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MacroGenics (MGNX) Earnings Call Presentation
2025-07-08 05:49
Developing Breakthrough Biologics, Life-changing Medicines® Corporate Update June 10, 2025 Legal Notices The information in this slide deck is current as of June 10, 2025, unless otherwise noted, and is qualified in its entirety by reference to MacroGenics' Annual, Quarterly and Current Reports filed with the SEC. MacroGenics undertakes no obligation to update any of the information herein. Cautionary Note on Forward-Looking Statements Any statements in this presentation about future expectations, plans and ...
Arcus Biosciences(RCUS) - 2024 Q4 - Earnings Call Presentation
2025-07-08 05:48
Casdatifan (HIF-2α) Program - Casdatifan 100mg QD tablet showed a 33% confirmed ORR (Overall Response Rate) with short follow-up[15,19] - Casdatifan 100mg QD tablet showed a 15% primary progressive disease (PD) rate[15] - Casdatifan 50mg BID cohort showed a median Progression Free Survival (mPFS) of 9.7 months[15,25] - Casdatifan 50mg QD cohort showed mPFS not reached with 12 months follow-up[15,25] - The PEAK-1 Phase 3 study for Casdatifan is on track to initiate in Q2 2025[33] Domvanalimab (Anti-TIGIT mAb) Program - Domvanalimab plus Zimberelimab in 1L Gastric Cancer showed ~13 months mPFS vs 7-8 months for benchmark data[11] - In 1L PD-L1 High NSCLC, Domvanalimab + Zimberelimab vs Zimberelimab showed OS Hazard Ratio of 0.64[11,58] - EDGE-Gastric data showed 13.8 months median PFS in TAP ≥5% and 11.3 months median PFS in TAP < 5%[47] - STAR-221 is a Phase 3 study evaluating Domvanalimab + Zimberelimab + Chemo in 1L Gastric/GEJ/EAC, with data expected in 2026[51,52] CD73-Adenosine Axis Programs - Quemli ± Zim + G/nP in 1L Metastatic PDAC showed 15.7 months mOS vs 9.8 months for Synthetic Control Arm, representing a 37% reduction in risk of death[70]
历下区去年软件产业规模达到800亿元,同比增长15%以上
Qi Lu Wan Bao Wang· 2025-07-08 03:35
齐鲁晚报·齐鲁壹点 夏侯凤超 历下区委副书记、代区长赵治文介绍,历下区重点产业不断壮大。历下区着力汇聚核心要素资源,精心 构建协同发展生态,全力推动电子信息、现代医药两大重点产业集群发展。在电子信息产业方面,通过 龙头企业的引领不断提升发展能级。作为电子信息产业的重点行业,2024年,全区软件产业规模达到 800亿元,同比增长15%以上,重点企业中创中间件成功上市,瑞泉电子、泰华智慧等150余家优质企业 入驻山东人工智能产业园、明湖国际信创产业园,信创产业获评山东省"雁阵型"产业集群。在现代医药 产业方面,逐步构建起特色鲜明的产业生态。加快布局细胞与基因治疗等特色前沿产业,丽山国际细胞 医学产业园、生物制药生产基地建成高标准厂房30万平方米,配套建设了细胞CDMO和公共实验平台, 引进了第三方检测认证服务机构,吸引中源协和(600645)、骏腾医疗、华测检测(300012)等60家优 质企业入驻发展。 发展质效持续提升。历下区始终坚持向质量要效益,全区现有规模以上工业企业49家,2024年完成规上 工业总产值422亿元,近三年平均增速超过10%。在保持平稳健康增长的同时,产业结构不断优化, 二、三产业比重调整 ...
