Welcome to our dedicated page for Outlook Therapeutics news (Ticker: OTLKW), a resource for investors and traders seeking the latest updates and insights on Outlook Therapeutics stock.
News for OTLKW reflects developments at Outlook Therapeutics, Inc., a biopharmaceutical company concentrated on ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma), an ophthalmic formulation of bevacizumab for retinal diseases such as wet age-related macular degeneration (wet AMD). Company news frequently reiterates this focus on enhancing or optimizing the standard of care for bevacizumab in retina indications.
Readers can expect coverage of regulatory milestones, including interactions with the U.S. Food and Drug Administration (FDA) around the Biologics License Application (BLA) for ONS-5010. Recent announcements have described complete response letters, Type A meetings, BLA resubmissions, and FDA acknowledgments of resubmissions as complete, along with associated Prescription Drug User Fee Act (PDUFA) goal dates. These updates provide context on the regulatory pathway for the investigational product in the United States.
The OTLKW news feed also includes information on European commercialization of LYTENAVA™ (bevacizumab gamma), where Outlook Therapeutics reports that the product has received Marketing Authorization from the European Commission and the UK MHRA for the treatment of wet AMD and has been launched commercially in Germany and the UK. News items describe initial sales into distribution channels, early prescribing trends, and efforts to expand into additional European markets, subject to pricing and reimbursement approvals in certain Member States.
Additional news topics include corporate and investor events, such as participation in healthcare conferences, presentations at ophthalmology-focused meetings, and the appointment of senior executives in corporate strategy and business development. Disclosures on stock option grants to new employees as employment inducement awards may also appear. For investors and observers following OTLKW, this news page offers a centralized view of Outlook Therapeutics’ reported clinical, regulatory, commercial, and corporate developments related to its ophthalmic bevacizumab program.
Outlook Therapeutics (Nasdaq: OTLK) on January 6, 2026 appointed Laura Cantrell as Vice President of Corporate Strategy and Business Development.
Ms. Cantrell brings more than 20 years of global biotechnology experience in corporate strategy, business development and portfolio leadership, and will lead strategic partnerships, licensing and corporate development initiatives as the company advances a differentiated ophthalmic formulation of bevacizumab.
Her background includes senior roles at Medivation (part of a team supporting a $14 billion acquisition by Pfizer), BeiGene, Sobi, Axovant Sciences, and Genentech/Roche; she holds an MBA from Emory and a BS in Biology from University of Michigan.
Outlook Therapeutics (Nasdaq: OTLK) said the U.S. Food and Drug Administration issued a Complete Response Letter (CRL) for the resubmitted biologics license application for ONS-5010/LYTENAVA (bevacizumab-vikg) for wet age-related macular degeneration (wet AMD), indicating the application cannot be approved in its present form.
The FDA noted one adequate and well-controlled study demonstrated efficacy but again requested confirmatory evidence of efficacy and did not specify what evidence would be acceptable. The resubmission was based on the NORSE clinical program (including NORSE TWO and NORSE EIGHT).
Outlook said it is exploring U.S. approval pathways and continuing commercial expansion in Europe, where LYTENAVA received European Commission and MHRA marketing authorizations and became commercially available in Germany and the UK in June 2025.
Outlook Therapeutics (Nasdaq: OTLK) announced on Dec 26, 2025 that, effective Dec 19, 2025, its Compensation Committee granted stock options to purchase an aggregate of 150,000 shares of common stock to two new employees.
The options carry a per‑share exercise price of $2.01 and were awarded as inducement grants under NASDAQ Listing Rule 5635(c)(4) to facilitate the employees entering into employment with the company.
Outlook Therapeutics (Nasdaq: OTLK) reported fiscal 2025 results for the year ended September 30, 2025. The company recorded a net loss of $62.4 million ($1.79 per share) and $1.4 million of revenue from initial European sales of LYTENAVA in June 2025. Gross profit was reduced by increased reserves for short-dated inventory from UK shipments. Operating expenses fell year-over-year driven by lower R&D after completion of NORSE Eight, offset by higher SG&A from the European launch. Cash and equivalents were $8.1 million at September 30, 2025, plus $14.9 million net ATM proceeds received after the period. The FDA PDUFA goal date for ONS-5010 is December 31, 2025.
Outlook Therapeutics (Nasdaq: OTLK) announced that CEO Bob Jahr will participate in a live fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Tuesday, December 2, 2025 at 10:00 AM ET.
Management is also available for one-on-one in-person meetings with qualified, registered investors at the conference. A live webcast will be available on the company Investors > Events page and the replay will be archived for 90 days after the event.
Outlook Therapeutics (Nasdaq: OTLK) announced the U.S. FDA has accepted the resubmission of its Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg) for wet age-related macular degeneration (wet AMD).
The FDA considers the resubmission a complete, Class 1 response to the August 27, 2025 action letter, initiating a 60-day review and setting a PDUFA goal date of December 31, 2025. If approved, ONS-5010 will be branded LYTENAVA for treatment of wet AMD.
Outlook Therapeutics (Nasdaq: OTLK) re-submitted its Biologics License Application (BLA) for ONS-5010 to the U.S. FDA on Nov 3, 2025 after receiving official minutes from an FDA Type A meeting held in September 2025. ONS-5010 is an investigational ophthalmic bevacizumab formulation proposed to be branded LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).
The company said the resubmission is intended to resolve the outstanding issue identified in a Complete Response Letter (CRL) dated August 2025 and that it is accelerating commercial efforts in Europe while positioning for a potential near-term U.S. approval.
Outlook Therapeutics (NASDAQ: OTLK) has completed its Type A Meeting with the FDA regarding the Complete Response Letter (CRL) for ONS-5010, its investigational ophthalmic bevacizumab formulation for wet AMD treatment. The meeting focused on discussing the CRL received on August 27, 2025, concerning the company's biologics license application (BLA).
Following the FDA discussion, Outlook Therapeutics plans to resubmit its BLA before the end of 2025, after reviewing the agency's feedback and meeting minutes. CEO Bob Jahr described the FDA meeting as productive and reaffirmed the company's commitment to providing a safe and effective ophthalmic bevacizumab treatment option for wet AMD patients in the U.S.
Outlook Therapeutics (NASDAQ:OTLK), a biopharmaceutical company specializing in bevacizumab treatments for retina diseases, will present at the EURETINA Innovation Spotlight during the 25th EURETINA Congress. The presentation titled "Optimising the treatment of retinal disease" will be delivered by CEO Bob Jahr on September 3, 2025 at 16:10 PM CEST / 10:10 AM EDT in Paris, France.
Outlook Therapeutics (Nasdaq: OTLK) has requested a Type A Meeting with the FDA following a Complete Response Letter (CRL) regarding their ONS-5010 biologics license application. The CRL, issued on August 27, 2025, acknowledged that the NORSE TWO pivotal trial met safety and efficacy endpoints but recommended additional confirmatory evidence for the wet AMD treatment.
ONS-5010 is an investigational ophthalmic formulation of bevacizumab designed to provide a regulated alternative to compounded bevacizumab, which has been used off-label as a first-line wet-AMD treatment. The Type A meeting aims to clarify the specific confirmatory evidence required by the FDA for approval.
