OTLK Stock Falls on Failure to Meet Non-Inferiority Goal in AMD Study

Zacks11-28 23:29

Outlook Therapeutics OTLK reported preliminary top-line results from the 90-day non-inferiority NORSE EIGHT clinical study evaluating ONS-5010 (Lytenava) to treat patients with wet age-related macular...

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The NORSE EIGHT study is the second of two adequate and well-controlled clinical studies evaluating ONS-5010 for the AMD indication.Per the data readout, the candidate failed to meet the pre-specified non-inferiority endpoint at week 8 outlined in the special protocol assessment with the FDA. ONS-5010 is an investigational ophthalmic formulation of bevacizumab, which is being developed to treat AMD and other retinal diseases. Shares of Outlook Therapeutics plunged 65.2% on Wednesday in response to the news.However, preliminary analysis of study data showed vision improvement, biological activity and a favorable safety profile for ONS-5010. Treatment with the candidate was also well-tolerated in the NORSE EIGHT study with overall ocular adverse event rates comparable to Lucentis.The sa","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4573":"虚拟现实","PFE":"辉瑞","BK4505":"高瓴资本持仓","LU1894683348.USD":"AMUNDI FUNDS US EQUITY RESEARCH VALUE \"A2\" (USD) INC","LU1571399168.USD":"ALLSPRING GLOBAL LONG/SHORT EQUITY \"IP\" (USD) ACC","LU1585245621.USD":"EASTSPRING INV GLOBAL LOW VOLATILITY EQUITY FUND \"A\" (USD) ACC B","LU1303367103.USD":"摩根大通多经理另类基金 A (acc)","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","IE00BLSP4452.SGD":"Legg Mason ClearBridge - Tactical Dividend Income A Mdis SGD-H Plus","ALLO":"Allogene Therapeutics Inc.","LU2458330169.SGD":"FRANKLIN SHARIAH TECHNOLOGY \"A\" (SGD) ACC","GFS":"GLOBALFOUNDRIES Inc.","CRL":"查尔斯河","LU2250418816.HKD":"BGF WORLD TECHNOLOGY \"A\" (HKD) ACC","LU0170899867.USD":"EASTSPRING INVESTMENTS WORLD VALUE EQUITY  \"A\" (USD) ACC","BK4530":"医药外包概念","LU1988902786.USD":"FULLERTON LUX FUNDS GLOBAL ABSOLUTE ALPHA \"I\" (USD) ACC","BK4529":"IDC概念","LU1839511570.USD":"WELLS FARGO GLOBAL FACTOR ENHANCED EQUITY \"I\" (USD) ACC","IE0004445239.USD":"JANUS HENDERSON US FORTY \"A2\" (USD) ACC","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","BK4583":"猴痘概念","LU0082616367.USD":"摩根大通美国科技A（dist）","BK4532":"文艺复兴科技持仓","LU0056508442.USD":"贝莱德世界科技基金A2","BK4554":"元宇宙及AR概念","LU0390134368.USD":"FRANKLIN GLOBAL GROWTH \"A\" (USD) ACC","LU1803068979.SGD":"FTIF - Franklin Technology A (acc) SGD-H1","BK4599":"减肥药","LU1057294990.SGD":"Blackrock World Healthscience A2 SGD-H","IE00BBT3K403.USD":"LEGG MASON CLEARBRIDGE TACTICAL DIVIDEND INCOME \"A(USD) ACC","SG9999011175.SGD":"Nikko AM Global Dividend Equity Dis SGD-H","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","BK4585":"ETF&股票定投概念","LU0321505868.SGD":"Schroder ISF Global Dividend Maximiser A Dis SGD","IE00BMPRXN33.USD":"NEUBERGER BERMAN 5G CONNECTIVITY \"A\" (USD) ACC","LU0985481810.HKD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" (HKD) INC M","LU0109392836.USD":"富兰克林科技股A","GILD":"吉利德科学","LU0058720904.USD":"联博国际健康护理基金A","IE00BZ1G4Q59.USD":"LEGG MASON CLEARBRIDGE US EQUITY SUSTAINABILITY LEADER \"A\"(USD) INC (A)","OTLK":"Outlook Therapeutics, Inc.","BK4578":"CAR-T","LU0979878070.USD":"FULLERTON LUX FUNDS - ASIA ABSOLUTE ALPHA \"A\" (USD) ACC","LU1852331112.SGD":"Blackrock World Technology Fund A2 SGD-H","BK4568":"美国抗疫概念","BK4141":"半导体产品","LU0198837287.USD":"UBS (LUX) EQUITY SICAV - USA GROWTH \"P\" (USD) ACC","LU0823434740.USD":"BNP PARIBAS US GROWTH \"C\" (USD) INC"},"translate_title":"OTLK股价因AMD研究未能达到非劣效性目标而下跌","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"PFE":1,"OTLK":1,"ALLO":1,"CRL":1,"GFS":1,"GILD":1},"content_text":"Outlook Therapeutics OTLK reported preliminary top-line results from the 90-day non-inferiority NORSE EIGHT clinical study evaluating ONS-5010 (Lytenava) to treat patients with wet age-related macular degeneration (AMD). The NORSE EIGHT study is the second of two adequate and well-controlled clinical studies evaluating ONS-5010 for the AMD indication.\nPer the data readout, the candidate failed to meet the pre-specified non-inferiority endpoint at week 8 outlined in the special protocol assessment with the FDA. ONS-5010 is an investigational ophthalmic formulation of bevacizumab, which is being developed to treat AMD and other retinal diseases. Shares of Outlook Therapeutics plunged 65.2% on Wednesday in response to the news.