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Outlook Therapeutics, Inc.

0.6449

+0.00380.59%

Post-market: 0.6400-0.0049-0.76%19:59 EDT

Volume:9.49M

Turnover:6.07M

Market Cap:156.71M

PE:-0.86

High:0.6586

Open:0.6500

Low:0.6191

Close:0.6411

52wk High:2.54

52wk Low:0.1611

Shares:243.00M

Float Shares:196.00M

Volume Ratio:0.86

T/O Rate:4.84%

Dividend:- -

Dividend Rate:- -

EPS(TTM):-0.7479

EPS(LYR):-1.7940

ROE:-3.65%

ROA:-143.17%

PB:-15.08

PE(LYR):-0.36

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Overview Company News Filings

NASDAQ Trade Halt Halt News Pending at 01:34 Pm

Outlook Therapeutics Grants CEO, CFO Options at $1.43 Per Share

Outlook Therapeutics Registers 17.3 Million Shares for Resale

MT Newswires Live

Outlook Therapeutics Shareholders Approve Increase in Authorized Common Shares to 600 Million

Rocket Pharma Names Joseph Manhede Principal Accounting Officer, Effective July 8

Analysts Have Conflicting Sentiments on These Healthcare Companies: Outlook Therapeutics (OTLK), Praxis Precision Medicines (PRAX) and Merck & Company (MRK)

Outlook Therapeutics Regains Nasdaq Compliance

MT Newswires Live

Outlook Therapeutics Regains NASDAQ Compliance After Shares Hold Above $1 Bid Threshold

Outlook Therapeutics Shares Surge After FDA Accepts Resubmitted Wet AMD Application

BUZZ-Outlook Therapeutics rises after US FDA accepts to review eye disease treatment

Outlook Therapeutics says FDA accepts resubmitted Lytentava BLA for wet AMD review

Outlook Therapeutics Announces FDA Acceptance of Resubmitted Biologics License Application for Ons-5010/Lytenava™ (Bevacizumab-Vikg) as a Treatment for Wet Amd

THOMSON REUTERS

Outlook Therapeutics - Pdufa Target Action Date Set for July 29, 2026

THOMSON REUTERS

Outlook Therapeutics - Initiates Pre-Launch Activities for Ons-5010/Lytenava

THOMSON REUTERS

Outlook Therapeutics director Yezan Munther Haddadin acquires 29,000 common shares for $24,145.40

Outlook Therapeutics beneficial owner Ghiath M. Sukhtian reports $5 million common share purchase

Outlook Therapeutics Resubmits Lytenava Biologics License Application to FDA

MT Newswires Live

Outlook Therapeutics resubmits FDA BLA for Lytneava in wet AMD

Outlook Therapeutics Announces Resubmission of Biologics License Application to U.S. FDA for Ons-5010/Lytenava™ (Bevacizumab-Vikg)

THOMSON REUTERS

Outlook Therapeutics - FDA Says No Additional Trials Required for Lytenava in Namd

