Soligenix Shares Rise After SuVax Gets Orphan Drug Designation from US FDA
By Chris Wack
Soligenix shares were up 52% to 59 cents in premarket trading after the company said that the U.S. Food and Drug Administration has granted orphan drug designation to the active ingredient in SuVax.
The biopharmaceutical company said its SuVax product is intended to be used as a vaccine for the prevention and post-exposure prophylaxis against Sudan ebolavirus 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, the 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, and certain tax credits.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
April 15, 2024 08:06 ET (12:06 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.-
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