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4D Molecular Therapeutics Stock Falls After Follow-Up Data From Mid-Stage Study Of Vision Loss Drug Candidate

4D Molecular Therapeutics Stock Falls After Follow-Up Data From Mid-Stage Study Of Vision Loss Drug Candidate

4d molecular therapeutics股价在中期视力损失药物候选病例的后续数据公布后下跌。
Benzinga ·  09/19 14:34

4D Molecular Therapeutics (NASDAQ:FDMT) stock is trading lower on Thursday after the company released interim follow-up data from the Phase 1/2 PRISM clinical trial and 4FRONT Phase 3 study design.

4d分子治疗(纳斯达克:FDMT)股票周四交易走低,此前公司发布了第1/2期PRISm临床试验和4FRONt第3期研究设计的中期追踪数据。

Robust and durable treatment burden reduction was observed in all PRISM populations studied with the planned Phase 3 dose of 3E10 vg/eye of 4D-150.

观察到在所有PRISm人群中,使用计划的纳斯达克第3阶段剂量3E10 vg/eye的4d molecular therapeutics,治疗负担减轻强健耐用。

83% overall reduction in annualized injections, 52% received 0 or 1 injection, and 44% injection-free in Phase 1/2a Severe study compared to Phase 2b Broad study with observations of 89%, 80%, and 70% injection-free, respectively.

与第20亿阶段广泛研究的观察相比,在第1/2a严重研究中,年化注射整体减少了83%,52%的人接受了0或1次注射,44%的人不需要注射,而在第20亿阶段,相应观察到了89%、80%和70%的不需要注射。

In Phase 2b, recently diagnosed patients, a 98% overall reduction in annualized injections, 100% received 0 or 1 injection, and 87% injection-free was observed.

在第20亿阶段,最近确诊的患者中,年化注射整体减少了98%,100%的人接受了0或1次注射,87%的人无需注射。

In June, 4D Molecular Therapeutics unveiled interim 24-week data from the Population Extension cohort of its PRISM Phase 2 Clinical Trial.

在6月,纳斯达克第2阶段临床试验的人群延伸队列公布了24周的临时数据。

The trial evaluates intravitreal 4D-150 in a broad wet AMD patient population.

该试验评估了广泛的湿性AMD患者人群内视网膜内注射的4d molecular therapeutics。

Central Subfield Thickness (CST): sustained anatomic control with fewer fluctuations.

中央视野厚度(CST):保持解剖上控制,并减少波动。

4D-150 continues to be well tolerated with a favorable safety profile

4d molecular therapeutics继续被很好地耐受,并且具有良好的安全性。

The rate of 4D-150 intraocular inflammation (IOI) is numerically similar to that reported for approved anti-VEGF agents.

4D-150眼内炎(IOI)的发病率与已批准的抗VEGF药物报告的数字类似。

  • Wet AMD:2.8% (2 of 71) had 4D-150–related IOI at any time point, and two patients had transient 1+ vitreous cells
  • 99% (70 of 71) completed steroid prophylaxis taper on schedule and 97% (69 of 71) remained off steroids completely.
  • Diabetic Macular Edema (DME; SPECTRA trial): No patients treated at any dose (n=22) have experienced IOI events at any time.
  • 湿性黄斑变性:2.8%(71中的2名患者)在任何时间点上与4D-150相关的IOI,并且有两名患者出现短暂的1+玻璃体细胞。
  • 99%(71中的70名患者)按计划完成类固醇预防性缓解,并且有97%(71中的69名患者)完全停用类固醇。
  • 糖尿病性黄斑水肿(DME;SPECTRA试验):任何剂量(n=22)的患者在任何时间点都未发生IOI事件。

In February this year, 4D Molecular Therapeutics released interim data from the Phase 2 PRISM clinical trial evaluating intravitreal 4D-150 in wet age-related macular degeneration (wet AMD) patients.

今年2月,4d molecular therapeutics发布了来自PRISm第2期临床试验的中期数据,评估湿性老年性黄斑变性(湿性AMD)患者的眼内注射4D-150。

The company plans for a global 4FRONT Phase 3 development program comparing a single dose of 4D-150 3E10 vg/eye to on-label Regeneron Pharmaceuticals Inc.'s (NASDAQ: REGNP Eylea (aflibercept) 2mg Q8 weeks. The trial is expected to start in the first quarter of 2025, with around 500 participants.

该公司计划开展全球4FRONt第3期开发计划,比较单次剂量的4D-150 3E10 vg/eye与Regeneron Pharmaceuticals Inc.(NASDAQ:REGNP)的(aflibercept)2mg Q8周的标准使用剂量。该试验预计于2025年第一季度开始,参与者约有500人。

Price Action: FDMT stock is down 18.80% at $13.66 at the last check on Thursday.

股价走势:FDMt股票在最后一次检查时下跌了18.80%,为13.66美元。

  • Hims & Hers To Offer Access To Compounded Diabetes And Weight Loss Drugs For Just $99/Month To Certain Professional Personnel.
  • Hims & Hers将为特定专业人员提供合成的糖尿病和减肥药物访问权限,每月仅需99美元。
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