THOMSON REUTERS

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8","url":"https://stock-news.laohu8.com/highlight/detail?id=2648256731","media":"Reuters","labels":["executive"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2648256731?lang=en_us&edition=fundamental","pubTime":"2026-07-01 05:16","pubTimestamp":1782854216,"startTime":"0","endTime":"0","summary":"Rocket Pharma names Joseph Manhede principal accounting officer, effective July 8Rocket Pharmaceuticals said VP of Finance, Senior Controller, Treasurer, Principal Accounting Officer John Militello wi","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260630:nNDL2l3GP3:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"executive","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["AMRX","BK4007","RCKT","OTLK","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2647468532","title":"Analysts Have Conflicting Sentiments on These Healthcare Companies: Outlook Therapeutics (OTLK), Praxis Precision Medicines (PRAX) and Merck & Company (MRK)","url":"https://stock-news.laohu8.com/highlight/detail?id=2647468532","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2647468532?lang=en_us&edition=fundamental","pubTime":"2026-06-30 18:20","pubTimestamp":1782814820,"startTime":"0","endTime":"0","summary":"Analysts have been eager to weigh in on the Healthcare sector with new ratings on Outlook Therapeutics (OTLK), Praxis Precision Medicines (PRAX) an...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/analysts-have-conflicting-sentiments-on-these-healthcare-companies-outlook-therapeutics-otlk-praxis-precision-medicines-prax-and-merck-company-mrk-blurbs-news?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/blurbs/analysts-have-conflicting-sentiments-on-these-healthcare-companies-outlook-therapeutics-otlk-praxis-precision-medicines-prax-and-merck-company-mrk-blurbs-news?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["IE00B2B36J28.USD","LU0070302665.USD","LU2357627491.SGD","SG9999002232.USD","LU2125154778.USD","LU0868494708.USD","IE0009355771.USD","LU2468319806.SGD","LU0211331839.USD","LU1037948897.HKD","LU1989772840.SGD","IE00BN8TJ469.HKD","LU1037948541.HKD","LU1162221912.USD","LU1035773651.USD","LU1430594728.SGD","LU2324357040.USD","LU2491049909.HKD","LU1069347547.HKD","LU1066051498.USD","LU2023250504.SGD","LU2433249047.HKD","LU0320765489.SGD","IE00BBT3K403.USD","LU2023250843.SGD","LU0006306889.USD","LU1941712264.USD","LU0477156953.USD","LU2491050071.SGD","LU1066053197.SGD","LU0122379950.USD","LU1917777945.USD","SG9999014542.SGD","LU0965508806.USD","LU0208291251.USD","LU0965509101.SGD","LU2125909593.SGD","LU2491050154.USD","LU0289739699.SGD","IE00B1BXHZ80.USD","LU2461242641.AUD","IE00BSNM7G36.USD","LU0985320562.USD","BK4139","IE00BLSP4452.SGD","SG9999001440.SGD","LU0203347892.USD","LU1061106388.HKD","BK4588","LU1929549753.HKD","LU2112291526.USD","IE0002141913.USD","LU1923622614.USD","BK4550","BK4533","LU0965509010.AUD","LU0861579265.USD","LU2106854487.HKD","SG9999001176.USD","LU1023059063.AUD","LU1983299246.USD","LU0106261372.USD","LU1201861249.SGD","LU0203345920.USD","BK4516","SG9999002224.SGD","IE000M9KFDE8.USD","LU1057294990.SGD","SG9999013999.USD","BK4534","LU1093756325.SGD","LU1066051811.HKD","SGXZ57979304.SGD","LU1934455277.USD","LU0320765646.SGD","LU0320765992.SGD","LU0109394709.USD","SG9999014559.SGD","SG9999015358.SGD","LU2361044865.SGD","LU0859254822.USD","LU0965509283.SGD","LU1291159041.SGD","LU0648001328.SGD","LU1093756168.USD","LU2361044949.HKD","LU0265550946.USD","LU1066051225.USD","LU0058720904.USD","LU0868494617.USD","PRAX","LU1571399168.USD","SG9999014567.USD","SG9999015341.SGD","LU1934455863.HKD","LU1974910355.USD","LU1699723380.USD","LU0130102774.USD","LU0130517989.USD","LU0889565916.HKD","LU0980610538.SGD","BK4559","BK4007","LU1989772923.USD","LU2361045086.USD","LU1585245621.USD","IE00BJT1NW94.SGD","LU1934455194.USD","LU2125909247.SGD","BK4585","LU0942090050.USD","IE00BJJMRZ35.SGD","LU1116320737.USD","LU0432979614.USD","IE00BLSP4239.USD","LU0265550359.USD","LU1116320901.HKD","LU0098860793.USD","LU0234572021.USD","SG9999001176.SGD","LU0238689110.USD","IE00BFTCPJ56.SGD","LU0266013472.USD","LU2125154935.USD","LU2089984988.USD","LU1941712348.USD","LU1989771016.USD","LU2360032135.SGD","OTLK","IE00B4R5TH58.HKD","MRK","SG9999014575.USD"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2647770273","title":"Outlook Therapeutics Regains Nasdaq