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Outlook's (OTLK) Shares Decline on CRL for Wet AMD Candidate
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Outlook Therapeutics’ (OTLK - Free Report) shares nosedived more than 80% on Aug 30, after receiving a complete response letter (CRL) from the FDA regarding the biologics new drug application (BLA) for Lytenava (ONS-5010).
ONS-5010 is an investigational ophthalmic formulation of bevacizumab being developed for the treatment of wet age-related macular degeneration (AMD) and other retinal diseases.
The FDA stated concerns related to Chemistry, Manufacturing, and Controls and open observations of the manufacturing process made during pre-approval inspections. Additional FDA cited that there was “a lack of substantial evidence”.
The BLA was based on a phase III NORSE TWO study, evaluating safety and efficiency of ONS-5010 compared to ranibizumab (Lucentis) for treating wet AMD.
We note that the NORSE TWO study met its primary and second endpoints, thereby confirming the safety and effectiveness of ONS-5010 for treating wet AMD.
In light of these circumstances, Outlook intends to engage in discussions with the FDA to gain a comprehensive understanding of the specific deficiencies in the BLA and work collaboratively with the FDA on finding the best path forward for resolution.
Shares of Outlook have lost 75.1% year to date compared with the industry’s 11.8% decline.
Image Source: Zacks Investment Research
There are currently no FDA- approved drug for ophthalmic formulation of bevacizumab to treat wet AMD. Also, as OTLK currently has no marketed drug in its portfolio, the approval of ONS-5010 would be a huge boost for the company.
A regulatory application seeking approval of ONS-5010 for the same indication as in the United States is currently under review in Europe. A decision regarding the same from the European Medicines Agency is expected in early 2024.
An approved drug in the market for wet AMD is Regeneron’s (REGN - Free Report) Eylea (aflibercept). Eylea is one of the key growth drivers for Regeneron. The drug is also approved for the treatment of diabetic macular edema (DME) and macular edema in the United States.
In the past 90 days, the Zacks Consensus Estimate forANI Pharmaceuticals’ earnings has gone up from $3.31 per share to $3.73 for 2023. The bottom-line estimate has increased from $4.32 to $4.35 for 2024 during the same time frame. Shares of the company have rallied 60.6% year to date.
ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 91.56%.
In the past 90 days, the Zacks Consensus Estimate for Annovis Bio has narrowed from a loss of $4.89 per share to a loss of $4.38 for 2023. The bottom-line estimate has narrowed from a loss of $3.18 to $2.77 for 2024 during the same time frame. Shares of the company have lost 7.9% year to date.
ANVS’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 13.40%.
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Outlook's (OTLK) Shares Decline on CRL for Wet AMD Candidate
Outlook Therapeutics’ (OTLK - Free Report) shares nosedived more than 80% on Aug 30, after receiving a complete response letter (CRL) from the FDA regarding the biologics new drug application (BLA) for Lytenava (ONS-5010).
ONS-5010 is an investigational ophthalmic formulation of bevacizumab being developed for the treatment of wet age-related macular degeneration (AMD) and other retinal diseases.
The FDA stated concerns related to Chemistry, Manufacturing, and Controls and open observations of the manufacturing process made during pre-approval inspections. Additional FDA cited that there was “a lack of substantial evidence”.
The BLA was based on a phase III NORSE TWO study, evaluating safety and efficiency of ONS-5010 compared to ranibizumab (Lucentis) for treating wet AMD.
We note that the NORSE TWO study met its primary and second endpoints, thereby confirming the safety and effectiveness of ONS-5010 for treating wet AMD.
In light of these circumstances, Outlook intends to engage in discussions with the FDA to gain a comprehensive understanding of the specific deficiencies in the BLA and work collaboratively with the FDA on finding the best path forward for resolution.
Shares of Outlook have lost 75.1% year to date compared with the industry’s 11.8% decline.
Image Source: Zacks Investment Research
There are currently no FDA- approved drug for ophthalmic formulation of bevacizumab to treat wet AMD. Also, as OTLK currently has no marketed drug in its portfolio, the approval of ONS-5010 would be a huge boost for the company.
A regulatory application seeking approval of ONS-5010 for the same indication as in the United States is currently under review in Europe. A decision regarding the same from the European Medicines Agency is expected in early 2024.
An approved drug in the market for wet AMD is Regeneron’s (REGN - Free Report) Eylea (aflibercept). Eylea is one of the key growth drivers for Regeneron. The drug is also approved for the treatment of diabetic macular edema (DME) and macular edema in the United States.
Zacks Rank & Stocks to Consider
Outlook currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the same industry are ANI Pharmaceuticals (ANIP - Free Report) and Annovis Bio (ANVS - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate forANI Pharmaceuticals’ earnings has gone up from $3.31 per share to $3.73 for 2023. The bottom-line estimate has increased from $4.32 to $4.35 for 2024 during the same time frame. Shares of the company have rallied 60.6% year to date.
ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 91.56%.
In the past 90 days, the Zacks Consensus Estimate for Annovis Bio has narrowed from a loss of $4.89 per share to a loss of $4.38 for 2023. The bottom-line estimate has narrowed from a loss of $3.18 to $2.77 for 2024 during the same time frame. Shares of the company have lost 7.9% year to date.
ANVS’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 13.40%.