Zevra Therapeutics Files 8-K Report

TL;DR

Zevra Therapeutics filed an 8-K, mostly standard stuff, check exhibits for details.

AI Summary

On March 26, 2024, Zevra Therapeutics, Inc. filed an 8-K report. The filing primarily concerns financial statements and exhibits, and other events, indicating updates or disclosures relevant to the company's operations and regulatory compliance. No specific financial figures or new material events were detailed in the provided excerpt.

Why It Matters

This filing serves as an official record of significant company events or disclosures, providing transparency to investors and the market about Zevra Therapeutics' status.

Risk Assessment

Risk Level: low — The filing is a routine 8-K report without immediate news of significant financial changes or strategic shifts.

Key Players & Entities

• ZEVRA THERAPEUTICS, INC. (company) — Registrant
• 0001434647 (company) — Central Index Key
• 2834 (company) — Standard Industrial Classification (Pharmaceutical Preparations)
• 03 Life Sciences (company) — Organization Name
• 205894398 (company) — IRS Number
• DE (company) — State of Incorporation
• 1231 (company) — Fiscal Year End
• 001-36913 (company) — SEC File Number
• 24785462 (company) — Film Number
• 1180 CELEBRATION BOULEVARD, SUITE 103 (company) — Business Address Street 1

FAQ

Filing Documents

• zvra20240326_8k.htm (8-K) — 42KB
• ex_645330.htm (EX-99.1) — 22KB
• picture3.jpg (GRAPHIC) — 6KB
• 0001437749-24-009476.txt ( ) — 210KB
• zvra-20240326.xsd (EX-101.SCH) — 3KB
• zvra-20240326_def.xml (EX-101.DEF) — 11KB
• zvra-20240326_lab.xml (EX-101.LAB) — 15KB
• zvra-20240326_pre.xml (EX-101.PRE) — 11KB
• zvra20240326_8k_htm.xml (XML) — 3KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On March 26, 2024, Zevra Therapeutics, Inc., a Delaware corporation (the Company), issued a press release announcing top-line data from the Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia (IH). 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 March 26, 2024, the Company announced top-line data from the Phase 2 Clinical Trial of KP1077 for IH. The positive top-line results of the Phase 2 trial support the safety and tolerability of KP1077 as measured by the primary endpoint of the study. The study also successfully fulfilled the objectives of providing key information for the design of a potentially pivotal efficacy trial, and the results of the secondary efficacy endpoints were supportive of initiating a Phase 3 trial of KP1077. KP1077 was shown to be well-tolerated at all dose levels evaluated in the trial, including the highest dose of 320 mg daily, regardless of dosing regimen (once or twice daily). The most common adverse events were insomnia, headache, anxiety, nausea, and decreased appetite. Due to its unique pharmacokinetic profile, adverse events were mostly mild in severity despite higher overall exposure levels when compared to both immediate and long-acting methylphenidate products currently used off-label for the treatment of IH. Topline results of the Phase 2 study include: KP1077 produced clinically meaningful improvement in excessive daytime sleepiness (EDS), as assessed by change from baseline in the Epworth Sleepiness Scale (ESS), that was maintained during both the five-week open-label titration period and throughout the 2-week double-blind withdrawal period for both dosing regimens. Patients administered KP1077 showed benefits in change from baseline for the IH Severity Scale (IHSS), Sleep Inertia Visual Analog Scale (SIVAS) and Brain Fog severity Scale (BFS) at the end of the open-label dose titration, and at the end of the double-blind withdrawal period. The results from the completed Phase 2 trial provide key information for the design of a potentially pivotal Phase 3 trial of KP1077 in patients with IH. The Company plans to request an end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration to seek gui

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 March 26, 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: March 26, 2024 By: /s/ Timothy J. Sangiovanni Timothy J. Sangiovanni, CPA Senior Vice President, Corporate Controller

View Full Filing

View this 8-K filing on SEC EDGAR