Lytenava (bevacizumab-vikg) / Outlook Therap, Cencora, Ligand - LARVOL DELTA

Outlook Therapeutics Reports Third Quarter Fiscal Year 2026 Financial Results and Provides Business Update Highlighting FDA Approval of LYTENAVA (GlobeNewswire) - "Outlook Therapeutics is advancing preparations for the U.S. commercial launch of LYTENAVA, planned before the end of calendar 2026. The Company is expanding payer engagement, scaling commercial supply, and building a focused commercial organization informed by feedback from retina physicians, practices, and other key stakeholders. Based on current estimates, management believes LYTENAVA has the potential to exceed $500 million in annual U.S. sales by 2030...As part of these efforts, the Company plans to submit an application for a permanent Healthcare Common Procedure Coding System or HCPCS code by October 1, 2026, to support reimbursement following launch."

Launch US • Sales projection • US reimbursement • Wet Age-related Macular Degeneration

In Europe, Outlook Therapeutics continues to expand the commercialization of LYTENAVA in Germany, Austria and the United Kingdom. (GlobeNewswire) - "The Company is also preparing for a planned launch in the Netherlands later in 2026 following its Netherlands submission. In Switzerland, the Company’s partner, Mediconsult, is leading regulatory and commercial activities in support of an anticipated launch in 2027."

EMA filing • Launch Europe • Wet Age-related Macular Degeneration

FDA Approves Outlook Therapeutics' Lytenava as First Ophthalmic Bevacizumab for Wet AMD (Eyewire News) - "Outlook said the product is supported by clinical data, validated manufacturing processes, FDA-approved labeling, and ongoing regulatory oversight. The company also expects Lytenava to receive 12 years of reference product exclusivity under the Biologics Price Competition and Innovation Act (BPCIA)....Outlook Therapeutics said it is preparing for the commercial launch of Lytenava by expanding reimbursement and patient support programs, building its retina-focused commercial organization, and working with physicians across the United States. The company expects the product to become available to eligible US patients before the end of the year."

FDA approval • Launch US • Wet Age-related Macular Degeneration

Outlook Therapeutics Announces Resubmission of Biologics License Application to U.S. FDA for ONS-5010/LYTENAVA (bevacizumab-vikg) (GlobeNewswire) - "The FDR decision directed the Division of Ophthalmology and Office of Specialty Medicine to work with Outlook Therapeutics to focus on reaching an agreement on final product labeling. Additionally, as indicated in the formal decision, this will be a Class 1 resubmission with a PDUFA date and decision expected within 60 days of FDA’s receipt of the resubmission."

FDA filing • Wet Age-related Macular Degeneration

Outlook Therapeutics Announces FDA Acceptance of Resubmitted Biologics License Application for ONS-5010/LYTENAVA (bevacizumab-vikg) as a Treatment for Wet AMD (GlobeNewswire) - "The Company has been informed that the resubmission is a Class 1 review, with a PDUFA target action date of July 29, 2026."

FDA filing • PDUFA • Wet Age-related Macular Degeneration

Outlook Therapeutics wins FDA appeal, to resubmit LYTENAVA BLA in June 2026 (TradingView) - "FDA granted the company’s FDR appeal, concluding substantial evidence of effectiveness for LYTENAVA in nAMD...Outlook Therapeutics expects to resubmit the ONS-5010/LYTENAVA BLA in June 2026 as a Class 1 resubmission...PDUFA decision is expected within 60 days of FDA’s receipt of the Class 1 resubmission."

FDA event • FDA filing • Age-related Macular Degeneration • Wet Age-related Macular Degeneration

NORSE SEVEN: A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders (clinicaltrials.gov) - P3 | N=120 | Active, not recruiting | Sponsor: Outlook Therapeutics, Inc. | Trial completion date: Mar 2025 ➔ Dec 2027 | Trial primary completion date: Mar 2025 ➔ Dec 2027

Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Outlook Therapeutics (OTLK) finishes FDA FDR meeting; ONS-5010 decision expected May 2026 (StockTitan.net) - "Outlook Therapeutics filed an 8-K after completing a Federal Dispute Resolution meeting with the FDA’s Office of New Drugs regarding ONS-5010/LYTENAVA, its investigational bevacizumab formulation for wet age-related macular degeneration in the United States. The company expects a formal FDA decision from this dispute process in May 2026 and plans to update the market after receiving the agency’s response."

