Company Product Description Indication Status
9 Meters Biopharma Inc., of Raleigh, N.C. Larazotide acetate Tight junction regulator  Celiac disease  Received a thorough QT study waiver from FDA’s Center for Drug Evaluation and Research
Appili Therapeutics Inc., of Halifax, Nova Scotia Favipiravir RNA synthesis inhibitor Prevention of COVID-19 Filed CTA with Health Canada for phase II study
Astrazeneca plc, of Dublin, and Daiichi Sankyo Co. Ltd., of Tokyo Enhertu (trastuzumab deruxtecan) HER2-directed antibody-drug conjugate Gastric or gastroesophageal junction adenocarcinoma FDA granted breakthrough therapy designation for treatment of patients with HER2-positive unresectable or metastatic disease who have received 2 or more prior regimens, including trastuzumab
Bellerophon Therapeutics Inc., of Warren, N.J. Inopulse  Inhaled nitric oxide therapy COVID-19 FDA accepted the IND for a phase III study in up to 500 patients infected with COVID-19
Crispr Therapeutics AG, of Zug, Switzerland, and Vertex Pharmaceuticals Inc., of Boston CTX-001 Autologous, gene-edited hematopoietic stem cell therapy Sickle cell disease and transfusion-dependent beta-thalassemia FDA granted regenerative medicine advanced therapy designation
Eli Lilly and Co., of Indianapolis Retevmo (selpercatinib) Selective RET kinase inhibitor Non-small-cell lung cancer and medullary thyroid cancer FDA approved under the accelerated pathway for treatment of adults with metastatic RET fusion-positive NSCLC and for treatment of adult and pediatric patients, 12 and older, with advanced or metastatic RET-mutant MTC who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)
Histogen Inc., of San Diego HST-001 Hair stimulating complex Androgenic alopecia in men FDA approved the IND for a phase Ib/IIa trial, expected to start in the second quarter of 2020
Merck & Co. Inc., of Kenilworth, N.J., and Astrazeneca plc, of Cambridge, U.K. Lynparza (olaparib) PARP inhibitor Advanced epithelial ovarian, fallopian tube or primary peritoneal cancer FDA approved for use in combination with bevacizumab as first-line maintenance treatment of adults who are in complete or partial remission to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency-positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability
Relief Therapeutics Holding AG, of Geneva RLF-100 Formulation of vasoactive intestinal polypeptide COVID-19 Partner Neurorx Inc. filed investigational protocol with FDA under the Coronavirus Treatment Acceleration Program for a phase II/III study assessing inhaled drug in patients with non-acute lung injury due to COVID-19
Tracon Pharmaceuticals Inc., of San Diego Envafolimab Single-domain antibody against PD-L1 Soft tissue sarcoma, subtypes of undifferentiated pleomorphic sarcoma and myxofibrosarcoma Completed type B pre-IND meeting with FDA, which agreed with company’s proposals for key elements of pivotal Envasarc trial; enrollment expected to start in second half of 2020

Notes

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

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