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OTLK Stock Crashes 54% as FDA Issues Second CRL for Eye Disease Drug
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Key Takeaways
OTLK stock dropped 54.1% after the FDA issued a second CRL for ONS-5010 in wet AMD.
The CRL cited insufficient efficacy as ONS-5010 missed the NORSE EIGHT non-inferiority endpoint.
OTLK will meet with the FDA for clarity regarding requirements.
Shares of Outlook Therapeutics (OTLK - Free Report) tumbled 54.1% after the FDA issued a second complete response letter (CRL) rejecting its biologics license application (BLA) resubmission for ONS-5010 in wet age-related macular degeneration (wet AMD).
The CRL cited a single deficiency — insufficient evidence of efficacy — highlighting that ONS-5010 failed to meet the primary efficacy endpoint in the NORSE EIGHT study, and recommending additional confirmatory data to support approval. ONS-5010 is an investigational ophthalmic formulation of bevacizumab, which is being developed to treat AMD and other retinal diseases.
Outlook Therapeutics first received a CRL from the FDA regarding the BLA for ONS-5010 in 2023. The FDA had stated concerns related to chemistry, manufacturing, and controls and open observations of the manufacturing process, which were made during pre-approval inspections and were later successfully remediated by the company.
Year to date, shares of OTLK have plummeted 42.3% against the industry’s 3.3% growth.
Image Source: Zacks Investment Research
Additionally, the regulatory body had cited that there was “a lack of substantial evidence” and asked for a second adequate and well-controlled study to be conducted, the NORSE EIGHT study. The first BLA was based on a phase III NORSE TWO study evaluating the safety and efficiency of ONS-5010 compared with ranibizumab for treating wet AMD. In the latest press release, the FDA confirmed that the NORSE TWO study met its primary endpoint for effectiveness.
The NORSE EIGHT non-inferiority study had enrolled newly diagnosed wet AMD patients, who were randomly divided equally to receive either 1.25 mg ONS-5010 or a 0.5 mg dose of Roche’s Lucentis (ranibizumab) intravitreal injections. All subjects were dosed thrice during the study period.
According to the preliminary top-line data from the NORSE EIGHT study, reported by Outlook Therapeutics in late 2024, the candidate failed to meet the pre-specified non-inferiority endpoint at week 8 outlined in the special protocol assessment with the FDA, which was agreed on after the first CRL.
Next Steps for OTLK
Following the second regulatory setback, Outlook Therapeutics plans to meet with the FDA to gain clarity on the requirements for potentially approving ONS-5010 as the first on-label bevacizumab product for intravitreal use in the United States.
The company emphasized that no other deficiencies were cited in the latest CRL and reaffirmed its commitment to offering patients an alternative to compounded Avastin. Alongside U.S. regulatory discussions, Outlook Therapeutics also intends to advance its efforts to secure approvals and expand into European markets.
Approval of OTLK’s ONS-5010/Lytenava Outside the US
ONS-5010 received regulatory approval in the EU and the United Kingdom in 2024 for the use of ONS-5010to treat wet AMD. The drug is marketed under the brand name Lytenava (bevacizumab gamma).
Outlook Therapeutics launched Lytenava in the United Kingdom and Germany in June 2025. Lytenava is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the EU and the United Kingdom. OTLK is confident that ONS-5010/Lytenava is a critical therapy for wet AMD, offering a regulated alternative to off-label repackaged Avastin (bevacizumab), which is not approved for ophthalmic use.
In the past 60 days, estimates for CorMedix’s earnings per share have increased from 93 cents to $1.22 for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.64 to $2.12. Year to date, shares of CRMD have surged 77.2%.
CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 34.85%.
In the past 60 days, estimates for Pharming Group’s 2025 loss per share have narrowed from 43 cents to 10 cents. For 2026, the estimate for PHAR’s earnings per share is currently pegged at 27 cents. PHAR stock has rallied 45% year to date.
Pharming Group’s earnings beat estimates in two of the trailing four reported quarters and missed on the remaining two occasions, delivering an average negative surprise of 39.14%.
In the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2025 earnings per share have increased from 74 cents to $1.03. Earnings per share estimates for 2026 have increased from $1.19 to $1.60 during the same period. KNSA stock has surged 69.4% year to date.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four reported quarters and missed on the remaining two occasions, delivering an average negative surprise of 330.56%.
