Company Product Description Indication Status
Bayer AG, of Leverkusen, Germany Mirena (levonorgestrel-releasing intrauterine system)  Progesterone receptor agonist Pregnancy prevention Submitted supplemental NDA to FDA seeking to extend duration of use for up to 7 years, based on results of phase III extension trial
Biohaven Pharmaceutical Holding Co. Ltd., of New Haven, Conn. Nurtec ODT (rimegepant) CGRP receptor antagonist in an orally disintegrating tablet Migraine FDA accepted for review the supplemental NDA seeking use for preventive treatment of migraine; PDUFA date is expected in second quarter of 2021
Direct Biologics LLC, of Austin, Texas Exoflo Extracellular vesicle product isolated from human bone marrow mesenchymal stem or stromal cells COVID-19-associated acute respiratory distress syndrome FDA granted expanded access for use as treatment for patients with severe COVID-19
Enlivex Therapeutics Ltd., of Nes Ziona, Israel Allocetra Autologous cell-based therapy COVID-19 Israeli Ministry of Health authorized initiation of proposed investigator-initiated phase II trial in severe and critical COVID-19 patients
Harmony Bioscience Holdings Inc., of Plymouth Meeting, Pa. Wakix (pitolisant) Selective histamine 3 receptor antagonist/inverse agonist Cataplexy FDA approved use for treating cataplexy in adults with narcolepsy; agency approved drug in 2019 for use in excessive daytime sleepiness in narcolepsy patients
Moderna Inc., of Cambridge, Mass. mRNA-1273 mRNA vaccine candidate COVID-19 Initiated rolling submission to Health Canada; in separate news, received written confirmation from EMA that vaccine candidate is eligible for submission of marketing authorization application under agency’s centralized procedure
Orca Bio Inc., of Menlo Park, Calif. Orca-T Allogeneic, high-precision cell therapy Hematopoietic stem cell transplant FDA granted regenerative medicine advanced therapy designation for use in patients with blood cancers who are eligible for hematopoietic stem cell transplant (HSCT); drug also received FDA orphan designation for enhancing cell engraftment in patients who quality for HSCT
Redhill Biopharma Ltd., of Tel Aviv, Israel RHB-204 Fixed-dose oral capsule of clarithromycin, rifabutin and clofazimine Nontuberculous mycobacteria disease FDA granted orphan designation
Scynexis Inc., of Jersey City, N.J. Oral ibrexafungerp  1,3 beta glucan synthase inhibitor Vulvovaginal candidiasis Submitted NDA to FDA
Sorrento Therapeutics Inc., of San Diego Abivertinib EGFR gene inhibitor; BTK tyrosine kinase inhibitor COVID-19 Brazilian regulator ANVISA cleared start of phase II study in mild, moderate and severe COVID-19 patients; about 400 patients will be enrolled
Taysha Gene Therapies Inc., of Dallas TSHA-102 AAV9-based gene therapy Rett syndrome Received FDA rare pediatric disease designation and orphan designation
Tevogen Bio Inc., of Metuchen, N.J. Antigen-specific T-cell technology Antigen-specific T-cell technology COVID-19 Submitted IND to the FDA to test in hospitalized COVID-19 patients
Y-mabs Therapeutics Inc., of New York 177Lu-omburtamab-DTPA Antibody radiolabeled with lutetium-177 Medulloblastoma FDA cleared the IND for a phase I/II trial expected to start screening patients during the fourth quarter of 2020

Notes

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