Compliance","url":"https://stock-news.laohu8.com/highlight/detail?id=2647770273","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2647770273?lang=en_us&edition=fundamental","pubTime":"2026-06-29 22:19","pubTimestamp":1782742749,"startTime":"0","endTime":"0","summary":"Outlook Therapeutics  said Friday it has regained compliance with Nasdaq's minimum bid price listing requirement.The company said it was notified that it had regained compliance as the closing bid price of its shares had been at $1 per share or greater for 10 consecutive business days.Shares of Outlook Therapeutics were 3.5% lower in Monday trading.","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["OTLK","BK4539","LENZ","NQmain","BK4007","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2646393361","title":"Outlook Therapeutics Regains NASDAQ Compliance After Shares Hold Above $1 Bid Threshold","url":"https://stock-news.laohu8.com/highlight/detail?id=2646393361","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2646393361?lang=en_us&edition=fundamental","pubTime":"2026-06-27 05:31","pubTimestamp":1782509465,"startTime":"0","endTime":"0","summary":"Outlook Therapeutics regains Nasdaq compliance after shares hold above $1 bid thresholdOutlook Therapeutics regained Nasdaq Capital Market compliance with the $1 minimum bid price rule, closing a deli","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260626:nNDL6QBlhJ:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","OTLK"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2643635917","title":"Outlook Therapeutics Shares Surge After FDA Accepts Resubmitted Wet AMD Application","url":"https://stock-news.laohu8.com/highlight/detail?id=2643635917","media":"Dow Jones","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2643635917?lang=en_us&edition=fundamental","pubTime":"2026-06-16 22:20","pubTimestamp":1781619600,"startTime":"0","endTime":"0","summary":"Outlook Therapeutics shares climbed Tuesday after the company said the U.S. Food and Drug Administration accepted its resubmitted biologics license application for ONS-5010/LYTENAVA as a treatment for age-related macular degeneration, a condition in which retina damage results in vision loss.Shares of the biopharmaceutical company were up around 20% at $1.39. The stock has more than quadrupled in the last month.The FDA classified the resubmission as a class 1 review and set a Prescription Drug User Fee Act, or PDUFA, target action date of July 29.If approved, the company said Lytenava would become the first FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration. Outlook Therapeutics said it has begun prelaunch activities ahead of the FDA's decision.","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":"Outlook Therapeutics Shares Surge After FDA Accepts Resubmitted Wet AMD Application","news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","OTLK"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2643681752","title":"BUZZ-Outlook Therapeutics rises after US FDA accepts to review eye disease treatment","url":"https://stock-news.laohu8.com/highlight/detail?id=2643681752","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2643681752?lang=en_us&edition=fundamental","pubTime":"2026-06-16 20:21","pubTimestamp":1781612517,"startTime":"0","endTime":"0","summary":"BUZZ-Outlook Therapeutics rises after US FDA accepts to review eye disease treatment** Shares of Outlook Therapeutics OTLK.O rise 8.6% to $1.25 premarket ** Drugmaker says the U.S. FDA has accepted for review its resubmitted marketing application for ONS-5010, branded as Lytenava, after the U.S. FDA declined to approve it in December** OTLK's treatment, Lytenava, targets wet age-related macular degeneration, a common eye disease that causes vision loss due to leaking blood vessels in the retina** The resubmission has been classified as a Class 1 review, with a target action date of July 29, co says** Lytenava is a specific, officially authorized formulation of FDA-approved drug bevacizumab** Up to last close, stock down 26.6% this year  ","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260616:nL4N42O12T:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","OTLK"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2643754762","title":"Outlook Therapeutics says FDA accepts resubmitted Lytentava BLA for wet AMD review","url":"https://stock-news.laohu8.com/highlight/detail?id=2643754762","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2643754762?lang=en_us&edition=fundamental","pubTime":"2026-06-16 20:03","pubTimestamp":1781611434,"startTime":"0","endTime":"0","summary":"Outlook