重大事件
即時報告
8-K
2026-07-20
4D Molecular Therapeutics 公佈基因療法 4D-150 二期兩年數據，注射次數減 78%
AI 繁中摘要
申報類型：8-K（其他重大事件）
4D Molecular Therapeutics（代碼：FDMT）於2026年7月18日公佈旗下基因療法4D-150在PRISM Phase 2b臨床試驗的兩年正面數據，對象為廣泛性濕性老年黃斑病變（wet AMD）患者。數據截止日為2026年5月18日。
📊 **試驗設計**
- 共45名患者接受單次玻璃體內注射，分為兩組劑量（3E10及1E10 vg/眼），其中3E10劑量已被選定作為4FRONT Phase 3試驗劑量。
- 整體隊列（n=30接受3E10）納入疾病活動廣泛者；亞組為最近確診（6個月內）患者（n=15接受3E10），與Phase 3試驗人群最匹配。
📈 **兩年療效結果**
- 最佳矯正視力（BCVA）維持穩定。
- 中央視網膜下層厚度（CST）由光學相干斷層掃描測量，控制理想。
- 治療負擔顯著下降：
- 整體隊列：平均僅需補充注射2.7次，較標籤用法（阿柏西普2mg每8週一次，約12次）減少78% 😮
- 最近確診亞組：平均補充注射1.6次，減幅達87% 🎯
- 劑量反應優勢持續兩年，支持Phase 3選用3E10劑量。
🛡️ **安全性數據（Phase 3劑量，合併Phase 1/2a及2b共71人）**
- 4D-150整體耐受性良好：
- 給藥後約首6個月（28週）內，2.8%（2/71）出現輕度（1+）眼內炎症，僅為單次時間點的短暫玻璃體細胞。
- 28週後截至數據截止日（最長超過4年追蹤），無新增炎症個案。
- 至今未觀察到與4D-150相關的低眼壓、眼內炎、血管炎、視網膜血管炎或脈絡膜滲出。
💡 **對投資者的潛在影響**
兩年數據顯示4D-150在廣泛wet AMD患者中能實現持續、持久的治療負擔減輕，且安全信號良好，為正在進行的4FRONT Phase 3試驗提供了堅實基礎。若Phase 3成功，4D-150有望成為wet AMD一線基因療法，大幅減少頻繁注射的醫療負擔。短期內市場反應料偏正面，但最終成敗仍取決於Phase 3結果及監管審批。
⚠️ 前瞻性陳述：本報告包含對4D-150治療潛力、耐久性及試驗成功的陳述，實際結果可能因風險因素等因素而有重大差異，詳見公司最新10-Q及後續SEC文件。
展開英文正文
8-K false 0001650648 0001650648 2026-07-18 2026-07-18 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): July 18, 2026 4D Molecular Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-39782 47-3506994 (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer Identification No.) 5858 Horton Street #455 Emeryville, California 94608 (Address of Principal Executive Offices) (Zip Code) Registrant’s Telephone Number, Including Area Code: (510) 505-2680 (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 Common Stock, $0.0001 par value per share FDMT Nasdaq Global Select Market Indicate by check mark whether the registrant is an emerging growth company 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 8.01 Other Events. On July 18, 2026, 4D Molecular Therapeutics, Inc. (the “Company”) reported positive 2-year data from the PRISM Phase 2b clinical trial evaluating 4D-150 in a broad wet age-related macular degeneration (“wet AMD”) population. 2-Year Data from PRISM Phase 2b Clinical Trial (Data Cutoff May 18, 2026): Trial and Patient Cohort Overview • The Phase 2b trial enrolled 45 patients at two dose levels of a single intravitreal dose of 4D-150 (3E10 and 1E10 vg/eye); 3E10 vg/eye was chosen as the dose for the 4FRONT Phase 3 clinical trials • The Phase 2b overall cohort enrolled patients with broad disease activity (n=30 dosed with 3E10 vg/eye and n=15 dosed with 1E10 vg/eye) • The Phase 2b cohort subgroup comprised recently diagnosed patients (diagnosed within 6 months, n=15 at 3E10 vg/eye), which is most comparable to the population enrolled in the 4FRONT Phase 3 clinical trials Phase 2b Efficacy Results Through 2 Years: • Consistent maintenance of best corrected visual acuity (“BCVA”) • Consistent control of central subfield thickness (“CST”) as measured by optical coherence tomography • Consistent, durable and clinically meaningful reduction in treatment burden: • Overall cohort: • 78% overall treatment burden reduction (2.7 mean supplemental injections per patient vs. 12.0 injections projected with on-label aflibercept 2 mg Q8W) • Recently diagnosed subgroup: • 87% overall treatment burden reduction (1.6 mean supplemental injections per patient vs. 12.0 injections projected with on-label aflibercept 2 mg Q8W) • Dose response maintained throughout 2 years in favor of the Phase 3 dose Safety Data for Phase 3 Dose in Overall PRISM Phase 1/2a & 2b Clinical Trial (n=71) • 4D-150 continues to be well tolerated: • Intraocular inflammation: • As previously reported, within approximately the first 6 months (28 weeks) post-4D-150 dosing, 2.8% (2 of 71) of patients had 4D-150-related 1+ (mild) intraocular inflammation (“IOI”) (SUN/NEI scales), which were transient 1+ vitreous cells noted at a single timepoint • Following the first 28 weeks post-4D-150 dosing, no new cases of inflammation with 2 to more than 4 years of follow-up on all patients as of the data cutoff • No 4D-150-related hypotony, endophthalmitis, vasculitis, occlusive/non-occlusive retinal vasculitis or choroidal effusions observed to date Forward-Looking Statements This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and expressed statements regarding the therapeutic potential, treatment-burden reduction, durability, and success of clinical trials for 4D-150. In some cases, you can identify these statements by forward-looking words such as “may,” “will,” “anticipate,” “intend,” “project,” “continue,” “target” or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including risks and uncertainties that are described in greater detail in the section entitled “Risk Factors” in the Company’s most recent Quarterly Report on Form 10-Q filed on May 7, 2026, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent 4D Molecular Therapeutics’ current views and should not be relied upon as representing its views as of any subsequent time. The Company explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. 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. 4D MOLECULAR THERAPEUTICS, INC. Date: July 20, 2026 By: /s/ Kristian Humer Kristian Humer Chief Financial Officer