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Roivant Sciences Ltd. (ROIV) Wins Orphan Drug Status in Japan for Mosliciguat
Yahoo Finance· 2025-09-11 23:11
公司业务与战略 - 临床阶段生物制药公司 专注于通过子公司网络加速药物和技术开发 [2] - 专门从大型制药公司授权引进有前景的候选药物并推动商业化 [2] - 战略重点集中于罕见病和免疫介导疾病领域 [4] 产品管线进展 - 主要候选药物包括治疗间质性肺病相关肺动脉高压的mosliciguat、治疗炎症性疾病的brepocitinib以及针对自身免疫性疾病的单克隆抗体IMVT-1402 [2] - mosliciguat是从拜耳获得许可的吸入式可溶性鸟苷酸环化酶激活剂 已获得日本厚生劳动省授予的孤儿药资格认定 [3] - brepocitinib项目正推进关键三期数据读取 [4] 市场地位与竞争优势 - Pulmovant子公司成为治疗选择有限的肺动脉高压适应症领域重要参与者 [3] - 孤儿药资格认定带来监管 benefits 和潜在市场独占权 [3] - 被列为当前值得购买的7支热门医疗股之一 [1][4]
Protalix BioTherapeutics to Present at Investor Summit Virtual
Accessnewswire· 2025-09-11 22:55
CARMIEL, ISRAEL / ACCESS Newswire / September 11, 2025 / Protalix BioTherapeutics, Inc. (NYSE American:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today announced that Eyal Rubin, the Company's former Sr. Vice President and Chief Financial Officer, will present at the Investor Summit Virtual on September 16, 2025, updating investors about t ...
MAIA Biotechnology Highlights Positive Efficacy Data from THIO-101 Phase 2 Clinical Trial in Non-Small Cell Lung Cancer
Globenewswire· 2025-09-11 21:27
CHICAGO, Sept. 11, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today highlighted positive efficacy data from its Phase 2 clinical trial, THIO-101, evaluating ateganosine (THIO) sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who had failed two or more standard-of-care ...
Nancy T. Chang, Proven Biotechnology Leader, Joins Immix Biopharma Board of Directors
Globenewswire· 2025-09-11 21:15
核心观点 - 前Tanox公司首席执行官Nancy T Chang博士加入Immix Biopharma董事会 同时作为Goose Capital创始成员进行投资[1] - Chang博士领导团队开发了多款FDA批准药物 包括XOLAIR®、TROGARZO®和EBGLYSS® 累计销售额超过50亿美元[2] - Immix Biopharma为临床阶段生物制药公司 专注于开发AL淀粉样变性及其他严重疾病的细胞疗法[3] 公司管理层变动 - Nancy T Chang加入Immix Biopharma董事会 其曾担任Tanox公司CEO[1] - Chang博士作为Goose Capital创始成员对公司进行投资[1] 行业经验与成就 - Chang博士团队发明并开发了XOLAIR®(奥马珠单抗)用于治疗严重哮喘[2] - 开发TROGARZO®(伊巴珠单抗)用于HIV治疗[2] - 开发EBGLYSS®(来金珠单抗)用于皮炎治疗[2] - 三款药物累计销售额超过50亿美元[2] - Tanox公司被Genentech/Roche以9.19亿美元收购[2] - EBGLYSS®由礼来公司商业化[2] 公司产品管线 - 主要候选药物为NXC-201 一种空间优化的BCMA靶向CAR-T细胞疗法[3] - NXC-201采用"数字过滤器"技术 可过滤非特异性激活[3] - 正在美国进行多中心研究NEXICART-2(NCT06097832)针对复发/难治性AL淀粉样变性[3] - NEXICART-2研究采用注册性设计 在ASCO 2025公布的中期结果中达到主要终点[3] - NXC-201获得美国FDA授予再生医学先进疗法(RMAT)资格[3] - 获得FDA和EMA授予孤儿药资格(ODD)[3] 公司背景 - Immix Biopharma为纳斯达克上市公司 代码IMMX[3] - 专注于开发AL淀粉样变性及其他严重疾病的细胞疗法[3] - 公司处于临床阶段[3]
Athira Pharma Announces Reverse Stock Split
Globenewswire· 2025-09-11 21:00
公司行动 - 公司宣布进行10比1的反向股票分割 将于2025年9月17日东部时间下午5点生效[1][2] - 反向分割后 每10股已发行普通股将合并为1股 授权普通股总数从9亿股减少至9000万股[3] - 普通股面值保持不变 仍为每股0.0001美元 优先股授权总数不减少 保持1亿股[3] 交易安排 - 分割调整后交易将于2025年9月18日在纳斯达克资本市场开始 股票代码维持"ATHA"[2] - 新CUSIP号码变更为04746L203 计算机服务公司担任本次反向股票分割的交换代理[2][4] - 以簿记形式持有股票的登记股东无需采取任何行动 经纪账户持股将自动调整[4] 实施目的 - 反向分割旨在提高每股价格 以满足纳斯达克1美元最低买入价要求[2] - 公司期望通过此举提升股票市场流动性和吸引力 吸引更广泛的投资者群体[2] 公司背景 - 公司为临床阶段生物制药企业 专注于开发恢复神经元健康的小分子药物[1][6] - 总部位于华盛顿州西雅图地区 通过调节神经营养HGF系统来改变神经疾病进程[6]
GRI Bio Reports 6-Week Interim Lung Function Data in Ongoing Phase 2a Study in Idiopathic Pulmonary Fibrosis (“IPF”)
Globenewswire· 2025-09-11 20:45
No decline in lung function observed at 6-week interim analysis builds upon positive safety and biomarker data Phase 2a study fully enrolled; Topline data on track for Q3 2025 Currently available treatments for IPF are limited to only two approved drugs that come with significant side-effects, limited patient compliance and no impact on survival LA JOLLA, CA, Sept. 11, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline ...
