Core Viewpoint - A securities class action lawsuit has been filed against Inovio Pharmaceuticals, alleging that the company misled investors regarding the manufacturing deficiencies of its CELLECTRA device and the regulatory prospects of its INO-3107 BLA [1][2]. Group 1: Lawsuit Details - The lawsuit is filed in the United States District Court for the Eastern District of Pennsylvania on behalf of all individuals or entities who purchased Inovio securities between October 10, 2023, and December 26, 2025 [1]. - The complaint claims that Inovio failed to disclose significant issues, including deficiencies in manufacturing for the CELLECTRA device and the unlikelihood of submitting the INO-3107 BLA to the FDA by the second half of 2024 [2]. Group 2: Allegations Against Inovio - Allegations include that Inovio lacked sufficient information to justify the eligibility of the INO-3107 BLA for FDA accelerated approval or priority review, leading to overstated regulatory and commercial prospects [2]. - The public statements made by Inovio were claimed to be materially false and misleading throughout the relevant period [2]. Group 3: Investor Information - Investors who acquired shares of Inovio are encouraged to contact the law firm Gainey McKenna & Egleston before the lead plaintiff motion deadline on April 7, 2026 [3].

Core Viewpoint - A class action has been filed against Inovio Pharmaceuticals, Inc. for allegedly misleading investors regarding the approval process of its CELLECTRA device and the INO-3107 Biologics License Application (BLA) [1][2]. Group 1: Allegations and Issues - Robbins LLP is investigating claims that Inovio misled investors by failing to disclose deficiencies in the manufacturing of the CELLECTRA device, which impacted the timeline for submitting the INO-3107 BLA to the FDA [2]. - The complaint states that Inovio was unlikely to submit the INO-3107 BLA by the second half of 2024 due to these manufacturing issues and lacked sufficient information to justify eligibility for FDA accelerated approval [2]. - The overall regulatory and commercial prospects of INO-3107 were allegedly overstated by the company [2]. Group 2: Stock Price Impact - Following a press release on August 8, 2024, revealing a delay in the submission timeline for the INO-3107 BLA to mid-2025, Inovio's stock price fell by $0.27 per share, or 3.1%, closing at $8.44 on August 9, 2024 [3]. - On December 29, 2025, after announcing that the FDA accepted the INO-3107 BLA on a standard review timeline rather than an accelerated one, Inovio's stock price dropped by $0.56 per share, or 24.45%, closing at $1.73 [4]. Group 3: Class Action Participation - Shareholders may be eligible to participate in the class action against Inovio Pharmaceuticals and can contact Robbins LLP if they wish to serve as lead plaintiff [5]. - Shareholders do not need to participate in the case to be eligible for recovery and can remain absent class members if they choose [5].

Core Viewpoint - A shareholder class action lawsuit has been filed against Inovio Pharmaceuticals, alleging false and misleading statements regarding the company's business and operations, particularly concerning the CELLECTRA device and the INO-3107 Biologics License Application [1] Group 1: Allegations in the Lawsuit - The lawsuit claims that Inovio's manufacturing for the CELLECTRA device was deficient [1] - It is alleged that Inovio is unlikely to submit the INO-3107 Biologics License Application to the FDA by the second half of 2024 [1] - The company reportedly lacks sufficient information to justify the INO-3107 BLA's eligibility for FDA accelerated approval or priority review [1] - Consequently, the overall regulatory and commercial prospects of INO-3107 are claimed to be overstated [1]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Inovio Pharmaceuticals and its executives [1] Group 1: Regulatory Developments - On December 29, 2025, the FDA accepted Inovio's Biologics License Application for INO-3107, a treatment for recurrent respiratory papillomatosis, but did not find sufficient information for accelerated approval [3] - Inovio announced it will not pursue approval under the standard review timeline and plans to meet with the FDA to discuss options for accelerated approval [3] Group 2: Market Reaction - Following the FDA announcement, Inovio's stock price dropped by $0.56 per share, a decline of 24.45%, closing at $1.73 per share on December 29, 2025 [4]

