Earnings summaries and quarterly performance for Outlook Therapeutics.
Executive leadership at Outlook Therapeutics.
Board of directors at Outlook Therapeutics.
Research analysts who have asked questions during Outlook Therapeutics earnings calls.
DT
Douglas Tsao
H.C. Wainwright & Co.
4 questions for OTLK
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DG
Daniil Gataulin
Chardan
3 questions for OTLK
Also covers: CGTX, CLSD, EYPT +3 more
EH
Eddie Hickman
Guggenheim Securities
2 questions for OTLK
Also covers: AXSM, TARS, ZVRA
TC
Timothy Chiang
Capital One
2 questions for OTLK
Also covers: AKYA, IRWD, ISR
BK
Brian Kemp Dolliver
Brookline Capital Markets, LLC
1 question for OTLK
Also covers: , BIOX, DARE +6 more
EW
Edward Woo
Ascendiant Capital Markets
1 question for OTLK
Also covers: AIM, AMTX, ATOS +17 more
Kemp Dolliver
Brookline Capital Markets
1 question for OTLK
Also covers: BIOX, EYEN, ICCM +4 more
Will Hidell
Brookline Capital Markets
1 question for OTLK
Also covers: DARE, IMNN, LSTA
Recent press releases and 8-K filings for OTLK.
Outlook Therapeutics Receives FDA Complete Response Letter for ONS-5010/LYTENAVA™ BLA
OTLK
Regulatory Update
Product Launch
- Outlook Therapeutics, Inc. announced on December 31, 2025, that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the resubmitted Biologics License Application (BLA) for ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).
- The FDA indicated that it cannot approve the application in its present form and recommended that confirmatory evidence of efficacy be submitted to support the application.
- Outlook Therapeutics disagrees with the FDA's decision but remains committed to taking all necessary steps to receive approval in the United States.
- LYTENAVA™ (bevacizumab gamma) was granted Marketing Authorization by the European Commission in the EU and by the MHRA in the UK for wet AMD, and became commercially available in Germany and the UK in June 2025.
Jan 2, 2026, 12:30 PM
Outlook Therapeutics Receives FDA Complete Response Letter for ONS-5010/LYTENAVA™ BLA Resubmission
OTLK
Product Launch
- The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for Outlook Therapeutics' ONS-5010/LYTENAVA™ (bevacizumab-vikg) Biologics License Application (BLA) resubmission for the treatment of wet age-related macular degeneration (wet AMD), indicating the application cannot be approved in its present form.
- The FDA recommended confirmatory evidence of efficacy but did not specify the type of evidence that would be acceptable.
- Outlook Therapeutics disagrees with the FDA's decision but remains committed to taking all necessary steps to receive U.S. approval for ONS-5010/LYTENAVA™.
- LYTENAVA™ (bevacizumab gamma) has already been granted Marketing Authorization by the European Commission in the EU and by the MHRA in the UK for wet AMD, and became commercially available in Germany and the UK in June 2025.
Dec 31, 2025, 9:15 PM
Outlook Therapeutics Reports Fiscal Year 2025 Financial Results
OTLK
Earnings
Product Launch
New Projects/Investments
- For the fiscal year ended September 30, 2025, Outlook Therapeutics reported a net loss of $62.4 million and revenue of $1.4 million, compared to a net loss of $75.4 million and no revenue in the prior fiscal year.
- The company's net loss per basic and diluted share was $1.79 for FY 2025, an improvement from $4.06 per share in FY 2024.
- Revenue in fiscal year 2025 was generated from initial sales of LYTENAVA™ in Germany and the UK, which commenced in June 2025.
- As of September 30, 2025, cash and cash equivalents totaled $8.1 million, which does not include an additional $14.9 million of net proceeds from sales under its at-the-market offering program after that date.
- A significant near-term milestone is the U.S. Food and Drug Administration (FDA) PDUFA goal date for ONS-5010 on December 31, 2025.
Dec 19, 2025, 1:30 PM
Outlook Therapeutics Reports Fiscal Year 2025 Financial Results and Business Updates
OTLK
Earnings
Product Launch
New Projects/Investments
- Outlook Therapeutics reported a net loss of $62.4 million, or $1.79 per basic and diluted share, for fiscal year 2025, an improvement from a $75.4 million net loss, or $4.06 per basic and diluted share, in fiscal year 2024.
- The company generated $1.4 million in revenue in fiscal year 2025 from initial sales of LYTENAVA™ in Germany and the UK, marking its first revenue compared to no revenue in the prior year.
- Overall expenses in fiscal year 2025 were $4.6 million lower than fiscal year 2024, primarily due to a significant reduction in R&D expenses following the completion of the NORSE Eight clinical trial.
- As of September 30, 2025, Outlook Therapeutics had $8.1 million in cash and cash equivalents, which does not include an additional $14.9 million in net proceeds from sales under its at-the-market offering program after that date.
- The company is awaiting a decision from the FDA for ONS-5010 with a PDUFA goal date of December 31, 2025, and is continuing commercial launch activities for LYTENAVA™ in Europe.
Dec 19, 2025, 1:05 PM
Zealand Pharma Announces Collaboration with OTR Therapeutics
OTLK
New Projects/Investments
M&A
- Zealand Pharma and OTR Therapeutics have entered a multi-program strategic collaboration and license agreement to discover and develop novel therapeutics for metabolic diseases.
- OTR Therapeutics will receive an initial upfront payment of USD 20 million, which may increase to USD 30 million under certain pre-agreed conditions.
