Company: ZVRA
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0001437749-25-016523
Chunk: 104

Company: ZEVRA THERAPEUTICS, INC.
Filing Date: 2025-05-13
Form: 10-Q
Item: Part I, Item 1
Chunk 104
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 Access Program (“EAP”) 
      Tracking Commercial Progress   Target MAA Submission in H2 2025 

      Sodium phenylbutyrate 
      Urea Cycle Disorders (UCD) 
      OLPRUVA 
      FDA Approved 
      Tracking Commercial Progress 

      Celiprolol 
      Vascular Ehlers Danlos Syndrome (VEDS) 
      Celiprolol 
      Clinical - Phase 3 
      Phase 3 Ongoing 

      Serdexmethylphenidate 
      Idiopathic Hypersomnia (IH) 
      KP1077IH 
      Clinical - Phase 2 
      Phase 3 Trial Ready; Seeking Strategic Alternatives 

      Serdexmethylphenidate 
      Narcolepsy 
      KP1077N 
      Clinical - Phase 1/2 
     Phase 3 Trial Potential; Seeking Strategic Alternatives

      Serdexmethylphenidate and dexmethylphenidate 
      Attention Deficit and Hyperactivity Disorder (ADHD) 
      AZSTARYS 
      FDA Approved and Partnered 
      Collecting Royalties and Milestones 

These anticipated milestones are based on information currently available to us. Our current plans and expectations are subject to a number of uncertainties, risks and other important factors that could materially impact our plans, including risks which are not solely within our control. See Part I, Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 12, 2025, as updated by Part II, Item 1A. “Risk Factors” of this Quarterly Report on Form 10-Q.

     MIPLYFFA

NPC is characterized by an inability of the body to transport cholesterol and lipids inside of cells. Symptoms of NPC include a progressive impairment of mobility, cognition, speech, and swallowing, often culminating in premature death. The incidence of NPC is estimated to be one in 100,000 to 130,000 live births. We estimate that there are approximately 1,800 individuals with NPC in the U.S. and Europe combined, of which approximately 900 are in the U.S. and 1,100 are in the EU, where there is a mature market with an approved treatment available for NPC. Of these, approximately 300 to 350 people have been diagnosed in the U.S. However, diagnostic challenges may affect the number of potential patients, and