Levi & Korsinsky, LLP: FDA Accelerated Approval Eligibility Challenged in Inovio Pharmaceuticals Securities Action

Time-Sensitive: Allegations Focus on Accelerated Approval and Priority Review Representations

"Investors deserve transparency about material risks that could affect their investments," stated Joseph E. Levi, Esq., managing partner of Levi & Korsinsky, LLP. "The adequacy of regulatory pathway disclosures is a fundamental issue for biotechnology investors."

INO INVESTOR ALERT

NEW YORK, March 02, 2026 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP alerts investors in Inovio Pharmaceuticals, Inc. (NASDAQ: INO) of a pending securities class action. The Court has set April 7, 2026 as the deadline to apply for lead plaintiff appointment.

• Class Period: October 10, 2023 through December 26, 2025
Submit your information to join this case or contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com | (212) 363-7500.

The Alleged FDA Regulatory Pathway Misrepresentations

The lawsuit asserts that management repeatedly touted Inovio's prospects for FDA accelerated approval and priority review for its lead product candidate's Biologics License Application. As alleged, Defendants indicated to investors that the Company was rapidly approaching its transition into a commercial-stage company with a product that would fill an unmet medical need.

What Management Allegedly Knew

The action claims that Defendants had insufficient information to justify the BLA's eligibility for FDA accelerated approval or priority review. Despite this, as alleged, management assured investors they had an "established path to BLA submission under the FDA's accelerated approval program."

Regulatory Trends in Biotechnology FDA Submissions

• Under FDA accelerated approval, drugs for serious conditions may be approved based on surrogate endpoints rather than clinical benefit measures
• Priority review designation targets FDA action within six months versus the standard ten-month timeline
• The action claims eligibility for these pathways requires demonstrating that the drug fills an unmet medical need or significantly improves treatment safety/effectiveness
• As alleged, the Company's BLA was ultimately accepted for standard review rather than accelerated review
• The FDA allegedly indicated the Company did not submit adequate information to justify accelerated approval eligibility

Why Accelerated Approval Eligibility Allegedly Matters to Investors

The commercial implications of accelerated approval were significant. The lawsuit asserts that this prospect formed a core part of the Company's overall investment thesis, and Defendants highlighted it throughout the Class Period. When the FDA accepted the BLA on a standard rather than accelerated timeline, the market allegedly reacted negatively.

Speak with an attorney about your options or contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com | (212) 363-7500.

WHY LEVI & KORSINSKY

Ranked in ISS Securities Class Action Services' Top 50 Report for seven consecutive years, Levi & Korsinsky, LLP is a nationally recognized leader in shareholder rights litigation. With a team of over 70 professionals, the firm has recovered hundreds of millions of dollars for investors across the country.

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