ACVR2B

▎Armstrong2024年2月5日，诺华与Morphosys达成全现金收购协议，收购对价27亿欧元，约合29亿美元。Morphosys为一家成立于1992年的德国生物技术公司，核心管线如下，CD19抗体Tafasitamab已经卖给Incyte，后续管线包括BET抑制剂Pelabresib和EZH2/EZH1抑制剂Tulmimetostat。作为抗体工程的先驱，Morphosys还有多款合作开发的抗体药物管线，包括诺华合作的BAFF-R抗体Ianalumab、Anthos合作的FXI抗体Abelacimab、Ultragenyx合作的硬骨素抗体Setrusumab、礼来合作的ACVR2B抗体Bimagrumab、HiBio及天境生物合作的CD38抗体Delzartamab。总结此次收购将进一步强化诺华在肿瘤领域的布局，其中BET抑制剂Pelabresib预计今年下半年递交上市申请。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir Biotech技术全梳理；Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理；Momenta技术全梳理；NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

LEXINGTON, Mass., Jan. 29, 2024 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros” or “we”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (“TGF-ß”) family of proteins, today announced that three abstracts will be presented from the KER-012 program at the Pulmonary Vascular Research Institute (“PVRI”) 2024 Annual Congress, to be held from January 31 through February 3, 2024. Clinical Presentations “Development of KER-012, a Novel Investigational Activin Receptor Type IIB Ligand Trap with High Activin/GDF Specificity and Target Engagement for the Treatment of Pulmonary Arterial Hypertension: Rationale and Design of the TROPOS Phase 2 Study” Presenter: Marc Humbert, M.D., Ph.D., Professor of Respiratory Medicine at the Université Paris-SaclayDate: February 2, 2024Presentation Time: 4:30 - 6:00 p.m. GMT “Administration of KER-012 to Healthy Post-Menopausal Women Elicited Biomarker Changes Suggesting Anti-Inflammatory and Anti-Fibrotic Effects That Target the Pathophysiology of Pulmonary Arterial Hypertension” Presenter: M. Kathryn Steiner, M.D., KerosDate: February 2, 2024Presentation Time: 4:30 - 6:00 p.m. GMT Preclinical Presentation “RKER-012, A Novel Modified ActRIIB Ligand Trap, Reduced Pulmonary Vascular Pathology in a Rat Model of Pulmonary Arterial Hypertension” Presenter: Keith Babbs, Ph.D., KerosDate: February 2, 2024Presentation Time: 4:20 p.m. GMT About TROPOS TROPOS is a randomized, double-blind, placebo-controlled, global Phase 2 clinical trial to evaluate KER-012 in combination with background therapy in patients with pulmonary arterial hypertension (“PAH”). The primary objective of this trial is to evaluate the effect of KER-012 on pulmonary hemodynamics compared to placebo in participants on background PAH therapy. The key secondary objective of this trial is to evaluate the effect of KER-012 on exercise capacity compared to placebo on participants on background PAH therapy. About KER-012 KER-012 is designed to bind to and inhibit the signaling of TGF-β ligands that stimulate smooth muscle hypertrophy and fibrosis, including activin A, activin B and myostatin. Keros believes that KER-012 has the potential to increase the signaling of bone morphogenic protein (“BMP”) pathways through this inhibition of activin A and activin B signaling, and consequently treat diseases such as PAH that are associated with reduced BMP signaling due to inactivating mutations in the BMP receptors. KER-012 is being developed for the treatment of PAH and for the treatment of cardiovascular disorders. About Keros Therapeutics, Inc. Keros is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the TGF-ß family of proteins. We are a leader in understanding the role of the TGF-ß family of proteins, which are master regulators of the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. By leveraging this understanding, we have discovered and are developing large and small molecules that have the potential to provide meaningful and potentially disease-modifying benefit to patients. Keros’ lead protein therapeutic product candidate, KER-050 (elritercept), is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros’ second product candidate, KER-012, is being developed for the treatment of PAH and for the treatment of cardiovascular disorders. Keros’ third product candidate, KER-065, is being developed for the treatment of obesity and for the treatment of neuromuscular diseases. Cautionary Note Regarding Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “would” and “future” or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros’ presentation plans for the upcoming PVRI 2024 Annual Congress. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros’ limited operating history and historical losses; Keros’ ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros’ dependence on the success of its product candidates, KER-050, KER-012 and KER-065; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros’ ability to obtain, maintain and protect its intellectual property; and Keros’ dependence on third parties in connection with manufacturing, clinical trials and preclinical studies. These and other risks are described more fully in Keros’ filings with the Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of Keros’ Quarterly Report on Form 10-Q, filed with the SEC on November 6, 2023, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Contact:Justin Frantzjfrantz@kerostx.com 617-221-6042

