重大事件
即時報告
8-K
2026-06-22
MapLight Therapeutics 提交 8-K 申報，公佈 ML-004 治療自閉症譜系障礙（ASD）嘅 Phase 2 IRIS 臨床試驗頂線結果
AI 繁中摘要
MapLight Therapeutics 提交 8-K 申報，公佈 ML-004 治療自閉症譜系障礙（ASD）嘅 Phase 2 IRIS 臨床試驗頂線結果 🧬
**申報類型**：8-K（即時報告）
**日期**：2026 年 6 月 22 日
**公司**：MapLight Therapeutics, Inc.（納斯達克代碼：MPLT，新興成長公司）
**事件重點**：
- 公司於當日舉行電話會議，匯報 IRIS（ML-004-002）Phase 2 研究嘅頂線結果。
- 同時發佈新聞稿及相關簡報（作為附件 99.1 及 99.2 提交）。
- ML-004 係一款針對自閉症譜系障礙嘅候選藥物，IRIS 研究係隨機、雙盲、安慰劑對照嘅二期試驗。
**關鍵數字**：
- 申報文件未有披露具體臨床數據（頂線結果詳情載於簡報及新聞稿中）。
- 投資者需參考公司電話會議及相關材料了解療效、安全性及統計顯著性等數字。
**管理層展望**：
- 公司未有直接表述展望，但公佈二期頂線結果係新藥開發關鍵里程碑，通常會影響後續註冊試驗及監管溝通計劃。
**對投資者潛在影響**：
- 臨床結果好壞直接影響股價波動 📈📉。若數據正面（如主要終點達標、安全性良好），將提升 ML-004 獲批機率及商業化價值；反之則可能打擊市場信心。
- 投資者應仔細閱讀新聞稿及簡報中嘅實際數字（例如改善評分量表、不良事件發生率等），並留意管理層在電話會議嘅補充解說。
- 由於公司係新興成長公司，未有盈利，此類臨床進展對估值尤其重要。
⚠️ 注意：本摘要僅基於 8-K 申報文件，實際頂線結果請以公司官方發佈為準。
展開英文正文
8-K false 0001770069 0001770069 2026-06-22 2026-06-22 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 22, 2026 MapLight Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-42914 83-2163243 (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.) 800 Chesapeake Drive Redwood City, California 94063 (Address of principal executive offices) Registrant’s telephone number, including area code: (617) 984-6300 N/A (Former name or former address, if changed since last report.) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading symbol(s) Name of each exchange on which registered Voting Common Stock, $0.0001 par value per share MPLT Nasdaq Global Select Market Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Item 7.01 Regulation FD Disclosure. On June 22, 2026, MapLight Therapeutics, Inc. (the “Company”) will hold a conference call to discuss the topline results from IRIS (ML-004-002), a Phase 2 study of ML-004 in autism spectrum disorder (the “IRIS Trial Results”). A copy of the presentation that will accompany the conference call is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K. In accordance with General Instruction B.2. of Form 8-K, the information in this Item 7.01 and Exhibit 99.1 hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing. Item 8.01 Other Events. On June 22, 2026, the Company issued a press release announcing the IRIS Trial Results. A copy of this press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit Number Exhibit Description 99.1 Company Presentation, dated June 22, 2026. 99.2 Press Release, dated June 22, 2026. 104 Cover Page Interactive Data File (formatted as inline XBRL). 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. MapLight Therapeutics, Inc. Dated: June 22, 2026 By: /s/ Christopher A. Kroeger Christopher A. Kroeger, M.D. Chief Executive Officer