Therapeutics won FDA acceptance of its resubmitted BLA for ONS-5010/LYTENAVA  to treat wet AMD.FDA set a Class 1 review with a PDUFA target action date of July 29, 2026.Decision could clear the first FDA-approved ophthalmic bevacizumab formulation, supporting standardized manufacturing, labeling, pharmacovigilance.","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260616:nNDL5VzcZt:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["IE00BN0W2T93.GBP","BK4585","IE00BN0W2W23.USD","LU0314104364.USD","SG9999014021.USD","IE00B64PRP62.GBP","LU2210149790.SGD","OTLK","BK4112","SG9999014005.SGD","IE00BN0W2V16.EUR","IE00B3QW5Z07.USD","BK4139","NDAQ","IE00BGHQF748.EUR","LU2210150020.SGD","IE00BKPKM429.USD","SG9999014039.USD","SG9999014013.SGD","BK4588","LU2095319765.USD"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2643754474","title":"Outlook Therapeutics Announces FDA Acceptance of Resubmitted Biologics License Application for Ons-5010/Lytenava™ (Bevacizumab-Vikg) as a Treatment for Wet Amd","url":"https://stock-news.laohu8.com/highlight/detail?id=2643754474","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2643754474?lang=en_us&edition=fundamental","pubTime":"2026-06-16 20:02","pubTimestamp":1781611320,"startTime":"0","endTime":"0","summary":null,"market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260616:nTUAKYQFM:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4139","OTLK"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2643754405","title":"Outlook Therapeutics - Pdufa Target Action Date Set for July 29, 2026","url":"https://stock-news.laohu8.com/highlight/detail?id=2643754405","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2643754405?lang=en_us&edition=fundamental","pubTime":"2026-06-16 20:02","pubTimestamp":1781611320,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260616:nTUAKYQFM:2","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["OTLK","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2643754298","title":"Outlook Therapeutics - Initiates Pre-Launch Activities for Ons-5010/Lytenava","url":"https://stock-news.laohu8.com/highlight/detail?id=2643754298","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2643754298?lang=en_us&edition=fundamental","pubTime":"2026-06-16 20:02","pubTimestamp":1781611320,"startTime":"0","endTime":"0","summary":null,"market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260616:nTUAKYQFM:3","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4139","OTLK"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2640182080","title":"Outlook Therapeutics director Yezan Munther Haddadin acquires 29,000 common shares for $24,145.40","url":"https://stock-news.laohu8.com/highlight/detail?id=2640182080","media":"Reuters","labels":["shareholding","insiderTrades","merge"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2640182080?lang=en_us&edition=fundamental","pubTime":"2026-06-04 06:03","pubTimestamp":1780524228,"startTime":"0","endTime":"0","summary":"Outlook Therapeutics director Haddadin Yezan Munther bought 29,000 common shares in an open-market purchase.The shares were acquired at USD 0.83 each.Munther’s direct holding rose to 66,167 common shares following the transaction.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Outlook Therapeutics Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission , on June 03, 2026, and is solely responsible for the information contained therein.","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260603:nNDL3VtC12:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":"Outlook Therapeutics director Yezan Munther Haddadin acquires 29,000 common shares for $24,145.40","news_tag":"shareholding,insiderTrades,merge","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","OTLK"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2640957679","title":"Outlook Therapeutics beneficial owner Ghiath M. Sukhtian reports $5 million common share purchase","url":"https://stock-news.laohu8.com/highlight/detail?id=2640957679","media":"Reuters","labels":["shareholding","insiderTrades"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2640957679?lang=en_us&edition=fundamental","pubTime":"2026-06-02 09:30","pubTimestamp":1780363847,"startTime":"0","endTime":"0","summary":"Outlook Therapeutics director and 10% owner Ghiath M. Sukhtian reported an indirect purchase of 8,539,709 common shares at USD 0.59.Indirect beneficial ownership rose to 22,092,068 common shares.Warrants held indirectly were reset to a USD 0.59 exercise price, covering 15,488,570 shares.