Outlook Therapeutics, Inc., a late clinical-stage biopharmaceutical company, focuses on developing and commercializing monoclonal antibodies for various ophthalmic indications. Its lead product candidate is ONS-5010, a proprietary ophthalmic formulation of bevacizumab product candidate that is in Phase-III clinical trial for the treatment of wet age related macular degeneration and other retina diseases. Outlook Therapeutics, Inc. has collaboration and license agreements with IPCA Laboratories Limited; Laboratorios Liomont, S.A. de C.V.; BioLexis Pte. Ltd.; and Zhejiang Huahai Pharmaceutical Co., Ltd. The company was formerly known as Oncobiologics, Inc. and changed its name to Outlook Therapeutics, Inc. in November 2018. Outlook Therapeutics, Inc. was incorporated in 2010 and is based in Iselin, New Jersey.
IPO Year: 2016
Exchange: NASDAQ
Website: outlooktherapeutics.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 3/27/2024 | $50.00 | Neutral → Buy | BTIG Research |
| 2/15/2024 | $3.00 | Neutral → Buy | Chardan Capital Markets |
| 1/25/2024 | Neutral → Buy | Guggenheim | |
| 12/27/2023 | $5.00 | Equal Weight → Overweight | CapitalOne |
| 8/31/2023 | $5.00 → $1.00 | Buy → Neutral | H.C. Wainwright |
| 8/31/2023 | Buy → Neutral | Chardan Capital Markets | |
| 8/30/2023 | Overweight → Equal Weight | CapitalOne | |
| 8/30/2023 | Buy → Neutral | Guggenheim | |
| 8/30/2023 | $4.50 → $1.00 | Overweight → Neutral | Cantor Fitzgerald |
| 8/30/2023 | Buy → Neutral | BTIG Research |
Access the CEO Connect segment here ISELIN, N.J., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year 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 Russell Trenary, President and CEO of Outlook Therapeutics participated in a Virtual Investor CEO Connect segment. As part of this segment, Mr. Trenary provided an overview of the Company's recent accomplishments and highlighted near-term value driving milestones as the Company wor
ISELIN, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year 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 Russell Trenary, President and CEO of Outlook Therapeutics will participate in the Virtual Investor Closing Bell Series on Thursday, September 19, 2024 at 4:00 PM ET. As part of the event, Mr. Trenary will provide a corporate overview and business outlook. In addition to the prepared remarks, there will be a live que
Webcast replay of fireside chat now available ISELIN, N.J., Sept. 13, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year 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 the Company recently participated in the 2nd Annual Chardan Virtual Ophthalmology Conference Series. Chardan's 2nd Annual Virtual Ophthalmology Summit focused on age-related macular degeneration (AMD) and diabetes-related ocular diseases and featured 8 companies pursuing
Topline results from NORSE EIGHT expected in Q4 CY2024 ISELIN, N.J., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced the completion of enrollment for its NORSE EIGHT clinical trial evaluating ONS-5010 in wet AMD patients. NORSE EIGHT is the subject of a Special Protocol Assessment (SPA) agreement with the FDA, and, if successful, is the final anticipated clinical trial required befo
ISELIN, N.J., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year 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 Russell Trenary, President and CEO of Outlook Therapeutics will present at the H.C. Wainwright 26th Annual Global Investment Conference being held September 9-11, 2024 in New York, NY. In addition to the presentation, management will be available to participate in in-person one-on-one meetings with qualified member
Received European Union (EU) and United Kingdom (UK) Marketing Authorization for LYTENAVA™ (bevacizumab gamma) for the treatment of wet AMDNORSE EIGHT current enrollment pace supports topline readout target of Q4 CY2024Resubmission of the ONS-5010 Biologics License Application (BLA) on track for Q1 CY2025Quarterly update conference call and webcast today, Wednesday, August 14th at 8:30 AM ET ISELIN, N.J., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company that has achieved regulatory approval in the EU and UK for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degenerati
ISELIN, N.J., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company focused on development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) for the treatment of retina diseases, today announced that Russell Trenary, President and CEO of Outlook Therapeutics will participate in a fireside chat at the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference being held on Thursday, August 15, 2024. A video webcast of the fireside chat will be accessible for viewing on-demand beginning on Thursday, August 15, 2024, at 7:00 AM ET for those registered for the event and will be accessible on the Events page in
