Alectinib Hydrochloride

John Flavin, Co-Founder and Founding Chairman, to serve as Lead Independent Director of the Board Leadership transition reflects continued focus on advancing MICVO through key clinical milestones BOSTON, Sept. 08, 2026 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, announced today that its Board of Directors has appointed Thomas Civik as Chief Executive Officer and Chairman of the Board, effective as of September 4, 2026. Mr. Civik has served as Interim Chief Executive Officer since February 2026 and as a member of Pyxis Oncology’s Board of Directors since 2021. In connection with Mr. Civik’s appointment as Chairman, John Flavin, co-founder and founding Chairman of Pyxis Oncology, will transition to Lead Independent Director and will continue to serve as a member of the Board. Mr. Flavin has provided leadership to Pyxis Oncology since its founding and has played an instrumental role in the Company’s formation, growth and evolution into the clinical-stage organization it is today. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); “Over the past several months, Tom has demonstrated the leadership, strategic focus and disciplined execution the Board believes are needed as Pyxis Oncology approaches key clinical milestones for MICVO,” said John Flavin, Lead Independent Director of Pyxis Oncology. “He brings a deep understanding of the Company, its science and its strategy, and during his time as Interim Chief Executive Officer, the Company has continued to advance MICVO, strengthen its financial position and remain focused on generating the clinical evidence needed to evaluate MICVO’s potential for patients. The Board has full confidence in Tom and is pleased to appoint him Chief Executive Officer and Chairman of the Board.” “I am honored by the Board’s confidence and proud to continue leading Pyxis Oncology at such an important time for the Company,” said Thomas Civik, Chief Executive Officer and Chairman of the Board. “I want to thank John for his tremendous leadership and commitment to Pyxis Oncology. His vision and guidance have helped shape the Company from its earliest days, and I am grateful that we will continue to benefit from his experience and perspective as Lead Independent Director.” Mr. Civik continued, “Our extraordinary team at Pyxis Oncology has executed with speed, precision, and a deep commitment to finding new treatment options for difficult-to-treat cancers. With important clinical milestones ahead, our focus remains on generating the clinical evidence needed to evaluate MICVO’s potential to address the significant unmet need in head and neck cancer. I look forward to working alongside our talented team as we continue to execute on our strategy and deliver meaningful progress for patients while building long-term value for shareholders.” Mr. Civik most recently served as the Chairman of ImCheck Therapeutics (acquired by Ipsen) and Repare Therapeutics (acquired by Xoma). He also served as President and Chief Executive Officer of Five Prime Therapeutics until its acquisition by Amgen for $1.9 billion in April 2021. He was previously Chief Commercial Officer at Foundation