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Inovio (INO) Up as Lead Drug Gets Innovative Medicine Tag in UK
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Inovio Pharmaceuticals (INO - Free Report) jumped 19% on Jul 11, after it announced that its lead DNA medicine candidate, INO-3107, has received the Innovation Passport designation under the United Kingdom's Innovative Licensing and Access Pathway (ILAP). This designation was granted by the ILAP Steering Group for the treatment of recurrent respiratory papillomatosis (RRP).
RRP is a rare degenerative disease that causes small growths (papillomas) in the respiratory tract. Generally, non-cancerous papillomas can cause severe and life-threatening airway obstruction and respiratory complications.
INO-3107 is Inovio’s investigational DNA medicine candidate designed to elicit a targeted T cell response against HPV-6 and HPV-11, the HPV types that cause RRP and other HPV-related diseases. INO-3107 is designed to target and cure the infection to potentially prevent or slow down the growth of new papillomas.
The Innovation Passport is the gateway to the ILAP program, which aims to speed up market entry and improve patient access to medicines in the United Kingdom. It offers a streamlined process for regulatory approval and development milestones. Recipients gain access to various development tools and enhanced input from regulators and other stakeholders. Key benefits include a potential 150-day accelerated marketing authorization application assessment, rolling review and continuous benefit-risk assessment.
ILAP is a collaboration between the regulatory body in the United Kingdom and several other institutions. Launched in early 2021, ILAP aims to accelerate the development and accessibility of promising early-stage medicines, supporting the United Kingdom's post-Brexit strategy to attract life sciences development.
Inovio believes that the Innovation Passport designation grant further bolsters the potential of INO-3107 to “transform” the treatment paradigm for RRP patients.
Year to date, shares of INO have surged 80.3% compared with the industry’s 5.1% rise.
Image Source: Zacks Investment Research
Inovio plans to hold further discussions with theILAP partners to decide on a regulatory pathway for the approval of INO-3107 in the United Kingdom as soon as possible.
In the United States, the company is gearing up to submit a biologics license application (BLA) for INO-3107 to treat RRP in the second half of 2024, under the FDA’s accelerated approval program. Subject to approval, the company expects to commercially launch INO-3107 in 2025.
Inovio has completed a phase I/II study evaluating INO-3107's safety, tolerability, immunogenicity and efficacy in patients with HPV-6 and/or HPV-11-related RRP. The study met its efficacy endpoint. Based on the encouraging results from the early to mid-stage study of the candidate, the FDA had advised Inovio against a pivotal phase III study for INO-3107 to treat RRP, stating that the completed study has the potential to support a BLA filing under the accelerated approval program.
The company, however, plans to initiate a confirmatory study of INO-3107 for RRP before submitting the BLA to the FDA.
After completing the BLA submission for INO-3107 to treat RRP, the company plans to request the regulatory body for a Priority Review.
If approved, INO-3107 could become the first DNA medicine available to RRP patients in the United States and Inovio’s first approved product.
Please note that the investigational candidate already enjoys the FDA’s Orphan Drug and Breakthrough Therapy designations in the United States for the RRP indication. The candidate also enjoys the Orphan Drug designation in the EU for the same indication.
Apart from INO-3107, INO’s clinical pipeline has several other DNA medicine candidates, which are currently being developed for several types of cancer and infectious diseases.
In the past 30 days, the Zacks Consensus Estimate for Compugen’s 2024 earnings per share has remained constant at 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents. Year to date, shares of CGEN have lost 11.6%.
CGEN’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%.
In the past 30 days, the Zacks Consensus Estimate for Arcutis Biotherapeutics’ 2024 loss per share has remained constant at $1.60. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.14. Year to date, shares of ARQT have skyrocketed 232.2%.
Arcutis Biotherapeutics beat estimates in three of the trailing four quarters and missed once, delivering an average earnings surprise of 14.93%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.95. Year to date, shares of ANVS have plunged 29.9%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
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Inovio (INO) Up as Lead Drug Gets Innovative Medicine Tag in UK
Inovio Pharmaceuticals (INO - Free Report) jumped 19% on Jul 11, after it announced that its lead DNA medicine candidate, INO-3107, has received the Innovation Passport designation under the United Kingdom's Innovative Licensing and Access Pathway (ILAP). This designation was granted by the ILAP Steering Group for the treatment of recurrent respiratory papillomatosis (RRP).
