Company Product Description Indication Status
Aerie Pharmaceuticals Inc., of Durham, N.C. AR-15512 TRPM8 agonist eye drop  Dry eye disease FDA accepted its IND application, and the company expects to initiate a phase IIb study in the fourth quarter of 2020
Ascendis Pharma A/S, of Copenhagen Transcon PTH Parathyroid hormone prodrug Adult hypoparathyroidism IND amendment submitted to FDA to initiate U.S. sites of phase III Pathway trial, with primary composite endpoint at 26 weeks of proportion of participants with serum calcium in normal range, independence from active vitamin D and taking ≤600 mg/day of calcium supplements
Bristol Myers Squibb Co., of New York, and Acceleron Pharma Inc., of Cambridge, Mass. Reblozyl  Luspatercept Red blood cell transfusion-dependent anemia associated with beta-thalassemia Health Canada approved it
Bridgebio Pharma Inc., of Boston, and subsidiary Origin Biosciences Fosdenopterin (BBP-870/ORGN-001) cPMP substrate replacement therapy Molybdenum cofactor deficiency type A FDA accepted its NDA and granted priority review designation
Histogen Inc., of San Diego HST-002 Human-derived collagen and extracellular matrix dermal filler Facial folds and wrinkles FDA’s Office of Combination Products deemed product a drug-biologic-device combination, which will be assigned to Center for Biologics Evaluation Research Office of Tissues and Advanced Therapies as the agency lead for premarket review and regulation
Infinity Pharmaceuticals Inc., of Cambridge, Mass. Eganelisib (IPI-549) PI3K-gamma inhibitor Inoperable locally advanced or metastatic triple-negative breast cancer  FDA granted fast track designation in combination with a checkpoint inhibitor and chemotherapy
Otsuka Pharmaceutical Co. Ltd., of Tokyo, and Medimetriks Pharmaceuticals Inc., of Fairfield, N.J. Difamilast (OPA-15406) PDE4 inhibitor Mild to moderate atopic dermatitis Otsuka submitted an NDA for approval in Japan
Neuren Pharmaceuticals Ltd., of Melbourne, Australia NNZ-2591 Synthetic analogue of molecule derived from IGF-1 Phelan-McDermid syndrome, Angelman syndrome and Pitt Hopkins syndrome Submitted orphan designation applications to the EMA for each indication
Organicell Regenerative Medicine Inc., of Miami Zofin Perinatal-derived microRNAs COVID-19 FDA granted expanded access 
Painreform Ltd., of Herzliya, Israel PRF-110 (ropivacaine gel, extended-release) Sodium channel inhibitor Postoperative pain FDA cleared IND for pivotal phase III trials
Pfizer Inc., of New York Xeljanz (tofacitinib) Janus kinase inhibitor Active polyarticular course juvenile idiopathic arthritis FDA approved it for the treatment of children and adolescents 2 and older 
Seed Health, of Boston DS-01 Broad-spectrum multispecies, multistrain probiotic Irritable bowel syndrome FDA authorized its IND application, and the company plans to initiate a phase II trial
Windtree Therapeutics Inc., of Warrington, Pa. Lyo lucinactant KL4 surfactant COVID-19-associated lung injury and acute respiratory distress syndrome FDA accepted the IND application for its phase II trial 

Notes

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