Zevra Therapeutics Files 8-K Report

TL;DR

Zevra Therapeutics filed an 8-K, mostly boilerplate with financial statements and exhibits.

AI Summary

On July 9, 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 new financial figures or material events were detailed in the provided excerpt.

Why It Matters

This filing indicates Zevra Therapeutics is providing updates or disclosures to the SEC, which could contain important information for investors regarding the company's status or recent activities.

Risk Assessment

Risk Level: low — The provided text is a standard SEC filing notification and does not contain specific material events or financial data that would indicate a change in risk.

Key Players & Entities

• ZEVRA THERAPEUTICS, INC. (company) — Registrant
• 0001434647 (company) — Central Index Key
• 205894398 (company) — IRS Number
• DE (company) — State of Incorporation
• 1231 (company) — Fiscal Year End
• 1180 CELEBRATION BOULEVARD, SUITE 103 (company) — Business Address
• CELEBRATION (company) — City
• FL (company) — State
• 34747 (company) — ZIP Code
• (321) 939-3416 (company) — Business Phone

FAQ

Filing Documents

• zvra20240614_8k.htm (8-K) — 38KB
• ex_696268.htm (EX-99.1) — 14KB
• picture3.jpg (GRAPHIC) — 6KB
• 0001437749-24-022362.txt ( ) — 196KB
• zvra-20240709.xsd (EX-101.SCH) — 3KB
• zvra-20240709_def.xml (EX-101.DEF) — 11KB
• zvra-20240709_lab.xml (EX-101.LAB) — 15KB
• zvra-20240709_pre.xml (EX-101.PRE) — 11KB
• zvra20240614_8k_htm.xml (XML) — 3KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On July 9, 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 indicated that it will convene a meeting with the recently formed Genetic Metabolic Diseases Advisory Committee (GeMDAC) on August 2, 2024, to review the New Drug Application (NDA) for arimoclomol as an orally delivered, first-in-class treatment for Niemann-Pick disease type C (NPC). 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 July 9, 2024, the Company announced that the FDA will convene a meeting with the GeMDAC on August 2, 2024, to review the NDA for arimocolomol. According to the notice provided, the FDA intends to make the background materials available to the public no later than two business days prior to the meeting. The GeMDAC consists of experts in the fields of medical genetics, inborn errors of metabolism, epidemiology, and other related specialties. The NDA for arimoclomol has been assigned a Prescription Drug User Fee Act (PDUFA) action date of September 21, 2024. 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 impact of meetings or communications with GeMDAC or the FDA, the content, information used for, timing or results of any NDA submissions or resubmissions for arimoclomol or any other drug product candidates for any specific disease indication or at any dosage, the potential launch or commercialization of any of drug product candidates or products, and our strategic and product development objectives, including with respect to becoming a leading, commercially focused rare disease company. Forward-looking statements are based on information currently available to the Company 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 the Company's

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 July 9, 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: July 9, 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