ISELIN, N.J., Aug. 07, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company that has achieved regulatory approval in the EU and UK for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet AMD, today announced that it will report its financial results for third quarter fiscal year 2024 on Wednesday, August 14, 2024. Outlook Therapeutics management will host its quarterly conference call and live audio webcast to discuss the operational and financial results at 8:30 AM ET that same day. The call will be led by Russell Trenary, President and Chief Executive Officer and Lawrence Kenyon, Chief Financial Officer
Company to participate in a fireside chat on Monday, August 5th at 8:00 AM ET ISELIN, N.J., July 30, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company focused on development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) for the treatment of retina diseases, today announced that Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics will participate in a fireside chat at the BTIG Virtual Biotechnology Conference 2024 on Monday, August 5, 2024 at 8:00 AM ET. In addition to the fireside chat, management will be available to participate in virtual one-on-one meetings with qualified member
UK MHRA marketing authorization follows recent European Commission Marketing Authorization for LYTENAVA™ (bevacizumab gamma) in the EU for the treatment of wet AMDInitial commercial launches of LYTENAVA™ (bevacizumab gamma) in the EU and UK anticipated in calendar Q1 2025Strategic partnership with Cencora (formerly AmerisourceBergen) to support the planned commercial launches of LYTENAVA in UK and EU ISELIN, N.J., July 08, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company focused on development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) for the treatment of retina diseases, today announced that the United
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ISELIN, N.J., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced the appointment of Jedd Comiskey as Senior VP – Head of Europe. Mr. Comiskey has a successful track record in the planning, organization and execution of product launches. Over the course of his career, he has demonstrated innovative, solution-focused results, navigating the highly complex European pharmaceutical landscape. "We believe in the potential of ONS-5010 to address the global need for an approved bevacizumab that meets ophtha
ISELIN, N.J., Aug. 15, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced the appointment of Julia A. Haller, MD, to the Company's Board of Directors. "We are pleased to welcome Dr. Haller to Outlook Therapeutics' Board of Directors. As one of the world's most accomplished professionals in ophthalmic education, research, and clinical ophthalmic practice, she will add tremendous value and insight to Outlook Therapeutics," said Randy Thurman, Executive Chairman of the Outlook Therapeutics Board o
Ms. Tozier has held commercial leadership positions across the full product lifecycle and exceeded goals for 14 launches across 70-plus global markets, with deep experience in ophthalmology and leadership for launching wet AMD/DME therapies. ISELIN, N.J., March 03, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that Alicia Tozier has been appointed as Senior Vice President, Marketing and Market Access. "We are pleased to strengthen our commercialization expertise with the addition of Alicia to our leader
Joel Prieve brings nearly 20 years of commercial operations expertise and proven track record in sales and account management ISELIN, N.J., Feb. 08, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced the appointment of Joel Prieve as Senior Vice President, Commercial Operations. "Outlook Therapeutics is thrilled to welcome Joel to our executive leadership team. We believe his background and expertise in commercialization and specialty biopharmaceutical distribution will be invaluable as we continue advan
Experienced executive with a track-record of successful eye care product launchesAppointment reflects Outlook Therapeutics' dedication to transition to commercial-stage company ISELIN, N.J., July 07, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced the appointment of C. Russell Trenary III as President, Chief Executive Officer and a member of the Board of Directors. Lawrence A. Kenyon, who has served as Outlook Therapeutics' President, CEO and CFO since June 2018, will continue serving as CFO and as a me
European Commission Approval Followed By Anticipated EU And UK Launches In Q1 2025; Strategic Partnership With Cencora To Support Launch
HC Wainwright & Co. analyst Douglas Tsao reiterates Outlook Therapeutics (NASDAQ:OTLK) with a Buy and maintains $30 price target.
Outlook Therapeutics (NASDAQ:OTLK) reported quarterly losses of $(1.55) per share which missed the analyst consensus estimate of $(0.85) by 82.35 percent.
