Biotech Stock Roundup: Updates From GILD, REGN, GSK, ANAB Down on Study Data, EWTX Gains

Zacks12-18

It was a busy week in the biotech sector with lots of regulatory and pipeline updates. Among bigwigs, Gilead Sciences, Inc. GILD and GSK plc GSK had a few regulatory updates. Recap of the Week’s Most ...

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Among bigwigs, Gilead Sciences, Inc. GILD and GSK plc GSK had a few regulatory updates.\nRecap of the Week’s Most ...</p>\n\n<a href=\"https://finance.yahoo.com/news/biotech-stock-roundup-updates-gild-142300473.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":"BK4007","symbol_name":"制药","start_time":0,"source_url":"https://finance.yahoo.com/news/biotech-stock-roundup-updates-gild-142300473.html","article_id":"2492730133","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/QieiOVP5CdM1cfxTnlcVfQ--~B/aD00MTM7dz02MjA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/e797ee31d4bee954c41ecfac218dc795"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2492730133","pubTimestamp":1734531780,"columns":[],"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"It was a busy week in the biotech sector with lots of regulatory and pipeline updates. Among bigwigs, Gilead Sciences, Inc. GILD and GSK plc GSK had a few regulatory updates.Gilead Sciences announced that the FDA has granted Breakthrough Therapy Designation to breast cancer drug Trodelvy  for the treatment of adult patients with extensive-stage small cell lung cancer  whose disease has progressed on or after platinum-based chemotherapy.The designation is based on results from the ES-SCLC cohort of the mid-stage study TROPiCS-03 study. Trodelvy demonstrated promising antitumor activity in both platinum-resistant and platinum-sensitive disease, and the safety profile was consistent with the previous studies. Gilead plans to initiate a phase III study in this patient population.Per the terms of the agreement, Terray will utilize the Terray tNova platform to discover and develop small molecule compounds against a set of targets selected by Gilead. The latter will be responsible for further","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4007":"制药","BK4566":"资本集团","BK4578":"CAR-T","IE00BKVL7J92.USD":"Legg Mason ClearBridge - US Equity Sustainability Leaders A Acc USD","IE00B3T34201.USD":"BNY MELLON GLOBAL EQUITY INCOME \"B\" (USD) INC","LU2362541273.HKD":"WELLINGTON NEXT GENERATION GLOBAL EQUITY \"A\" (HKD) ACC","BK4568":"美国抗疫概念","LU1571399168.USD":"ALLSPRING GLOBAL LONG/SHORT EQUITY \"IP\" (USD) ACC","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","BK4550":"红杉资本持仓","LU1829250122.USD":"高盛欧洲核心股票组合Acc","BK4588":"碎股","LU0114720955.EUR":"SUSTAINABLE GLOBAL HEALTH CARE \"A\" INC","LU2362541513.USD":"WELLINGTON NEXT GENERATION GLOBAL EQUITY \"A\" (USD) ACC","LU1974910355.USD":"Allianz Thematica Cl AMg DIS USD","LU1917777945.USD":"安联专题基金Cl AT Acc","LU2089984988.USD":"MANULIFE GF HEALTHCARE \"AA\" (USD) ACC","GSK":"葛兰素史克","LU0234570918.USD":"高盛全球核心股票组合Acc Close","LU1839511570.USD":"WELLS FARGO GLOBAL FACTOR ENHANCED EQUITY \"I\" (USD) ACC","LU0053666078.USD":"摩根大通基金-美国股票A（离岸）美元","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","EWTX":"Edgewise Therapeutics, Inc.","ANAB":"Anaptysbio Inc","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC","IE0002270589.USD":"LEGG MASON CLEARBRIDGE VALUE \"A\" (USD) INC","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","IE00B19Z3B42.SGD":"Legg Mason ClearBridge - Value A Acc SGD","LU2023250504.SGD":"Allianz Thematica Cl AMg DIS H2-SGD","REGN":"再生元制药公司","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","GILD":"吉利德科学","IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","GSK.UK":"葛兰素史克","LU2362540622.SGD":"WELLINGTON NEXT GENERATION GLOBAL EQUITY \"A\" (SGDHDG) ACC","BK4583":"猴痘概念","LU0058720904.USD":"联博国际健康护理基金A","BK4539":"次新股","IE00BZ1G4Q59.USD":"LEGG MASON CLEARBRIDGE US EQUITY SUSTAINABILITY LEADER \"A\"(USD) INC (A)","BK4532":"文艺复兴科技持仓","PBC":"Prospect Capital Corp","LU1430594728.SGD":"Eastspring Investments - Global Low