- The agreement includes potential preclinical, development, regulatory, and commercial milestone payments for OTR Therapeutics, totaling up to USD ~2.5 billion, with the majority representing commercial milestones, plus tiered single-digit royalties on worldwide net sales.
- OTR Therapeutics will lead research and preclinical development, while Zealand Pharma will be responsible for clinical development, regulatory submissions, and global commercialization.
Dec 11, 2025, 6:00 AM
Outlook Therapeutics Discusses Regulatory Path and Commercial Strategy for Ophthalmic Bevacizumab
OTLK
Product Launch
Regulatory Approval
New Projects/Investments
- Outlook Therapeutics is awaiting a PDUFA decision for its ophthalmic bevacizumab following a Complete Response Letter (CRL) and subsequent resubmission, with the FDA's concerns primarily focused on the NORSE EIGHT trial's missed eight-week endpoint.
- The company clarified that the CRL did not involve manufacturing or CMC issues, and the resubmission led to a Class 1 review and a PDUFA before year-end.
- In the U.S., Outlook Therapeutics targets the significant market currently using compounded bevacizumab, which accounts for approximately 3 million annual injections and 44% of anti-VEGF claims, by offering the first and only FDA-approved bevacizumab for wet AMD.
- The company has initiated commercialization in Europe, with approval in the U.K. in late December 2024 and commercial launch in mid-summer; Germany, representing almost 50% of Europe's bevacizumab market, has achieved 77% market access.
- Outlook Therapeutics anticipates its product pricing to be competitive, positioned around biosimilar pricing, aiming to provide an affordable, FDA-approved alternative.
Dec 2, 2025, 3:00 PM
Outlook Therapeutics Provides Update on Regulatory Status and Commercial Strategy for Ophthalmic Bevacizumab
OTLK
Product Launch
New Projects/Investments
Guidance Update
- Outlook Therapeutics is awaiting a PDUFA decision for its ophthalmic form of bevacizumab, Lytenava, following a recent resubmission after addressing a Complete Response Letter (CRL) related to the NORSE 1 trial's missed 8-week endpoint. The FDA confirmed no manufacturing or CMC-related issues.
- The company aims to capture a significant portion of the roughly 3 million annual compounded anti-VEGF injections in the US, positioning Lytenava as the first and only FDA-approved bevacizumab for wet AMD.
- Commercialization efforts in Europe began mid-summer 2025, with the product approved in the U.K. and Germany in late December 2024. Germany, a major bevacizumab market, has achieved 77% market access for Signalens.
- Outlook Therapeutics plans to build a US commercial team of 30 to 50 people, focusing on sales, medical science liaisons (MSLs), and market access, with pricing expected to be around biosimilar levels.
Dec 2, 2025, 3:00 PM
Outlook Therapeutics Provides Update on Ophthalmic Bevacizumab Regulatory Status and Commercial Plans
OTLK
Product Launch
New Projects/Investments
- Outlook Therapeutics received a Complete Response Letter (CRL) in late August 2025 for its ophthalmic bevacizumab (Lytenava) due to the NORSE 1 trial missing its eight-week endpoint, but has since resubmitted following a Type A meeting with the FDA. The PDUFA date is expected before the end of 2025.
- The company aims to capture a share of the ~3 million annual injections of compounded anti-VEGF treatments in the US, positioning its FDA-approved bevacizumab as a high-quality alternative to current compounded options, which represent 44% of anti-VEGF claims.
- Outlook Therapeutics plans to price its product around biosimilar levels and build a US commercial team of 30-50 individuals to focus on market access and reimbursement.
- In Europe, the product was approved in the U.K. in late December 2024 and commercialization began in mid-2025. In Germany, the company has secured approximately 77% market access for Signalens, with Germany historically accounting for almost 50% of the European bevacizumab market.
Dec 2, 2025, 3:00 PM
Outlook Therapeutics Announces FDA Acceptance of ONS-5010 BLA Resubmission
OTLK
Product Launch
New Projects/Investments
- Outlook Therapeutics announced the FDA accepted the resubmission of the Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).
- The FDA considers the BLA resubmission a complete, Class 1 response, and has set a Prescription Drug User Fee Act (PDUFA) goal date of December 31, 2025.
- If approved in the United States, ONS-5010 will be branded as LYTENAVA™ (bevacizumab-vikg).
- LYTENAVA™ (bevacizumab gamma) has already received Marketing Authorization in the EU and UK for wet AMD, with commercial launch commenced in Germany and the UK.
Nov 13, 2025, 1:30 PM
Outlook Therapeutics Re-Submits BLA for ONS-5010
OTLK
Product Launch
New Projects/Investments
- Outlook Therapeutics, Inc. re-submitted its Biologics License Application (BLA) for ONS-5010 to the U.S. Food and Drug Administration (FDA) on November 3, 2025.
- ONS-5010 is an investigational ophthalmic formulation of bevacizumab, intended to be branded as LYTENAVA™ (bevacizumab-vikg), for the treatment of wet age-related macular degeneration (wet AMD).
- The company believes this resubmission will resolve the outstanding issue highlighted in the Complete Response Letter (CRL) received in August 2025, following a Type A meeting with the FDA in September 2025.
- Outlook Therapeutics is accelerating commercial efforts in Europe for LYTENAVA™ (bevacizumab gamma), which has already received Marketing Authorization in the EU and UK for wet AMD, with commercial launch commenced in Germany and the UK.
Nov 3, 2025, 10:01 PM
Quarterly earnings call transcripts for Outlook Therapeutics.
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