Soligenix Receives FDA Orphan Drug Designation For 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
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Soligenix has been granted FDA Orphan Drug Designation for the active ingredient in SuVax, a subunit protein vaccine aimed at preventing and providing post-exposure prophylaxis against Sudan Ebolavirus (SUDV) infection. This designation is a significant step for Soligenix in the development and potential commercialization of SuVax.
April 11, 2024 | 11:32 am
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Soligenix's receipt of FDA Orphan Drug Designation for SuVax's active ingredient marks a pivotal advancement in its pipeline, potentially accelerating the vaccine's development and enhancing its market exclusivity.
The FDA Orphan Drug Designation is known to provide benefits such as tax credits, user fee waivers, and market exclusivity for seven years post-approval. This can significantly impact Soligenix's financials and stock price by potentially reducing development costs and limiting competition.
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