Zevra Therapeutics Files 8-K Report

TL;DR

Zevra Therapeutics filed an 8-K, likely with financial updates and other disclosures.

AI Summary

On September 20, 2024, Zevra Therapeutics, Inc. filed an 8-K report. The filing primarily concerns financial statements and exhibits, along with other events and a Regulation FD disclosure. No specific financial figures or new material events were detailed in the provided excerpt.

Why It Matters

This filing indicates Zevra Therapeutics is providing updated information to the SEC, which could include material disclosures relevant to investors.

Risk Assessment

Risk Level: low — The filing is a standard 8-K report without immediate indication of significant negative events or financial distress.

Key Players & Entities

• ZEVRA THERAPEUTICS, INC. (company) — Registrant
• 0001434647 (company) — Central Index Key
• 20240920 (date) — Filing Date
• 1180 CELEBRATION BOULEVARD, SUITE 103 (address) — Principal Executive Offices
• CELEBRATION, FL 34747 (address) — Principal Executive Offices

FAQ

Filing Documents

• zvra20240920_8k.htm (8-K) — 37KB
• ex_726150.htm (EX-99.1) — 33KB
• picture3.jpg (GRAPHIC) — 6KB
• 0001437749-24-029747.txt ( ) — 218KB
• zvra-20240920.xsd (EX-101.SCH) — 3KB
• zvra-20240920_def.xml (EX-101.DEF) — 11KB
• zvra-20240920_lab.xml (EX-101.LAB) — 15KB
• zvra-20240920_pre.xml (EX-101.PRE) — 11KB
• zvra20240920_8k_htm.xml (XML) — 3KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On September 20, 2024, Zevra Therapeutics, Inc., a rare disease therapeutics company (the Company), issued a press release announcing that the U.S. Food and Drug Administration (FDA) has approved MIPLYFFA (MY-PLY-FAH) (arimoclomol) capsules as an orally delivered treatment for Niemann-Pick disease type C (NPC). The first NPC drug approved by the FDA, 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. 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 September 20, 2024, the Company announced that the FDA approved MIPLYFFA capsules as an orally delivered treatment for NPC. In addition, the Company announced that it has received a rare pediatric disease priority review voucher in conjunction with the approval. 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 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, 2023, Zevra's quarterly report for the three months ended June 30, 2024, and Zevra's other filings with the Securities and Exchange Commission. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we cannot assure that such expectations will prove correct. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this Current Report on Form 8-K.

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 September 20, 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: September 20, 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