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GSK准备重新推出Blenrep;激进分子挑战另一家“僵尸”生物技术公司

GSK prepares to relaunch Blenrep; Activists challenge another ‘zombie’ biotech

BioPharma Dive 等信源发布 2025-04-18 23:42

可切换为仅中文


Today, a brief rundown of news involving GSK and Bristol Myers Squibb, as well as updates from Elevation Oncology, Bayer and Airna that you may have missed.

今天,简要介绍一下你可能错过的有关GSK、百时美施贵宝、Elevation Oncology、拜耳和Airna的新闻动态。

GSK’s

葛兰素史克的

Blenrep

Blenrep

has been approved in the U.K. to treat people whose multiple myeloma has progressed after one line of therapy, the

已在英国获批用于治疗多发性骨髓瘤已在接受一线治疗后进展的患者,

company said Thursday

公司周四表示

. The clearance is Blenrep’s first since it was

。这是Blenrep自获得批准以来的首次清除

withdrawn from the market

退出市场

three years ago following the failure of a confirmatory trial, and comes after the company

三年前,在一项验证性试验失败后,公司

succeeded in additional studies

在额外的研究中取得了成功

that have since positioned it for a relaunch. The

这些措施为其重启奠定了基础。

Food and Drug Administration

食品药品监督管理局

is

set to decide

决定设置

on a new approval in the U.S. by July 23. —

在美国获得新的批准,截止日期为7月23日。——

Jonathan Gardner

乔纳森·加德纳

Investment firm

投资公司

BML Capital Management

BML资本管理

has called for cancer drug developer

呼吁癌症药物开发商

Elevation Oncology

高程肿瘤学

to liquidate and return all of its cash to shareholders, according to a

根据规定,进行清算并将所有现金返还给股东,

regulatory filing

监管备案

. Elevation dropped its lead drug, laid off a majority of its staff, and began a strategic review

Elevation公司放弃了其主打药物,裁掉了大部分员工,并开始进行战略评估。

after reporting disappointing study data

在报告令人失望的研究数据后

last month. That process often ends in a “reverse merger” with a privately held company that then continues on in the public markets. However, BML, which owns 9.9% of Elevation stock, argued in a letter to management that winding down is the company’s “best course of action” given the state of the equity markets and the “abysmal performance” of many recent reverse mergers.

上个月。该过程通常以与一家私人控股公司的“反向合并”告终,然后继续在公开市场上运作。然而,拥有Elevation公司9.9%股份的BML公司在给管理层的一封信中辩称,鉴于股票市场的状况以及最近许多反向合并的“惨淡表现”,清盘是公司的“最佳行动方案”。

Multiple .

多个。

other struggling biotechs

其他陷入困境的生物技术公司

, including fellow cancer drug developer

,包括其他癌症药物开发商同仁

Essa Pharma

埃萨制药

, have recently faced activist pressure as well. —

,最近也面临了维权者的压力。——

Ben Fidler

本·菲德勒

The FDA

美国食品药品监督管理局

updated the prescribing information

更新了处方信息

for

为了

Bristol Myers Squibb

百时美施贵宝

’s hypertrophic cardiomyopathy drug

肥厚型心肌病药物

Camzyos

康维佐斯

to ease

减轻

risk monitoring requirements

风险监控要求

and lower the number of therapies it’s contraindicated with, the company said Thursday. The updated prescribing information lowers the frequency of echocardiogram monitoring for some patients and removes two kinds of inhibitor drugs as contraindicated therapies. The move suggests “greater comfort” with so-called cardiac myosin inhibitors like Camzyos and should help “build out the still nascent” market for them, wrote Stifel analyst James Condulis.

该公司于周四表示,此举将减少其禁忌的治疗数量。更新后的处方信息降低了部分患者的超声心动图监测频率,并移除了两种抑制剂药物作为禁忌疗法。Stifel分析师詹姆斯·康杜利斯写道,这一举措表明对像Camzyos这样的所谓心脏肌球蛋白抑制剂的“更大信心”,并应有助于“进一步拓展”它们仍处于初期的市场。

Camzyos generated .

Camzyos 生成。

$602 million in sales

6.02亿美元的销售额

last year, and could

去年,并且能够

soon face competition

很快将面临竞争

from

Cytokinetics

细胞动力学

aficamten

阿非卡姆滕

, which is currently being reviewed by U.S. regulators. —

,目前正在接受美国监管机构的审查。——

Ben Fidler

本·菲德勒

Ligand Pharmaceuticals

配体制药公司

and

Channel Therapeutics

渠道治疗学

will combine a trio of subsidiaries in a deal that will create a new company,

将把三家子公司合并在一起,打造一家新公司,

Pelthos Therapeutics

佩尔索斯治疗学

, focused on selling an already-approved prescription gel for molluscum infections. Pelthos will also own a portfolio of pain drugs aimed at Nav1.7, a target of interest to other developers as well, including Vertex Pharmaceuticals and SiteOne Therapeutics.Ligand will invest $18 million in the combined company, with a group led by investment firm .

,专注于销售已获批准的用于治疗软体动物感染的处方凝胶。佩尔索斯还将拥有一系列针对Nav1.7的止痛药,这一目标也引起了包括Vertex制药和SiteOne治疗在内的其他开发者的兴趣。Ligand将向这家合并后的公司投资1800万美元,由投资公司牵头的一组投资者参与其中。

Murchinson

默奇森

kicking in another $32 million. —

又投入了3200万美元。——

Ben Fidler

本·菲德勒

Bayer

拜耳

on Wednesday debuted a

周三首次亮相

70,000-square-foot expansion

70,000平方英尺的扩建

to a Myerstown, Pennsylvania, facility that now represents the largest manufacturing site for its consumer health division. The expansion follows a $44 million investment in 2022 and will help the company more efficiently manufacture products like

至宾夕法尼亚州迈尔斯敦的一处设施,该设施如今是其消费者健康部门最大的制造基地。此次扩建是在2022年投资4400万美元的基础上进行的,将帮助公司更高效地生产如下的产品:

Aspirin

阿司匹林

,

Claritin

克拉立定

and

Midol

美得乐

. The facility employs more than 585 full-time workers, according to a

该设施雇用了超过585名全职员工,根据

published report

已发布报告

.

— Ben Fidler

— 本·菲德勒

RNA editing startup

RNA编辑初创公司

Airna

艾尔娜

has named former

已任命前

Sarepta Therapeutics

Sarepta Therapeutics

executive

执行的

Jacob Elkins

雅各布·埃尔金斯

as its chief medical officer

作为其首席医疗官

. Elkins was most recently Sarepta’s CMO and head of development sciences, and in that role helped support the development of the company’s “exon skipping” RNA therapies and the

埃尔金斯最近担任Sarepta的首席医学官(CMO)兼开发科学主管,在该职位上帮助支持了公司“外显子跳跃”RNA疗法的开发以及

Duchenne muscular dystrophy gene therapy

杜氏肌营养不良基因治疗

Elevidys

艾勒维迪斯

. At Airna, he’ll oversee development of an

在Airna,他将负责监督开发工作。

experimental treatment for alpha-1 antitrypsin deficiency that’s nearing human testing

即将进行人体试验的α-1抗胰蛋白酶缺乏症的实验性治疗

, and help expand the company’s pipeline into more common conditions as well. —

,并帮助公司将研发管线扩展到更多常见疾病领域。——

Ben Fidler

本·菲德勒