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Outlook Therapeutics Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission , on June 01, 2026, and is solely responsible for the information contained therein.","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260602:nNDLb19B5v:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":"Outlook Therapeutics beneficial owner Ghiath M. Sukhtian reports $5 million common share purchase","news_tag":"shareholding,insiderTrades","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["OTLK","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2640295284","title":"Outlook Therapeutics Resubmits Lytenava Biologics License Application to FDA","url":"https://stock-news.laohu8.com/highlight/detail?id=2640295284","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2640295284?lang=en_us&edition=fundamental","pubTime":"2026-06-01 21:16","pubTimestamp":1780319781,"startTime":"0","endTime":"0","summary":"Outlook Therapeutics  has resubmitted its biologics license application for ONS-5010, or Lytenava, for the treatment of neovascular age-related macular degeneration to the US Food and Drug Administration, the company said Monday.The resubmission comes after the company's successful appeal of the previously announced complete response letter for the drug, where the agency's Office of New Drugs concluded that substantial evidence of effectiveness had been established and no additional trials were required, according to a statement.The decision directed the Division of Ophthalmology and Office of Specialty Medicine to work with the company to reach an agreement on final product labeling, Outlook said.A Prescription Drug User Fee Act date and decision is expected within 60 days of the agency's receipt of the resubmission, the company said.","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["LABU","BK4585","BK4139","OTLK","BK4007","BK4588","BK4539","LENZ"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2640095481","title":"Outlook Therapeutics resubmits FDA BLA for Lytneava in wet AMD","url":"https://stock-news.laohu8.com/highlight/detail?id=2640095481","media":"Reuters","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2640095481?lang=en_us&edition=fundamental","pubTime":"2026-06-01 20:46","pubTimestamp":1780317982,"startTime":"0","endTime":"0","summary":"Outlook Therapeutics resubmitted its BLA to the FDA for ONS-5010/LYTENAVA  to treat wet age-related macular degeneration.The FDA upheld the company’s appeal of a Complete Response Letter, concluding effectiveness evidence is sufficient, eliminating the need for additional trials.The resubmission was designated Class 1, setting an FDA decision deadline within 60 days of receipt.","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260601:nNDL42C9fb:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4588","BK4139","IE00BN0W2W23.USD","IE00BN0W2T93.GBP","IE00BKPKM429.USD","LU2210149790.SGD","LU2095319765.USD","SG9999014005.SGD","IE00B3QW5Z07.USD","LU0314104364.USD","SG9999014039.USD","BK4585","LU2210150020.SGD","IE00BGHQF748.EUR","BK4112","SG9999014013.SGD","IE00B64PRP62.GBP","OTLK","IE00BN0W2V16.EUR","SG9999014021.USD","NDAQ"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2640954868","title":"Outlook Therapeutics Announces Resubmission of Biologics License Application to U.S. FDA for Ons-5010/Lytenava™ (Bevacizumab-Vikg)","url":"https://stock-news.laohu8.com/highlight/detail?id=2640954868","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2640954868?lang=en_us&edition=fundamental","pubTime":"2026-06-01 20:46","pubTimestamp":1780317960,"startTime":"0","endTime":"0","summary":null,"market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260601:nTUA5WXSPG:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4139","OTLK"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2640548149","title":"Outlook Therapeutics - FDA Says No Additional Trials Required for Lytenava in Namd","url":"https://stock-news.laohu8.com/highlight/detail?id=2640548149","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2640548149?lang=en_us&edition=fundamental","pubTime":"2026-06-01 20:46","pubTimestamp":1780317960,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260601:nTUA5WXSPG:2","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["OTLK","BK4139"],"isVideo":false,"video":null,"gpt_icon":0}],"pageSize":20,"totalPage":6,"pageCount":3,"totalSize":113,"code":"91000000","status":"200"}]}}