Palvella Therapeutics Says No Additional Efficacy Study Planned for Qtorin Rapamycin

MT Newswires Live

Jun 03

Palvella Therapeutics (PVLA) said Wednesday that no additional efficacy study has been planned for Qtorin rapamycin in microcystic lymphatic malformations to support the planned submission of a new drug application in H2.

The company said that based on the minutes of its pre-NDA meeting with the US Food and Drug Administration, the planned filing would be supported by the existing evidence package.

The evidence package will include efficacy and safety results from a phase 3 trial, data from a phase 2 study used as basis for Qtorin rapamycin's breakthrough therapy designation, as well as real-world evidence from published literature and clinical experience with off-label rapamycin in microcystic lymphatic malformations, according to the company.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

{"basename":"","ssrTDKData":{"titleTemplate":"%s - Tiger Brokers","title":"Tiger Brokers | Global Stocks, Options & Futures Trading App","description":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","keywords":"tiger brokers,tiger trade,tiger brokers singapore,broker online,stock trading in singapore,share trading singapore,brokerage firm singapore,trading app,stock broker singapore,stock trading platforms,trading account","social":{"ogDescription":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www.itiger.com/news/2640490178"},"companyName":"Tiger Brokers"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental"},"isCrawlerRequest":true,"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2640490178\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2640490178?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-06-03 20:17","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2640490178","market":"sg","top_or_hot":-1,"title":"Palvella Therapeutics Says No Additional Efficacy Study Planned for Qtorin Rapamycin","media":"MT Newswires Live","content":"<html><body><p> <a href=\"https://laohu8.com/S/PVLA\">Palvella Therapeutics</a> (PVLA) said Wednesday that no additional efficacy study has been planned for Qtorin rapamycin in microcystic lymphatic malformations to support the planned submission of a new drug application in H2.</p><p>The company said that based on the minutes of its pre-NDA meeting with the US Food and Drug Administration, the planned filing would be supported by the existing evidence package.</p><p>The evidence package will include efficacy and safety results from a phase 3 trial, data from a phase 2 study used as basis for Qtorin rapamycin's breakthrough therapy designation, as well as real-world evidence from published literature and clinical experience with off-label rapamycin in microcystic lymphatic malformations, according to the company.</p></body></html>","source":"mtnewswires_news","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Palvella Therapeutics Says No Additional Efficacy Study Planned for Qtorin Rapamycin</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nPalvella Therapeutics Says No Additional Efficacy Study Planned for Qtorin Rapamycin\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1092851196\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">MT Newswires Live </p>\n<p class=\"h-time\">2026-06-03 20:17</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html><body><p> <a href=\"https://laohu8.com/S/PVLA\">Palvella Therapeutics</a> (PVLA) said Wednesday that no additional efficacy study has been planned for Qtorin rapamycin in microcystic lymphatic malformations to support the planned submission of a new drug application in H2.</p><p>The company said that based on the minutes of its pre-NDA meeting with the US Food and Drug Administration, the planned filing would be supported by the existing evidence package.</p><p>The evidence package will include efficacy and safety results from a phase 3 trial, data from a phase 2 study used as basis for Qtorin rapamycin's breakthrough therapy designation, as well as real-world evidence from published literature and clinical experience with off-label rapamycin in microcystic lymphatic malformations, according to the company.</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2640490178","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2640490178","pubTimestamp":1780489028,"columns":[],"sourceInfo":{"source_id":"mtnewswires_news","name":"MT Newswires"},"weMediaInfo":{"media_name":"MT Newswires Live","introduction":"The most recognized names in North America, Europe and Asia rely on MT Newswires to power their applications. Better news, better service, better price.","home_visible":1,"id":"1092851196","head_image":"https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e"},"summary":"Palvella Therapeutics  said Wednesday that no additional efficacy study has been planned for Qtorin rapamycin in microcystic lymphatic malformations to support the planned submission of a new drug application in H2.The company said that based on the minutes of its pre-NDA meeting with the US Food and Drug Administration, the planned filing would be supported by the existing evidence package.The evidence package will include efficacy and safety results from a phase 3 trial, data from a phase 2 study used as basis for Qtorin rapamycin's breakthrough therapy designation, as well as real-world evidence from published literature and clinical experience with off-label rapamycin in microcystic lymphatic malformations, according to the company.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","PVLA":"Palvella Therapeutics"},"translate_title":"Palvella Therapeutics表示没有计划对Qtorin雷帕霉素进行额外的疗效研究","themeId":"f6f7c9f6a0174df79daf9f1dfd21f836","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"PVLA":1.5},"content_text":"Palvella Therapeutics (PVLA) said Wednesday that no additional efficacy study has been planned for Qtorin rapamycin in microcystic lymphatic malformations to support the planned submission of a new drug application in H2.The company said that based on the minutes of its pre-NDA meeting with the US Food and Drug Administration, the planned filing would be supported by the existing evidence package.The evidence package will include efficacy and safety results from a phase 3 trial, data from a phase 2 study used as basis for Qtorin rapamycin's breakthrough therapy designation, as well as real-world evidence from published literature and clinical experience with off-label rapamycin in microcystic lymphatic malformations, according to the company.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"}}}