Company Product Description Indication Status
Abivax SA, of  Paris ABX-464 Binds to cap binding complex  Moderate to severe active ulcerative colitis French regulators approved a phase IIb study 
Aerie Pharmaceuticals Inc., of Durham, N.C. Rhokiinsa (netarsudil ophthalmic solution) 0.02% Rho kinase inhibitor Open-angle glaucoma or ocular hypertension Approved by European Commission for use in reducing elevated intraocular pressure in adults
Astrazeneca plc, of Cambridge, U.K. Calquence (acalabrutinib) BTK inhibitor Chronic lymphocytic leukemia or small lymphocytic lymphoma Approved by FDA for use in adults; granted approval under the FDA’s Real-Time Oncology Review and Project Orbis programs
Bio-Path Holdings Inc., of Houston BP-1002 Liposomal Bcl-2 Refractory/relapsed lymphoma and chronic lymphocytic leukemia FDA cleared the IND for a phase I trial
CNS Pharmaceuticals Inc., of Houston Berubicin for I.V. Anthracycline Glioblastoma multiforme Filed pre-IND meeting request to the FDA’s Administration Division of Oncology Products 2, Center for Drug Evaluation and Research
Immuron Ltd., of Melbourne, Australia IMM-124E Oral polyclonal antibody therapy Travelers’ diarrhea Following FDA feedback, company plans to file IND application during the first half of 2020 for phase III trial
MC2 Therapeutics A/S of Copenhagen Wynzora cream Topical fixed-dose combination of calcipotriene and betamethasone dipropionate Plaque psoriasis FDA accepted NDA for review; PDUFA date of July 20, 2020
Proqr Therapeutics NV, of Leiden, the Netherlands QR-1123 Antisense oligonucleotide Autosomal dominant retinitis pigmentosa due to P23H mutation in rhodopsin gene Received orphan designation
Tonix Pharmaceuticals Holding Corp., of New York TNX-102 SL Cyclobenzaprine HCl sublingual tablets Alcohol use disorder  Received minutes from recent type B pre-IND meeting with FDA; plans to submit IND in first quarter of 2020 to support phase II proof-of-concept study


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

No Comments