FDA Accepts for Review INOVIO's BLA for INO-3107 for the Treatment of Adults with Recurrent Respiratory Papillomatosis (RRP)

Rhea-AI Summary

INOVIO (NASDAQ: INO) announced the U.S. FDA accepted its Biologics License Application (BLA) for INO-3107 to treat adults with recurrent respiratory papillomatosis (RRP).

FDA assigned a PDUFA goal date of October 30, 2026 and classified the review as Standard. The FDA indicated it is not currently planning an advisory committee meeting.

The BLA was filed under the accelerated approval pathway; FDA flagged a potential review issue, preliminarily finding inadequate information to justify accelerated approval. INOVIO plans to request a meeting with FDA and continues to believe INO-3107 meets accelerated approval criteria. The BLA includes Phase 1/2 data and long-term durability results published in Nature Communications and The Laryngoscope.

Positive

• FDA accepted BLA for INO-3107 for RRP
• FDA set a PDUFA goal date of October 30, 2026
• BLA includes Phase 1/2 and long-term durability data published

Negative

• FDA preliminarily flagged inadequate information for accelerated approval eligibility
• INOVIO is not pursuing traditional approval pathway if accelerated fails

Key Figures

PDUFA goal date October 30, 2026 FDA review goal date for INO-3107 BLA

Trial phase Phase 1/2 Trial supporting INO-3107 BLA in adults with RRP

Prior surgeries Two or more surgeries Eligibility criterion in year before INO-3107 treatment

Durability follow-up Second twelve-month period Retrospective durability data without additional dosing

Share price $2.29 Pre-news price vs. BLA acceptance headline

52-week range $1.30–$2.98 Positioned 23.13% below 52-week high before news

Market cap $154,582,594 Equity value before FDA BLA acceptance announcement

Short interest 12.31% Reported short position as share of float

Market Reality Check

$1.59 Last Close

Volume Volume 538,357 is below 20-day average of 1,468,880, suggesting a muted pre-news positioning. low

Technical Shares at $2.29 were trading above the 200-day MA of $2.01 before this announcement.

Peers on Argus

Peers in Biotechnology showed mixed but mostly positive moves, with names like CYBN and PLX up around 2%, while ACTU was down, indicating this catalyst appears more stock-specific than a broad sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 19	Inducement grant	Neutral	-1.3%	Small stock option grant to a new hire under inducement plan.
Nov 18	Investor conferences	Neutral	-4.5%	Planned participation in December healthcare and rare disease conferences.
Nov 11	Offering priced	Negative	-7.0%	Underwritten equity offering priced at $1.90 with $25M gross proceeds.
Nov 10	Equity offering plan	Negative	+1.4%	Announcement of planned underwritten common stock offering under shelf.
Nov 10	Q3 2025 earnings	Negative	+1.4%	Reported net loss, cash burn, and going-concern language alongside INO-3107 update.

Pattern Detected

Recent history shows negative financing and earnings headlines often met with mixed reactions, including two instances where the stock rose on arguably negative news and one aligned selloff on offering pricing.

Recent Company History

Over the last few months, INOVIO issued several capital markets and corporate updates, including Q3 2025 results highlighting losses and going-concern language, followed by proposed and priced equity offerings in November 2025 to support INO-3107 commercialization. Conference participation and a small inducement grant rounded out news flow. Compared to those financing-driven headlines, today’s BLA acceptance for INO-3107 marks a clear regulatory milestone building on prior disclosures about the submission.

Market Pulse Summary

The stock dropped -24.4% in the session following this news. A negative reaction despite BLA acceptance could fit a pattern where investors focus on risk factors rather than milestones. The FDA’s preliminary view that information may be inadequate for accelerated approval and the company’s decision not to pursue the traditional pathway introduce regulatory uncertainty. Combined with a history of losses and recent equity offerings, some holders might reassess risk, so a sharp decline would not necessarily contradict the underlying news tenor.

