RTTNews BiotechCodex · 实盘不做把握 8/10
北京时间·🕒 发布 07-30 19:25:19时区推断·⟳ 抓取 07-30 19:30:23·⚡ 决策 08-01 02:08:43 +1d06h·88.2 天前
Cytokinetics的MYQORZO获英国MHRA上市授权并获NICE推荐
MYQORZO用于成人症状性梗阻性肥厚型心肌病的英国准入与NICE推荐对Cytokinetics是正面商业化进展。
📄 原文RTTNews Biotech↗ 原文
Cytokinetics Secures MHRA Marketing Authorization For MYQORZO In OHCM
Cytokinetics, Incorporated (CYTK) announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has…
不做 Cytokinetics（CYTK.US）
同一具体催化已在已处理消息库命中：08-01 00:55 CST的ir_page版本已处理MYQORZO获英国MHRA授权并获NICE推荐，当前RTTNews稿件为重复转述，不再建仓或重复推卡。
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)
研究档案
🔎 新鲜度:最早出现 2026-07-30 · 扩散 medium · price-in 风险 high ↗
关键理由
- MYQORZO用于成人症状性梗阻性肥厚型心肌病的英国准入与NICE推荐对Cytokinetics是正面商业化进展。
- 但同一具体催化已在近72小时已处理消息库中命中，08-01 00:55 CST已有ir_page版本、08-01 00:41 CST已有twitter版本，不应重复推卡。
主要风险
- 本次输出按去重闸不建仓，未继续展开商业化量级和反证核查。
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原文全文
展开原文 · 2,706 字
Cytokinetics, Incorporated (CYTK) announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for MYQORZO (aficamten) to treat adult patients with obstructive hypertrophic cardiomyopathy, classified as New York Heart Association (NYHA) class II-III. At the same time, the National Institute for Health and Care Excellence (NICE) issued positive guidance recommending aficamten for eligible patients in England and Wales.
Obstructive hypertrophic cardiomyopathy (oHCM) is a chronic condition in which the heart muscle becomes abnormally thick, obstructing blood flow and leading to symptoms such as shortness of breath, chest pain, and fatigue. Treatment options have historically been limited, making new therapies significant for patients.
MYQORZO (aficamten) is a next-generation cardiac myosin inhibitor designed to reduce hypercontractility of the heart muscle, improve bloodflow, and relive symptoms. Its approval represents an important advance in addressing the unmet needs of people living with oHCM.
NICE guidance specifies that aficamten may be used as an option alongside optimised standard care— including beta-blockers, non-dihydropyridine— or alone if these treatments are contraindicated, provided the company supplies it under the agreed commercial arrangement.
Joseph Dagher, Senior Vice President and Head of Europe, Cytokinetics, said the company is committed to supporting access through the NHS, with availability expected later this year.
The MHRA's review drew on data from SEQUOIA-HCM, a Phase 3 multicenter double-blind placebo-controlled randomized study in 282 adults. Results showed aficamten significantly improved peak oxygen uptake compared with placebo (mean change 1.8 mL/kg/min vs. 0.0 mL/kg/min; p < 0.001).
The most common adverse reactions included hypertension (7.7%), palpitations (7.0%), dizziness (4.2%) and systolic dysfunction (3.5%).
The authorization and NICE guidance mark a major milestone for Cytokines as MYQORZO becomes available to patients in the UK, expanding treatment options for obstructive hypertrophic cardiomyopathy.
CYTK has traded between $32.89 and $88.31 over the past year. The stock closed Wednesday's trading at $78.39, down 1.34%. In pre-market trading the stock is at $78.50, up 0.15%.
For comments and feedback contact: editorial@rttnews.com
Business News
July 30, 2026 04:24 ET The August 2026 FDA calendar features several important PDUFA decisions that could influence the biotech sector, healthcare innovation, and investor sentiment. In this video, we break down five major FDA decisions expected in August 2026, including the therapies, companies, and diseases under review:
Obstructive hypertrophic cardiomyopathy (oHCM) is a chronic condition in which the heart muscle becomes abnormally thick, obstructing blood flow and leading to symptoms such as shortness of breath, chest pain, and fatigue. Treatment options have historically been limited, making new therapies significant for patients.
MYQORZO (aficamten) is a next-generation cardiac myosin inhibitor designed to reduce hypercontractility of the heart muscle, improve bloodflow, and relive symptoms. Its approval represents an important advance in addressing the unmet needs of people living with oHCM.
NICE guidance specifies that aficamten may be used as an option alongside optimised standard care— including beta-blockers, non-dihydropyridine— or alone if these treatments are contraindicated, provided the company supplies it under the agreed commercial arrangement.
Joseph Dagher, Senior Vice President and Head of Europe, Cytokinetics, said the company is committed to supporting access through the NHS, with availability expected later this year.
The MHRA's review drew on data from SEQUOIA-HCM, a Phase 3 multicenter double-blind placebo-controlled randomized study in 282 adults. Results showed aficamten significantly improved peak oxygen uptake compared with placebo (mean change 1.8 mL/kg/min vs. 0.0 mL/kg/min; p < 0.001).
The most common adverse reactions included hypertension (7.7%), palpitations (7.0%), dizziness (4.2%) and systolic dysfunction (3.5%).
The authorization and NICE guidance mark a major milestone for Cytokines as MYQORZO becomes available to patients in the UK, expanding treatment options for obstructive hypertrophic cardiomyopathy.
CYTK has traded between $32.89 and $88.31 over the past year. The stock closed Wednesday's trading at $78.39, down 1.34%. In pre-market trading the stock is at $78.50, up 0.15%.
For comments and feedback contact: editorial@rttnews.com
Business News
July 30, 2026 04:24 ET The August 2026 FDA calendar features several important PDUFA decisions that could influence the biotech sector, healthcare innovation, and investor sentiment. In this video, we break down five major FDA decisions expected in August 2026, including the therapies, companies, and diseases under review:
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