FDA event • Wet Age-related Macular Degeneration

Outlook Therapeutics Announces Formal Dispute Resolution Request for ONS-5010/LYTENAVA (bevacizumab-vikg) Accepted by FDA (Outlook Therapeutics Press Release) - "The FDA has accepted the FDRR and has granted a meeting with the deciding official to be conducted in April 2026....The Company’s submission includes a comprehensive presentation of the existing clinical, functional, and pharmacodynamic data, and safety findings, which Outlook Therapeutics believes collectively support the efficacy and safety of ONS-5010/LYTENAVA for the treatment of neovascular age-related macular degeneration."

FDA event • Wet Age-related Macular Degeneration

Outlook Therapeutics Provides Update Following Type A Meeting with FDA Regarding ONS-5010/LYTENAVA (bevacizumab-vikg) - "The Type A meeting was conducted to clarify the outstanding issue identified in the CRL regarding substantial evidence of effectiveness and to discuss potential paths forward for regulatory approval....The Company expects to continue engaging in discussions with the FDA to further clarify the Agency’s views on confirmatory evidence and the appropriate path forward. Outlook Therapeutics is evaluating the available regulatory options to advance ONS-5010/LYTENAVA toward potential U.S. approval."

FDA event • Wet Age-related Macular Degeneration

Outlook Therapeutics Seeks FDA Clarification After Drug Rejection (AD HOC NEWS) - "The company submitted an application for a Type A Meeting with the Food and Drug Administration (FDA) yesterday. This move is a direct response to the Complete Response Letter the agency issued on December 30, 2025, which rejected the drug's application for treating wet age-related macular degeneration (wet AMD)....The primary goal of the requested meeting is to address the FDA's concerns without embarking on entirely new clinical trials."

FDA event • Wet Age-related Macular Degeneration

Repurposing biosimilars, rethinking costs: a framework for sustainable drug pricing for repurposed bevacizumab for intravitreal injections. (PubMed, Eur J Health Econ) - "While off-label bevacizumab has been standard in clinical practice for over a decade, recently, a repurposed formulation (brand name: Lytenava®, Outlook Therapeutics Ltd), developed specifically for vascular retinal conditions, received marketing approval from the European Medicines Agency...Ultimately, this approach contributes to the development of pricing strategies that balance affordability for healthcare systems with sustainable returns for manufacturers while fostering the broader development of repurposed treatments. The findings of this paper aim to advance the dialogue on equitable pricing for repurposed therapies."

Journal • Pricing • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Macular Edema • Oncology • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Outlook Therapeutics Provides Regulatory Update on U.S. Food and Drug Administration Review of ONS-5010/LYTENAVA (bevacizumab-vikg) for the Treatment of Wet AMD (GlobeNewswire) - "FDA issues Complete Response Letter (CRL) for resubmitted ONS-5010 BLA....In the CRL, the FDA noted that the additional mechanistic and natural history data information provided in the BLA resubmission does not alter the previous review conclusion that while the one adequate and well-controlled study demonstrated efficacy, the FDA has again recommended that confirmatory evidence of efficacy be submitted to support the application, however the FDA has not indicated what type of confirmatory evidence would be acceptable."

CRL • Wet Age-related Macular Degeneration

Network Meta-Analysis of Bevacizumab Gamma Versus Competing Interventions for Treating Neovascular Age-Related Macular Degeneration in the United Kingdom. (PubMed, J Mark Access Health Policy) - "The included anti-VEGF treatments were ranibizumab, aflibercept, faricimab, and bevacizumab gamma. At 12 months, all anti-VEGF treatments were similarly efficacious to ranibizumab 0.5 mg every four weeks (Q4W) in terms of CFB in BCVA, the proportion of patients gaining 15 or more letters, and the proportion of patients losing less than 15 letters (except for ranibizumab 0.5 mg every 12 weeks [Q12W] and ranibizumab 0.5 mg pro re nata [PRN]). Bevacizumab gamma provided similar improvements in visual acuity to other anti-VEGF treatments."

Journal • Retrospective data • Review • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Outlook Therapeutics Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD (GlobeNewswire) - "The FDA has advised that it considers the BLA resubmission a complete, Class 1 response to the August 27, 2025 action letter, which results in a 60 day review period from the date of resubmission. As a result, the FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of December 31, 2025. ONS-5010, if approved, will be branded as LYTENAVA (bevacizumab-vikg) for the treatment of wet AMD."

FDA filing • PDUFA • Wet Age-related Macular Degeneration

Outlook Therapeutics Re-Submits Biologics License Application for ONS-5010 (GlobeNewswire) - "ONS-5010 is an investigational ophthalmic formulation of bevacizumab which, if approved, will be branded as LYTENAVA (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD)."