RRP is a rare degenerative disease that causes small growths (papillomas) in the respiratory tract. Generally, non-cancerous papillomas can cause severe and life-threatening airway obstruction and respiratory complications.
INO-3107 is Inovio’s investigational DNA medicine candidate designed to elicit a targeted T cell response against HPV-6 and HPV-11, the HPV types that cause RRP and other HPV-related diseases. INO-3107 is designed to target and cure the infection to potentially prevent or slow down the growth of new papillomas.
The Innovation Passport is the gateway to the ILAP program, which aims to speed up market entry and improve patient access to medicines in the United Kingdom. It offers a streamlined process for regulatory approval and development milestones. Recipients gain access to various development tools and enhanced input from regulators and other stakeholders. Key benefits include a potential 150-day accelerated marketing authorization application assessment, rolling review and continuous benefit-risk assessment.
ILAP is a collaboration between the regulatory body in the United Kingdom and several other institutions. Launched in early 2021, ILAP aims to accelerate the development and accessibility of promising early-stage medicines, supporting the United Kingdom's post-Brexit strategy to attract life sciences development.
Inovio believes that the Innovation Passport designation grant further bolsters the potential of INO-3107 to “transform” the treatment paradigm for RRP patients.
Year to date, shares of INO have surged 80.3% compared with the industry’s 5.1% rise.
Image Source: Zacks Investment Research
Inovio plans to hold further discussions with theILAP partners to decide on a regulatory pathway for the approval of INO-3107 in the United Kingdom as soon as possible.
In the United States, the company is gearing up to submit a biologics license application (BLA) for INO-3107 to treat RRP in the second half of 2024, under the FDA’s accelerated approval program. Subject to approval, the company expects to commercially launch INO-3107 in 2025.
Inovio has completed a phase I/II study evaluating INO-3107's safety, tolerability, immunogenicity and efficacy in patients with HPV-6 and/or HPV-11-related RRP. The study met its efficacy endpoint. Based on the encouraging results from the early to mid-stage study of the candidate, the FDA had advised Inovio against a pivotal phase III study for INO-3107 to treat RRP, stating that the completed study has the potential to support a BLA filing under the accelerated approval program.
The company, however, plans to initiate a confirmatory study of INO-3107 for RRP before submitting the BLA to the FDA.
After completing the BLA submission for INO-3107 to treat RRP, the company plans to request the regulatory body for a Priority Review.
If approved, INO-3107 could become the first DNA medicine available to RRP patients in the United States and Inovio’s first approved product.
Please note that the investigational candidate already enjoys the FDA’s Orphan Drug and Breakthrough Therapy designations in the United States for the RRP indication. The candidate also enjoys the Orphan Drug designation in the EU for the same indication.
Apart from INO-3107, INO’s clinical pipeline has several other DNA medicine candidates, which are currently being developed for several types of cancer and infectious diseases.
Inovio Pharmaceuticals, Inc. Price and Consensus
Inovio Pharmaceuticals, Inc. price-consensus-chart | Inovio Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Inovio currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industryare Arcutis Biotherapeutics (ARQT - Free Report) , Annovis Bio (ANVS - Free Report) and Compugen (CGEN - Free Report) . While CGEN currently sports a Zacks Rank #1 (Strong Buy), ANVS and ARQT carry a Zacks Rank #2 (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 Compugen’s 2024 earnings per share has remained constant at 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents. Year to date, shares of CGEN have lost 11.6%.
CGEN’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%.
In the past 30 days, the Zacks Consensus Estimate for Arcutis Biotherapeutics’ 2024 loss per share has remained constant at $1.60. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.14. Year to date, shares of ARQT have skyrocketed 232.2%.
Arcutis Biotherapeutics beat estimates in three of the trailing four quarters and missed once, delivering an average earnings surprise of 14.93%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.95. Year to date, shares of ANVS have plunged 29.9%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.