Soligenix, Inc. (NASDAQ: SNGX) saw its stock prices slightly off early Thursday. The Princeton, New Jersey-based company, a late-stage biopharmaceutical concern focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient in SuVax™, the subunit protein vaccine of recombinantly expressed Sudan ebolavirus (SUDV) glycoprotein, for “the prevention and post-exposure prophylaxis against SUDV infection.”
The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders, defined as one that affects fewer than 200,000 people in the U.S. 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.
Said Chief Scientific Officer Oreola Donini, “SuVax™ is based on our novel vaccine platform which includes three major components: a robust protein manufacturing process that has been demonstrated on multiple protein antigens, a novel nano-emulsion adjuvant which induces broad immunity, and a formulation procedure which enables thermostabilization of the combination of adjuvant and antigen in a single vial.”
SNGX shares lost 0.035 cents to 45 cents.