Medicine, and before that, held various roles over a 17-year career at Genentech, with responsibility for several important therapies such as Avastin, Tecentriq, Alecensa and Tarceva. Mr. Civik earned a B.A. from St. Norbert College, and an M.B.A. from Northwestern University Kellogg School of Management. ezstandalone.cmd.push(function () { ezstandalone.showAds(132); }); Pyxis Oncology expects to report updated data from the ongoing MICVO Phase 1 monotherapy study in second-line and beyond (2L+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in the Fall of 2026. The update is expected to include detailed analysis of patients treated at or below dose cap, including the impact on safety, tolerability, efficacy and initial durability. The Company also expects to report updated data from its ongoing Phase 1/2 combination study with pembrolizumab in first-line (1L) R/M HNSCC in the fourth quarter of 2026. About Pyxis Oncology, Inc. Pyxis Oncology, Inc. is a clinical-stage biopharmaceutical company developing therapeutics for difficult-to-treat cancers. The Company’s lead candidate, micvotabart pelidotin (MICVO), is a first-in-concept antibody-drug conjugate (ADC) that targets extradomain-B of fibronectin (EDB+FN), a non-cellular structural component of the tumor extracellular matrix (ECM). EDB+FN is selectively overexpressed in the tumor microenvironment of a wide range of solid tumors and largely absent from normal adult tissues. MICVO is designed to treat solid tumors through a three-pronged mechanism of action: direct cancer cell killing, bystander effect and immunogenic cell death. MICVO is currently being evaluated as monotherapy in a Phase 1 clinical study in patients with recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA ® (pembrolizumab) in a Phase 1/2 clinical study in patients with R/M HNSCC and other solid tumors. Pyxis Oncology is focused on advancing MICVO, with the goal of improving outcomes for patients living with R/M HNSCC and contributing to meaningful progress in cancer treatment. MICVO received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of adult patients with R/M HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 therapy. KEYTRUDA ® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. ezstandalone.cmd.push(function () { ezstandalone.showAds(133); }); To learn more, visit or follow us on LinkedIn . Forward-Looking Statements This press release contains forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws. These statements are often identified by the use of words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “to be,” “will,” “would,” or the negative or plural of these words, or similar expressions or variations, although not all forward-looking statements contain these words. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified herein, and those discussed in the section titled “Risk Factors” set forth in Part II, Item 1A. of the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 13, 2026, and our other filings, each of which is on the Securities and Exchange Commission. These risks are not exhaustive. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date hereof and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements. Pyxis Oncology Contact IR@pyxisoncology.com ezstandalone.cmd.push(function () { ezstandalone.showAds(134); });

