EN
登录

Dyne寻求Duchenne药物批准;Kymera、Wave和Structure股价飙升

Dyne to seek Duchenne drug approval; Kymera, Wave and Structure shares soar

BioPharma Dive 等信源发布 2025-12-08 23:46

可切换为仅中文


Listen to the article

听取文章

4 min

4分钟

This audio is auto-generated. Please let us know if you have

此音频是自动生成的。如果有任何问题,请告诉我们。

feedback

反馈

.

Today, a brief rundown of news from Dyne Therapeutics and Kymera Therapeutics, as well as updates from Wave Life Sciences and Structure Therapeutics that you may have missed.

今天,简单介绍一下您可能错过的 Dyne Therapeutics 和 Kymera Therapeutics 的新闻,以及 Wave Life Sciences 和 Structure Therapeutics 的最新动态。

Dyne Therapeutics

动力治疗公司

will seek approval

将寻求批准

of a new type of “exon skipping” drug for Duchenne muscular dystrophy. According to Dyne, treatment with the therapy,

一种新型“外显子跳跃”药物,用于治疗杜氏肌营养不良症。据 Dyne 称,使用该疗法进行治疗,

z-rostudirsen

z-rostudirsen

, led to a more than 5% increase in levels of a muscle-protecting protein in a registrational trial. Drug recipients also displayed improvements, after six months, on multiple indicators of motor function, though the study wasn’t powered to detect a statistical benefit on those measures. Dyne intends to file for an accelerated U.S.

,导致在一项注册试验中肌肉保护蛋白水平增加了超过5%。用药者在六个月后多项运动功能指标上也显示出改善,尽管该研究并未设计为能在这些指标上检测到统计学上的益处。Dyne公司计划申请美国的加速审批。

clearance next year in Duchenne patients who have mutations in exon 51 of the dystrophin gene. There is some “consternation” from investors, as volatility at the Food and Drug Administration and the .

明年将对患有抗肌萎缩蛋白基因第51号外显子突变的杜氏患者进行清除。由于食品药品监督管理局和.的波动,投资者感到有些“惊慌”。

failures of multiple confirmatory trials

多个验证性试验的失败

have raised concerns about the regulatory bar for Duchenne medicines, wrote Stifel analyst Paul Matteis. Still, Dyne’s data on functional measures are the “best ever generated” for a drug of its kind in a placebo-controlled trial, he claimed.

富勒分析师保罗·马蒂斯写道,有人对杜氏肌营养不良症药物的监管门槛提出了担忧。不过,他声称,Dyne公司在功能指标上的数据是“有史以来最好的”,针对同类药物的安慰剂对照试验中。

Shares of

股票

Kymera Therapeutics

凯米拉治疗学

rose by more than 50% on new study results the company revealed for a protein-degrading drug it’s developing for inflammatory conditions. Kymera disclosed in June that the drug,

基于公司公布的新研究结果,其正在开发的一种用于炎症性疾病的蛋白质降解药物上涨超过50%。凯米拉公司在六月透露,该药物

KT-621

KT-621

, appeared

,出现了

safe and able to degrade a tough-to-reach protein

安全且能够降解难以触及的蛋白质

in the blood and skin that’s linked to inflammation. Data

在血液和皮肤中,这与炎症有关。数据

announced on Monday

周一宣布

build on those results, indicating KT-621 — an oral medication — is impacting markers of disease in atopic dermatitis with “biologic-like or better efficacy,” wrote Mizuho Securities analyst Joseph Catanzaro. One mid-stage trial is ongoing in atopic dermatitis, and a second in asthma should begin next year..

基于这些结果,Mizuho Securities分析师Joseph Catanzaro写道,KT-621(一种口服药物)正在“以类似生物制剂或更好的疗效”影响特应性皮炎的疾病标志物。目前,一项针对特应性皮炎的中期试验正在进行中,而另一项针对哮喘的试验预计将于明年开始。

Wave Life Sciences

波浪生命科学

saw its share price nearly double after initial study data suggested one of its drug prospects

在初步研究数据表明其一种药物前景良好后,其股价几乎翻了一番。

might have potential treating obesity

可能有治疗肥胖的潜力

. When compared to a placebo, a single, low dose of the therapy, an oligonucleotide-based treatment called

与安慰剂相比,这种疗法的单一低剂量是一种叫做寡核苷酸的治疗

WVE-007

WVE-007

, was associated with a 9% reduction in harmful “visceral” fat, a 4% decline in total body fat, and a slight improvement in lean mass after three months. There have been no study discontinuations or serious treatment-emergent adverse events, either. Wave is planning Phase 2 trials testing WVE-007 as a monotherapy and alongside incretin drugs for weight loss.

,与三个月后有害的“内脏”脂肪减少9%、全身脂肪减少4%以及瘦体重略有改善相关。此外,目前尚无研究中断或严重的治疗相关不良事件发生。Wave公司正计划进行第二阶段试验,测试WVE-007作为单一疗法以及与肠促胰岛素药物联合用于减重的效果。

The results so far “signal this program will be competitive,” Leerink Partners analyst Joseph Schwartz wrote. .

截至目前,结果“表明该项目将具有竞争力,”Leerink Partners 分析师 Joseph Schwartz 写道。

Structure Therapeutics

结构疗法

also

此外

reported positive results

报告了积极的结果

for a prospective obesity drug. Called

用于一种潜在的肥胖症药物。被称为

aleniglipron

阿勒尼格利普隆

, the treatment is a GLP-1 pill, much like a therapy known as

,这种治疗是一种GLP-1药丸,很像一种被称为

orforglipron

orforglipron

that

那个

Eli Lilly

礼来公司

could soon bring to market. In a Phase 2 trial, a 120 milligram dose of

可能很快就会推向市场。在二期试验中,120毫克的剂量

aleniglipron

阿列尼格利普隆

spurred weight loss of 11% after nine months compared to a placebo, “similar” efficacy to Lilly’s drug, wrote Leerink’s David Risinger. And though the drug appeared less tolerable — rates of vomiting were higher than what’s been observed in testing of orforglipron — a low starting dose compared more favorably, Risinger added.

与安慰剂相比,该药物在九个月后促使体重减轻了11%,Leerink的David Risinger写道,这一疗效与礼来公司的药物“相似”。Risinger补充道,尽管该药物的耐受性似乎较差——呕吐率高于在orforglipron测试中观察到的水平——但起始低剂量的表现相对较好。

Structure said the findings support advancement into Phase 3 trials. Company shares, which .

结构表示,这些发现支持推进到第三阶段试验。公司股价。

debuted at $15 apiece in 2023

2023年每股以15美元的价格首次亮相

, more than doubled and are now changing hands at over $90 apiece.

,翻了一倍多,现在每股交易价格超过 90 美元。