Inovio Pharmaceuticals' INO-3107 BLA Accepted by FDA, PDUFA Date Set for October 30, 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 29 2025
0mins
Source: NASDAQ.COM
- FDA Review Progress: Inovio's Biologics License Application (BLA) for INO-3107 has been accepted for review by the FDA, with a PDUFA date set for October 30, 2026, although the agency indicated that additional information may be required to support accelerated approval, introducing uncertainty into the regulatory timeline.
- Clinical Trial Results: In a Phase 1/2 trial for recurrent respiratory papillomatosis (RRP), 72% of patients experienced a 50-100% reduction in surgeries after treatment with INO-3107, highlighting the potential efficacy of the therapy.
- Sustained Patient Benefits: A follow-up analysis revealed that 86% of evaluable patients maintained clinical benefits in the second year without additional dosing, with half of the patients requiring no surgeries, suggesting that INO-3107 may provide long-term therapeutic effects.
- Financial Position: As of September 30, 2025, Inovio reported cash and short-term investments totaling $50.8 million, expected to fund operations into the second quarter of 2026, although the FDA's review outcome raised investor concerns, leading to a 19.21% drop in stock price.
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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: 1.530
Low
3.00
Averages
7.33
High
13.00
Current: 1.530
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.
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.
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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.
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