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FDA Accepts SNY Filing for Expanded Use of T1D Drug in Young Children
ZACKS· 2026-01-05 16:26
Key Takeaways Sanofi seeks FDA approval to expand Tzield use to children aged one and older with stage 2 T1D.SNY's filing received priority review, with an FDA decision expected by April 29, 2026.The application is backed by interim phase IV PETITE-T1D data in children under eight.Sanofi (SNY) announced that the FDA has accepted a regulatory filing seeking to expand the use of its type 1 diabetes (T1D) drug, Tzield (teplizumab), in individuals aged one year and older. The agency has granted priority review ...
Zealand Pharma to present at the J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-05 16:05
Press release – No. 1 / 2026 Zealand Pharma to present at the J.P. Morgan Healthcare Conference Copenhagen, Denmark, January 5, 2026 – Zealand Pharma A/S ("the Company" or “Zealand Pharma”) (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company transforming the future of metabolic health, today announced that the Company will participate in the 44th J.P. Morgan Healthcare Conference on January 12-15, 2026 in San Francisco, California. Adam Steensberg, President and Chief Executive Officer, will take par ...
SHAREHOLDER ALERT: Purcell & Lefkowitz LLP Announces Shareholder Investigation of Citius Oncology, Inc. (NASDQ: CTOR)
Prnewswire· 2026-01-05 15:30
NEW YORK, Jan. 5, 2026 /PRNewswire/ -- Purcell & Lefkowitz LLP announces that it is investigating Citius Oncology, Inc. (NASDAQ: CTOR) on behalf of the company's shareholders. The investigation seeks to determine whether Citius Oncology's directors breached their fiduciary duties in connection with recent corporate actions. If you are a shareholder of Citius Oncology and are interested in obtaining additional information about your rights and options, please visit us at: https://pjlfirm.com/citius-oncolog ...
Psyence BioMed Achieves Milestone in Natural Ibogaine HCl Production and Strengthens Balance Sheet With No Debt and $12m Cash
Globenewswire· 2026-01-05 14:15
NEW YORK, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”), a biopharmaceutical company advancing nature-derived psilocybin and ibogaine therapies for unmet mental health needs, today announced a significant scientific and manufacturing achievement. Through its investment in PsyLabs, Psyence BioMed has become the first Nasdaq-listed company to produce GMP-compliant, high-purity ibogaine hydrochloride (Ibogaine HCl) derived from a naturally extracted ...
Processa Pharmaceuticals Completes Enrollment of 20th Patient for Formal Interim Analysis in Phase 2 NGC-Cap Breast Cancer Study
Globenewswire· 2026-01-05 14:15
Interim safety and efficacy data to be reported in Q1 VERO BEACH, Fla., Jan. 05, 2026 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage biopharmaceutical company developing Next Generation Cancer (NGC) therapies, today reported that it completed the enrollment and dosing of the 20 patients required for the planned formal interim analysis in its ongoing Phase 2 clinical study evaluating NGC-Cap, Processa’s proprietary combination treatment of PCS6422 and capecitabine, in pat ...
Nxera Pharma to Present at the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-05 13:58
公司近期动态 - 公司总裁兼首席执行官Chris Cargill将于2026年1月13日太平洋标准时间下午1:30在第43届摩根大通医疗健康年会上发表演讲 [1] - 投资者、分析师及公众可通过网络直播链接收听演讲实况 [1] - 演示文稿将在公司网站的投资者关系板块发布 [2] 公司业务定位与战略 - 公司是一家技术驱动的生物制药公司 致力于为日本及全球未满足需求的患者研发新的专科药物 [2] - 公司在日本建立了敏捷的新一代商业化业务 以开发和商业化创新药物 包括多款已上市产品 旨在服务日本这一高价值、庞大且增长的市场以及更广泛的亚太地区市场 [3] 研发管线与平台 - 公司依托其独特的NxWave™发现平台 正在推进一个包含超过30个活跃项目的广泛研发管线 涵盖从早期发现到后期临床阶段 [4] - 该管线由内部开发及与领先药企和生物技术公司合作推进 [4] - 管线中的候选药物具有潜在同类首创或同类最佳潜力 专注于解决肥胖及代谢疾病、神经学/神经精神疾病以及免疫与炎症等一些增长最快的医疗领域内未满足的重大需求 [4] 公司基本情况 - 公司在日本东京和大阪、英国伦敦和剑桥、瑞士巴塞尔以及韩国首尔等关键地点拥有约400名员工 [5] - 公司在东京证券交易所上市 股票代码为4565 [5]
TELIX PHARMACEUTICALS (NASDAQ: TLX) CLASS ACTION DEADLINE APPROACHING: Berger Montague Advises Investors to Inquire About a Securities Fraud Class Action by January 9, 2026
Prnewswire· 2026-01-05 13:36
PHILADELPHIA, Jan. 5, 2026 /PRNewswire/ -- National plaintiffs' law firm Berger Montague PC announces that a class action lawsuit has been filed against Telix Pharmaceuticals Ltd. (NASDAQ: TLX) ("Telix" or the "Company") on behalf of investors who purchased Telix securities during the period of February 21, 2025 through August 28, 2025 (the "Class Period"). Investor Deadline: Investors who purchased Telix securities during the Class Period may, no later than January 9, 2026, seek to be appointed as a lead ...
Xenon to Present at the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-05 13:30
VANCOUVER, British Columbia and BOSTON, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq: XENE), a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development and commercialization of life-changing therapeutics for patients in need, today announced that the company will present at the 44th Annual J.P. Morgan Healthcare Conference, taking place in San Francisco, CA from January 12-15, 2026. Company Presentation Details: Date:Monday, January 12, 2026 T ...
Appointment of Fiona Sharp to the Board as Chief Financial Officer and Company Secretary
Globenewswire· 2026-01-05 13:30
January 05, 2026 Biodexa Pharmaceuticals PLC Appointment of Fiona Sharp to the Board as Chief Financial Officer and Company Secretary Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, is delighted to announce the promotion of Fiona Sharp to Chief Financial Officer and Company Secretary along with her election to the Board of Directors of the ...
CRISPR Therapeutics to Present at the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-05 13:30
ZUG, Switzerland and BOSTON, Jan. 05, 2026 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today announced that members of its senior management team will present at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026 at 8:15 a.m. PT in San Francisco. A live webcast of the presentation will be available on the "Events & Presentations" page in the Investors section of th ...