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GeoVax Receives Formal EMA Scientific Advice Supporting Pivotal Phase 3 Immunobridging Trial for GEO-MVA
EMA Concurrence Enables Acceleration Toward Phase 3 Initiation and Represents a Major Milestone on GeoVax's Path to Commercialization ATLANTA, GA - December 18, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology co...
About this update from Geovax Labs, Inc.
[{"type":"image","caption":"","headline":"GeoVax Highlights 2026 as a Pivotal Year for Progress","size":{"original":{"width":140,"height":140,"url":"https://media.zenfs.com/en/newsmediawire_165/6b870301b9c37c9b2d12fc8f9b2a2ecc"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/CK3y_RQaAtNDQGf8lPQXOQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTIxMDtoPTIxMDtjZj13ZWJw/https://media.zenfs.com/en/newsmediawire_165/6b870301b9c37c9b2d12fc8f9b2a2ecc","width":140,"height":140}}},{"type":"text","content":"EMA Concurrence Enables Acceleration Toward Phase 3 Initiation and Represents a Major Milestone on GeoVax's Path to Commercialization","length":137,"tagName":"p"},{"type":"text","content":"ATLANTA, GA - December 18, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today announced that it has received formal Scientific Advice (SA) from the European Medicines Agency (EMA) confirming regulatory alignment on the Company's proposed pivotal Phase 3 immunobridging trial design for GEO-MVA, its Modified Vaccinia Ankara (MVA)-based vaccine candidate for the prevention of Mpox and smallpox.","length":524,"tagName":"p"},{"type":"text","content":"The EMA's feedback concurs with GeoVax's proposed strategy to evaluate GEO-MVA through a single, pivotal Phase 3 immuno-bridging study versus the approved MVA vaccine, Imvanex(R), and supports the Company's plan to proceed directly into this trial without the need for additional Phase 1 or Phase 2 clinical studies. Receipt of this formal Scientific Advice represents a significant regulatory milestone and enables GeoVax to accelerate operational planning toward implementation and initiation of the Phase 3 program, currently projected to begin in the second half of 2026.","length":587,"tagName":"p"},{"type":"text","content":""This formal Scientific Advice from EMA represents a pivotal step forward for GEO-MVA and meaningfully de-risks our regulatory path in Europe," said David Dodd, Chairman and Chief Executive Officer of GeoVax. "EMA's concurrence positions GeoVax to move efficiently toward a single, registrational Phase 3 study. This is a major milestone on our path toward commercialization."","length":400,"tagName":"p"},{"type":"text","content":"The Scientific Advice confirms that n...