Company Product Description Indication Status
Adastra Pharmaceuticals Inc., of Princeton, N.J. Zotiraciclib  Multikinase inhibitor  Glioma FDA and EMA both granted orphan drug designation
APR Applied Pharma Research SA, of Balerna, Switzerland APR-TD011 Hypotonic acid-oxidizing solution Epidermolysis bullosa FDA granted orphan drug designation
Bio-Thera Solutions Ltd., of Guangzhou, China BAT-2206 Biosimilar of Stelara (ustekinumab) Healthy volunteers China National Medical Products Administration approved the IND for a phase I study comparing the drug to U.S.-sourced and EU-sourced reference product
Bioxcel Therapeutics Inc., of New Haven, Conn. BXCL-501 Sublingual thin film of selective alpha-2a receptor agonist dexmedetomidine Agitation in schizophrenia and bipolar disorder Reached agreement with FDA on elements for design of Serenity program of 2 phase III trials; studies to begin by year-end
Bristol-Myers Squibb Co., of New York Orencia (abatacept) Selective co-stimulation modulator of T-cell activation Acute graft-vs.-host disease prophylaxis FDA granted breakthrough designation
CASI Pharmaceuticals Inc., of Rockville, Md., and Juventas Cell Therapy Ltd., of Beijing CNCT-19 CAR T targeting CD19 Relapsed/refractory B-cell acute lymphoblastic leukemia and relapsed/refractory B-cell non-Hodgkin lymphoma China National Medical Product Administration approved the clinical trial applications; studies expected to begin in early 2020
Foundation Medicine Inc., of Cambridge, Mass. Foundationone Cdx Next-generation sequencing diagnostic HR+, HER2-, PIK3CA mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen FDA approved test as a companion diagnostic for Piqray (alpelisib, Novartis AG) in combination with fulvestrant
Ikena Oncology Inc., of Boston (formerly Kyn Therapeutics Inc.) IK-175 Small-molecule antagonist of aryl hydrocarbon receptors Cancers with activated AHR FDA cleared IND for first-in-human study
Immunitybio Inc., of Culver City, Calif.  N-803 Interleukin-15 agonist Bacillus Calmette-Guerin-unresponsive non-muscle invasive bladder carcinoma in situ FDA granted breakthrough designation
Innovative Cellular Therapeutics Co. Ltd., of Shanghai ICTCAR-014 CAR T targeting CD19 Relapsed/refractory non-Hodgkin lymphoma FDA approved IND; clinical trial to start in first part of 2020
Roche Holding AG, of Basel, Switzerland Tecentriq (atezolizumab) Monoclonal antibody targeting PD-L1 First-line metastatic nonsquamous non-small-cell lung cancer with no EGFR or ALK aberrations FDA approved drug in combination with chemotherapy (Abraxane [nab-paclitaxel] and carboplatin)
Tetra Bio-Pharma Inc., of Ottawa, Ontario Delta-9-tetrahydrocannabinol Cannabinoid Hepatocellular carcinoma FDA granted orphan drug designation


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

No Comments