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) reported Q1 FY2026 results and a regulatory update on Feb 17, 2026. The company recorded a $23.1M net loss ($0.38/share) and an adjusted net loss of $13.5M ($0.22/share). Unit sales of LYTENAVA more than doubled quarter-over-quarter and Austria launched in January 2026. A Type A meeting request was submitted to the FDA following a Dec 30, 2025 CRL for ONS-5010.
Outlook Therapeutics (Nasdaq: OTLK) submitted a Type A meeting request to the FDA on Feb 11, 2026 after receiving a Complete Response Letter (Dec 30, 2025) for its BLA for ONS-5010/LYTENAVA (bevacizumab-vikg) in wet AMD. The CRL cited a single deficiency alleging lack of substantial evidence of effectiveness and requested additional confirmatory evidence.
The company cites positive Phase 3 NORSE TWO results at 12 months, complementary data from NORSE EIGHT, mechanistic/pharmacodynamic evidence, favorable safety findings, and existing EU and UK marketing authorizations.
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.