Zevra Therapeutics Files 8-K: Reg FD, Other Events

TL;DR

Zevra Therapeutics (ZEVRA) filed an 8-K on Nov 21, 2024, covering Reg FD disclosures and other events.

AI Summary

On November 21, 2024, Zevra Therapeutics, Inc. filed an 8-K report detailing a Regulation FD Disclosure and Other Events. The filing also includes financial statements and exhibits. The company, formerly known as KemPharm, Inc., is incorporated in Delaware and headquartered in Celebration, Florida.

Why It Matters

This 8-K filing provides important updates and disclosures from Zevra Therapeutics, Inc. to the public, impacting investor understanding of the company's current status.

Risk Assessment

Risk Level: low — This filing is a routine 8-K report and does not appear to contain significant negative news or events.

Key Numbers

• 001-36913 — SEC File Number (Identifies the company's filing with the SEC.)
• 20-5894398 — IRS Employer Identification Number (Company's tax identification number.)

Key Players & Entities

• ZEVRA THERAPEUTICS, INC. (company) — Registrant
• KEMPHARM, INC (company) — Former company name
• November 21, 2024 (date) — Date of earliest event reported
• Delaware (jurisdiction) — State of incorporation
• Celebration, FL (location) — Principal executive office address

FAQ

Filing Documents

• zvra20241121_8k.htm (8-K) — 38KB
• ex_751176.htm (EX-99.1) — 27KB
• picture3.jpg (GRAPHIC) — 6KB
• 0001437749-24-035988.txt ( ) — 212KB
• zvra-20241121.xsd (EX-101.SCH) — 3KB
• zvra-20241121_def.xml (EX-101.DEF) — 11KB
• zvra-20241121_lab.xml (EX-101.LAB) — 15KB
• zvra-20241121_pre.xml (EX-101.PRE) — 11KB
• zvra20241121_8k_htm.xml (XML) — 3KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On November 21, 2024, Zevra Therapeutics, Inc., a Delaware corporation (the Company), issued a press release announcing that MIPLYFFA (arimoclomol), the first treatment approved by the United States Food and Drug Administration for the treatment of Niemann-Pick Disease Type C (NPC), is now commercially available for dispense. MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of NPC in adult and pediatric patients 2 years of age and older. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The information in this Item 7.01 and Exhibit 99.1 attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.

01. Other Events

Item 8.01. Other Events. As noted in Item 7.01 above, on November 21, 2024, the Company announced that MIPLYFFA, the first FDA-approved treatment for Niemann-Pick disease type C, is available at Zevra's specialty pharmacy for dispense. The Company is utilizing its comprehensive patient support program, AmplifyAssist, to support the individual needs of eligible patients and those who care for them. Available resources include personalized insurance coverage education and support, copay and alternate funding identification assistance for eligible patients' product needs, disease state information and therapy management counseling, and ongoing interactions to address barriers while facilitating timely prescription refills. Caution Concerning Forward-Looking Statements This Current Report on Form 8-K may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation statements regarding the promise and potential impact of our preclinical or clinical trial data, the initiation, timing, design, or results of any clinical trials or readouts, the potential benefits of any of our products or product candidates for any specific disease indication or at any dosage, and upcoming events or Zevra's participation at such events. Forward-looking statements are based on information currently available to Zevra and its current plans or expectations. They are subject to several known and unknown uncertainties, risks, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the "Risk Factors" section of Zevra's Annual Report on Form 10-K for the year ended December 31, 2

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits. The following exhibit relating to Item 7.01 shall be deemed to be furnished, and not filed: (d) Exhibits Exhibit No. Description 99.1 Press Release dated November 21, 2024. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Zevra Therapeutics, Inc . Date: November 21, 2024 By: /s/ Timothy J. Sangiovanni Timothy J. Sangiovanni, CPA Senior Vice President, Finance and Corporate Controller

View Full Filing

View this 8-K filing on SEC EDGAR