo Pharmaceuticals Inc.’s $93.8 million IPO last month brought renewed attention to primary mitochondrial myopathy (PMM), a genetic disorder that impairs oxidative phosphorylation, affecting mainly muscles. The San Diego-based firm sold about 6.2 million shares at $15 each, but the stock (NASDAQ:RPHM) has since taken a dive, closing May 19 at $8.83.
There’s been a change of plans. Following a preliminary review of briefing materials for a type C meeting, the FDA told Reata Pharmaceuticals Inc. that a pre-NDA meeting is instead the next best step in the development of omaveloxolone (RT-408) for treating Friedreich’s ataxia (FA).
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acceleron, Apeiron, Astrazeneca, Biomarin, CNS, Cytokinetics, Galapagos, Idera, Immunocore, Pfizer, Silence, Veru.
DUBLIN – Bergenbio ASA joins an expanding list of companies whose candidate drug has failed to attain the primary endpoint of a clinical trial in COVID-19.
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