Relmada Therapeutics Stock Plummets Losing 80% Value - Here's Why
Relmada Therapeutics Stock Plummets Losing 80% Value - Here's Why
No new safety signals were reported.On Wednesday, Relmada Therapeutics, Inc. (NASDAQ:RLMD) announced a preplanned interim analysis of the Reliance II Phase 3 study.
週三，Relmada Therapeutics, Inc.（納斯達克股票代碼：RLMD）宣佈了對信實二期三期研究的預先計劃的中期分析。
Reliance II is designed to evaluate REL-1017 as an adjunctive treatment for major depressive disorder (MDD), to be used in combination with other approved anti-depressants.
Reliance II 旨在評估 REL-1017 作爲重度抑鬱症 (MDD) 的輔助療法，可與其他批准的抗抑鬱藥聯合使用。
The Independent Data Monitoring Committee (DMC) analysis indicated that the Reliance II Phase 3 study is futile and unlikely to meet the primary efficacy endpoint with statistical significance.
獨立數據監測委員會（DMC）的分析表明，Reliance II 3期研究是徒勞的，不太可能達到具有統計意義的主要療效終點。
No new safety signals were reported.
沒有報告新的安全信號。
"We are disappointed with the outcome of this interim analysis," said Sergio Traversa, Chief Executive Officer of Relmada. "Based on these results, Relmada will evaluate the full dataset to determine next steps for the REL-1017 program. The Company will continue to advance the Phase 1 study of REL-P11, an investigational agent for the treatment of metabolic disease, currently in a Phase 1 first-in-human study. We are grateful to the investigative sites and patients who participated in the REL-1017 program."
Relmada首席執行官塞爾吉奧·特拉弗薩說：「我們對這次中期分析的結果感到失望。」「基於這些結果，Relmada 將評估完整的數據集，以確定 REL-1017 計劃的下一步行動。該公司將繼續推進用於治療代謝性疾病的研究藥物 REL-P11 的1期研究，目前正在進行第一階段的首次人體研究。我們感謝參與了 REL-1017 計劃的調查場所和患者。」
In July 2021, Relmada acquired the development and commercial rights to a novel psilocybin and derivatives program. Psilocybin has neuroplastogen effects that have the potential to ameliorate neurodegenerative conditions.
2021年7月，Relmada獲得了一項新型迷幻藥及其衍生物計劃的開發和商業權。psilocybin具有神經塑化作用，有可能改善神經退行性疾病。
Relmada identified the potential to use low-dose psilocybin to treat metabolic diseases and published the data at the American Society for the Study of Liver Disease.
Relmada確定了使用低劑量的psilocybin治療代謝性疾病的可能性，並在美國肝病研究學會發布了該數據。
Last year, Relmada Therapeutics released efficacy results for the de novo (or new to treatment) patients (204 patients) and safety results for all subjects (627 patients) from the Phase 3 trial (Study 310) of REL-1017 in patients with Major Depressive Disorder (MDD).
去年，Relmada Therapeutics發佈了針對重度抑鬱症（MDD）患者的 REL-1017 三期試驗（310號研究）中從頭（或剛開始接受治療）患者（204名患者）的療效結果和所有受試者（627名患者）的安全性結果。
Patients treated daily with REL-1017 for up to one year experienced rapid, clinically meaningful, and sustained improvements in depressive symptoms and associated functional impairment.
每天接受 REL-1017 治療長達一年的患者的抑鬱症狀和相關的功能障礙得到快速、具有臨床意義和持續的改善。
In November, Relmada Therapeutics initiated dosing in a Phase 1 SAD study of REL-P11, an investigational agent for metabolic disease. Phase 2a proof-of-concept study is expected to begin in the first half of 2025.
11月，Relmada Therapeutics開始對代謝性疾病的研究藥物 REL-P11 進行1期SAD研究的給藥。2a階段的概念驗證研究預計將於2025年上半年開始。
Price Action: RLMD stock is down 75.4% at $0.68 at last check Wednesday.
價格走勢：週三最後一次檢查時，RLMD股價下跌75.4％，至0.68美元。
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