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Inovio Pharma (INO) Stock Rallies 134% in a Month: Here's Why
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Inovio Pharmaceuticals (INO - Free Report) makes DNA medicines to potentially treat and prevent diseases associated with human papillomavirus (HPV), cancer and infectious ailments, using its proprietary optimized plasmid design and delivery technology.
The company’s lead candidate is INO-3107, which is currently being developed for the treatment of recurrent respiratory papillomatosis (RRP).
RRP is a rare degenerative disease that causes small growths (papillomas) in the respiratory tract. Although non-cancerous papillomas can cause severe and life-threatening airway obstruction and respiratory complications.
INO-3107 is Inovio Pharma’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.
In the past month, shares of INO have skyrocketed 134.2% compared with the industry’s 6.5% rise. The significant uptick in the stock price was observed after the company announced plans 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.
Image Source: Zacks Investment Research
Inovio Pharma held a Type B meeting where the company reached an agreement with the FDA regarding the regulatory pathway for INO-3107 under the accelerated approval program. Following the completion of the BLA submission for INO-3107 to treat RRP, the company plans to request the regulatory body for a Priority Review.
Subject to a Priority Review grant by the FDA to the impending INO-3107 BLA, the review duration of the approval-seeking application will be reduced to approximately six months from the time of the submission being accepted. In comparison, a standard review by the FDA takes approximately 10 months.
If approved, INO-3107 could become the first DNA medicine made available to RRP patients in the United States and Inovio Pharma’s first approved product.
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.
The company 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, reporting positive results therefrom. The study’s efficacy endpoint was the reduction in the number of surgical interventions in the year following the initial administration of INO-3107 compared with the year before treatment.
Based on the encouraging results from the early to mid-stage study of the candidate, the FDA had advised Inovio Pharma 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 to treat RRP before submitting the BLA for the candidate to the FDA.
Also in January 2024, the company announced a clinical collaboration and supply agreement to evaluate the combination therapy of INO-3112 and Coherus BioSciences’ (CHRS - Free Report) Loqtorzi(toripalimab-tpzi) to treat patients with locoregionally advanced, high-risk and HPV-related oropharyngeal squamous cell carcinoma (OPSCC). This is likely to have contributed to the stock price surge.
Notably, OPSCC is a type of head and neck cancer commonly known as throat cancer.
Loqtorzi, developed by Coherus BioSciences, is a PD-1 inhibitor that has been approved by the FDA for the treatment of recurrent locally advanced/metastatic nasopharyngeal carcinoma.
Both Inovio Pharma and Coherus BioSciences believe that there is a potential clinical benefit of combining INO-3112 with a PD-1 inhibitor for the treatment of HPV-related head and neck cancer.
Per the terms of the agreement, INO is tasked with conducting the phase III study of the INO-3112/Loqtorzi combo for the OPSCC indication, after reaching alignment with the FDA regarding the study design, while Coherus BioSciences will supply Loqtorzi for the study.
No financial considerations for the research agreement were disclosed.
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 month, shares of PBYI have gained 14%.
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 narrowed from 3 cents to 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 22 cents. Over the past month, shares of ADMA have gained 23.2%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
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Inovio Pharma (INO) Stock Rallies 134% in a Month: Here's Why
Inovio Pharmaceuticals (INO - Free Report) makes DNA medicines to potentially treat and prevent diseases associated with human papillomavirus (HPV), cancer and infectious ailments, using its proprietary optimized plasmid design and delivery technology.
The company’s lead candidate is INO-3107, which is currently being developed for the treatment of recurrent respiratory papillomatosis (RRP).
RRP is a rare degenerative disease that causes small growths (papillomas) in the respiratory tract. Although non-cancerous papillomas can cause severe and life-threatening airway obstruction and respiratory complications.
INO-3107 is Inovio Pharma’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.
In the past month, shares of INO have skyrocketed 134.2% compared with the industry’s 6.5% rise. The significant uptick in the stock price was observed after the company announced plans 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.
Image Source: Zacks Investment Research
Inovio Pharma held a Type B meeting where the company reached an agreement with the FDA regarding the regulatory pathway for INO-3107 under the accelerated approval program. Following the completion of the BLA submission for INO-3107 to treat RRP, the company plans to request the regulatory body for a Priority Review.
Subject to a Priority Review grant by the FDA to the impending INO-3107 BLA, the review duration of the approval-seeking application will be reduced to approximately six months from the time of the submission being accepted. In comparison, a standard review by the FDA takes approximately 10 months.
If approved, INO-3107 could become the first DNA medicine made available to RRP patients in the United States and Inovio Pharma’s first approved product.
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.
The company 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, reporting positive results therefrom. The study’s efficacy endpoint was the reduction in the number of surgical interventions in the year following the initial administration of INO-3107 compared with the year before treatment.
Based on the encouraging results from the early to mid-stage study of the candidate, the FDA had advised Inovio Pharma 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 to treat RRP before submitting the BLA for the candidate to the FDA.
Also in January 2024, the company announced a clinical collaboration and supply agreement to evaluate the combination therapy of INO-3112 and Coherus BioSciences’ (CHRS - Free Report) Loqtorzi(toripalimab-tpzi) to treat patients with locoregionally advanced, high-risk and HPV-related oropharyngeal squamous cell carcinoma (OPSCC). This is likely to have contributed to the stock price surge.
Notably, OPSCC is a type of head and neck cancer commonly known as throat cancer.
Loqtorzi, developed by Coherus BioSciences, is a PD-1 inhibitor that has been approved by the FDA for the treatment of recurrent locally advanced/metastatic nasopharyngeal carcinoma.
Both Inovio Pharma and Coherus BioSciences believe that there is a potential clinical benefit of combining INO-3112 with a PD-1 inhibitor for the treatment of HPV-related head and neck cancer.
Per the terms of the agreement, INO is tasked with conducting the phase III study of the INO-3112/Loqtorzi combo for the OPSCC indication, after reaching alignment with the FDA regarding the study design, while Coherus BioSciences will supply Loqtorzi for the study.
No financial considerations for the research agreement were disclosed.
Inovio Pharmaceuticals, Inc. Price and Consensus
Inovio Pharmaceuticals, Inc. price-consensus-chart | Inovio Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Inovio Pharma currently has a Zacks Rank #3 (Hold).
Some better-ranked drug/biotech stocks worth mentioning are Puma Biotechnology, Inc. (PBYI - Free Report) and ADMA Biologics (ADMA - 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 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 month, shares of PBYI have gained 14%.
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 narrowed from 3 cents to 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 22 cents. Over the past month, shares of ADMA have gained 23.2%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.