Company Product Description Indication Status
Biocryst Pharmaceuticals Inc., of Research Triangle Park, N.C. BCX-9930 Factor D inhibitor Paroxysmal nocturnal hemoglobinuria FDA granted orphan drug designation
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
Cormedix Inc., of Berkeley Heights, N.J. Defencath Antibacterial and antifungal catheter lock Prevention of catheter-related bloodstream infections in hemodialysis patients FDA accepted the NDA; PDUFA action date is Feb. 28, 2021
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
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
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
Lipocine Inc., of Salt Lake City, Calif. Tlando Oral testosterone Hypogonadism FDA needs additional time to complete its review of the NDA, which had a PDUFA action date of Aug. 28, 2020; agency expects to complete its review in the coming weeks
Mustang Bio Inc., of Worcester, Mass. MB-207  Lentiviral gene therapy X-linked severe combined immunodeficiency FDA granted rare pediatric disease designation
Omeros Corp., of Seattle OMS-906  Monoclonal antibody targeting mannan-binding lectin-associated serine protease-3  Healthy subjects (eventually paroxysmal nocturnal hemoglobinuria) FDA cleared an IND for a phase I study testing the safety, tolerability, pharmacodynamics and pharmacokinetics of OMS-906
Oncopeptides AB, of Stockholm Melflufen flufenamide Peptide-drug conjugate targeting aminopeptidases Multiple myeloma refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent and 1 anti-CD38 monoclonal antibody FDA granted a priority review for the NDA; PDUFA action date is Feb. 28, 2021
Revive Therapeutics Ltd., of Toronto Bucillamine  Xanthine oxidase inhibitor Mild to moderate COVID-19 Phase III study received institutional review board approval
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
Spero Therapeutics Inc., of Cambridge, Mass. SPR-720 Antimicrobial agent Nontuberculous mycobacterial pulmonary disease FDA accepted the IND for a phase IIa study, which is scheduled to start before the end of 2020
Velosbio Inc., of San Diego VLS-101 Antibody-drug conjugate targeting receptor tyrosine kinase-like orphan receptor 1 Mantle cell lymphoma FDA granted fast track and orphan drug designation
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

Notes

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

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