Company Product Description Indication Status
Astrazeneca plc, of Cambridge, U.K., Merck & Co. Inc., of Kenilworth, N.J. and Foundation Medicine Inc., of Cambridge, Mass. Lynparza (olaparib) PARP inhibitor

Homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer

FDA approved the expanded indication for the drug and the Foundationone companion diagnostic
Atea Pharmaceuticals Inc., of Boston AT-527 Nucleotide prodrug Hospitalized patients with moderate COVID-19 FDA cleared the IND for a phase II study
Eiger Biopharmaceuticals Inc., of Palo Alto, Calif. Zokinvy (lonafarnib) Farnesyltransferase inhibitor Progeria and progeroid laminopathies FDA accepted the NDA and granted a priority review; PDUFA action date is Nov. 20, 2020; agency doesn't plan to hold an advisory committee meeting
Evoke Pharma Inc., of Solana Beach, Calif. Gimoti Nasal spray formulation of metoclopramide, which inhibits dopamine D2 and serotonin 5-HT3 receptors Diabetic gastroparesis FDA conditionally accepted the proprietary brand name
Fate Therapeutics Inc., of San Diego FT-538 CRISPR-edited, iPSC-derived natural killer cell immunotherapy Acute myeloid leukemia and multiple myeloma FDA cleared the IND for a phase I study testing FT-538 as a monotherapy for AML and in combination with daratumumab for MM
Incyte Corp., of Wilmington, Del., and Morphosys AG, of Martinsried, Germany Tafasitamab Anti-CD19 antibody Relapsed or refractory diffuse large B-cell lymphoma EMA validated the MAA seeking approval for use in combination with lenalidomide, followed by tafasitamab monotherapy, for treating adults, including those whose DLBCL arises from low-grade lymphoma, who are not candidates for autologous stem cell transplantation
Karyopharm Therapeutics Inc., of Newton, Mass. Xpovio (selinexor) Oral selective inhibitor of nuclear transport Multiple myeloma Submitted a supplemental NDA to FDA seeking approval in patients with previously treated disease
Octapharma USA Inc., of Paramus, N.J.  Octagam 10% Intravenous human immune globulin COVID-19 with severe disease progression FDA approved the IND for a phase III study

Notes

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

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