We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Outlook (OTLK) Surges 31% on Regulatory Update for AMD Study
Read MoreHide Full Article
Outlook Therapeutics, Inc. (OTLK - Free Report) announced that it has reached alignment with the FDA regarding the next steps to advance the developmental program of its clinical-stage pipeline candidate, ONS-5010 (Lytenava), to treat patients with neovascular age-related macular degeneration (AMD).
The FDA has provided the company with a written agreement under a Special Protocol Assessment (SPA), after a thorough review of the study protocol, to begin a 90-day non-inferiority NORSE EIGHT clinical study evaluating ONS-5010 for AMD.
ONS-5010 is an investigational ophthalmic formulation of bevacizumab, which is being developed to treat AMD and other retinal diseases.
The company expects to share positive top-line results from the NORSE EIGHT study, followed by the resubmission of the biologics new drug application (BLA) for ONS-5010 by the end of 2024.
We remind the investors that in August 2023, Outlook received a complete response letter (CRL) from the FDA regarding the BLA for ONS-5010.
The FDA stated concerns related to chemistry, manufacturing and controls and open observations of the manufacturing process, which were made during pre-approval inspections. 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 first BLA was based on a phase III NORSE TWO study evaluating the safety and efficiency of ONS-5010 compared with ranibizumab (Lucentis) for treating wet AMD.
According to the latest agreement with the FDA under SPA, if the impending NORSE EIGHT study of ONS-5010 for AMD is successful, it would satisfy the regulatory body’s requirements, thereby fully addressing the clinical deficiency identified in the CRL.
The planned NORSE EIGHT non-inferiority study is expected to enroll approximately 400 newly diagnosed wet AMD patients, who will be divided equally to receive either 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections. All subjects will be dosed thrice during the study period.
The primary endpoint of the study will be the mean change in best-corrected visual acuityfrom baseline to week eight.
OTLK further announced that it has entered into a securities purchase agreement with top-tier institutional investors for up to $172 million in gross proceeds (common stock and exercise of warrants subject to closing conditions) to fund the clinical program of ONS-5010through potential FDA approval and launch.
Shares of Outlook swiftly surged 30.5% on Jan 23, in response to the encouraging news. The stock continued to gain another 5.9% in the after-market hours. In the past year, shares of OTLK plunged 60% compared with the industry’s 14.1% fall.
Image Source: Zacks Investment Research
There are currently no FDA-approved drugs for the ophthalmic formulation of bevacizumab to treat wet AMD. This provides the company a significant opportunity to capture the $9.5 billion ophthalmic anti-VEGF market in the United States, contingent upon the successful development and commercialization of ONS-5010 for neovascular AMD.
In the press release, Outlook also stated that it has figured out the approaches needed to resolve the chemistry, manufacturing and controls comments in the CRL through additional dialogues with the FDA.
The company is currently working to address the open items and expects to resolve these comments before the expected completion of the NORSE EIGHT study of ONS-5010 for AMD.
An approved drug in the market for wet AMD is Regeneron’s (REGN - Free Report) Eylea (aflibercept). Notably, Eylea is one of the key growth drivers for REGN. The drug is also approved for the treatment of diabetic macular edema, macular edema and diabetic retinopathy in the United States. The FDA recently approved REGN’s Eylea to treat preterm infants with retinopathy of prematurity as well.
However, Regeneron’s Eylea sales declined in 2023 due to competitive pressure from other large players in the eye diseases market. The sub-par performance of the product will hurt the stock as Eylea is Regeneron’s key growth driver. Competitors are also developing eye-drop formulations, oral therapies and gene/cell therapies for various indications that, if approved, may weigh on Eylea sales in the future.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has increased from 72 cents to 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 64 cents to 69 cents. Over the past year, shares of PBYI have gained 9.2%.
