Longboard Stock Soars on FDA Designations for Epilepsy Drug

Zacks09-21

Shares of Longboard Pharmaceuticals LBPH gained 14% on Thursday after it announced that the FDA granted two designations — orphan drug and rare pediatric disease — to its lead pipeline drug ...

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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\">\nLongboard Stock Soars on FDA Designations for Epilepsy Drug\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-09-21 01:33 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/longboard-stock-soars-fda-designations-173300703.html><strong>Zacks</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Shares of Longboard Pharmaceuticals LBPH gained 14% on Thursday after it announced that the FDA granted two designations — orphan drug and rare pediatric disease — to its lead pipeline drug ...</p>\n\n<a href=\"https://finance.yahoo.com/news/longboard-stock-soars-fda-designations-173300703.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"ILMN","symbol_name":"Illumina","start_time":0,"source_url":"https://finance.yahoo.com/news/longboard-stock-soars-fda-designations-173300703.html","article_id":"2469603608","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/B7EfA6ERTo_QO90H15uyXw--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/9c1d11cd27737fac4805145de6e5eee0"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2469603608","pubTimestamp":1726853580,"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"Shares of Longboard Pharmaceuticals LBPH gained 14% on Thursday after it announced that the FDA granted two designations — orphan drug and rare pediatric disease — to its lead pipeline drug bexicaserin for the treatment of Dravet syndrome .An orphan drug designation is granted by the FDA to the candidates developed to treat, diagnose or prevent a rare disease or condition. This designation makes the sponsor eligible to receive seven years of market exclusivity following a potential approval and tax credit for qualified clinical studies.The FDA designations come at a time when Longboard is planning to start a phase III study evaluating bexicaserin in DS patients in the coming weeks. The grant of these designations suggests that the agency recognizes the innovative approach of the LBPH drug for treating DS patients. The company’s stock price rose likely in response to this factor.","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":["earning"],"viewcount":null,"language":"en","relate_stocks":{"ILMN":"Illumina","BVS":"Bioventus Inc.","LBPH":"Longboard Pharmaceuticals, Inc.","KRYS":"Krystal Biotech Inc."},"translate_title":"FDA指定癫痫药物，长板股票飙升","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"BVS":0.9,"ILMN":0.9,"KRYS":0.9,"LBPH":0.9},"content_text":"Shares of Longboard Pharmaceuticals LBPH gained 14% on Thursday after it announced that the FDA granted two designations — orphan drug and rare pediatric disease — to its lead pipeline drug bexicaserin for the treatment of Dravet syndrome (DS).\nAn orphan drug designation is granted by the FDA to the candidates developed to treat, diagnose or prevent a rare disease or condition. This designation makes the sponsor eligible to receive seven years of market exclusivity following a potential approval and tax credit for qualified clinical studies.\nIf the FDA grants a candidate rare pediatric disease designation, then upon potential approval of the drug, the sponsor is eligible to receive a priority review voucher (PRV). This PRV can either be used by the sponsor to obtain priority review for a different product or may even be sold by the sponsor to another to boost cash reserves.\nThe FDA designations come at a time when Longboard is planning to start a phase III study evaluating bexicaserin in DS patients in the coming weeks. The grant of these designations suggests that the agency recognizes the innovative approach of the LBPH drug for treating DS patients. The company’s stock price rose likely in response to this factor.\nYear to date, shares of Longboard have skyrocketed 453.9% compared with the industry’s 1.3% growth.\nImage Source: Zacks Investment Research\nRecent Developments Responsible for the Surge in LBPH Stock\nThis surge in share price began at the onset of the year after management reported encouraging data from the phase Ib/IIa PACIFIC study, which evaluated bexicaserin for seizures associated with a broad range of Developmental and Epileptic Encephalopathies (DEEs). DS and Lennox-Gastaut Syndrome (LGS) are some of the many types of epilepsies that fall into the DEE group.\nThe PACIFIC study achieved its primary efficacy endpoint. Treatment with the drug achieved a median seizure reduction of 53.3% in the countable motor seizure frequency compared with 20.8% for those receiving placebo.\nIn June, management also reported positive interim data from an ongoing 52-week open-label extension of the PACIFIC Study evaluating bexicaserin in DEE patients. Results demonstrated sustained and durable response in seizure reduction and a favorable safety and tolerability profile across a broad range of DEE patients.\nThe FDA had previously granted breakthrough therapy designation (BTD) to bexicaserin in June for the treatment of seizures associated with DEEs. The grant of this designation makes Longboard the first company to receive it for this indication. Drugs that receive the BTD tag receive more intensive guidance and organizational support from the agency.\nLBPH’s Zacks Rank\nLBPH currently carries a Zacks Rank #4 (Sell).\n\nLongboard Pharmaceuticals, Inc. Price\n\nLongboard Pharmaceuticals, Inc. price | Longboard Pharmaceuticals, Inc. Quote\n\n \nOur Key Picks Among Biotech Stocks\nSome better-ranked stocks in the overall healthcare sector are Bioventus BVS, Illumina ILMN and Krystal Biotech KRYS. Each stock presently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.\nIn the past 60 days, estimates for Bioventus’ 2024 earnings per share (EPS) have risen from 27 cents to 40 cents. Estimates for 2025 have increased from 43 cents to 45 cents during the same period. Year to date, shares of Bioventus have surged 119.9%.\nBVS’ earnings beat estimates in three of the last four quarters and missed the mark on one occasion. Bioventus delivered a four-quarter average earnings surprise of 102.86%.\nIn the past 60 days, estimates for Illumina’s 2024 EPS have risen from $1.84 to $3.63. Estimates for 2025 have increased from $3.22 to $4.43 during the same period. Year to date, Illumina’s shares have lost 3.5%.\nEarnings of Illumina beat estimates in each of the last four quarters. Illumina delivered a four-quarter average earnings surprise of 463.46%.\nIn the past 60 days, estimates for Krystal Biotech’s 2024 EPS have risen from $2.09 to $2.38. Estimates for 2025 have increased from $4.33 to $7.31 during the same period. Year to date, Krystal Biotech’s shares have surged 48.7%.\nEarnings of Krystal Biotech beat estimates in three of the last four quarters and missed the mark on one occasion. Krystal Biotech delivered a four-quarter average earnings surprise of 45.95%.\nWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report\nIllumina, Inc. (ILMN) : Free Stock Analysis Report\nKrystal Biotech, Inc. (KRYS) : Free Stock Analysis Report\nBioventus Inc. (BVS) : Free Stock Analysis Report\nLongboard Pharmaceuticals, Inc. (LBPH) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":null,"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,"symbols":[],"gpt_button":1},"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":"4.28.1","shortVersion":"4.28.1","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/2469603608"}