Company Product Description Indication Status Date
Can-Fite Biopharma Ltd., of Petach Tikva, Israel Piclidenoson A3 adenosine receptor agonist COVID-19 FDA issued a safe to proceed notice for the IND for a 40-patient phase II study 8/31/20
Capricor Therapeutics Inc., of Los Angeles CAP-1002 Allogeneic cardiac cell therapy COVID-19 The FDA accepted its IND application for a phase II clinical trial 8/25/20
Cstone Pharmaceuticals Co. Ltd., of Suzhou, China Sugemalimab (CS-1001) Anti-PD-L1 monoclonal antibody Relapsed or refractory extranodal natural killer/T-cell lymphoma FDA issued a study may proceed letter for the IND for a phase II study 8/31/20
FSD Pharma Inc., of Toronto FSD-201 (ultramicronized palmitoylethanolamide) Anti-inflammatory  COVID-19 Submitted an IND to the FDA for a phase II study testing 2 dose levels of the drug 8/31/20
Gilead Sciences Inc., of Foster City, Calif. Veklury (remdesivir) Antiviral COVID-19 FDA expanded the EUA to include all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19 8/31/20
Hifibio Therapeutics Inc., of Cambridge, Mass. HFB-30132A COVID-19 spike glycoprotein inhibitor; ACE2 inhibitor COVID-19 Submitted an IND for phase I ascending dose study 8/26/20
Laurent Pharmaceuticals Inc., of Montreal LAU-7b  Oral formulation of synthetic retinoid fenretinide  COVID-19 FDA approved the start of a phase II study 8/27/20
Revive Therapeutics Ltd., of Toronto Bucillamine Xanthine oxidase inhibitor COVID-19 Submitted its clinical trial protocol for IRB approval; exploring the FDA expanded access program 8/26/20
Revive Therapeutics Ltd., of Toronto Bucillamine  Xanthine oxidase inhibitor Mild to moderate COVID-19 Phase III study received institutional review board approval 8/31/20
Sirtex Medical US Holdings Inc., of Woburn, Mass. SIR-Spheres Y-90  Resin microspheres Liver cancer China's National Medical Products Administration granted a notice of drug clinical trial approval 8/27/20
Sound Pharmaceuticals Inc., of Seattle Ebselen (SPI-1005) Glutathione peroxidase stimulator  Moderate or severe COVID-19 FDA allowed the start of 2 phase II studies of 120 adults 8/31/20
TLC Biopharmaceuticals Inc., of South San Francisco and 3Sbio Inc., of Shenyang, China Ampholipad (amphotericin B liposome) Complex generic Systemic fungal infections NMPA's Center for Drug Evaluation accepted its marketing authorization application for Ampholipad 8/26/20
Xortx Therapeutics Inc., of Calgary, Alberta XRx-101 (oxypurinol) Xanthine oxidase inhibitor Acute kidney injury associated with COVID-19 Requested a pre-IND meeting with the FDA 8/31/20

Notes

The date indicated refers to the BioWorld Regulatory actions table in which the news item can be found.

For more information about individual companies and/or products, see Cortellis.

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