-SEC Filing
Although U.S. stocks closed mixed on Thursday, there were a few notable insider trades. When insiders purchase shares, it indicates their confidence in the company's prospects or that they view the stock as a bargain. Either way, this signals an opportunity to go long on the stock. Insider purchases should not be taken as the only indicator for making an investment or trading decision. At best, it can lend conviction to a buying decision. Below is a look at a few recent notable insider purchases. For more, check out Benzinga's insider transactions platform. CION Investment The Trade: CION Investment Corporation (NYSE:CION) Co-Chairman & Co-CEO Mark Gatto acquired a total of 1,150
BTIG Research upgraded Outlook Therapeutics from Neutral to Buy and set a new price target of $50.00
Chardan Capital Markets upgraded Outlook Therapeutics from Neutral to Buy and set a new price target of $3.00
Guggenheim upgraded Outlook Therapeutics from Neutral to Buy
CapitalOne upgraded Outlook Therapeutics from Equal Weight to Overweight and set a new price target of $5.00
H.C. Wainwright downgraded Outlook Therapeutics from Buy to Neutral and set a new price target of $1.00 from $5.00 previously
Chardan Capital Markets downgraded Outlook Therapeutics from Buy to Neutral
CapitalOne downgraded Outlook Therapeutics from Overweight to Equal Weight
Guggenheim downgraded Outlook Therapeutics from Buy to Neutral
Cantor Fitzgerald downgraded Outlook Therapeutics from Overweight to Neutral and set a new price target of $1.00 from $4.50 previously
BTIG Research downgraded Outlook Therapeutics from Buy to Neutral
Received European Union (EU) and United Kingdom (UK) Marketing Authorization for LYTENAVA™ (bevacizumab gamma) for the treatment of wet AMDNORSE EIGHT current enrollment pace supports topline readout target of Q4 CY2024Resubmission of the ONS-5010 Biologics License Application (BLA) on track for Q1 CY2025Quarterly update conference call and webcast today, Wednesday, August 14th at 8:30 AM ET ISELIN, N.J., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company that has achieved regulatory approval in the EU and UK for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degenerati
ISELIN, N.J., Aug. 07, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company that has achieved regulatory approval in the EU and UK for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet AMD, today announced that it will report its financial results for third quarter fiscal year 2024 on Wednesday, August 14, 2024. Outlook Therapeutics management will host its quarterly conference call and live audio webcast to discuss the operational and financial results at 8:30 AM ET that same day. The call will be led by Russell Trenary, President and Chief Executive Officer and Lawrence Kenyon, Chief Financial Officer
Positive opinion received from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for ONS-5010/LYTENAVA™ (bevacizumab gamma)United Kingdom (UK) Marketing Authorization Application (MAA) submitted NORSE EIGHT fully underway in the US; Topline readout expected in Q4 CY2024Resubmission of the ONS-5010 Biologics License Application (BLA) planned by the end of CY2024 Company to host inaugural quarterly update conference call and webcast on Thursday, May 16th at 8:30 AM ET ISELIN, N.J., May 15, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to achieve regulatory approval for the first authorized
ISELIN, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that it will report its financial results for second quarter fiscal year 2024 on Thursday, May 16, 2024. Outlook Therapeutics management will host its inaugural quarterly conference call and live audio webcast to discuss the operational and financial results at 8:30 AM ET that same day. The call will be led by Russell Trenary, President and Chief Executive Officer and Lawrence Kenyon, Chief Financial Officer of Outloo
NORSE EIGHT underway with first subject dosed and additional clinical sites beginning enrollment Continue to expect planned resubmission of the ONS-5010 Biologics License Application (BLA) by the end of CY2024 Anticipate review decision from European regulators in the first half of CY2024 ISELIN, N.J., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to achieve regulatory approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced financial results for first quarter fiscal year 2024 and provided a corporate update. "We are proud of the recent progress our team has ma
Commencement of ONS-5010 NORSE EIGHT clinical trial targeted for first calendar quarter of 2024Company reaffirms potential for European approval for ONS-5010 with Marketing Authorization Application (MAA) decision date anticipated in the first half of 2024 Resubmission of the ONS-5010 Biologics License Application (BLA) expected by the end of calendar year 2024 ISELIN, N.J., Dec. 22, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to achieve U.S. Food and Drug Administration (FDA) approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced recent corporate highlights and financia
FDA issues Complete Response Letter (CRL) for ONS-5010 BLA based on CMC and need for further confirmatory clinical evidence Outlook Therapeutics working with FDA to address the Agency's issues Company to host conference call and webcast, today, August 30 at 8:30 AM ET ISELIN, N.J., Aug. 30, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced the U.S. Food and Drug Administration (FDA) has issued a CRL to the Company's BLA for ONS-5010, an investigational ophthalmic formulation of bevacizumab under developmen
Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023 for ONS-5010, an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD) ISELIN, N.J., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of wet AMD, today announced recent corporate highlights and financial results for its fiscal third quarter ended June 30, 2023. Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics, commented, "We continue to be focused on our pre-launch activ
Upcoming Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023 for ONS-5010, an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD)Pre-launch commercial activities continue in preparation for potential approval and launch of ONS-5010 ISELIN, N.J., May 15, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced recent corporate highlights and financial results for its fiscal second quarter ended March 31, 2023.
Pre-launch commercial activities underway as Company advances toward U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023 for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation for the treatment of wet age-related macular degeneration (wet AMD)Cash runway through the anticipated FDA approval of ONS-5010 in the third calendar quarter of 2023 and into the fourth calendar quarter of 2023 ISELIN, N.J., Feb. 14, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use i