PBYI beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has remained constant at 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 22 cents. Over the past year, shares of ADMA have rallied 47.2%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Outlook (OTLK) Surges 31% on Regulatory Update for AMD Study
Outlook Therapeutics, Inc. (OTLK - Free Report) announced that it has reached alignment with the FDA regarding the next steps to advance the developmental program of its clinical-stage pipeline candidate, ONS-5010 (Lytenava), to treat patients with neovascular age-related macular degeneration (AMD).
The FDA has provided the company with a written agreement under a Special Protocol Assessment (SPA), after a thorough review of the study protocol, to begin a 90-day non-inferiority NORSE EIGHT clinical study evaluating ONS-5010 for AMD.
ONS-5010 is an investigational ophthalmic formulation of bevacizumab, which is being developed to treat AMD and other retinal diseases.
The company expects to share positive top-line results from the NORSE EIGHT study, followed by the resubmission of the biologics new drug application (BLA) for ONS-5010 by the end of 2024.
We remind the investors that in August 2023, Outlook received a complete response letter (CRL) from the FDA regarding the BLA for ONS-5010.
The FDA stated concerns related to chemistry, manufacturing and controls and open observations of the manufacturing process, which were made during pre-approval inspections. 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 first BLA was based on a phase III NORSE TWO study evaluating the safety and efficiency of ONS-5010 compared with ranibizumab (Lucentis) for treating wet AMD.
According to the latest agreement with the FDA under SPA, if the impending NORSE EIGHT study of ONS-5010 for AMD is successful, it would satisfy the regulatory body’s requirements, thereby fully addressing the clinical deficiency identified in the CRL.
The planned NORSE EIGHT non-inferiority study is expected to enroll approximately 400 newly diagnosed wet AMD patients, who will be divided equally to receive either 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections. All subjects will be dosed thrice during the study period.
The primary endpoint of the study will be the mean change in best-corrected visual acuityfrom baseline to week eight.
OTLK further announced that it has entered into a securities purchase agreement with top-tier institutional investors for up to $172 million in gross proceeds (common stock and exercise of warrants subject to closing conditions) to fund the clinical program of ONS-5010through potential FDA approval and launch.
Shares of Outlook swiftly surged 30.5% on Jan 23, in response to the encouraging news. The stock continued to gain another 5.9% in the after-market hours. In the past year, shares of OTLK plunged 60% compared with the industry’s 14.1% fall.
Image Source: Zacks Investment Research
There are currently no FDA-approved drugs for the ophthalmic formulation of bevacizumab to treat wet AMD. This provides the company a significant opportunity to capture the $9.5 billion ophthalmic anti-VEGF market in the United States, contingent upon the successful development and commercialization of ONS-5010 for neovascular AMD.
In the press release, Outlook also stated that it has figured out the approaches needed to resolve the chemistry, manufacturing and controls comments in the CRL through additional dialogues with the FDA.
The company is currently working to address the open items and expects to resolve these comments before the expected completion of the NORSE EIGHT study of ONS-5010 for AMD.
An approved drug in the market for wet AMD is Regeneron’s (REGN - Free Report) Eylea (aflibercept). Notably, Eylea is one of the key growth drivers for REGN. The drug is also approved for the treatment of diabetic macular edema, macular edema and diabetic retinopathy in the United States. The FDA recently approved REGN’s Eylea to treat preterm infants with retinopathy of prematurity as well.
However, Regeneron’s Eylea sales declined in 2023 due to competitive pressure from other large players in the eye diseases market. The sub-par performance of the product will hurt the stock as Eylea is Regeneron’s key growth driver. Competitors are also developing eye-drop formulations, oral therapies and gene/cell therapies for various indications that, if approved, may weigh on Eylea sales in the future.
Zacks Rank and Stocks to Consider
Outlook currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the same industry worth mentioning are Puma Biotechnology, Inc. (PBYI - Free Report) and ADMA Biologics (ADMA - Free Report) , sporting a Zacks Rank #1 (Strong Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has increased from 72 cents to 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 64 cents to 69 cents. Over the past year, shares of PBYI have gained 9.2%.
PBYI beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has remained constant at 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 22 cents. Over the past year, shares of ADMA have rallied 47.2%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.