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Cincinnati Children's Activated as the Seventh Qualified Treatment Center for ZEVASKYN®
Globenewswire· 2026-07-21 19:30
CLEVELAND, July 21, 2026 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases, today announced the activation of Cincinnati Children’s as the seventh Qualified Treatment Center (QTC) for the administration of ZEVASKYN® (prademagene zamikeracel), the first and only autologous gene-modified cellular sheets for the treatment of wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB). “ ...
Jupiter Neurosciences (NASDAQ: JUNS) Signs Definitive Agreement for Exclusive U.S. Rights to ALA-002 in Transaction Valued at Up to $100 Million
Globenewswire· 2026-07-21 19:13
Transaction expands Jupiter into a dual clinical-stage CNS company by adding a differentiated FDA- designated Novel Chemical Entity alongside its Phase II Parkinson's disease program About ALA-002 ALA-002 is a patented, non-racemic MDMA formulation that has received Novel Chemical Entity (NCE) designation from the U.S. Food and Drug Administration (FDA), providing enhanced regulatory protection and a five-year data exclusivity period upon approval. ALA-002 has been engineered to deliver materially improved ...
Agios Provides Update on Phase 2 Trial of Tebapivat in Sickle Cell Disease
Globenewswire· 2026-07-21 19:00
公司核心动态 - Agios Pharmaceuticals 宣布了其在研药物 tebapivat 针对镰状细胞病的二期临床试验顶线结果,该药物是一种口服丙酮酸激酶激活剂 [1] - 公司已决定不继续推进 tebapivat 在镰状细胞病领域的开发,因为试验结果未能证明该药物具备支持继续开发所需的差异化水平 [3] - 公司的另一款基础性PK激活剂 mitapivat 用于镰状细胞病的补充新药申请已获得美国FDA的优先审评资格,处方药用户费用法案目标日期为2026年11月1日 [4][7] tebapivat 二期临床试验详情 - 试验旨在描述 tebapivat 在镰状细胞病中的剂量反应关系,并评估其是否相对于其他PK激活剂具有显著差异化特征 [2] - 试验包含为期12周的双盲、安慰剂对照期,59名参与者以2:2:2:1的比例随机分配,接受三种每日一次(2.5 mg, 5.0 mg, 或 7.5 mg)的 tebapivat 剂量之一或安慰剂 [2] - 在12周治疗期内,所有 tebapivat 剂量组均观察到血红蛋白水平和溶血指标的改善,这与已知的PK激活机制一致 [3] - 试验的主要终点是血红蛋白应答(第10至12周的平均血红蛋白浓度较基线增加≥1.0 g/dL),2.5 mg、5.0 mg 和 7.5 mg 剂量组的应答率分别为 43.8% (7/16)、47.1% (8/17) 和 29.4% (5/17),安慰剂组为 33.3% (3/9) [3] - tebapivat 在二期试验中的安全性和耐受性与之前镰状细胞病试验中观察到的一致 [3] 公司战略与管线 - 公司首席医疗官表示,这些数据进一步证实了PK激活是镰状细胞病中一个经过临床验证的机制,但 tebapivat 的结果未能达到所需的差异化水平 [4] - 公司目前重点仍放在其基础性PK激活剂 mitapivat 上,该药物预计将在今年晚些时候在美国获批,有望成为该领域的一流药物 [4] - Agios 是一家商业阶段的生物制药公司,总部位于马萨诸塞州剑桥市,专注于为罕见病患者提供创新药物,尤其在血液学领域有深厚基础 [5]
ZEO ScientifiX Strengthens South Florida's Growing Biotechnology Ecosystem Through Regenerative Medicine Innovation
Accessnewswire· 2026-07-21 19:00
ZEO ScientifiX Strengthens South Florida's Growing Biotechnology Ecosystem Through Regenerative Medicine InnovationBack to the NewsroomZEO ScientifiX Strengthens South Florida's Growing Biotechnology Ecosystem Through Regenerative Medicine InnovationOperating from Nova Southeastern University's Center for Collaborative Research, ZEO ScientifiX is expanding physician education, scientific collaboration, and regenerative biologic innovation as Florida emerges as a national life sciences hub.DAVIE, FL / ACCESS ...