Ascentage Pharma Appoints Dr. Veet Misra as Chief Financial Officer and Eric Huang as Senior Vice President of Global Corporate Development and Finance
Globenewswire· 2025-07-07 23:30
Core Viewpoint - Ascentage Pharma Group International has appointed Veet Misra, Ph.D., as Chief Financial Officer and Eric Huang as Senior Vice President of Global Corporate Development and Finance, aiming to accelerate its global growth strategy in the biopharmaceutical sector [1][2][3] Management Appointments - Dr. Veet Misra brings over 20 years of investment banking experience, particularly in the biopharmaceutical sector, and holds a Ph.D. in Molecular Biology and an MBA in Finance & Strategy [4][5] - Mr. Eric Huang has over 20 years of experience in the global pharmaceutical industry, previously serving as CFO for Greater China and Asia-Pacific at Beigene, and holds an MBA in Finance [5] Company Strategy and Growth - The company is entering a notable growth phase, with the new executives expected to enhance its global strategy and operational excellence [2][3] - Ascentage Pharma is focused on becoming a leading fully integrated global biopharmaceutical company, leveraging its dual listing on the Hong Kong Stock Exchange and Nasdaq [2][4] Product Pipeline - Ascentage Pharma has a robust pipeline of innovative drug candidates targeting cancers, including apoptosis-targeted therapies and next-generation kinase inhibitors [6][7] - The lead asset, olverembatinib, is a third-generation BCR-ABL1 inhibitor approved in China for specific types of chronic myeloid leukemia (CML) and is undergoing global Phase III trials [8] - Another key asset, lisaftoclax, is a Bcl-2 inhibitor for hematologic malignancies, with its NDA accepted for Priority Review in China and multiple global Phase III trials ongoing [9] Partnerships and Collaborations - The company has established partnerships with leading pharmaceutical firms such as Takeda, AstraZeneca, Merck, and Pfizer, enhancing its research and development capabilities [10]
ROSEN, A LEADING INVESTOR RIGHTS LAW FIRM, Encourages Sarepta Therapeutics, Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action – SRPT
GlobeNewswire News Room· 2025-07-07 21:35
Core Viewpoint - Rosen Law Firm is reminding investors who purchased securities of Sarepta Therapeutics, Inc. during the specified Class Period of the upcoming lead plaintiff deadline on August 25, 2025 [1]. Group 1: Class Action Details - Investors who purchased Sarepta securities between June 22, 2023, and June 24, 2025, may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and those wishing to serve as lead plaintiff must act by August 25, 2025 [3]. - The lawsuit alleges that Sarepta made false and misleading statements regarding the safety and efficacy of its gene therapy product, ELEVIDYS, which is intended for treating Duchenne muscular dystrophy [5]. Group 2: Legal Representation - Investors are encouraged to select qualified legal counsel with a proven track record in securities class actions, as many firms may not have the necessary experience or resources [4]. - The Rosen Law Firm has a history of successful settlements, including the largest securities class action settlement against a Chinese company at the time, and has recovered hundreds of millions of dollars for investors [4]. Group 3: Case Specifics - The lawsuit claims that Sarepta failed to disclose significant safety risks associated with ELEVIDYS, which led to adverse events that could impact the therapy's approval and recruitment in clinical trials [5].
Rocket Pharmaceuticals, Inc. Sued for Securities Law Violations – Investors Should Contact The Gross Law Firm Before August 11, 2025 to Discuss Your Rights – RCKT
GlobeNewswire News Room· 2025-07-07 20:47
Core Viewpoint - Rocket Pharmaceuticals, Inc. is facing a class action lawsuit due to allegations of providing misleading statements regarding the safety and clinical trial protocol of its RP-A501 treatment, which resulted in a significant drop in stock price following the announcement of a clinical hold by the FDA [3][4]. Summary by Sections Allegations - The complaint alleges that Rocket Pharmaceuticals made overwhelmingly positive statements while concealing material adverse facts about RP-A501's safety and the clinical trial protocol, including the risk of Serious Adverse Events (SAEs) [3]. - The company amended the trial protocol to include a new immunomodulatory agent without informing shareholders, leading to artificially inflated stock prices [3]. - Following the announcement of a clinical hold by the FDA due to a SAE, including a participant's death, Rocket's stock price plummeted from $6.27 to $2.33, a decline of approximately 37% in one trading day [3]. Class Action Details - The class period for the lawsuit is from February 27, 2025, to May 26, 2025, with a deadline for shareholders to register as lead plaintiffs by August 11, 2025 [4]. - Shareholders who register will receive updates on the case's status through a portfolio monitoring software [4]. Law Firm Information - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights against deceit and fraud [5]. - The firm aims to ensure companies adhere to responsible business practices and seeks recovery for investors who suffered losses due to misleading statements [5].
