Company Product Description Indication Status
Astellas Pharma Inc., of Tokyo Xtandi (enzalutamide) Androgen receptor signaling inhibitor Metastatic hormone-sensitive prostate cancer European Commission approved the expanded indication
Carmot Therapeutics Inc., of Berkeley, Calif. CT-868 GLP-1 and GIP receptor modulator Overweight and obese patients with type 2 diabetes FDA cleared the IND for a phase II study; also plans to run studies in non-diabetic insulin-resistant patients and in patients with diabetes under the IND, which are both scheduled to start in the second half of 2021
Clarity Pharmaceuticals, of Sydney 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA Radiotherapeutic  Prostate-specific membrane antigen-positive prostate cancers FDA cleared the IND for a phase I/IIa dose-escalation study with a cohort expansion planned for up to 44 patients; 64Cu-SAR-bisPSMA will be used in conjunction with positron emission tomography for selection of patients suitable for therapy cycles with 67Cu-SAR-bis-PSMA
Eli Lilly and Co., of Indianapolis Baricitinib Dual JAK1/JAK2 inhibitor Treatment of hospitalized COVID-19 patients requiring supplemental oxygen Received a receipt of permission for restricted emergency use in India; Lilly is offering donations of baricitinib to the Indian government while also working with local pharma companies to execute royalty-free licensing agreements to accelerate manufacturing and distribution, and an initial donation of 400,000 tablets is being made immediately available 
Hutchmed Ltd., of Hong Kong, Shanghai and Florham Park, N.J. Surufatinib Oral angio-immuno kinase inhibitor Pancreatic and extra-pancreatic neuroendocrine tumors Completed rolling submission of NDA to FDA
Immunomet Therapeutics Inc., of Houston IM-156 Protein complex 1 inhibitor Idiopathic pulmonary fibrosis FDA granted fast track designation
Newron Pharmaceuticals SpA, of Milan, Italy Xadago (safinamide) Inhibitor of dopamine reuptake, MAO-B and glutamate release Parkinson's disease Received a paragraph IV notice letter regarding the submission by a generic manufacturer of an ANDA to FDA, seeking approval to engage in the manufacture, use or sale of safinamide mesylate before expiration of certain U.S. patents
Pfizer Inc., of New York Elranatamab (PF-06863135) Bispecific antibody targeting BCMA and CD3 Relapsed/refractory multiple myeloma New enrollment in the registration-enabling phase II MagnetisMM-3 study has been paused while the company provides additional information to FDA regarding 3 cases of peripheral neuropathy observed in the ongoing phase I MagnetisMM-1 study; patients who are deriving clinical benefit from elranatamab may continue treatment
Quercis Pharma AG, of Zug, Switzerland Isoquercetin Employs a pathway based on a mechanism of action to prevent or reverse thrombus formation To effect thromboembolic events in metastatic pancreatic cancer patients Entered a special protocol assessment with FDA for the protocol for a randomized, placebo-controlled, double-blind phase III trial 
R-Pharm Germany GmbH, of Illertissen, Germany Sputnik V Adenovirus-based vaccine COVID-19 prophylaxis EMA’s Committee for Medicinal Products for Human Use has started a rolling review
Siga Technologies Inc., of New York Tpoxx (tecovirimat) intravenous formulation Antiviral Smallpox Filed an NDA with FDA
Viiv Healthcare Ltd., of London Cabotegravir Antiviral Prevention of HIV (pre-exposure prophylaxis) Initiated a rolling submission of NDA with FDA

Notes

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