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Sanofi Expands Cardiovascular Portfolio with Aficamten Acquisition in Greater China
Sanofi will acquire exclusive rights to aficamten for treating hypertrophic cardiomyopathy in Greater China from Corxel Pharmaceuticals.
Overview of the Agreement
Cytokinetics, Inc. announced that Sanofi will secure exclusive rights to aficamten from Corxel Pharmaceuticals for treating hypertrophic cardiomyopathy (HCM) in Greater China. Aficamten, a next-generation cardiac myosin inhibitor, is designed to address both obstructive and non-obstructive forms of HCM. In 2020, Corxel obtained the rights from Cytokinetics, and since then, aficamten has received Breakthrough Therapy Designation from China’s drug regulatory authority, currently undergoing priority review. This acquisition means Cytokinetics could earn milestone payments up to $150 million, in addition to royalties from future sales in the region. Cytokinetics aims to utilize Sanofi’s cardiovascular expertise to enhance aficamten’s availability for HCM patients in Greater China.
Advantages of the Acquisition
- Sanofi’s exclusive rights allow Cytokinetics to enhance its market presence and boost revenue through milestone payments and royalties.
- Receiving Breakthrough Therapy Designation and Priority Review signifies aficamten’s therapeutic potential, positioning Cytokinetics positively in the industry.
- Transferring rights to a renowned company like Sanofi indicates strong confidence in aficamten’s viability and demand, likely improving its standing in the biopharmaceutical sector.
- Cytokinetics can collaborate with Sanofi, leveraging their expertise to fast-track the development and commercialization of aficamten, ultimately benefiting patient access.
Concerns About the Deal
- The decision to grant Sanofi exclusive rights raises concerns that Cytokinetics may relinquish control over a key asset, potentially affecting its future revenue from aficamten.
- The acquisition announcement mentions an “undisclosed amount,” leading to uncertainties regarding the financial consequences for Cytokinetics if the deal’s terms are unfavorable.
- Cytokinetics’ potential earnings from milestone payments and royalties may seem inadequate since they will not have direct involvement in commercialization in Greater China, possibly limiting growth opportunities.
Frequently Asked Questions
What is Aficamten used for?
Aficamten is a cardiac myosin inhibitor aimed at treating obstructive and non-obstructive hypertrophic cardiomyopathy (HCM).
Who is acquiring Aficamten rights in Greater China?
Sanofi will obtain exclusive rights to develop and commercialize Aficamten in Greater China from Corxel Pharmaceuticals.
What designation has Aficamten received from regulatory agencies?
Aficamten was awarded Breakthrough Therapy Designation from the U.S. FDA for treating symptomatic obstructive hypertrophic cardiomyopathy.
How much can Cytokinetics potentially earn from this agreement?
Cytokinetics may receive up to $150 million in milestone payments and royalties from future Aficamten sales.
What is the clinical significance of Aficamten?
Aficamten seeks to enhance exercise capacity and alleviate symptoms in patients with HCM, targeting myocardial hypercontractility.
Disclaimer: This summary is generated from a press release distributed by GlobeNewswire. The model used may contain errors. Refer to the full release for more details.
$CYTK Insider Trading Activity
$CYTK insiders have engaged in trading $CYTK stock on 48 occasions in the last six months, with none being purchases and all being sales.
Recent insider trades of $CYTK stock over the past six months include:
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- ROBERT I BLUM (President & CEO) sold 81,000 shares over 11 trades, with 0 purchases.
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Full Release
SOUTH SAN FRANCISCO, Calif., Dec. 20, 2024 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today revealed that Sanofi will acquire exclusive rights to develop and commercialize
aficamten
from Corxel Pharmaceuticals (CORXEL) aimed at treating patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) in Greater China.
Aficamten
is a next-in-class cardiac myosin inhibitor potentially addressing HCM patients.
In 2020, CORXEL (formerly Ji Xing) secured rights to develop and commercialize
aficamten
in Greater China (including the Chinese mainland, Hong Kong SAR, Macau SAR, and Taiwan) from Cytokinetics under Cytokinetics’ global registration programs.