更精准的突变、更细分的患者人群，肿瘤创新药密集登场。 撰文｜Kathy 医保谈判进入第三天，谈判桌上的重磅新品还在增加。 早上8点左右，企业代表已经陆续抵达。相比前两天，今天明显特点是肿瘤药企高度集中： 从上午的肺癌靶向药扎堆，到下午的血液瘤、乳腺癌混战，一批今年备受关注的肿瘤新品密集登场。 “肿瘤专场”之外，默沙东带来了今年刚刚在国内获批的肺动脉高压新药索特西普，让一个过去长期依赖西地那非、内皮素受体拮抗剂等药物的疾病迎来新的治疗机制。 呼吸领域同样聚集了阿斯利康、GSK等跨国药企。在重度哮喘等疾病中，生物制剂正在从过去相对有限的选择走向不同炎症通路、不同患者表型之间的竞争。 目录内外、新老产品最焦灼的两场竞争，还是落在了肺癌和血液瘤两大领域。一个是中国创新药最拥挤的肺癌靶向治疗市场，医保目录已经拥有多代产品，后来者依然在不断出现；另一个则是治疗越来越精准、技术路线越来越丰富的血液瘤。 今天的赶考选手更是云集了如阿斯利康、罗氏、诺华、辉瑞这样的全球TOP级MNC以及百济、恒瑞、翰森、科伦博泰、诺诚健华这样的中国创新排头兵们。 肺癌卷王靶点，太挤了 第三天上午，肺癌靶向药密集登场，其中最热闹的还是EGFR。 阿斯利康、翰森、南京圣和先后出现在现场。三家公司分别手握奥希替尼、阿美替尼和瑞厄替尼，三款EGFR-TKI都已经进入医保。 但这还只是今天来到现场的企业。 在整个医保目录内，第三代EGFR-TKI的牌桌已经相当拥挤：除了奥希替尼、阿美替尼、瑞厄替尼，还有艾力斯的伏美替尼、贝达药业的贝福替尼等。再往前，吉非替尼、厄洛替尼、埃克替尼、阿法替尼等一、二代药物已经在临床使用多年。 EGFR算得上是中国肺癌靶向药市场过去十多年变化最剧烈的赛道之一。 早期市场主要由进口产品主导，随着埃克替尼的面世，以及此后的阿美替尼、伏美替尼、贝福替尼、瑞厄替尼等国产产品陆续上市，中国企业已经从一代EGFR一路进化到第三代。与此同时，第三代EGFR-TKI的使用也不断从晚期治疗向更前线、更多治疗场景延伸。 产品越来越多，医保也在不断改变这个市场。 奥希替尼最早经过医保谈判大幅降价后进入目录，此后多款国产第三代EGFR-TKI陆续跟进。如今的EGFR赛道早就是一个仅仅是同代产品就有多个选择、不同代际药物同时存在的成熟市场。 但即使这样，新玩家还在继续入场。第三天上午出现的杭州中美华东，今年申报了马来酸美凡厄替尼。 对于后来者而言，前面不仅已经站着奥希替尼这样的全球重磅产品，也有一批经过医保放量的国产创新药。疗效、安全性、耐药以及适用患者范围，都在考验着新入局者。 而EGFR的竞争，还在从常见突变往更精准、更细分的患者群体延伸。如鞍石药业的安达艾替尼瞄准EGFR 20号外显子插入突变。 与最常见的EGFR 19号外显子缺失、21号外显子L858R突变不同，20号外显子插入突变患者占比更小，传统EGFR-TKI对这部分患者的治疗效果也相对有限，因此长期以来一直是EGFR肺癌中治疗选择相对不足的一类患者。 不过在医保目录中，也已经有了先行者。迪哲医药的舒沃替尼已经率先进入医保。也就是说，安达艾替尼如果进一步向医保迈进，面对的同样不是一个已经被舒沃替尼打开的市场。 而肺癌的新品并不只集中在EGFR。 第三天上午到场的首药控股，其康特替尼瞄准的是ALK阳性非小细胞肺癌，用于既往未接受ALK抑制剂治疗的局部晚期或转移性患者。 相比几年前，目前医保目录内已经有克唑替尼、阿来替尼、塞瑞替尼、恩沙替尼、布格替尼、洛拉替尼等多款ALK抑制剂，从早期一代产品到后续新一代药物，治疗选择已经相当丰富。 这意味着，康特替尼如果进一步进入医保，面对的也是一个卷王赛道。 可以说，类似的变化正在整个肺癌靶向治疗市场发生。 过去十多年，非小细胞肺癌不断被EGFR、ALK、ROS1、MET、RET、NTRK等驱动基因重新划分。随着检测能力提升和新药出现，一些过去只能接受化疗或者缺少针对性治疗的患者，也陆续拥有了自己的靶向药。 MET就是近几年迅速热起来的一条赛道。 针对MET 14号外显子跳跃突变，赛沃替尼、谷美替尼、伯瑞替尼等产品已经陆续上市并进入医保竞争，卡马替尼、特泊替尼等产品又进一步增加了国内治疗选择。一个过去相对“小众”的肺癌靶点，已经快速聚集起多家国内外药企。 ROS1也在经历产品迭代。从较早进入临床的克唑替尼，到恩曲替尼、安奈克替尼、瑞普替尼等后来者，针对脑转移、耐药突变等临床问题，新一代产品仍在不断寻找自己的位置。 更罕见的靶点还有NTRK，患者人数更少，但随着检测普及和针对性药物出现，这些过去容易被淹没在“肺癌”中的患者，但随着恩曲替尼等产品进入临床使用，以及诺诚健华佐来曲替尼等后来者出现，针对这部分少见患者的治疗选择也在增加。 推荐阅读  *国谈DAY1：强生、云顶谈了4小时！辉瑞、恒瑞、信达、再鼎齐登场，第一天就燃爆了？ *国谈DAY2：CAR-T上桌！信达、荣昌、再鼎血战突围，AZ、默沙东、罗氏硬仗开打！ 血液瘤集中上新 血液瘤是第三天下午另一个新品密集出现的领域。 百济神州、第一三共、诺华、辉瑞、恒瑞、亚盛先后出现在谈判现场。从急性髓系白血病、慢性髓性白血病，到外周T细胞淋巴瘤、B细胞急性淋巴细胞白血病，都有产品涉及。 其中，奎扎替尼瞄准新诊断FLT3-ITD阳性的成人急性髓系白血病。 FLT3是急性髓系白血病中一个重要的分子标志。一部分患者携带FLT3突变后，白血病细胞会获得更强的异常增殖信号。因此，即使同样被诊断为急性髓系白血病，患者是否携带FLT3-ITD突变，也会直接影响后续的治疗选择。 慢性髓性白血病也有望迎来新产品。 现行目录中，覆盖了从伊马替尼，到尼洛替尼、达沙替尼、氟马替尼等多代产品，亚盛医药的奥雷巴替尼又进一步覆盖部分耐药患者。今年，诺华的阿思尼布来到谈判桌前。 对于慢性髓性白血病这样需要长期治疗的疾病，患者是否耐药、是否不耐受、此前使用过哪些药物，本身就在影响后续治疗选择。新品进入医保以后，增加的也是不同患者在不同治疗阶段的选择。 淋巴系统血液肿瘤同样有新品登场。 百济神州的索托克拉是一款BCL-2抑制剂，此次申报医保的其中一个适应证是既往接受过BTK抑制剂治疗的慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）患者。这一领域已经有BTK抑制剂等多种靶向治疗。 同样是淋巴系统肿瘤，恒瑞的泽美妥司他瞄准的则是另一群患者——既往接受过至少一线系统治疗的复发或难治性外周T细胞淋巴瘤。 此外，辉瑞的奥加伊妥珠单抗，针对成人复发或难治性B细胞前体急性淋巴细胞白血病也是今年医保谈判的看点之一。 就在前一天，合源生物的纳基奥仑赛已经走上基本医保的谈判桌。这款CAR-T同样用于成人复发或难治性B细胞急性淋巴细胞白血病，并且此前已经进入2025年商保创新药目录。 同一个患者群体面前，抗体药物和CAR-T都开始争取医保支付。 虽然两种疗法并不是简单的替代关系，具体使用还取决于患者既往治疗、疾病状态等因素。但如果CAR-T最终进入基本医保，过去最突出的价格和支付门槛有望进一步降低，血液瘤后线治疗的选择也会随之增加。 一审| 石宛佳 二审| 李芳晨 三审| 李静芝