The FDA's Orphan Drug designation is granted to drugs that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. This designation provides the sponsor of the drug certain benefits and incentives, including a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. The potential financial and marketing benefits could have a positive impact on Harmony Biosciences' stock in the short term.