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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 21:35
牛牛AI助理已提取核心訊息
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,臨床階段藥物開發公司Incannex Healthcare Inc. 提供了2024年第一季度的季度最新情況,詳細介紹了其研發計劃的進展。該更新突顯了他們的治療產品線的進展,包括阻塞性睡眠呼吸暫停(OSA)的 IHL-42X 候選藥物,該藥物目前正處於 2/3 期臨床試驗。該公司還報告了用於類風溼關節炎(RA)的 IHL-675A,該方案正在進行2b期研究,以及針對廣泛性焦慮症的PSI-GAD psilocybin治療方案,在成功完成2期概念驗證後,該方案現已進入2b期研究。此外,Incannex開設了第一家提供迷幻輔助心理治療的Clarion診所。該公司正在爲 IHL-...展開全部
2024年4月16日,臨床階段藥物開發公司Incannex Healthcare Inc. 提供了2024年第一季度的季度最新情況,詳細介紹了其研發計劃的進展。該更新突顯了他們的治療產品線的進展,包括阻塞性睡眠呼吸暫停(OSA)的 IHL-42X 候選藥物,該藥物目前正處於 2/3 期臨床試驗。該公司還報告了用於類風溼關節炎(RA)的 IHL-675A,該方案正在進行2b期研究,以及針對廣泛性焦慮症的PSI-GAD psilocybin治療方案,在成功完成2期概念驗證後,該方案現已進入2b期研究。此外,Incannex開設了第一家提供迷幻輔助心理治療的Clarion診所。該公司正在爲 IHL-42X 的 repoSA 2/3 期臨床試驗中的患者給藥做準備,並在 IHL-675A 的 2 期臨床試驗中取得了重大進展。Incannex 還打算根據生物利用度/生物等效性研究,使用 FDA 505 (b) 2 途徑提交 IHL-42X 的新藥申請。該公司首席執行官喬爾·萊瑟姆表示對其產品的市場潛力充滿信心,理由是缺乏用於治療睡眠呼吸暫停的FDA或EMA註冊藥物。Incannex在納斯達克以IXHL的名義上市,擁有19項已獲授權的專利和30項待批申請,專注於開發一系列疾病的治療方法,包括OSA、創傷性腦損傷、肺部炎症、關節炎、炎症性腸病、焦慮症、成癮症和疼痛。

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