Shareholders that lost money on Iovance Biotherapeutics, Inc. (IOVA) Urged to Join Class Action – Contact The Gross Law Firm to Learn More
GlobeNewswire News Room· 2025-07-07 20:47
Core Viewpoint - Iovance Biotherapeutics, Inc. is facing a class action lawsuit due to allegations of providing misleading statements about its growth potential and financial performance, leading to significant stock price decline [1][3]. Group 1: Allegations and Financial Performance - The class period for the lawsuit is from May 9, 2024, to May 8, 2025 [3]. - Allegations include that Iovance made overwhelmingly positive statements while concealing material adverse facts about its ability to generate demand for its treatments [3]. - On July 25, 2024, Iovance announced a reduction in revenue guidance for fiscal year 2024, attributing it to maintenance issues, lower-than-expected Proleukin sales, and a variable pace of treatment initiation [3]. - Following the announcement, Iovance's stock price plummeted from $3.17 per share on May 8, 2025, to $1.75 per share on May 9, 2025, marking a decline of approximately 44.795% in one day [3]. Group 2: Next Steps for Shareholders - Shareholders are encouraged to register for the class action by July 14, 2025, to participate in potential recovery [4]. - Registered shareholders will receive updates through a portfolio monitoring software regarding the case's status [4]. - There is no cost or obligation for shareholders to participate in the case [4]. Group 3: Law Firm Information - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights against deceit and fraud [5]. - The firm aims to ensure companies adhere to responsible business practices and seeks recovery for investors affected by misleading statements [5].
The Gross Law Firm Reminds Shareholders of a Lead Plaintiff Deadline of August 25, 2025 in Sarepta Lawsuit – SRPT
GlobeNewswire News Room· 2025-07-07 20:40
Core Viewpoint - The Gross Law Firm has issued a notice to shareholders of Sarepta Therapeutics, Inc. regarding a class action lawsuit related to misleading statements about the safety and efficacy of its gene therapy product, ELEVIDYS [1][3]. Group 1: Allegations - The complaint alleges that during the class period from June 22, 2023, to June 24, 2025, Sarepta Therapeutics made materially false and misleading statements regarding ELEVIDYS [3]. - Specific allegations include that ELEVIDYS posed significant safety risks, trial protocols failed to detect severe side effects, and adverse events would lead to a halt in trials and increased regulatory scrutiny [3]. Group 2: Shareholder Actions - Shareholders who purchased shares during the specified class period are encouraged to register for the class action, with a deadline of August 25, 2025, to seek lead plaintiff status [4]. - Once registered, shareholders will receive updates through a portfolio monitoring software regarding the case's progress [4]. Group 3: Law Firm's Mission - The Gross Law Firm aims to protect investors' rights and ensure companies adhere to responsible business practices, seeking recovery for losses incurred due to misleading statements [5].
NANOBIOTIX Announces Regulatory Harmonization and New Composition of Matter Patent Filed for JNJ-1900 (NBTXR3)
Globenewswire· 2025-07-07 20:15
Core Insights - Nanobiotix announced significant developments regarding JNJ-1900 (NBTXR3), a potential first-in-class radioenhancer for cancer treatment, which is licensed by Janssen Pharmaceutica NV, a Johnson & Johnson company [1][4] Regulatory Developments - Health authorities in major European countries have reclassified JNJ-1900 (NBTXR3) from a medical device to a drug, aligning its regulatory status with that in the United States and other major markets [2][9] - This reclassification supports a unified global regulatory classification, facilitating future global strategies and filings [9] Intellectual Property - Nanobiotix has filed a new composition of matter patent for JNJ-1900 (NBTXR3) to strengthen the intellectual property foundation supporting the product candidate [3][9] Clinical Development - JNJ-1900 (NBTXR3) is undergoing a comprehensive global clinical development program across multiple tumor types, including a pivotal Phase 3 trial in head and neck cancer [4][6] - The product candidate has shown proof-of-concept in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018 [5] Mechanism of Action - JNJ-1900 (NBTXR3) consists of functionalized hafnium oxide nanoparticles, administered via one-time intratumoral injection and activated by radiotherapy, designed to induce significant tumor cell death and trigger an adaptive immune response [5] Collaboration and Strategy - Nanobiotix has engaged in a collaboration strategy to expand the development of JNJ-1900 (NBTXR3), including a partnership with The University of Texas MD Anderson Cancer Center for several Phase 1 and Phase 2 studies [7]
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of argenx SE - ARGX
Prnewswire· 2025-07-07 19:58
Core Viewpoint - Pomerantz LLP is investigating claims of potential securities fraud or unlawful business practices involving argenx SE and its officers or directors [1] Group 1: Regulatory Concerns - On June 30, 2025, the FDA issued an alert regarding argenx's Vyvgart Hytrulo product, indicating a potential risk of "severe worsening of chronic inflammatory demyelinating polyradiculoneuropathy" [2] - The FDA is currently evaluating the need for regulatory action based on reports received [2] Group 2: Market Reaction - Following the FDA alert, argenx's American Depositary Share (ADS) price decreased by $8.92, or 1.59%, closing at $551.22 per ADS on June 30, 2025 [2]