Jstan
2021-12-21
Likr pls
Aldeyra's Dry Eye Disease Candidate Disappoints In Late-Stage Study<blockquote>Aldeyra 的干眼病候选人在后期研究中令人失望</blockquote>
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The company expects topline results in mid-2022.</li> <li>The company intends to file the marketing application for dry eye disease indication in mid-2022.</li> <li>Application for allergic conjunctivitis, another proposed indication, is expected to occur after the dry eye disease submission and following completion of an additional allergen chamber trial requested by the FDA.</li> <li>No safety signals were observed, and reproxalap was well tolerated; there were no treatment-related discontinuations or moderate or severe adverse events.</li> <li><b>Price Action:</b> ALDX shares are down 38.29% at $4.4 during the premarket session on the last check Tuesday.</li> </ul> <img src=\"https://static.tigerbbs.com/b2918c536ca5a074f762901ace4764fc\" tg-width=\"710\" tg-height=\"614\" width=\"100%\" height=\"auto\"></p><p><blockquote><ul><li>该试验未能满足眼睛发红的主要终点，但对于次要终点Schirmer试验的干眼症体征，它确实达到了统计学意义。</li><li>超过10 mm的Schirmer试验应答者的事后评估也达到了统计学显著性。</li><li>即将进行的III期TRANQUILITY-2试验的主要终点已经修改，如果Schirmer检验或眼睛发红显示统计学意义，则终点将得到满足。</li><li>此外，TRANQUILITY-2 的目标入组人数已从 300 名患者增加到多达 400 名患者。该公司预计将于 2022 年中期公布营收业绩。</li><li>公司拟于2022年年中提交干眼症适应症的上市申请。</li><li>过敏性结膜炎（另一个拟议适应症）的申请预计将在干眼症提交后以及FDA要求的额外过敏原室试验完成后进行。</li><li>未观察到安全性信号，reproxalap耐受性良好；无治疗相关停药或中度或重度不良事件。</li><li><b>价格行为：</b>周二最后一次检查时，ALDX 股价在盘前交易中下跌 38.29%，至 4.4 美元。</li></ul></blockquote></p><p></p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; 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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: 12.5px; color: #7E829C; margin: 0;}\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\">\nAldeyra's Dry Eye Disease Candidate Disappoints In Late-Stage Study<blockquote>Aldeyra 的干眼病候选人在后期研究中令人失望</blockquote>\n</h2>\n<h4 class=\"meta\">\n<div class=\"head\" \">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/d08bf7808052c0ca9deb4e944cae32aa);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Benzinga Earnings </p>\n<p class=\"h-time smaller\">2021-12-21 19:16</p>\n</div>\n</div>\n</h4>\n</header>\n<article>\n<p><b>Aldeyra Therapeutics Inc</b> reported topline data from Phase 3 TRANQUILITY Trial of reproxalap ophthalmic solution for dry eye disease.</p><p><blockquote><b>阿尔代拉治疗公司</b>reproxalap滴眼液治疗干眼症的III期TRANQUILITY试验报告的顶线数据。</blockquote></p><p> <ul> <li>The trial failed to meet the primary endpoint of ocular redness, but it did achieve statistical significance for the dry eye disease sign of the Schirmer test, a secondary endpoint.</li> <li>Statistical significance was also achieved for the post-hoc assessment of Schirmer test responders of over 10 mm.</li> <li>The primary endpoint of the upcoming Phase 3 TRANQUILITY-2 trial has been modified such that the endpoint will have been met if either the Schirmer test or ocular redness demonstrates statistical significance.</li> <li>In addition, target enrollment in TRANQUILITY-2 has been increased from 300 to up to 400 patients. The company expects topline results in mid-2022.</li> <li>The company intends to file the marketing application for dry eye disease indication in mid-2022.</li> <li>Application for allergic conjunctivitis, another proposed indication, is expected to occur after the dry eye disease submission and following completion of an additional allergen chamber trial requested by the FDA.</li> <li>No safety signals were observed, and reproxalap was well tolerated; there were no treatment-related discontinuations or moderate or severe adverse events.</li> <li><b>Price Action:</b> ALDX shares are down 38.29% at $4.4 during the premarket session on the last check Tuesday.</li> </ul> <img src=\"https://static.tigerbbs.com/b2918c536ca5a074f762901ace4764fc\" tg-width=\"710\" tg-height=\"614\" width=\"100%\" height=\"auto\"></p><p><blockquote><ul><li>该试验未能满足眼睛发红的主要终点，但对于次要终点Schirmer试验的干眼症体征，它确实达到了统计学意义。</li><li>超过10 mm的Schirmer试验应答者的事后评估也达到了统计学显著性。</li><li>即将进行的III期TRANQUILITY-2试验的主要终点已经修改，如果Schirmer检验或眼睛发红显示统计学意义，则终点将得到满足。</li><li>此外，TRANQUILITY-2 的目标入组人数已从 300 名患者增加到多达 400 名患者。该公司预计将于 2022 年中期公布营收业绩。</li><li>公司拟于2022年年中提交干眼症适应症的上市申请。</li><li>过敏性结膜炎（另一个拟议适应症）的申请预计将在干眼症提交后以及FDA要求的额外过敏原室试验完成后进行。</li><li>未观察到安全性信号，reproxalap耐受性良好；无治疗相关停药或中度或重度不良事件。</li><li><b>价格行为：</b>周二最后一次检查时，ALDX 股价在盘前交易中下跌 38.29%，至 4.4 美元。</li></ul></blockquote></p><p></p>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"ALDX":"Aldeyra Therapeutics Inc"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1148289841","content_text":"Aldeyra Therapeutics Inc reported topline data from Phase 3 TRANQUILITY Trial of reproxalap ophthalmic solution for dry eye disease.\n\nThe trial failed to meet the primary endpoint of ocular redness, but it did achieve statistical significance for the dry eye disease sign of the Schirmer test, a secondary endpoint.\nStatistical significance was also achieved for the post-hoc assessment of Schirmer test responders of over 10 mm.\nThe primary endpoint of the upcoming Phase 3 TRANQUILITY-2 trial has been modified such that the endpoint will have been met if either the Schirmer test or ocular redness demonstrates statistical significance.\nIn addition, target enrollment in TRANQUILITY-2 has been increased from 300 to up to 400 patients. The company expects topline results in mid-2022.\nThe company intends to file the marketing application for dry eye disease indication in mid-2022.\nApplication for allergic conjunctivitis, another proposed indication, is expected to occur after the dry eye disease submission and following completion of an additional allergen chamber trial requested by the FDA.\nNo safety signals were observed, and reproxalap was well tolerated; there were no treatment-related discontinuations or moderate or severe adverse events.\nPrice Action: ALDX shares are down 38.29% at $4.4 during the premarket session on the last check Tuesday.","news_type":1,"symbols_score_info":{"ALDX":0.9}},"isVote":1,"tweetType":1,"viewCount":1249,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"CN","currentLanguage":"CN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":7,"subscribersOnly":false,"subscribersOnlyAccessible":false,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/693727109"}
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