Inovio Pharmaceuticals' BLA for INO-3107 Accepted by FDA, Stock Drops 24.38%
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 29 2025
0mins
Should l Buy INO?
Source: Benzinga
- FDA Acceptance: Inovio's Biologics License Application (BLA) for INO-3107 has been accepted by the FDA for review as a treatment for adults with Recurrent Respiratory Papillomatosis (RRP), although concerns regarding the accelerated approval pathway may impact future progress.
- Review Timeline: The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of October 30, 2026, marking a critical milestone in the drug development process that could affect investor confidence.
- Clinical Data Support: The BLA is backed by data from a Phase 1/2 trial involving adult RRP patients who had undergone two or more surgeries, demonstrating that most evaluable patients continued to experience clinical benefits in the 12 months post-treatment, despite FDA's concerns about eligibility for accelerated approval.
- Company Response Strategy: Inovio plans to request a meeting with the FDA to discuss next steps to maintain eligibility under the accelerated approval program, reflecting the company's confidence in the product's potential, even as its stock price fell significantly due to market reactions.
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Analyst Views on INO
Wall Street analysts forecast INO stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for INO is 7.33 USD with a low forecast of 3.00 USD and a high forecast of 13.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
3 Analyst Rating
2 Buy
1 Hold
0 Sell
Moderate Buy
Current: 1.560
Low
3.00
Averages
7.33
High
13.00
Current: 1.560
Low
3.00
Averages
7.33
High
13.00
About INO
Inovio Pharmaceuticals, Inc. is a biotechnology company focused on developing and commercializing deoxyribonucleic acid (DNA) medicines to help treat and protect people from human papillomavirus (HPV)-related diseases, cancer, and infectious diseases. Its proprietary investigational CELLECTRA devices are designed to deliver the plasmids into the body’s cells for optimal effect, without the use of chemical adjuvants, lipid nanoparticles or viral vectors. Its lead candidate is INO-3107 for the treatment of recurrent respiratory papillomatosis (RRP), a chronic, rare and debilitating disease caused by HPV-6 and HPV-11. Its DNA medicines in the pipeline include INO-3112 for the Treatment of HPV-related Oropharyngeal Squamous Cell Carcinoma, VGX-3100 for the Treatment of HPV-related Cervical HSIL, VGX-3100 for the Treatment of Anal or Perianal HSIL, INO-5401 for the Treatment of Glioblastoma Multiforme (GBM), and INO-5401 for the Prevention of Cancer for People with BRCA1/2 Mutation.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Pomerantz LLP Investigates Inovio Securities Fraud Claims
- Investigation Launched: Pomerantz LLP is investigating claims of securities fraud against Inovio Pharmaceuticals, focusing on whether the company and its executives engaged in unlawful business practices, which could lead to significant investor losses.
- FDA Review Update: On December 29, 2025, the FDA accepted Inovio's Biologics License Application for INO-3107 but indicated that the company failed to provide adequate information for accelerated approval, highlighting serious regulatory hurdles.
- Stock Price Plunge: Following the FDA announcement, Inovio's stock price fell by $0.56, a 24.45% drop, closing at $1.73 per share, reflecting market pessimism regarding the company's future prospects.
- Future Plans: Inovio announced it does not plan to seek approval under the standard review timeline but intends to meet with the FDA to discuss how to pursue accelerated approval, a strategy that may significantly impact its future market performance.
See More
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- Disposition Completed: Inovalis REIT announced the completion of the Trio property disposition, which had been reclassified as an asset held for sale in its financial statements as of September 30, 2025, and this transaction is expected to enhance financial stability.
- Loan Repayment: Proceeds from the disposition were used to repay the mortgage loan secured by the Trio property, with all related financing arrangements fully satisfied and discharged, thereby alleviating the REIT's financial burden.
- Occupancy Impact: At the time of disposition, the Trio property had an occupancy rate of approximately 40%, negatively impacting the REIT's cash flow, and this transaction is anticipated to improve overall cash flow conditions.
- LTV Reduction: The transaction reduced the REIT's overall loan-to-value (LTV) ratio by approximately 5% to 61.5%, aligning with its ongoing portfolio management strategy and reflecting a disciplined approach to asset management.
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- Securities Fraud Investigation: Pomerantz LLP is investigating whether Inovio Pharmaceuticals and its executives have engaged in securities fraud or other unlawful business practices, potentially leading to significant losses for investors.
- FDA Review Update: On December 29, 2025, the FDA accepted Inovio's Biologics License Application for INO-3107, but the company failed to provide adequate information for accelerated approval, highlighting regulatory compliance challenges.
