Company Product Description Indication Status
Adamis Pharmaceuticals Corp., of San Diego Zimhi High-dose naloxone injection  Opioid overdose Held a type A meeting with the FDA to review the company’s response to the FDA’s complete response letter issued in November 2020; plans to resubmit the NDA within the next 45 days
Airway Therapeutics Inc., of Cincinnati AT-100 Recombinant human surfactant protein D COVID-19 FDA accepted the IND for a phase Ib study to confirm the feasibility of intratracheal administrations of AT-100 and its safety and tolerability profile; data expected in the third quarter of 2021
Akari Therapeutics plc, of London Nomacopan  Inhibits C5 complement and leukotriene B4 Moderate and severe bullous pemphigoid FDA cleared the IND for a phase III study expected to start in mid-2021; primary endpoint is disease remission on minimal oral corticosteroids
Genmab A/S, of Copenhagen, Denmark, and Seagen Inc., of Bothell, Wash. Tisotumab vedotin Antibody-drug conjugate targeting tissue factor Recurrent or metastatic cervical cancer  FDA accepted the BLA for priority review, seeking approval for use in patients with disease progression on or after chemotherapy; PDUFA target action date is Oct. 10, 2021
Jazz Pharmaceuticals Inc. plc, of Dublin Xywav (calcium, magnesium, potassium and sodium oxybates) GABA B receptor agonist  Idiopathic hypersomnia FDA accepted the supplemental NDA for priority review; PDUFA target action date is Aug. 12, 2021
Junshi Biosciences Inc., of Shanghai Toripalimab Monoclonal antibody targeting PD-1 Locally advanced or metastatic urothelial carcinoma  National Medical Products Administration of China granted a conditional approval for the expanded indication for use in patients after failure of a platinum-containing chemotherapy or progression within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy
Nugenerex Immuno-Oncology, a unit of Generex Biotechnology Corp., of Moramar, Fla. Ii-Key-SARS-CoV-2 vaccine COVID-19 vaccine containing 5 epitopes from the spike and membrane proteins  COVID-19 prophylaxis Submitted responses to the FDA’s pre-IND written response, including sequences of the epitopes, data from a mouse study showing specific antibody production, GMP manufacturing information and a revised protocol based on the FDA’s comments and requests
Pfizer Inc., of New York, and Biontech SE, of Mainz, Germany Pfizer-BioNTech vaccine (BNT-162b2) mRNA-based vaccine COVID-19 prophylaxis Requested FDA amend the emergency use authorization to include use in adolescents 12 to 15 years of age
Resverlogix Corp., of Calgary, Alberta Apabetalone Bromodomain and extra-terminal inhibitor Hospitalized COVID-19 Health Canada issued a no objection letter for a phase II study
Scilex Holding, a unit of Sorrento Therapeutics Inc., of Palo Alto, Calif. Ztlido (lidocaine) Anesthetic  Pain associated with postherpetic neuralgia FDA approved the supplemental NDA to add data showing wet topical systems can be successfully reapplied and remain adhered for up to the labeled administration period of 12 hours

Notes

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