Volatility Equity AS SGD","LU1066051498.USD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM2\" (USD) INC","LU0882574055.USD":"富达全球健康医疗A ACC","LU2468319806.SGD":"MANULIFE GF HEALTHCARE \"AA\" (SGDHDG) ACC","LU1066053197.SGD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM3\" (SGDHDG) INC","BK4585":"ETF&股票定投概念","LU2087621335.USD":"ALLSPRING GLOBAL FACTOR ENHANCED EQUITY \"A\" (USD) ACC","BK4139":"生物科技","IE00B7SZLL34.SGD":"Legg Mason ClearBridge - Value A Acc SGD-H"},"translate_title":"生物科技股综述：GILD、REGN、GSK、ANAB更新研究数据下跌，EWTX上涨","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"REGN":1,"ANAB":1,"GSK":1,"GILD":1,"EWTX":1,"PBC":1,"GSK.UK":0.6},"content_text":"It was a busy week in the biotech sector with lots of regulatory and pipeline updates. Among bigwigs, Gilead Sciences, Inc. GILD and GSK plc GSK had a few regulatory updates.\nRecap of the Week’s Most Important Stories:\nUpdates From Gilead Sciences\nGilead Sciences announced that the FDA has granted Breakthrough Therapy Designation to breast cancer drug Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy.\nThe designation is based on results from the ES-SCLC cohort of the mid-stage study TROPiCS-03 study. Trodelvy demonstrated promising antitumor activity in both platinum-resistant and platinum-sensitive disease, and the safety profile was consistent with the previous studies. Gilead plans to initiate a phase III study in this patient population.\nConcurrently, GILD announced entering a strategic collaboration with Terray Therapeutics to discover and develop novel, small molecule therapies across multiple targets.\nPer the terms of the agreement, Terray will utilize the Terray tNova platform to discover and develop small molecule compounds against a set of targets selected by Gilead. The latter will be responsible for further development and commercialization activities for products resulting from the collaboration if it exercises its option to exclusively license the compounds directed to a target.\nIn exchange, Terray will receive an upfront payment and be eligible to receive milestone payments associated with achieving preclinical, clinical, and sales milestones as well as tiered royalties on net sales of products commercialized by Gilead in connection with the collaboration.\nThe Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) recommended approval of seladelpar. The CHMP adopted a positive opinion recommending seladelpar for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. A final decision from the European Commission is expected in the first quarter of 2025. The drug is already approved in the United States under the brand name Livdelzi.\nGilead currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.\nRegeneron’s Study Meets Goals\nRegeneron Pharmaceuticals REGN announced that the primary endpoint was met in the late-stage QUASAR trial on Eylea HD (aflibercept) injection 8 mg. QUASAR is a global, double-masked, active-controlled phase III study evaluating the efficacy and safety of Eylea HD, compared to Eylea 2 mg, D in patients with macular edema secondary to retinal vein occlusion (RVO), including those with central retinal vein occlusion, branch retinal vein occlusion, or hemiretinal vein occlusion.\nEylea HD demonstrated non-inferior vision gains with an 8-week dosing regimen compared to Eylea injection of 2 mg dosed every 4 weeks.  The safety data remains consistent with the known safety profiles of Eylea HD and Eylea.\nRegeneron plans to submit a supplementary biologics license application to the FDA in the first quarter of 2025.\nANAB Stock Down on Study Results\nAnaptysBio, Inc. ANAB announced that the phase IIb study of pipeline candidate, ANB032, a BTLA agonist, was unsuccessful. Shares of this clinical-stage biotechnology company were down on the results.\nThe ARISE-AD study evaluated the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of ANB032 monotherapy in patients with moderate-to-severe atopic dermatitis (AD) or eczema.  