FDA filing • Wet Age-related Macular Degeneration

Outlook Therapeutics Requests Type A Meeting with FDA (GlobeNewswire) - "...Type A Meeting request has been submitted to the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated August 27, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD....The requested Type A meeting seeks to clarify the details of the confirmatory evidence required by the FDA."

FDA event • Age-related Macular Degeneration

Outlook Therapeutics, Inc…announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) to its biologics license application (BLA) resubmission, indicating that the FDA cannot approve the application in its present form for the treatment of wet age-related macular degeneration (wet AMD). (The Manila Times) - "In the CRL, the FDA advised that, because ONS-5010 did not meet the primary efficacy endpoint in NORSE EIGHT, it is recommended that confirmatory evidence of efficacy be submitted to support the application for ONS-5010. Additionally, the FDA reiterated that NORSE TWO met its primary endpoint for effectiveness."

CRL • Wet Age-related Macular Degeneration

Financial Highlights for the Fiscal Third Quarter Ended June 30, 2025 (GlobeNewswire) - "For the fiscal third quarter ended June 30, 2025, Outlook Therapeutics reported net loss attributable to common stockholders of $20.2 million, or $0.55 per basic and diluted share, and $1.5 million of revenue. Revenue consisted of the initial sales into Germany and the UK for LYTENAVA where title to the product has transferred to the distributor. This compares with net loss attributable to common stockholders of $0.89 per basic and diluted share for the same period last year, and no revenue."

Sales • Wet Age-related Macular Degeneration

ONS-5010/LYTENAVA (bevacizumab-vikg) Clinical and Regulatory Update (GlobeNewswire) - "The FDA set a PDUFA goal date of August 27, 2025. ONS-5010, if approved, will be branded as LYTENAVA (bevacizumab-vikg) in the United States for the treatment of wet AMD and is expected to receive 12 years of regulatory exclusivity....The ONS-5010 BLA resubmission was based on the efficacy and safety demonstrated in NORSE EIGHT..."

PDUFA • Wet Age-related Macular Degeneration

bevacizumab gamma (Lytenava) is accepted for use within NHSScotland (Scottish Medicines Consortium) - "Indication under review: in adults for treatment of neovascular (wet) age-related macular degeneration (nAMD). Bevacizumab gamma offers an additional treatment choice in the therapeutic class of vascular endothelial growth factor inhibitors. This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower."

Reimbursement • Wet Age-related Macular Degeneration

Outlook Therapeutics Announces Commercial Launch of LYTENAVA (bevacizumab gamma) in Germany and the UK for the Treatment of Wet AMD (GlobeNewswire) - "Outlook Therapeutics, Inc...announced that LYTENAVA (bevacizumab gamma) is now commercially available in Germany and the UK for the treatment of wet age-related macular degeneration (wet AMD). LYTENAVA (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the European Union and UK."

Launch Europe • Wet Age-related Macular Degeneration

Efficacy of combined therapy with gamma knife radiosurgery and bevacizumab on survival outcomes in patients with recurrent high-grade glioma: a systematic review and meta-analysis. (PubMed, Neurosurg Rev) - "High heterogeneity was noted for overall survival (I² = 98.24%), warranting cautious interpretation. This meta-analysis suggests that while Gamma Knife combined with bevacizumab significantly prolongs progression-free survival in patients with recurrent high-grade glioma, it does not confer an overall survival advantage."

Clinical • Journal • Retrospective data • Review • Brain Cancer • Glioma • Malignant Glioma • Oncology • Solid Tumor

Outlook Therapeutics Reports Financial Results for Second Quarter Fiscal Year 2025 and Provides Corporate Update (GlobeNewswire) - "Upcoming Anticipated Milestones: (i) Initial commercial launches in Germany and the UK planned to commence in Q2 CY2025; and (ii) Potential for approval from the U.S. Food and Drug Administration (FDA) of ONS-5010 in Q3 CY2025."

FDA approval • Launch Europe • Wet Age-related Macular Degeneration

Outlook Therapeutics Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD (GlobeNewswire) - "Outlook Therapeutics...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 FDA has determined that the BLA is a Class 2 review, which results in a six-month review period from the date of resubmission. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025. ONS-5010, if approved, will be branded as LYTENAVA (bevacizumab-vikg) in the United States for the treatment of wet AMD and is expected to receive 12 years of regulatory exclusivity....The ONS-5010 BLA resubmission was based on the efficacy and safety demonstrated in NORSE EIGHT, as well as additional chemistry, manufacturing and controls (CMC) information requested by the FDA."

FDA filing • PDUFA • Wet Age-related Macular Degeneration