- Taldefgrobep is a novel myostatin inhibitor with the potential to be an important therapy for neuromuscular disorders and metabolic diseases including obesity. - Taldefgrobep monotherapy significantly reduced fat and increased lean muscle mass in an obese mouse model; potential body composition changes relevant to individuals living with overweight and obesity. - Biohaven presented an analysis supporting change in waist circumference as a strong correlate for weight loss, suggesting potential alternative endpoints for obesity studies. NEW HAVEN, Conn., Oct. 16, 2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), announced the presentation of preclinical data demonstrating the ability of taldefgrobep alfa to significantly reduce fat mass while increasing lean mass in an obese mouse model. Separately, data supporting the correlation between change in waist circumference and change in total body weight among adults living with overweight and obesity treated with approved anti-obesity medications were reported. Both sets of data were presented on October 15, 2023 at The Obesity Society's annual ObesityWeek conference held in Dallas, TX. Poster 210: Correlation Between Reduction in Total Body Weight and Change in Waist Circumference Poster 211: Taldefgrobep Alfa Reduces Fat and Increases Muscle in an Obese Mouse Model The poster presentations hightlight the potential benefit of taldefgrobep in the treatment of adults living with overweight and obesity and suggest anthropometric measures of central obesity, such as waist circumference or waist-to-height ratio, may be considered as effective alternative estimations of therapeutic effect. In a mouse model of diet-induced obesity, untreated mice exhibited an increase in fat mass of 31%, while the taldefgrobep-treated mice demonstrated increases in lean mass of 25% from baseline (p£.0.001; Figure 1) and lost 11% of their baseline fat (p£.0.001; Figure 2) compared to vehicle (placebo) treated mice. Insulin and leptin levels were consistently lower in taldefgrobep-treated mice compared to untreated. There was no difference in food intake over time across the taldefgrobep and untreated mice, counter to what has been observed with incretin mimetics (e.g., semaglutide) which are consistently associated with a reduction in energy intake. "The disease of obesity is a public health crisis for which alternative treatment options remain necessary. With the unprecedented amount of weight loss generated by the latest anti-obesity medications, it is important that we carefully consider the quality of resulting body composition changes, including the degree of lean muscle loss. Taldefgrobep's differentiated mechanism offers the potential for a meaningful reduction in fat mass, the primary pathogenic tissue in obesity, while increasing lean mass. These body changes are unique relative to all approved anti-obesity medications which achieve reductions in total body weight based on a composite of fat mass loss and lean muscle mass loss, the latter of which may pose important adverse long-term health consequences" said Peter Ackerman, M.D., Vice President and Clinical Lead for Metabolic Disorders at Biohaven. A Phase 2 obesity study with taldefgrobep is planned for 2024. Full posters will be available on the Posters and Presentations page at: . Irfan Qureshi, MD, Chief Medical Officer at Biohaven, commented, "Together these posters support the development of taldefgrobep as a novel therapy for the treatment of overweight and obesity that can result in significant fat loss while increasing lean mass. This is a paradigm-shift from traditional obesity therapies that focus on overall weight loss despite significant difficult to reverse loss in muscle mass." About Taldefgrobep alfa Taldefgrobep alfa (BHV-2000) is a fully human recombinant protein designed to specifically designed to bind to myostatin (GDF-8) and inhibit the signaling of both myostatin and activin A, both key regulators of muscle and adipose tissue. Taldefgrobep binds myostatin. The myostatin-taldefgrobep complex then acts as an Activin 2a/2b receptor antagonist. Anti-myostatin therapy has a novel mechanism of action that may reduce fat mass, increase lean mass, and improve other metabolic parameters. About Biohaven Biohaven is a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies for people with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven is advancing a pipeline of best-in-class therapies for diseases with little or no treatment options, leveraging its proven drug development capabilities and proprietary platforms, including Kv7 ion channel modulation for epilepsy and neuronal hyperexcitability; glutamate modulation for obsessive-compulsive disorder and spinocerebellar ataxia and myostatin inhibition for neuromuscular diseases. Biohaven's portfolio of early- and late-stage product candidates also includes discovery research programs focused on TRPM3 channel activation for neuropathic pain and CD-38 antibody recruiting, bispecific molecules for multiple myeloma. More information about Biohaven is available at . Forward-looking Statements This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "believe", "may" and "will" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven's management about taldefgrobep alfa as treatment for patients with neuromuscular or obesity disorders. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates are not guarantees of future performance or results and involve substantial risks and uncertainties. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this new release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Biohaven Contact: Jennifer Porcelli Vice President, Investor Relations [email protected] 201-248-0741 Mike Beyer Sam Brown Inc. [email protected] 312-961-2502 SOURCE Biohaven Ltd.