Zevra Therapeutics Files 8-K

TL;DR

Zevra Therapeutics filed an 8-K, mostly about financials and exhibits.

AI Summary

On August 2, 2024, Zevra Therapeutics, Inc. filed an 8-K report. The filing primarily concerns the company's 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 financial details or disclosures relevant to investors.

Risk Assessment

Risk Level: low — The provided excerpt is a standard 8-K filing notification without specific material events or financial data that would indicate immediate risk.

Key Players & Entities

• ZEVRA THERAPEUTICS, INC. (company) — Registrant
• August 2, 2024 (date) — Date of Earliest Event Reported
• 1180 Celebration Boulevard, Suite 103, Celebration, FL 34747 (address) — Principal Executive Offices
• KEMPHARM, INC (company) — Former Company Name

FAQ

Filing Documents

• zvra20240802_8k.htm (8-K) — 40KB
• ex_707898.htm (EX-99.1) — 14KB
• picture3.jpg (GRAPHIC) — 6KB
• 0001437749-24-024543.txt ( ) — 198KB
• zvra-20240802.xsd (EX-101.SCH) — 3KB
• zvra-20240802_def.xml (EX-101.DEF) — 11KB
• zvra-20240802_lab.xml (EX-101.LAB) — 15KB
• zvra-20240802_pre.xml (EX-101.PRE) — 11KB
• zvra20240802_8k_htm.xml (XML) — 3KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On August 2, 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) Genetic Metabolic Diseases Advisory Committee (GeMDAC) voted favorably (11 yes, 5 no) that the data support that arimoclomol is effective in the treatment of patients with 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 August 2, 2024, the Company announced that the FDA GeMDAC voted favorably (11 yes, 5 no) that the data support that arimoclomol is effective in the treatment of patients with NPC. The GeMDAC, which consists of experts in the fields of medical genetics, inborn errors of metabolism, epidemiology and other related specialties, discussed the benefits and risks of arimoclomol, including the data recently presented at the 45 th Annual Meeting of the Society for Inherited Metabolic Disorders (SIMD), and reviewed comments received from independent experts, NPC patients, and patient advocacy group representatives. The committee's recommendation will be considered by the FDA as it completes its independent review of the arimoclomol NDA; however, the feedback from the GeMDAC is not binding upon the FDA. The arimoclomol NDA 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

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 August 2, 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: August 2, 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