Key Terms

biologics license application regulatory

"announced that the U.S. Food and Drug Administration (FDA) accepted the company's Biologics License Application"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

prescription drug user fee act regulatory

"The FDA assigned INO-3107 a Prescription Drug User Fee Act (PDUFA) review goal date"

A federal program that lets drug makers pay fees to the U.S. regulator to fund and speed up the review of new medicines and label changes. Investors care because it affects how quickly a drug can move from testing to market and how predictable approval timelines and regulatory interactions are — like buying a faster lane at a busy checkpoint that can reduce uncertainty about a product’s commercial timing.

pdufa regulatory

"Prescription Drug User Fee Act (PDUFA) review goal date of October 30, 2026"

PDUFA, short for the Prescription Drug User Fee Act, is a law that allows drug companies to pay fees to the government to speed up the review process for new medicines. This helps bring important drugs to market more quickly, which can impact their availability and pricing. For investors, PDUFA timelines can influence the timing of a drug’s approval and potential market success.

accelerated approval regulatory

"INOVIO filed its BLA under the accelerated approval pathway"

Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.

advisory committee meeting regulatory

"FDA has indicated that it is not currently planning to hold an advisory committee meeting"

A regulatory advisory committee meeting brings together independent experts to review clinical, safety, or technical data about a drug, medical device, or other regulated product and offer nonbinding recommendations to the agency that oversees approvals. Investors watch these meetings like a public review panel because the experts’ questions, concerns or endorsements can strongly influence whether a product clears regulatory hurdles, affecting a company’s future revenue and stock value.

phase 1/2 trial medical

"The BLA is supported by data from a Phase 1/2 trial evaluating INO-3107"

A phase 1/2 trial combines the earliest human safety testing with an initial look at whether a treatment works, typically starting by checking tolerability and side effects and then expanding to measure early signs of benefit and the best dose. For investors, results from these trials are an early indicator of a drug’s clinical promise and regulatory path: positive data can materially increase a company’s value and reduce development risk, while negative data can sharply lower expectations.

AI-generated analysis. Not financial advice.

PLYMOUTH MEETING, Pa., Dec. 29, 2025 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted the company's Biologics License Application (BLA) for INO-3107 for review as a potential treatment for adults with RRP. The review classification designated by FDA is Standard.

The FDA assigned INO-3107 a Prescription Drug User Fee Act (PDUFA) review goal date of October 30, 2026, which is the date by which it intends to take action on the application. The FDA has indicated that it is not currently planning to hold an advisory committee meeting to discuss this application.

INOVIO filed its BLA under the accelerated approval pathway. In the file acceptance letter, the FDA noted as a potential review issue its preliminary conclusion that the company has not submitted adequate information to justify eligibility for the accelerated approval pathway. INOVIO continues to believe that INO-3107 provides a meaningful therapeutic benefit over existing treatments and fulfills the criteria for accelerated approval. INOVIO plans to request a meeting with FDA to discuss next steps to remain eligible under the accelerated approval program. INOVIO is not currently planning to seek approval for INO-3107 under the traditional pathway.

"We believe there remains a critical unmet need among patients diagnosed with this rare and devastating disease and that every RRP patient deserves access to a non-surgical treatment option that can work for them," said Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer. "In clinical trials INO-3107 demonstrated it has the potential to expand the treatment options for RRP patients. This is based on a unique mechanism of action, clinical effectiveness and tolerability data and the simplicity of its patient centric treatment regimen, which does not require additional surgeries during the dosing window. Every surgery matters to patients and we look forward to continuing to collaborate with the FDA during the BLA review cycle."

The BLA is supported by data from a Phase 1/2 trial evaluating INO-3107 in adult patients with RRP who had two or more surgeries in the year prior to treatment. Long-term durability data from a retrospective trial of the original trial participants was also included in the BLA filing, demonstrating that the majority of evaluable patients continued to see clinical benefit in the second twelve-month period after treatment, without additional dosing. These data were published in Nature Communications and The Laryngoscope, the leading journal for otolaryngologists.

About RRP
RRP is a debilitating and rare disease caused primarily by HPV-6 and/or HPV-11. RRP is characterized by the development of small, wart-like growths, or papillomas, in the respiratory tract. While papillomas are generally benign, they can cause severe, life-threatening airway obstruction and respiratory complications. RRP can also significantly affect quality of life for patients by affecting the voice box, limiting the ability to speak effectively. Surgery to remove papillomas is the current standard of care for RRP; however, the papillomas often grow back. INOVIO's market research to date with patients and healthcare professionals indicates that a reduction of even one surgery matters, because every surgery poses a significant risk of causing permanent damage to the vocal cords and comes with potential costs to the patient, including adverse impacts to both quality of life and finances. The most widely cited U.S. epidemiology data published in 1995 estimated that there were 14,000 active cases and about 1.8 per 100,000 new cases of RRP in adults each year. 

