{"id":808556,"date":"2025-02-04T09:17:14","date_gmt":"2025-02-04T14:17:14","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/outlook-therapeutics-participates-in-virtual-investor-what-this-means-segment-2\/"},"modified":"2025-02-04T09:17:14","modified_gmt":"2025-02-04T14:17:14","slug":"outlook-therapeutics-participates-in-virtual-investor-what-this-means-segment-2","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/outlook-therapeutics-participates-in-virtual-investor-what-this-means-segment-2\/","title":{"rendered":"Outlook Therapeutics\u00ae Participates in Virtual Investor \u201cWhat This Means\u201d Segment"},"content":{"rendered":"
\n

\n Dr. Jennifer Kissner, SVP Clinical Development, discusses the 12-week safety and efficacy results for NORSE EIGHT clinical trial<\/em>\n <\/p>\n

\n
\n Watch the \u201cWhat This Means\u201d segment here<\/em>
\n <\/a>
\n \n <\/p>\n

ISELIN, N.J., Feb. 04, 2025 (GLOBE NEWSWIRE) — Outlook Therapeutics, Inc.<\/a> (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (UK) for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced that Jennifer Kissner, Ph.D., SVP Clinical Development of Outlook Therapeutics participated in a Virtual Investor \u201cWhat This Means\u201d segment<\/a>.<\/p>\n

As part of the segment, Dr. Kissner discusses the complete 12-week safety and efficacy results for NORSE EIGHT, the second of two adequate and well controlled clinical trials evaluating ONS-5010 in wet AMD patients and the Company\u2019s planned Biologics License Application (BLA) resubmission of ONS-5010 in the first quarter of calendar 2025.<\/p>\n

The Virtual Investor \u201cWhat This Means\u201d segment featuring Outlook Therapeutics is now available here<\/a>.<\/p>\n

\n About Outlook Therapeutics, Inc.<\/strong>\n <\/p>\n

Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010\/LYTENAVA\u2122 (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, including wet AMD. LYTENAVA\u2122 (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics is working to initiate its commercial launch of LYTENAVA\u2122 (bevacizumab gamma) in the EU and the UK as a treatment for wet AMD, expected in the first half of calendar 2025. In the United States, ONS-5010\/LYTENAVA\u2122 is investigational, is being evaluated in an ongoing non-inferiority study for the treatment of wet AMD, and if successful, the data may be sufficient for Outlook to resubmit a BLA to the FDA in the United States. If approved in the United States, ONS-5010\/LYTENAVA\u2122, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD.<\/p>\n

\n Forward-Looking Statements<\/strong>\n <\/p>\n

This press release contains forward-looking statements. All statements other than statements of historical facts are \u201cforward-looking statements,\u201d including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccontinue,\u201d \u201cexpect,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cwill,\u201d or \u201cwould\u201d the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, Outlook Therapeutics\u2019 ability to remediate or otherwise resolve deficiencies identified in the CRL issued by the FDA, plans to resubmit the BLA for ONS-5010 and the timing thereof, Outlook Therapeutics\u2019 plans for commercial launch of LYTENAVA\u2122 in the\u00a0UK\u00a0and EU and timing thereof, expectations concerning the therapeutic potential of LYTENAVA\u2122 as a treatment of wet AMD, Outlook Therapeutics\u2019 commercialization strategy, expectations concerning decisions of regulatory bodies and the timing thereof, ONS-5010\/LYTENAVA\u2122\u2019s potential as the first FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal indications, including wet AMD, in\u00a0the United States and other statements that are not historical fact. Although\u00a0Outlook Therapeutics\u00a0believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting\u00a0Outlook Therapeutics\u00a0and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics\u2019 resources, as well as those risks detailed in Outlook Therapeutics\u2019 filings with the\u00a0Securities and Exchange Commission\u00a0(SEC), including the Annual Report on Form 10-K for the fiscal year ended\u00a0September 30, 2024, filed with the\u00a0SEC\u00a0on\u00a0December 27, 2024, and future quarterly reports\u00a0Outlook Therapeutics\u00a0files with the\u00a0SEC, which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflicts, high interest rates, inflation and potential future bank failures on the global business environment. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.\u00a0Outlook Therapeutics\u00a0does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.<\/p>\n

\n Investor Inquiries:<\/strong>
\n
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 908.824.0775
OTLK@jtcir.com<\/a><\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

Dr. Jennifer Kissner, SVP Clinical Development, discusses the 12-week safety and efficacy results for NORSE EIGHT clinical trial Watch the \u201cWhat This Means\u201d segment here ISELIN, N.J., Feb. 04, 2025 (GLOBE NEWSWIRE) — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (UK) for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced that Jennifer Kissner, Ph.D., SVP Clinical Development of Outlook Therapeutics participated in a Virtual Investor \u201cWhat This Means\u201d segment. As part of the segment, Dr. Kissner discusses the complete 12-week safety and efficacy results for NORSE EIGHT, the second of two adequate … <\/p>\n

Continue reading “Outlook Therapeutics\u00ae Participates in Virtual Investor \u201cWhat This Means\u201d Segment”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-808556","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nOutlook Therapeutics\u00ae Participates in Virtual Investor \u201cWhat This Means\u201d Segment - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/outlook-therapeutics-participates-in-virtual-investor-what-this-means-segment-2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Outlook Therapeutics\u00ae Participates in Virtual Investor \u201cWhat This Means\u201d Segment - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Dr. Jennifer Kissner, SVP Clinical Development, discusses the 12-week safety and efficacy results for NORSE EIGHT clinical trial Watch the \u201cWhat This Means\u201d segment here ISELIN, N.J., Feb. 04, 2025 (GLOBE NEWSWIRE) — Outlook Therapeutics, Inc. 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