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8-K: Current report

8-K: Current report

8-K:重大事件
美股sec公告 ·  04/16 09:35
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On April 16, 2024, Incannex Healthcare Inc., a clinical stage pharmaceutical development company, provided a quarterly update for Q1 2024, detailing progress in their research and development programs. The update highlighted the advancement of their therapeutic pipeline, including the IHL-42X drug candidate for Obstructive Sleep Apnea (OSA), which is currently in Phase 2/3 clinical trials. The company also reported on IHL-675A for Rheumatoid Arthritis (RA), which is in Phase 2b studies, and the Psi-GAD psilocybin treatment protocol for generalized anxiety disorder, now entering Phase 2b studies following a successful Phase 2 proof of concept. Additionally, Incannex opened its first Clarion Clinic for psychedelic-assisted psychotherapies. The company is preparing for patient dosing in the RePOSA Phase 2/3 Clinical Trial for IHL-42X and has made significant progress in the...Show More
On April 16, 2024, Incannex Healthcare Inc., a clinical stage pharmaceutical development company, provided a quarterly update for Q1 2024, detailing progress in their research and development programs. The update highlighted the advancement of their therapeutic pipeline, including the IHL-42X drug candidate for Obstructive Sleep Apnea (OSA), which is currently in Phase 2/3 clinical trials. The company also reported on IHL-675A for Rheumatoid Arthritis (RA), which is in Phase 2b studies, and the Psi-GAD psilocybin treatment protocol for generalized anxiety disorder, now entering Phase 2b studies following a successful Phase 2 proof of concept. Additionally, Incannex opened its first Clarion Clinic for psychedelic-assisted psychotherapies. The company is preparing for patient dosing in the RePOSA Phase 2/3 Clinical Trial for IHL-42X and has made significant progress in the Phase 2 clinical trial for IHL-675A. Incannex also intends to submit a New Drug Application for IHL-42X using the FDA 505(b)2 pathway, based on a Bioavailability/Bioequivalence Study. The company's CEO, Joel Latham, expressed confidence in the market potential for their products, citing the lack of FDA or EMA registered drugs for the treatment of sleep apnea. Incannex is listed on NASDAQ as IXHL and holds 19 granted patents with 30 pending applications, focusing on developing treatments for a range of conditions including OSA, traumatic brain injury, lung inflammation, RA, inflammatory bowel disease, anxiety disorders, addiction disorders, and pain.
2024年4月16日,临床阶段药物开发公司Incannex Healthcare Inc. 提供了2024年第一季度的季度最新情况,详细介绍了其研发计划的进展。该更新突显了他们的治疗产品线的进展,包括阻塞性睡眠呼吸暂停(OSA)的 IHL-42X 候选药物,该药物目前正处于 2/3 期临床试验。该公司还报告了用于类风湿关节炎(RA)的 IHL-675A,该方案正在进行2b期研究,以及针对广泛性焦虑症的PSI-GAD psilocybin治疗方案,在成功完成2期概念验证后,该方案现已进入2b期研究。此外,Incannex开设了第一家提供迷幻辅助心理治疗的Clarion诊所。该公司正在为 IHL-...展开全部
2024年4月16日,临床阶段药物开发公司Incannex Healthcare Inc. 提供了2024年第一季度的季度最新情况,详细介绍了其研发计划的进展。该更新突显了他们的治疗产品线的进展,包括阻塞性睡眠呼吸暂停(OSA)的 IHL-42X 候选药物,该药物目前正处于 2/3 期临床试验。该公司还报告了用于类风湿关节炎(RA)的 IHL-675A,该方案正在进行2b期研究,以及针对广泛性焦虑症的PSI-GAD psilocybin治疗方案,在成功完成2期概念验证后,该方案现已进入2b期研究。此外,Incannex开设了第一家提供迷幻辅助心理治疗的Clarion诊所。该公司正在为 IHL-42X 的 repoSA 2/3 期临床试验中的患者给药做准备,并在 IHL-675A 的 2 期临床试验中取得了重大进展。Incannex 还打算根据生物利用度/生物等效性研究,使用 FDA 505 (b) 2 途径提交 IHL-42X 的新药申请。该公司首席执行官乔尔·莱瑟姆表示对其产品的市场潜力充满信心,理由是缺乏用于治疗睡眠呼吸暂停的FDA或EMA注册药物。Incannex在纳斯达克以IXHL的名义上市,拥有19项已获授权的专利和30项待批申请,专注于开发一系列疾病的治疗方法,包括OSA、创伤性脑损伤、肺部炎症、关节炎、炎症性肠病、焦虑症、成瘾症和疼痛。
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