About INO-3107
INO-3107 is an investigational DNA medicine designed to elicit an antigen-specific T cell response against both HPV-6 and HPV-11 proteins. These targeted T cells seek out and kill HPV-6 and HPV-11 infected cells, with the aim of potentially preventing or slowing the growth of new papillomas. In a Phase 1/2 trial of 32 participants (RRP-001), 72% of patients saw a 50-to-100% reduction in the number of surgeries after starting treatment with INO-3107 at the end of the first year. A retrospective study involving 28 of the original trial participants (RRP-002) showed this number increasing to 86% at the end of the second 12-month period with no additional dosing. Half of those patients required no surgeries at all. Patients in RRP-001 had a median of 4 surgeries (range: 2-8) in the year prior to dosing. At the outset of the trial (Day 0), patients had a clinically warranted procedure to have papillomas surgically removed, but any surgery performed after Day 0 was counted against the efficacy endpoint. Treatment with INO-3107 generated a strong immune response in the trial, inducing activated CD4 T cells and activated CD8 T cells with lytic potential. T cell responses were also observed at Week 52, indicating a persistent cellular memory response. INO-3107 was well tolerated, with trial participants experiencing mostly low-grade (Grade 1) treatment-emergent adverse effects such as injection site pain and fatigue. Like other DNA medicines, INO-3107 has shown the ability to generate antigen-specific T cells that is not affected by anti-vector immunity impacting immunogenicity, either before administration or after the first dose, unlike other T cell generating platforms such as viral vectors. This feature of DNA medicines is anticipated to allow INO-3107 to maintain T cell response and overall efficacy, which could make it an important therapeutic option for a majority of RRP patients.

The FDA has granted INO-3107 both Orphan Drug and Breakthrough Therapy designations. The European Commission granted INO-3107 Orphan Drug designation. In addition, INOVIO has CE-marked its CELLECTRA^® delivery device in the EU, which allows INOVIO to commercialize the device in the EU and other geographies that recognize CE-marking. The United Kingdom awarded INO-3107 the Innovation Passport. This designation serves as the entry point to the Innovative Licensing and Access Pathway (ILAP), which aims to accelerate time to market and facilitate patient access to medicines.

About INOVIO's DNA Medicines Platform
INOVIO's DNA medicines platform has two innovative components: precisely designed DNA plasmids, delivered by INOVIO's proprietary investigational medical device, CELLECTRA. INOVIO uses proprietary technology to design its DNA plasmids, which are small circular DNA molecules that work like software the body's cells can download to produce specific proteins to target and fight disease. INOVIO's proprietary CELLECTRA delivery devices are designed to optimally deliver its DNA medicines to the body's cells without requiring chemical adjuvants or lipid nanoparticles and without the risk of the anti-vector response historically seen with viral vector platforms.

About INOVIO
INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit www.inovio.com.

Forward-Looking Statements
This press release contains certain forward-looking statements relating to our business, including the FDA's acceptance of our BLA for INO-3107 with a PDUFA target action date set for October 30, 2026, the FDA's plans not to hold an advisory committee meeting to discuss the application, INOVIO's ability to access the accelerated approval pathway, as well as the potential benefits of INO-3107. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured, or commercialized, that the results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.

Contacts
Media: Jennie Willson, (267) 429-8567, communications@inovio.com
Investors: Peter Vozzo - ICR Healthcare, (443) 213-0505, investor.relations@inovio.com 

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SOURCE INOVIO Pharmaceuticals, Inc.

FAQ

What did INOVIO (INO) announce about INO-3107 on December 29, 2025?

The company said the FDA accepted its BLA for INO-3107 for adult RRP and set a PDUFA date of October 30, 2026.

What is the FDA review classification and timeline for INOVIO's INO-3107 (INO)?

FDA classified the review as Standard and assigned a PDUFA goal date of October 30, 2026.

Why might accelerated approval for INOVIO's INO-3107 be at risk?

FDA's file acceptance letter noted a preliminary conclusion that INOVIO did not submit adequate information to justify accelerated approval eligibility.

What clinical evidence supports INOVIO's BLA for INO-3107?

The BLA includes data from a Phase 1/2 trial and long-term durability results showing continued benefit in the second 12-month period; those data were published in Nature Communications and The Laryngoscope.

Will FDA hold an advisory committee meeting for INO-3107 (INO)?

The FDA indicated it is not currently planning to hold an advisory committee meeting for this application.

What are INOVIO's next steps after FDA acceptance of the INO-3107 BLA?

INOVIO plans to request a meeting with FDA to discuss next steps to preserve accelerated approval eligibility.