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 |
|---|---|---|---|
| 12/2/2024 | Buy → Neutral | Chardan Capital Markets | |
| 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 |
4 - Outlook Therapeutics, Inc. (0001649989) (Issuer)
4 - Outlook Therapeutics, Inc. (0001649989) (Issuer)
4 - Outlook Therapeutics, Inc. (0001649989) (Issuer)
4 - Outlook Therapeutics, Inc. (0001649989) (Issuer)
ISELIN, N.J., May 23, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced the pricing of an underwritten public offering of 9,285,714 shares of its common stock, together with accompanying warrants to purchase 18,571,428 shares of its common stock. The combined public offering price of common stock and accompanying warrant is $1.40. The common stock is being sold in combination with an accompanying warrant to purchase two shares of common stock issued for each share of common stock sold. The accompanying warrant has an exercise price of
ISELIN, N.J., May 22, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it has commenced an underwritten public offering of its common stock and accompanying warrants exercisable for shares of its common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Outlook Therapeutics intends to use the net proceeds from the offering for working capital and other general corporate purposes. BTIG
LYTENAVA™ (bevacizumab gamma) on track for planned first commercial launches in Germany and the United Kingdom (UK) in Q2 CY2025Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025 in the United States ISELIN, N.J., May 15, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today reported financial results for the second quarter of fiscal year 2025 and provided a corporate update. "Outlook Therapeutics remains on track in 2025 to transform into a commercial-stage company with the planned upcoming commercial launch of LYTENAVA™ (bevaciz
Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025 ISELIN, N.J., April 08, 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 the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet AMD. The
ISELIN, N.J., Feb. 28, 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 it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, an investigational ophthalmic product which, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD). "We remain committed to bringing
On-demand video webcast now available here ISELIN, N.J., Feb. 19, 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 it participated in the Virtual Investor "Top 5 for ‘25" On-Demand Conference. As part of the event, Lawrence A. Kenyon, Chief Financial Officer and Interim Chief Executive Officer of Outlook Therapeutics, presented the top five reasons of why he believes the investment community and
ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Biologics License Application (BLA) resubmission on track to meet target of Q1 CY2025LYTENAVA™ (bevacizumab gamma) on track for first commercial launches in Germany and the United Kingdom (UK) planned for Q2 CY2025 ISELIN, N.J., Feb. 14, 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 financial results for the first quarter of fiscal year 2025 and provided a co
Dr. Jennifer Kissner, SVP Clinical Development, discusses the 12-week safety and efficacy results for NORSE EIGHT clinical trial Watch the "What This Means" 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 "What This Means" segment. As part of the segm
ISELIN, N.J., Jan. 31, 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 Faisal G. Sukhtian has been appointed as Chairman of the Board of Directors, effective immediately. Mr. Sukhtian will assume the role from Randy Thurman, who will remain on the Board as Lead Independent Director. "On behalf of the Board of Directors, management, and employees of Outlook Therapeutics, I want to extend my deepest
Data presented at Hawaiian Eye and Retina 2025 MeetingResults confirmed that intravitreal ONS-5010 provided early and sustained anatomic improvements, with steady gains in BCVA and reliable, consistent safetyONS-5010 demonstrated to be non-inferior to Lucentis at 4 and 12 weeksCompany on track for anticipated BLA resubmission in calendar Q1 2025 ISELIN, N.J., Jan. 23, 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)
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LYTENAVA™ (bevacizumab gamma) on track for planned first commercial launches in Germany and the United Kingdom (UK) in Q2 CY2025Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025 in the United States ISELIN, N.J., May 15, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today reported financial results for the second quarter of fiscal year 2025 and provided a corporate update. "Outlook Therapeutics remains on track in 2025 to transform into a commercial-stage company with the planned upcoming commercial launch of LYTENAVA™ (bevaciz
ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Biologics License Application (BLA) resubmission on track to meet target of Q1 CY2025LYTENAVA™ (bevacizumab gamma) on track for first commercial launches in Germany and the United Kingdom (UK) planned for Q2 CY2025 ISELIN, N.J., Feb. 14, 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 financial results for the first quarter of fiscal year 2025 and provided a co
LYTENAVA™ is the first and only approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the European Union (EU) and United Kingdom (UK); First commercial launch anticipated in H1 CY25Received NICE recommendation of LYTENAVA™ (bevacizumab gamma) for the treatment of wet AMD ISELIN, N.J., Dec. 27, 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 financial results for fisca
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
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Chardan Capital Markets downgraded Outlook Therapeutics from Buy to Neutral
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
ISELIN, N.J., Jan. 31, 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 Faisal G. Sukhtian has been appointed as Chairman of the Board of Directors, effective immediately. Mr. Sukhtian will assume the role from Randy Thurman, who will remain on the Board as Lead Independent Director. "On behalf of the Board of Directors, management, and employees of Outlook Therapeutics, I want to extend my deepest
ISELIN, N.J., Dec. 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 LYTENAVA™ (bevacizumab gamma), the first ophthalmic formulation of bevacizumab authorized for the treatment of wet age-related macular degeneration (wet AMD) in adults, today announced that Russell Trenary has stepped down as the Company's President and Chief Executive Officer (CEO), effective immediately. Lawrence Kenyon, Executive Vice President, Chief Financial Officer and member of the board of directors, has been appointed Interim CEO. "On behalf of our management team
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
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4 - Outlook Therapeutics, Inc. (0001649989) (Issuer)
4 - Outlook Therapeutics, Inc. (0001649989) (Issuer)
4 - Outlook Therapeutics, Inc. (0001649989) (Issuer)
4 - Outlook Therapeutics, Inc. (0001649989) (Issuer)
4 - Outlook Therapeutics, Inc. (0001649989) (Issuer)
4 - Outlook Therapeutics, Inc. (0001649989) (Issuer)
4 - Outlook Therapeutics, Inc. (0001649989) (Issuer)
4 - Outlook Therapeutics, Inc. (0001649989) (Issuer)