Liquidia Announces Poster Presentations at the Pulmonary Hypertension Professional Association (PHPN) Symposium
Globenewswire· 2025-09-11 20:30
MORRISVILLE, N.C., Sept. 11, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, announced today that the company will present four posters at the Pulmonary Hypertension Professional Association (PHPN) Symposium taking place September 18 – 20, 2025, in Seattle. In a live thematic poster session, Liquidia will highlight new safety and exploratory efficacy data pertaining to patients with pulm ...
SELLAS Life Sciences Group Announces Exercise of Existing Warrants Held by a Current Institutional Investor for $23.6 Million in Gross Proceeds
Globenewswire· 2025-09-11 20:30
NEW YORK, Sept. 11, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced the immediate exercise of warrants, previously issued in January 2025, to purchase up to 19,685,040 shares of its common stock for gross cash proceeds of approximately $23.6 million. In consideration for the immediate exercise in full of th ...
Lexicon Pharmaceuticals to Present Additional Clinical Data on Pilavapadin at Three Upcoming Medical Meetings
Globenewswire· 2025-09-11 20:30
Presentations collectively highlight pilavapadin’s potential to improve pain management care for patients with diabetic peripheral neuropathic pain (DPNP) Breadth of the data across Phase 2 program to be discussed at Arrowhead’s 19th Annual Pain Summit THE WOODLANDS, Texas, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the presentation of clinical data for its investigational, AAK1-inhibitor, pilavapadin, for the treatment of diabetic peripheral neuropathic ...
中国生物技术-全球医疗保健大会总结 - 第二天-China Biotech Global Healthcare Conference Wrap - Day 2
2025-09-11 20:11
**行业与公司** * 行业聚焦中国生物科技与医疗健康领域 涉及全球医疗健康会议第二天的讨论内容[1][2][7] * 提及的具体公司包括再鼎医药(Zai Lab Ltd ZLAB)[4][8]、百奥赛图(BeOne)[3]、Innovent(信达生物)、Keymed(科迈生物)、Akeso(康方生物)[4]等多家中国生物制药企业 **核心观点与论据** * 出现独特的业务发展选项 鉴于中国生物制药活跃的对外授权活动 对直接持有中国股票持谨慎态度的海外投资者可能对购买已对外授权创新药物的特许权交易感兴趣 例如近期的BeOne/Imdelltra交易[3][7] * 对新免疫学靶点热情高涨 一家大型生物制药公司对其OX40L、IL-13/TSLP和IL-33等靶点资产表达了不同程度的信心 其中对OX40L差异化的治疗定位热情最高 这涉及到Innovent的IBI356、Keymed的CM512和Akeso的AK139等资产[4][7] * 再鼎医药(ZLAB)的关注点集中在Vyvgart和KarXT的商业前景以及ZL-1310的研发进展上[4] * Vyvgart:指南纳入、治疗持续时间(DoT)延长以及皮下制剂纳入国家医保目录(NRDL)是近期的关键驱动因素[8] * KarXT:在中国纳入NRDL后的潜在定价为美国价格的10-15% 中国以住院患者为主的市场格局有利于其商业采纳[8] * ZL-1310:其二线小细胞肺癌(2L SCLC)数据更新预计在2025年10月 60%以上的客观缓解率(ORR)和约6个月的中位无进展生存期(mPFS)被视为获得有利评价的门槛[8] **其他重要内容** * 摩根士丹利对所述中国医疗保健行业持“吸引人”(Attractive)的行业观点[7] * 报告包含大量标准化的合规声明、披露事项及评级定义 表明其与众多中国医疗健康公司存在广泛的投资银行业务、做市及持有证券等业务关系[5][6][9][10][11][12][13][14][15][16][17][18][19][21][22][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48][49][50][51][52][53][54][55] * 报告末尾附有覆盖公司的详细评级列表及股价信息[56][58][59][61]