Patients were randomized to receive for 12 weeks either 100mg of subcutaneous ANB032 every four weeks (Q4W), 400mg every four weeks (Q4W) or 400mg every two weeks (Q2W), or placebo. The primary and secondary endpoints were assessed at week 14. However, ANB032 did not meet the primary endpoint of the proportion of patients who achieved at least a 75% improvement from baseline in Eczema Area and Severity Index score (EASI-75), irrespective of the patient type.\nANB032 did not meet any of the secondary endpoints at week 14, including EASI-90, the mean change in baseline EASI or a 4-point reduction in itch severity as measured by the peak Pruritus Numerical Rating Scale (PNRS), compared with placebo.\nDue to the disappointing efficacy data from the study, ANAB will discontinue further investment in this asset.\nRegulatory and Pipeline Updates From GSK\nGSK’s HIV subsidiary, ViiV Healthcare, announced that the CHMP gave a positive opinion recommending marketing authorization to Vocabria (cabotegravir long-acting injections) in combination with Johnson & Johnson’s Rekambys (rilpivirine long-acting injections) for the treatment of HIV-1 infection in virologically suppressed adolescents aged 12 years and above, weighing at least 35 kg.\nA decision from the European Commission is expected in the upcoming months.\nGSK also announced that the CHMP has recommended expanded use of Jemperli (dostarlimab) in combination with chemotherapy (carboplatin and paclitaxel) for first-line treatment of all adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy. This population includes patients with mismatch repair proficient/microsatellite stable tumors, who represent 70-75% of patients diagnosed with endometrial cancer with limited treatment options.\nGSK announced that the FDA has granted Breakthrough Therapy designation to Jemperli for the treatment of patients with locally advanced mismatch repair deficient or microsatellite instability-high rectal cancer.\nEdgewise Stock Up on Study Data\nEdgewise Therapeutics EWTX announced positive results from the mid-stage CANYON study on its lead pipeline drug, sevasemten, in patients with a rare genetic disorder called Becker Muscular Dystrophy (“BMD”). Shares gained on the news.\nThe study met its primary endpoint of change from baseline in creatine kinase (CK), a biomarker associated with skeletal muscle damage. Data from the study showed a significant reduction in CK levels in the sevasemten-treated group, with an average decrease of 28% compared to placebo between six and 12 months. The drug was also well-tolerated by study participants.\nTreatment with sevasemten showed a trend toward improvement in the key secondary endpoint of the North Star Ambulatory Assessment, a scale commonly used to rate motor function.\nEdgewise remains on schedule to complete recruitment for a pivotal cohort of the CANYON study, called GRAND CANYON, expected to be achieved in the first quarter of 2025. If data from this cohort is also positive, management intends to start discussions with the FDA and EMA for seeking approval for sevasemten in the BMD indication.\nPerformance\nThe Nasdaq Biotechnology Index has declined 1.98% in the past five trading sessions and Regeneron’s shares have lost 4.95%. In the past six months, shares of MRNA have plunged 70.44%. (See the last biotech stock roundup here: Biotech Stock Roundup: BIOA Down on Study Update, QURE, CRDF Gain on Study Data & More)\nImage Source: Zacks Investment Research\nWhat's Next in Biotech?\nStay tuned for more pipeline updates. \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\nRegeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report\nGSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report\nGilead Sciences, Inc. (GILD) : Free Stock Analysis Report\nAnaptysBio, Inc. (ANAB) : Free Stock Analysis Report\nEdgewise Therapeutics, Inc. (EWTX) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","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,"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":"4.29.3","shortVersion":"4.29.3","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/2492730133"}