- Stock Price Volatility: Following the FDA's review outcome, Inovio's stock price fell by $0.56, or 24.45%, closing at $1.73 per share on December 29, 2025, reflecting market pessimism about the company's future prospects.
- Uncertain Future Plans: Inovio announced it does not plan to seek approval under the standard review timeline and intends to meet with the FDA to discuss the possibility of accelerated approval, indicating uncertainty in its product launch strategy.
See More
Inovio Pharmaceuticals Faces Investigation as Stock Plummets 24.45%
- Securities Fraud Investigation: Pomerantz LLP is investigating whether Inovio Pharmaceuticals has engaged in securities fraud or other unlawful business practices, which could undermine investor confidence and lead to further declines in stock price.
- FDA Review Update: On December 29, 2025, the FDA accepted Inovio's Biologics License Application for INO-3107 but denied accelerated approval due to inadequate information, potentially delaying product launch and impacting future revenue.
- Stock Price Reaction: Following the FDA announcement, Inovio's stock price fell by $0.56, a 24.45% drop, closing at $2.29 per share, reflecting market pessimism regarding the company's outlook.
- Future Plans: Inovio announced plans to meet with the FDA to discuss pursuing accelerated approval, which, if successful, could restore market confidence in its product and improve stock performance.
See More
Inovio Pharmaceuticals Faces 24.45% Stock Drop After FDA Rejects Accelerated Approval for INO-3107
- FDA Review Outcome: On December 29, 2025, the FDA accepted Inovio's Biologics License Application but rejected its request for accelerated approval, indicating significant challenges in the company's drug development efforts.
- Stock Price Reaction: Following the FDA's rejection, Inovio's stock price fell by $0.56, or 24.45%, closing at $2.29 per share on December 29, 2025, reflecting a pessimistic market sentiment regarding the company's future prospects.
- Legal Investigation Initiated: Pomerantz LLP is investigating whether Inovio and its executives have engaged in securities fraud or other unlawful business practices, which could further damage the company's reputation and shareholder confidence.
- Uncertain Future Plans: Inovio announced it does not plan to seek approval under the standard review timeline and intends to meet with the FDA to discuss the possibility of pursuing accelerated approval, creating uncertainty that may affect investor confidence and future investment decisions.
See More
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- Stock Plunge: Ultragenyx Pharmaceutical's shares fell sharply by 42% to $19.84 on Monday, primarily due to the failure of its Phase 3 Orbit and Cosmic studies for setrusumab (UX143) in Osteogenesis Imperfecta, leading to a significant decline in market confidence.
- Clinical Trial Failure: The results from Mereo BioPharma and Ultragenyx indicated that setrusumab did not achieve statistical significance in reducing the annualized clinical fracture rate, which not only impacts the company's short-term financial performance but may also have long-term negative implications for its future R&D investments and market competitiveness.
- Severe Market Reaction: The disappointing trial results raised investor concerns about Ultragenyx's future prospects, resulting in a substantial decrease in its market capitalization, reflecting the high sensitivity of investors to the success or failure of clinical trials in the biopharmaceutical sector.
- Industry Impact: Ultragenyx's failure could have a ripple effect across the biopharmaceutical industry, particularly in the bone metabolism disease space, as investors may adopt a more cautious approach towards similar product developments, potentially affecting financing and R&D strategies of related companies.
See More
Pomerantz LLP Investigates Inovio Securities Fraud Claims
- Investigation Launched: Pomerantz LLP is investigating claims of securities fraud against Inovio Pharmaceuticals, focusing on whether the company and its executives engaged in unlawful business practices, which could lead to significant investor losses.
- FDA Review Update: On December 29, 2025, the FDA accepted Inovio's Biologics License Application for INO-3107 but indicated that the company failed to provide adequate information for accelerated approval, highlighting serious regulatory hurdles.
- Stock Price Plunge: Following the FDA announcement, Inovio's stock price fell by $0.56, a 24.45% drop, closing at $1.73 per share, reflecting market pessimism regarding the company's future prospects.
- Future Plans: Inovio announced it does not plan to seek approval under the standard review timeline but intends to meet with the FDA to discuss how to pursue accelerated approval, a strategy that may significantly impact its future market performance.
See More
Inovalis REIT Completes Disposition of Trio Property
- Disposition Completed: Inovalis REIT announced the completion of the Trio property disposition, which had been reclassified as an asset held for sale in its financial statements as of September 30, 2025, and this transaction is expected to enhance financial stability.
