Update for April 4, 2023

Regulatory Update
 
The FDA approved retifanlimab (Zynyz, Incyte), on 3/22/2023, for the treatment of metastatic or recurrent locally advanced Merkel cell carcinoma.
 
The FDA approved rezafungin (Rezzayo, Cidara Therapeutics), on 3/22/2023, for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options.
 
The FDA approved leniolisib (Joenja, Pharming), on 3/25/2023, for the treatment of activated phosphoinositide 3-kinase delta syndrome.
 
Iovance submitted a BLA for lifileucel for the treatment of unresectable or metastatic melanoma.
 
J&J discontinued development of its respiratory syncytial virus (RSV) vaccine and the Phase III EVERGREEN study to prioritize other assets.
 
With Chinese strict COVID-19 travel restriction being loosened the FDA has scheduled manufacturing facility inspections for 2Q23 for BeiGene’s tislelizumab and Junshi Biosciences’ toripalimab.
 
The FDA granted RRx-001 a Fast Track Designation for the prevention/attenuation of severe oral mucositis in chemotherapy and radiation-treated head & neck cancer patients.