Core Viewpoint - Inovio Pharmaceuticals is under investigation for potential violations of federal securities laws following the FDA's rejection of its accelerated approval request for INO-3107, leading to a significant drop in its stock price. Group 1: FDA Announcement - The FDA accepted Inovio's Biologics License Application (BLA) for INO-3107 for recurrent respiratory papillomatosis on a standard review timeline [2] - The FDA indicated that Inovio did not provide sufficient information to qualify for accelerated approval [2] - Inovio plans to request a meeting with the FDA to discuss pursuing accelerated approval despite the current standard review timeline [2] Group 2: Stock Market Reaction - Following the FDA announcement, Inovio's stock price fell over 24% on the same day [3] Group 3: Legal Investigation - Levi & Korsinsky has commenced an investigation into Inovio Pharmaceuticals regarding potential violations of federal securities laws [1] - The firm has a strong track record in securities litigation, having secured hundreds of millions of dollars for shareholders over the past 20 years [4]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices by Inovio Pharmaceuticals and its officers/directors, following a significant stock price drop after FDA news regarding its drug application [1][3][4]. Group 1: Investigation Details - Pomerantz LLP is representing investors of Inovio Pharmaceuticals, urging them to contact the firm regarding potential claims [1]. - The investigation focuses on whether Inovio and its executives have engaged in securities fraud or other unlawful practices [1]. Group 2: FDA Announcement and Stock Impact - On December 29, 2025, the FDA accepted Inovio's Biologics License Application for INO-3107 but indicated that the company did not provide sufficient information for accelerated approval [3]. - Inovio announced it would not pursue approval under the standard review timeline and plans to meet with the FDA to discuss options for accelerated approval [3]. - Following this announcement, Inovio's stock price fell by $0.56, or 24.45%, closing at $1.73 per share [4].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices by Inovio Pharmaceuticals and its officers/directors, following a significant stock price drop after FDA news regarding its drug application [1][4]. Group 1: FDA Announcement and Stock Impact - On December 29, 2025, the FDA accepted Inovio's Biologics License Application for INO-3107, a treatment for recurrent respiratory papillomatosis, but did not find sufficient information for accelerated approval [3]. - Inovio's stock price fell by $0.56, or 24.45%, closing at $1.73 per share on the same day [4]. Group 2: Legal Investigation - Pomerantz LLP is reaching out to investors of Inovio regarding claims of potential securities fraud and is encouraging them to contact the firm for further information [1].

Company Overview - Inovio Pharmaceuticals, Inc. (INO) is a biotechnology company focused on developing DNA therapeutics targeting HPV, oncology, and infectious diseases [1]. Technology and Innovation - The company utilizes CELLECTRA electroporation devices to facilitate the introduction of DNA into cells, enabling the body to produce specific proteins [1].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices by Inovio Pharmaceuticals and its executives following the FDA's rejection of the company's request for accelerated approval of its treatment INO-3107 [1][3]. Group 1: FDA Announcement - On December 29, 2025, the FDA accepted Inovio's Biologics License Application (BLA) for INO-3107, a treatment for recurrent respiratory papillomatosis, but did not find sufficient information for accelerated approval [3]. - Inovio announced it does not plan to pursue approval under the standard review timeline and intends to meet with the FDA to discuss options for accelerated approval [3]. Group 2: Stock Market Reaction - Following the FDA announcement, Inovio's stock price dropped by $0.56 per share, representing a decline of 24.45%, closing at $2.29 per share on December 29, 2025 [4].

Core Viewpoint - INOVIO's Biologics License Application (BLA) for INO-3107 has been accepted by the FDA for review as a potential treatment for adults with recurrent respiratory papillomatosis (RRP), with a standard review classification assigned [1][2] Group 1: FDA Review Process - The FDA has set a Prescription Drug User Fee Act (PDUFA) review goal date of October 30, 2026, for INO-3107, indicating when it intends to take action on the application [2] - INOVIO filed the BLA under the accelerated approval pathway, although the FDA has raised concerns about the adequacy of information submitted for this pathway [3] Group 2: Clinical Data and Efficacy - INO-3107 has shown potential therapeutic benefits in clinical trials, with 72% of patients experiencing a 50-to-100% reduction in surgeries after one year of treatment, increasing to 86% in the second year without additional dosing [6][4] - The BLA is supported by data from a Phase 1/2 trial involving adult patients with RRP who had undergone multiple surgeries prior to treatment, demonstrating long-term clinical benefits [4][6] Group 3: Disease Background and Market Need - RRP is a rare disease primarily caused by HPV-6 and HPV-11, leading to the development of benign papillomas in the respiratory tract, which can cause severe complications [5] - Current standard care involves surgical removal of papillomas, but they often regrow, highlighting the need for effective non-surgical treatment options [5] Group 4: INO-3107 and its Mechanism - INO-3107 is designed to elicit a T cell response against HPV-6 and HPV-11, potentially preventing or slowing the growth of new papillomas [6][7] - The treatment has shown a strong immune response and was well tolerated in clinical trials, with mostly low-grade adverse effects reported [6][7] Group 5: Regulatory Designations and Market Access - INO-3107 has received Orphan Drug and Breakthrough Therapy designations from the FDA, as well as Orphan Drug designation from the European Commission [8] - The CELLECTRA delivery device has been CE-marked in the EU, allowing for commercialization in regions recognizing this certification [8]