Welcome to our dedicated page for Outlook Therapeutics news (Ticker: OTLK), a resource for investors and traders seeking the latest updates and insights on Outlook Therapeutics stock.
Outlook Therapeutics, Inc. (Nasdaq: OTLK) is a biopharmaceutical company centered on ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma), an ophthalmic formulation of bevacizumab for retina diseases such as wet age-related macular degeneration (wet AMD). News about Outlook Therapeutics typically focuses on clinical, regulatory, and commercial milestones related to this product candidate and its marketed formulation in Europe and the UK.
Readers following OTLK news can expect updates on interactions with the U.S. Food and Drug Administration (FDA), including Biologics License Application (BLA) submissions, complete response letters (CRLs), Type A meetings, and review classifications such as Class 1 reviews with specified PDUFA goal dates. These regulatory developments are central to understanding the potential U.S. path for ONS-5010/LYTENAVA™ as an investigational treatment for wet AMD.
In addition, Outlook Therapeutics issues news on its European and UK activities, including Marketing Authorizations granted by the European Commission and the MHRA, the commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK, and early commercial performance indicators such as initial sales into distribution channels. Company announcements may also cover efforts to expand into additional European markets and explore collaborations with commercial and distribution partners in other regions.
Corporate and financial news items provide insight into Outlook Therapeutics’ leadership changes, strategic hires in areas like corporate strategy and business development, stock-based inducement grants, and periodic financial results that reference revenue from LYTENAVA™ sales and spending patterns related to clinical trials and launches. Conference participation, investor presentations, and scientific meeting appearances are also common topics. For investors and observers interested in the evolution of ophthalmic bevacizumab therapies and wet AMD treatment approaches, the Outlook Therapeutics news feed offers a focused view of the company’s progress.
Outlook Therapeutics (Nasdaq: OTLK) has announced the completion of enrollment for its NORSE EIGHT clinical trial, evaluating ONS-5010 in wet AMD patients. This trial, subject to a Special Protocol Assessment (SPA) agreement with the FDA, is the final anticipated clinical study before the expected resubmission of the company's Biologics License Application (BLA) for ONS-5010.
Key points:
- NORSE EIGHT is a randomized, controlled study comparing ONS-5010 to ranibizumab
- Topline results are expected in Q4 2024
- BLA resubmission is planned for Q1 2025
- The trial aims to address the clinical deficiency identified in the previous Complete Response Letter
If approved by the FDA, Outlook Therapeutics plans to commercialize ONS-5010/LYTENAVA™ (bevacizumab-vikg) directly in the U.S. and is exploring partnering options for Europe and other regions.
Outlook Therapeutics (Nasdaq: OTLK), a biopharmaceutical company, announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024, in New York. Russell Trenary, President and CEO, will present at the conference and be available for one-on-one meetings with qualified investors.
The company recently achieved regulatory approval in the European Union and the United Kingdom for the first authorized ophthalmic formulation of bevacizumab to treat wet age-related macular degeneration (wet AMD). A video webcast of the presentation will be available on-demand from September 9, 2024, at 7:00 AM ET for registered attendees and on the company's website for 90 days following the event.
Outlook Therapeutics (Nasdaq: OTLK) reported financial results for Q3 FY2024 and provided a corporate update. Key highlights include:
1. Received EU and UK Marketing Authorization for LYTENAVA™ (bevacizumab gamma) for wet AMD treatment.
2. NORSE EIGHT clinical trial enrollment on track for Q3 CY2024 completion, with topline results expected in Q4 CY2024.
3. ONS-5010 BLA resubmission targeted for Q1 CY2025.
4. Reported net income of $44.4 million, or $1.91 per basic share, compared to a net loss of $20.7 million in the same period last year.
5. Cash and cash equivalents of $32.0 million as of June 30, 2024.
6. Commercial launch of LYTENAVA™ in EU and UK anticipated in H1 CY2025.
Outlook Therapeutics (Nasdaq: OTLK), a biopharmaceutical company developing ONS-5010/LYTENAVA™ (bevacizumab-vikg) for retina diseases, announced its participation in the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference on August 15, 2024. Russell Trenary, President and CEO, will engage in a fireside chat during the event.
