HOTH - Hoth Therapeutics spikes on FDA's Orphan Drug status for mastocytosis therapy

The shares of development-stage biopharma company, Hoth Therapeutics (HOTH +44.7%) have gained sharply on Thursday after the U.S. Food and Drug Administration (FDA) granted it the Orphan Drug Designation for a potential therapy targeted at mastocytosis. According to the FDA database, the designation awarded on March 10 covers an experimental therapy with the name, “c-KIT-targeting, dendrimer-linked phosphorodiamidate morpholino oligonucleotide.” With its orphan drug designation, the FDA aims to offer financial incentives to drug developers targeting rare diseases and conditions. In addition to tax credits for clinical trial costs and waiver of the user fee for marketing applications, the developers of orphan drugs can claim seven years of marketing exclusivity upon regulatory approval for the treatment.

For further details see:

Hoth Therapeutics spikes on FDA’s Orphan Drug status for mastocytosis therapy