On Monday, Soligenix Inc (NASDAQ:SNGX) received an FDA orphan drug designation for the active ingredient in MarVax, the subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein, for the prevention and post-exposure prophylaxis against MARV infection.
In addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designation also positions Soligenix to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a Biologics License Application (BLA), and certain tax credits.
Marburg marburgvirus causes Marburg Virus Disease, a highly related disease to the more commonly known Ebola Virus Disease.
Although MARV has caused fewer outbreaks, they remain highly fatal and a significant risk in continental Africa, with the most recent outbreak occurring in 2023. There is no approved vaccine for MARV, and the only approved vaccines for filovirus-type disease is specific to Zaire ebolavirus.
Just last week, the FDA granted Orphan Drug status to the active ingredient in Soligenix's SuVax, the subunit protein vaccine of recombinantly expressed Sudan ebolavirus (SUDV) glycoprotein, for the prevention and post-exposure prophylaxis against SUDV infection.
Price Action: SNGX shares are up 37.2% at $0.53 on the last check Monday.