The video webcast of the fireside chat will be available on-demand starting at 7:00 AM ET on August 15 for registered attendees. It will also be accessible on the company's website in the Investors section's Events page. The webcast replay will remain archived for 90 days after the event.
Outlook Therapeutics (Nasdaq: OTLK), a biopharmaceutical company that has received regulatory approval in the EU and UK for the first authorized ophthalmic formulation of bevacizumab to treat wet AMD, has announced its upcoming financial results release. The company will report its third quarter fiscal year 2024 results on Wednesday, August 14, 2024. Following the release, management will host a conference call and live audio webcast at 8:30 AM ET to discuss operational and financial outcomes.
The call will be led by Russell Trenary, President and CEO, and Lawrence Kenyon, CFO. Investors can join the call by dialing (877) 407-8291 (domestic) or (201) 689-8345 (international). A live webcast will also be available on the company's website and archived for 90 days.
Outlook Therapeutics (Nasdaq: OTLK), a biopharmaceutical company developing ONS-5010/LYTENAVA™ (bevacizumab-vikg) for retina diseases, announced its participation in the BTIG Virtual Biotechnology Conference 2024. Russell Trenary, President and CEO, will engage in a fireside chat on Monday, August 5th at 8:00 AM ET.
The company's management team will also be available for one-on-one virtual meetings with qualified investors attending the conference. Interested parties are advised to contact their BTIG representative to schedule meetings with Outlook Therapeutics during the event.
Outlook Therapeutics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for LYTENAVA™ (bevacizumab gamma), an ophthalmic formulation for treating wet AMD. This follows a similar approval by the European Commission. The commercial launch in the UK and EU is anticipated for Q1 2025. Outlook Therapeutics has partnered with Cencora to support these launches, ensuring market access and efficient distribution. The MHRA's approval marks a significant milestone, offering the first authorized ophthalmic bevacizumab for wet AMD in these regions.
Outlook Therapeutics (Nasdaq: OTLK) will present at the Virtual Investor Pitch Conference on June 18, 2024, at 12:00 PM ET. CEO Russell Trenary will deliver an elevator pitch and discuss the company's upcoming milestones, focusing on the commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg). The event will be live-streamed on the Investors section of the company's website, with a replay available for 90 days. Investors can submit questions during the live presentation.
Outlook Therapeutics has received European Commission Marketing Authorization for LYTENAVA™ (bevacizumab gamma), an ophthalmic formulation for treating wet AMD. This makes it the first ophthalmic bevacizumab formulation approved for wet AMD in the EU.
This authorization covers all 27 EU Member States and will extend to Iceland, Norway, and Liechtenstein within 30 days. The company is planning a commercial launch for Q1 2025, with ten years of market exclusivity in the EU.
Outlook Therapeutics has partnered with Cencora to support the commercial launch, providing comprehensive services such as pharmacovigilance, regulatory affairs, and distribution.
Outlook Therapeutics (Nasdaq: OTLK), a biopharmaceutical company focused on retinal disease treatments, announced its Q2 FY2024 financial results and provided a corporate update. The company reported a net loss of $114.3 million ($8.01 per share), up from $6.7 million ($0.52 per share) last year. Adjusted net loss was $22.1 million ($1.55 per share), influenced by warrant-related expenses. As of March 31, 2024, Outlook Therapeutics had $47.2 million in cash.
Key milestones include a CHMP positive opinion for ONS-5010 in the EU, UK MAA submission, NORSE EIGHT trial progress, and planned resubmission of the ONS-5010 BLA by end of CY2024. The company anticipates potential FDA approval and commercial launch of ONS-5010 in 2025.
Outlook Therapeutics hosted its inaugural quarterly update call on May 16, 2024, discussing these developments and future plans.
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