OKYO Pharma Announces Purchase of Shares by Chairman
Globenewswire· 2026-07-21 19:00
公司核心事件 - 公司董事长通过其拥有受益权的实体Panetta Partners Ltd,以每股1.40美元的价格增持了25,000股普通股 [1] - 此次增持使其总持股数达到10,851,416股普通股,占已发行股本的20.51% [1] 公司业务与管线 - 公司是一家临床阶段的生物制药公司,致力于开发治疗神经性角膜疼痛(NCP)和眼前节眼疾的研究性疗法 [1][2] - 公司计划在今年下半年启动一项全球性的关键性3期临床试验,计划招募约111名患者,以评估单剂量urcosimod治疗NCP的疗效 [2] 公司基本信息 - 公司名称为OKYO Pharma Limited,在纳斯达克资本市场上市,股票代码为OKYO [1][2]
PharmAla Biotech Executes Definitive License Agreement Granting Jupiter Neurosciences Exclusive U.S. Rights to ALA-002
Globenewswire· 2026-07-21 19:00
TORONTO, July 21, 2026 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTCQB: MDXXF), a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules (including its LaNeo™ MDMA), is pleased to announce that it has entered into a definitive license agreement (the “Agreement”) on July 20th, 2026 with Jupiter Neurosciences, Inc. (NASDAQ: JUNS) (“Jupiter”), under which PharmAla has granted Jupiter an exclusive, perpetual ...
BioNTech to Report Second Quarter 2026 Financial Results and Corporate Update on August 4, 2026
Globenewswire· 2026-07-21 18:45
BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning i ...
ADMA Lawsuit Notice: ADMA Biologics Channel Stuffing Allegations and 29% Stock Drop Trigger Securities Fraud Class Action
Prnewswire· 2026-07-21 18:17
公司概况 - ADMA Biologics Inc 是一家端到端的商业生物制药公司,专注于生产、营销和开发专业生物制剂 [5] - 公司的旗舰产品是ASCENIV,一种用于治疗成人和青少年原发性体液免疫缺陷的液体免疫球蛋白溶液 [5] 诉讼与指控 - 一家证券律师事务所代表投资者对ADMA Biologics及其部分高级管理人员提起了证券欺诈集体诉讼 [1][2] - 诉讼指控公司违反了《1934年证券交易法》第10(b)条和第20(a)条 [3] - 诉讼起因是Culper Research发布了一份报告,指控公司进行渠道填充以虚增收入 [1][6] - 报告指控,在2025年,公司通过提供回扣和延长付款期限,诱导其一家分销商囤积过量的ASCENIV产品,以满足订单预期 [6] - 据称,这一行为使公司得以确认收入并报告虚假增长,若未进行此操作,公司2025年收入本应下降3%,而非报告的增长20% [6] - 诉讼还指控公司未披露关联方交易 [5] 市场反应与股价影响 - Culper Research的报告于2026年3月24日发布,导致ADMA股价从2026年3月23日的收盘价每股13.59美元下跌2.26美元(跌幅16.6%),至2026年3月24日的每股11.33美元 [7] - 次日(2026年3月25日),股价进一步下跌1.70美元(跌幅15%),收于每股9.63美元 [7] - 随后在2026年3月26日,因Investing.com报道Cantor因做空报告担忧下调ADMA评级,股价从2026年3月25日的收盘价每股9.63美元下跌1.34美元(跌幅13.9%),至2026年3月29日的每股8.29美元 [9] - 自相关事件以来,公司股价累计下跌了29% [1] 法律程序 - 该集体诉讼案件正在美国新泽西地区法院审理,案件编号为26-cv-6918,案名为Mazzarino v. ADMA Biologics, Inc., et al. [3] - 投资者申请成为本案首席原告的截止日期为2026年8月10日 [3][8]
Ligand Pharmaceuticals (LGND.O): Resuming Coverage with Buy/H Rating and $387 TP Following Close of XOMA Acquisition Which Opens Up100+ Shots On Goal-20260721
花旗· 2026-07-21 17:10
Ac t i o n | 21 Jul 2026 05:00:00 ET │ 14 pages Ligand Pharmaceuticals (LGND.O) Resuming Coverage with Buy/H Rating and $387 TP Following Close of XOMA Acquisition Which Opens Up 100+ Shots On Goal CITI'S TAKE We resume coverage of LGND after a period of Rating Suspended with a Buy/H rating and $387 TP post-close of XOMA acquisition. We continue to see upside to current levels as the highly compelling acquisition of XOMA for $39/shr (~$739M equity value), plus a CVR tied to ongoing Tremfya litigation, was s ...
1H26 Earnings Preview: BD Outlook Outshining Transient Domestic Disruption-20260721
摩根士丹利· 2026-07-21 16:17
July 21, 2026 08:00 AM GMT China Pharmaceuticals | Asia Pacific M Idea 1H26 Earnings Preview: BD Outlook Outshining Transient Domestic Disruption Valuation remains well supported by robust business development (BD) outlook and manageable domestic policy impact, in our view. We preview 1H26 earnings, partner execution progress of announced BD deals and new deal outlook, key clinical readouts, and other major catalysts into 2H26. Key Takeaways With this report, Alexis Yan assumes primary coverage of Nanjing L ...