FDA is said to see “path forward” for ecstasy-based drug

seekingalpha10-19

Lykos Therapeutics, whose lead asset, midomafetamine capsules (MDMA), failed to win the FDA nod in August, said that the regulator has indicated a path forward for the Ecstasy-based drug, which, if ...

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Midomafetamine, based on the mind-altering drug MDMA, commonly known as Ecstasy or Molly, was rejected by the FDA in August for the treatment of post-traumatic stress disorder (\"PTSD\") in adults. Announcing the FDA’s complete response letter indicating the rejection, the privately held biotech said at the time that it would seek a meeting with the FDA to obtain the regulatory feedback regarding a potential resubmission of its marketing request. In a press release late Friday, Lykos said its new leadership, including interim CEO Michael Mullette and medical chief David Hough, conducted a meeting with the FDA last week. “The meeting resulted in a path forward, including an additional Phase 3 trial and a potential independent third-party review of prior Phase 3 clinical data,” the San Jose, California-based drug developer added. The update is expected to renew interest in psychedelic drug developers, which traded sharply higher last week amid a private placement worth $35M for Bright Minds Biosciences (NASDAQ:DRUG). In addition to Bright Minds Bio (NASDAQ:DRUG), other notable gainers included 180 Life Sciences (ATNF), Clearmind Medicine (CMND), Mind Medicine (NASDAQ:MNMD), GH Research (GHRS), Cybin (CYBN), Atai Life Sciences (ATAI), Revive Therapeutics (OTCQB:RVVTF), Enveric Bio (NASDAQ:ENVB), and COMPASS Pathways (NASDAQ:CMPS).","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"Policy And Regulatory","news_rank":0,"symbols":[],"gpt_button":0},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.1","shortVersion":"4.29.1","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2476058766"}