- Loan Repayment: Proceeds from the disposition were used to repay the mortgage loan secured by the Trio property, with all related financing arrangements fully satisfied and discharged, thereby alleviating the REIT's financial burden.
- Occupancy Impact: At the time of disposition, the Trio property had an occupancy rate of approximately 40%, negatively impacting the REIT's cash flow, and this transaction is anticipated to improve overall cash flow conditions.
- LTV Reduction: The transaction reduced the REIT's overall loan-to-value (LTV) ratio by approximately 5% to 61.5%, aligning with its ongoing portfolio management strategy and reflecting a disciplined approach to asset management.
See More
Inovio Pharmaceuticals Under Investigation, Stock Plummets 24.45%
- Securities Fraud Investigation: Pomerantz LLP is investigating whether Inovio Pharmaceuticals and its executives have engaged in securities fraud or other unlawful business practices, potentially leading to significant losses for investors.
- FDA Review Update: On December 29, 2025, the FDA accepted Inovio's Biologics License Application for INO-3107, but the company failed to provide adequate information for accelerated approval, highlighting regulatory compliance challenges.
- Stock Price Volatility: Following the FDA's review outcome, Inovio's stock price fell by $0.56, or 24.45%, closing at $1.73 per share on December 29, 2025, reflecting market pessimism about the company's future prospects.
- Uncertain Future Plans: Inovio announced it does not plan to seek approval under the standard review timeline and intends to meet with the FDA to discuss the possibility of accelerated approval, indicating uncertainty in its product launch strategy.
See More
Inovio Pharmaceuticals Faces Investigation as Stock Plummets 24.45%
- Securities Fraud Investigation: Pomerantz LLP is investigating whether Inovio Pharmaceuticals has engaged in securities fraud or other unlawful business practices, which could undermine investor confidence and lead to further declines in stock price.
- FDA Review Update: On December 29, 2025, the FDA accepted Inovio's Biologics License Application for INO-3107 but denied accelerated approval due to inadequate information, potentially delaying product launch and impacting future revenue.
- Stock Price Reaction: Following the FDA announcement, Inovio's stock price fell by $0.56, a 24.45% drop, closing at $2.29 per share, reflecting market pessimism regarding the company's outlook.
- Future Plans: Inovio announced plans to meet with the FDA to discuss pursuing accelerated approval, which, if successful, could restore market confidence in its product and improve stock performance.
See More
Inovio Pharmaceuticals Faces 24.45% Stock Drop After FDA Rejects Accelerated Approval for INO-3107
- FDA Review Outcome: On December 29, 2025, the FDA accepted Inovio's Biologics License Application but rejected its request for accelerated approval, indicating significant challenges in the company's drug development efforts.
- Stock Price Reaction: Following the FDA's rejection, Inovio's stock price fell by $0.56, or 24.45%, closing at $2.29 per share on December 29, 2025, reflecting a pessimistic market sentiment regarding the company's future prospects.
- Legal Investigation Initiated: Pomerantz LLP is investigating whether Inovio and its executives have engaged in securities fraud or other unlawful business practices, which could further damage the company's reputation and shareholder confidence.
- Uncertain Future Plans: Inovio announced it does not plan to seek approval under the standard review timeline and intends to meet with the FDA to discuss the possibility of pursuing accelerated approval, creating uncertainty that may affect investor confidence and future investment decisions.
See More
Ultragenyx Shares Plunge 42% Following Phase 3 Study Failures for Setrusumab
- Stock Plunge: Ultragenyx Pharmaceutical's shares fell sharply by 42% to $19.84 on Monday, primarily due to the failure of its Phase 3 Orbit and Cosmic studies for setrusumab (UX143) in Osteogenesis Imperfecta, leading to a significant decline in market confidence.
- Clinical Trial Failure: The results from Mereo BioPharma and Ultragenyx indicated that setrusumab did not achieve statistical significance in reducing the annualized clinical fracture rate, which not only impacts the company's short-term financial performance but may also have long-term negative implications for its future R&D investments and market competitiveness.
- Severe Market Reaction: The disappointing trial results raised investor concerns about Ultragenyx's future prospects, resulting in a substantial decrease in its market capitalization, reflecting the high sensitivity of investors to the success or failure of clinical trials in the biopharmaceutical sector.
- Industry Impact: Ultragenyx's failure could have a ripple effect across the biopharmaceutical industry, particularly in the bone metabolism disease space, as investors may adopt a more cautious approach towards similar product developments, potentially affecting financing and R&D strategies of related companies.
See More
