Company Product Description Indication Status
Apexigen Inc., of San Carlos, Calif. APX-005M  Monoclonal antibody targeting CD40 Esophageal and gastroesophageal junction cancer and pancreatic cancer FDA granted orphan drug designations
Armata Pharmaceuticals Inc., of Marina Del Rey, Calif. AP-PA02 Bacteriophage  Pseudomonas aeruginosa infections FDA cleared the IND for Swarm-P.a., a phase Ib/IIa single ascending dose and multiple ascending dose study
Eton Pharmaceuticals Inc., of Deer Park, Ill. Zonisamide  Blocks T-type calcium channels Partial seizures in patients with epilepsy FDA accepted the NDA; PDUFA target action date is May 29, 2021
Merck & Co. Inc., of Kenilworth, N.J. Keytruda (pembrolizumab) Monoclonal antibody targeting PD-1 Relapsed or refractory classical Hodgkin lymphoma FDA approved the expanded label for adults after front-line therapy and for children with refractory disease or disease that relapsed after 2 or more lines of therapy
Immunitybio Inc., of Culver City, Calif. hAd5-COVID-19 Vaccine that targets the nucleocapsid and spike proteins  COVID-19 prophylaxis FDA authorized the IND for a 35-patient phase I study
OS Therapies Inc., of Cambridge, Md. OST-HER2 Attenuated Listeria monocytogenes expressing a tLLO-chimeric HER2 fusion protein Recurrent osteosarcoma FDA cleared the IND for a phase II study; plans to start the study in early 2021
Regeneron Pharmaceuticals, of Tarrytown, N.Y. Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Monoclonal antibodies targeting Zaire ebolavirus Ebola virus infection FDA approved the drug
Zhittya Genesis Medicine Inc., of Las Vegas Human FGF-1 Fibroblast growth factor  Amyotrophic lateral sclerosis Mexican regulatory authorities gave permission to start a study

Notes

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