Shake Up At Lykos Therapeutics After FDA Blocks Ecstasy-Based Treatment, CEO Steps Down
Shake Up At Lykos Therapeutics After FDA Blocks Ecstasy-Based Treatment, CEO Steps Down
Effective immediately, Amy Emerson, the CEO of Lykos Therapeutics, has stepped down from her role at the company, the WSJ reported.
Lykos Therapeutics首席執行官Amy Emerson已辭去公司職務，據華爾街日報報道。
This announcement comes nearly a month after the Food and Drug Administration (FDA) rejected Lykos's application for its ecstasy-based therapy intended to treat post-traumatic stress disorder (PTSD).
這一消息是在食品藥品監督管理局(FDA)拒絕批准Lykos公司用於治療創傷後應激障礙(PTSD)的搖頭丸療法申請近一個月後傳出的。
The company, which had sought approval for its midomafetamine therapy – commonly known as MDMA or Ecstasy – was informed last month that the FDA found insufficient evidence to support the treatment's safety and efficacy.
該公司曾尋求批准其midomafetamine療法(通常稱爲MDMA或Ecstasy)，但上個月被告知FDA認爲缺乏足夠的證據來支持該療法的安全性和療效。
Leadership Change Amidst FDA Rejection
FDA拒絕之際的領導層變動
Effective immediately, Michael Mullette, the company's chief operating officer for the past two years, will take over as interim CEO. Mullette brings a wealth of experience from his previous roles at Moderma and Sanofi.
公司現任首席運營官Michael Mullette將立即接任臨時首席執行官職務。Mullette在Moderma和賽諾菲的前任職期間積累了豐富的經驗。
Emerson, who initially began her association with Lykos's sister nonprofit, the Multidisciplinary Association for Psychedelic Studies (MAPS), in 2003, will transition to a senior adviser role and serve as an observer on Lykos's board until the end of the year.
Emerson最初於2003年加入Lykos的非營利姐妹機構——多領域精神研究協會(MAPS)，她將過渡到高級顧問職務，並在今年年底之前擔任Lykos董事會觀察員。
Emerson's departure marks a significant shift for Lykos, a company that has been a pioneer in psychedelic research. She's been at the helm of the company since its rebranding from MAPS's for-profit spin-off earlier this year.
Emerson的離職標誌着Lykos這家在迷幻研究領域具有開創性地位的公司發生了重大變革。她自公司早些時候從MAPS的營利派生機構進行了重新品牌塑造以來一直擔任首席。
FDA's Concerns And Lykos's Response
FDA的擔憂與Lykos的回應
The FDA's decision was influenced by concerns over the adequacy of data supporting the therapy's safety and effectiveness. In response, Lykos has announced plans to conduct additional clinical studies and aims to resubmit its application for approval. The company has also made substantial reductions in its workforce, cutting approximately 75% of its staff.
FDA的決定受到了對療法安全性和有效性支持數據的充分性的擔憂影響。作爲回應，賽諾菲安萬特宣佈計劃進行額外的臨床研究，並計劃重新提交批准申請。該公司還大幅度減少了人員規模，裁員約75%。
Recent reports from The Wall Street Journal have cast further scrutiny on Lykos's research. Allegations include overlooked serious side effects among study participants, such as suicidal thoughts and the involvement of therapists who conducted unauthorized MDMA therapy sessions. This led the FDA to broaden its investigation into Lykos's studies.
《華爾街日報》最近的報道進一步審查了賽諾菲安萬特的研究。指控包括在研究參與者中忽視了嚴重的副作用，如自殺念頭以及未經授權進行MDMA療法的治療師的參與。這導致FDA對賽諾菲安萬特的研究進行了擴大調查。
Psychedelic Therapy's Future And Industry Trends
迷幻療法的未來和行業趨勢
Despite the setback for Lykos, the broader psychedelic therapy landscape continues to evolve. Other companies are advancing their own research into psychedelic treatments. Compass Pathways PLC (NASDAQ:CMPS), for instance, is in the final stages of studies examining psilocybin, commonly known as magic mushrooms, for treatment-resistant depression.
儘管賽諾菲安萬特遭遇了挫折，但更廣泛的迷幻療法領域仍在不斷髮展。其他公司正在推進他們自己對迷幻治療的研究。例如，指南針通道PLC（納斯達克股票代碼：CMPS）正處於研究治療抵抗性抑鬱症的小靈芝（通常稱爲迷幻蘑菇）的最後階段。
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譯文內容由第三人軟體翻譯。