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OTLK Stock Crashes 54% as FDA Issues Second CRL for Eye Disease Drug
Key Takeaways
Shares of Outlook Therapeutics (OTLK - Free Report) tumbled 54.1% after the FDA issued a second complete response letter (CRL) rejecting its biologics license application (BLA) resubmission for ONS-5010 in wet age-related macular degeneration (wet AMD).
The CRL cited a single deficiency — insufficient evidence of efficacy — highlighting that ONS-5010 failed to meet the primary efficacy endpoint in the NORSE EIGHT study, and recommending additional confirmatory data to support approval. ONS-5010 is an investigational ophthalmic formulation of bevacizumab, which is being developed to treat AMD and other retinal diseases.
Outlook Therapeutics first received a CRL from the FDA regarding the BLA for ONS-5010 in 2023. The FDA had stated concerns related to chemistry, manufacturing, and controls and open observations of the manufacturing process, which were made during pre-approval inspections and were later successfully remediated by the company.
Year to date, shares of OTLK have plummeted 42.3% against the industry’s 3.3% growth.
Image Source: Zacks Investment Research
Additionally, the regulatory body had cited that there was “a lack of substantial evidence” and asked for a second adequate and well-controlled study to be conducted, the NORSE EIGHT study. The first BLA was based on a phase III NORSE TWO study evaluating the safety and efficiency of ONS-5010 compared with ranibizumab for treating wet AMD. In the latest press release, the FDA confirmed that the NORSE TWO study met its primary endpoint for effectiveness.
The NORSE EIGHT non-inferiority study had enrolled newly diagnosed wet AMD patients, who were randomly divided equally to receive either 1.25 mg ONS-5010 or a 0.5 mg dose of Roche’s Lucentis (ranibizumab) intravitreal injections. All subjects were dosed thrice during the study period.
According to the preliminary top-line data from the NORSE EIGHT study, reported by Outlook Therapeutics in late 2024, the candidate failed to meet the pre-specified non-inferiority endpoint at week 8 outlined in the special protocol assessment with the FDA, which was agreed on after the first CRL.
Next Steps for OTLK
Following the second regulatory setback, Outlook Therapeutics plans to meet with the FDA to gain clarity on the requirements for potentially approving ONS-5010 as the first on-label bevacizumab product for intravitreal use in the United States.
The company emphasized that no other deficiencies were cited in the latest CRL and reaffirmed its commitment to offering patients an alternative to compounded Avastin. Alongside U.S. regulatory discussions, Outlook Therapeutics also intends to advance its efforts to secure approvals and expand into European markets.
Approval of OTLK’s ONS-5010/Lytenava Outside the US
ONS-5010 received regulatory approval in the EU and the United Kingdom in 2024 for the use of ONS-5010to treat wet AMD. The drug is marketed under the brand name Lytenava (bevacizumab gamma).
Outlook Therapeutics launched Lytenava in the United Kingdom and Germany in June 2025. Lytenava is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the EU and the United Kingdom. OTLK is confident that ONS-5010/Lytenava is a critical therapy for wet AMD, offering a regulated alternative to off-label repackaged Avastin (bevacizumab), which is not approved for ophthalmic use.
Oncobiologics, Inc. Price and Consensus
Oncobiologics, Inc. price-consensus-chart | Oncobiologics, Inc. Quote
OTLK’s Zacks Rank and Stocks to Consider
Outlook currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are CorMedix (CRMD - Free Report) , Pharming Group (PHAR - Free Report) and Kiniksa Pharmaceuticals (KNSA - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CorMedix’s earnings per share have increased from 93 cents to $1.22 for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.64 to $2.12. Year to date, shares of CRMD have surged 77.2%.
CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 34.85%.
In the past 60 days, estimates for Pharming Group’s 2025 loss per share have narrowed from 43 cents to 10 cents. For 2026, the estimate for PHAR’s earnings per share is currently pegged at 27 cents. PHAR stock has rallied 45% year to date.
Pharming Group’s earnings beat estimates in two of the trailing four reported quarters and missed on the remaining two occasions, delivering an average negative surprise of 39.14%.
In the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2025 earnings per share have increased from 74 cents to $1.03. Earnings per share estimates for 2026 have increased from $1.19 to $1.60 during the same period. KNSA stock has surged 69.4% year to date.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four reported quarters and missed on the remaining two occasions, delivering an average negative surprise of 330.56%.