Company Product Description Indication Status
Adamis Pharmaceuticals Corp., of San Diego Tempol Superoxide dismutase modulator COVID-19 FDA cleared IND to proceed with phase II/III study enrolling patients early in the infection
Amgen Inc., of Thousand Oaks, Calif. Otezla (apremilast) Small-molecule PDE4 inhibitor Mild to moderate plaque psoriasis Submitted supplemental NDA seeking use in patients who are candidates for phototherapy or systemic therapy
Astrazeneca plc, of Cambridge, U.K. Imfinzi (durvalumab) PD-L1 inhibitor Locally advanced or metastatic bladder cancer Company voluntarily withdrew indication in U.S.; decision made in consultation with FDA; Imfinzi was granted accelerated approval in May 2017, but post-approval phase III Danube study failed to meet primary endpoints in 2020
Brainstorm Cell Therapeutics Inc., of New York Nurown Autologous MSC-NTF cells Amyotrophic lateral sclerosis Received FDA feedback, with agency concluding current level of clinical data does not provide threshold of substantial evidence FDA is seeking to support BLA; FDA also advised that this recommendation does not preclude company from proceeding with BLA submission
Cassava Sciences Inc., of Austin, Texas Simufilam Filamin A modulator Alzheimer's disease Completed end-of-phase II meeting with FDA; reached agreement on key elements for pivotal phase III program to support NDA filing
Celsion Corp., of Lawrenceville, N.J. GEN-1 DNA-mediated interleukin-12 immunotherapy Advanced ovarian cancer FDA granted fast track designation
Curocell Inc., of Daejeon, South Korea CRC-01 CD19 CAR T-cell therapy Relapsed/refractory diffuse large B-cell lymphoma Korea's Ministry of Food and Drug Safety approved the phase I/II clinical study application; trial expected to start in the first half of 2021
Federal Research Center for Research and Development of Immunobiological Preparations in Russia Kovivac COVID-19 vaccine COVID-19 Registered by the Russian Ministry of Health for the prevention of COVID-19
Intra-Cellular Therapies Inc., of New York Caplyta (lumateperone) Serotonin 5-HT2A receptor/dopamine D2 receptor antagonist Bipolar I or II disorder Submitted supplemental NDAs for 2 indications: as monotherapy and as adjunctive therapy with lithium or valproate for treating bipolar depression in adults
Junshi Biosciences Co. Ltd., of Shanghai Toripalimab Anti-PD-1 monoclonal antibody Recurrent or metastatic nasopharyngeal carcinoma China's NMPA granted conditional approval to treat patients after failure of at least 2 lines of prior systemic therapy
Supernus Pharmaceuticals Inc., Rockville, Md. SPN-812 Norepinephrine uptake inhibitor; psychomodulator Attention deficit hyperactivity disorder Received notice from the FDA that the NDA resubmission seeking approval for use in pediatric patients is considered a class I resubmission, with a PDUFA date in early April 2021
Zosano Pharma Corp., of Fremont, Calif. Qtrypta (zolmitriptan transdermal microneedle system) 5-HT 1b receptor agonist; 5-HT 1d receptor agonist Migraine Received official type A meeting minutes from FDA regarding requirements for resubmission of 505(b)(2) NDA following complete response letter received Oct. 20, 2020; company maintains plan to conduct additional pharmacokinetic (PK) study for inclusion in resubmission package; FDA also recommended a skin assessment on patients in the planned PK study

Notes

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