Aficamten
gained Breakthrough Therapy Designation for treating symptomatic obstructive hypertrophic cardiomyopathy (oHCM) from The Center for Drug Evaluation of the China National Medical Products Administration, which has now accepted the New Drug Application for
aficamten
tablets for the Priority Review process related to oHCM treatment.
With the acquisition, Sanofi will take over CORXEL’s rights concerning
aficamten
in Greater China for an undisclosed amount. Cytokinetics is still eligible to receive up to $150 million in various milestone payments alongside royalties in the low-to-high teens based on future
aficamten
sales in Greater China. Additional undisclosed payments may also be received by Cytokinetics upon the execution of the agreement between Sanofi and CORXEL.
“We have enjoyed a productive collaboration with CORXEL and appreciate the ongoing support…”
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Cytokinetics Partners with Sanofi to Expand Aficamten in Greater China
Leadership Highlights Collaboration Goals
“We now look forward to partnering with Sanofi with a shared objective to leverage their cardiovascular expertise and expand the reach of aficamten to patients suffering from HCM throughout Greater China,” stated Robert I. Blum, President and CEO of Cytokinetics.
Understanding Aficamten
Aficamten is a small molecule cardiac myosin inhibitor that has been developed through an extensive optimization process. This investigational drug aims to target and reduce the excessive contractility seen in hypertrophic cardiomyopathy (HCM). By binding to a special site on cardiac myosin, aficamten prevents myosin from entering a state that creates force, which may lead to improved heart function for those affected.
In the pivotal SEQUOIA-HCM clinical trial, aficamten demonstrated promising results, earning Breakthrough Therapy Designation from the U.S. Food & Drug Administration (FDA). Recently, the FDA accepted Cytokinetics’ New Drug Application (NDA) for aficamten, with a target action date set for September 26, 2025. Additionally, a Marketing Authorization Application has been submitted to the European Medicines Agency.
Ongoing Clinical Trials
Cytokinetics is actively working on several clinical trials for aficamten. The drug is being tested in MAPLE-HCM, a study comparing it to metoprolol for patients with obstructive HCM, as well as in ACACIA-HCM and CEDAR-HCM, focusing on non-obstructive HCM and pediatric cases, respectively. The FOREST-HCM trial is designed to gather more data on aficamten among patients with HCM.
Hypertrophic Cardiomyopathy: A Closer Look
Hypertrophic cardiomyopathy (HCM) is a condition characterized by the abnormal thickening of heart muscle, which can restrict blood flow and lead to various symptoms, such as chest pain and shortness of breath. It is notably the most common inherited cardiovascular disorder in the United States, affecting approximately 280,000 diagnosed patients, with many more undiagnosed. One significant risk with HCM is the potential for life-threatening heart conditions, particularly among younger individuals and athletes.
About Cytokinetics
Cytokinetics specializes in biopharmaceuticals, focusing on developing treatments that enhance muscle function, particularly in the heart. Through their innovative approach, the company is working not only on aficamten but also on other candidates like omecamtiv mecarbil, CK-586, and CK-089, which target different aspects of muscle performance and various heart-related conditions.
For more information, visit www.cytokinetics.com, and follow them on social media platforms.
Forward-Looking Statements
This announcement includes forward-looking statements under the Private Securities Litigation Reform Act of 1995. Cytokinetics disclaims any intention to update these statements, as actual results may differ due to various risks and uncertainties, such as clinical trial challenges or regulatory delays. Investors should refer to the company’s SEC filings for more information on those risks.
CYTOKINETICS® and its logo are registered trademarks of Cytokinetics.
References
- CVrg: Heart Failure 2020-2029, p 44; Maron et al. 2013 DOI: 10.1016/S0140-6736(12)60397-3; Maron et al 2018 10.1056/NEJMra1710575
- Symphony Health 2016-2021 Patient Claims Data DoF;
- Maron MS, et al., Am J Cardiol. 2016; 15;117(10):1651-1654.
- Gersh, B.J., et al. 2011 ACCF/AHA guidelines for the diagnosis and treatment of HCM.
- Hong Y, et al., Current Opinion in Cardiology. 2022 Jan 1;37(1):15-21
Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757
This article first appeared on Quiver News; see the full story there.
The views expressed here are those of the author and do not necessarily reflect those of Nasdaq, Inc.