\nThe NORSE EIGHT non-inferiority study enrolled newly diagnosed wet AMD patients, who were randomly divided equally to receive either 1.25 mg ONS-5010 or 0.5 mg Lucentis (ranibizumab) intravitreal injections. All subjects were dosed thrice during the study period. The primary endpoint of the study was the mean change in best-corrected visual acuity from baseline to week eight.\nHowever, preliminary analysis of study data showed vision improvement, biological activity and a favorable safety profile for ONS-5010. Treatment with the candidate was also well-tolerated in the NORSE EIGHT study with overall ocular adverse event rates comparable to Lucentis. The safety profile of ONS-5010 observed in the NORSE EIGHT study was consistent with that observed in prior clinical studies, with no cases of retinal vasculitis reported in either study arm.\nFurther analysis of the NORSE EIGHT study data is currently ongoing with full three-month results expected to be reported in January 2025. Following the availability of the detailed three-month efficacy and safety data, Outlook Therapeutics plans to resubmit the biologics license application (BLA) for ONS-5010 in the first quarter of 2025. Year to date, shares of OTLK have plummeted 78.4% compared with the industry’s 7.8% decline.\nImage Source: Zacks Investment Research\nWe remind the investors that in August 2023, Outlook Therapeutics received a complete response letter (CRL) from the FDA regarding the BLA for ONS-5010.\nThe FDA stated concerns related to chemistry, manufacturing, and controls and open observations of the manufacturing process, which were made during pre-approval inspections. Additionally, the regulatory body had cited that there was “a lack of substantial evidence” and asked for a second adequate and well-controlled study to be conducted. The first BLA was based on a phase III NORSE TWO study evaluating the safety and efficiency of ONS-5010 compared with ranibizumab for treating wet AMD.\nIn the latest press release, Outlook Therapeutics reported that it has successfully remediated the chemistry, manufacturing and controls issues raised by the FDA which formed the basis of the earlier CRL.  \nApproval of OTLK’s ONS-5010/Lytenava Outside the US\nPlease note that ONS-5010 received regulatory approval in the EU and the U.K. earlier this year for the first authorized use of an ophthalmic formulation of bevacizumab to treat wet AMD. The drug will be marketed under the brand name, Lytenava.\nOutlook Therapeutics plans to launch Lytenava in the U.K. and Germany in 2025, either independently or through a licensing partner. Dialogues with potential licensing partners for markets outside of the United States are ongoing.\nThe company is confident that ONS-5010/Lytenava is a critical therapy for wet AMD, offering a regulated alternative to off-label repackaged Avastin (bevacizumab), which is not approved for ophthalmic use.\nOTLK Price and Consensus Chart\nImage Source: Zacks Investment Research\nZacks Rank and Stocks to Consider\nOutlook currently carries a Zacks Rank #3 (Hold).\nSome better-ranked pharma stocks are Allogene Therapeutics ALLO, Pfizer PFE and Gilead Sciences GILD, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.\nOver the past 60 days, Allogene Therapeutics’ estimates for loss per share have narrowed from $1.40 to $1.35 for 2024, and that for 2025 has narrowed from $1.46 to $1.34. ALLO shares have lost 21.5% year to date.\nAllogene Therapeutics’ earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 9.42%.\nOver the past 60 days, Pfizer’s earnings estimates have risen from $2.62 to $2.91 per share for 2024, while that for 2025 has increased from $2.84 to $2.91. PFE shares have lost 10.6% year to date.\nPfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.\nOver the past 60 days, Gilead Sciences’ earnings estimates have risen from $3.79 to $4.32 per share for 2024 while that for 2025 has increased from $7.24 to $7.38. GILD shares have risen 12.8% year to date.\nGilead Sciences’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 15.46%.\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\nPfizer Inc. (PFE) : Free Stock Analysis Report\nGilead Sciences, Inc. (GILD) : Free Stock Analysis Report\nAllogene Therapeutics, Inc. (ALLO) : Free Stock Analysis Report\nOncobiologics, Inc. (OTLK) : 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":"-1","news_tag":"dataReport","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":"4.29.3","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/2487734943"}