Alligator Receives Positive Scientific Advice from EMA on Phase 3 Trial of Mitazalimab

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[{"type":"text","content":"LUND, SE / ACCESS Newswire / June 17, 2025 / Alligator Bioscience (STO:ATORX) - Lund, Sweden, 17 June 2025 - Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immunotherapies, today announced that the European Medicines Agency (EMA) has provided positive scientific advice supporting the overall design of the planned Phase 3 study of mitazalimab in metastatic pancreatic cancer.","length":442,"tagName":"p"},{"type":"text","content":"The advice confirms that the proposed Phase 3 study of mitazalimab in combination with mFOLFIRINOX is appropriately designed to support future marketing authorization application. The guidance confirms that the information submitted supports mitazalimab advancement to registrational trials, and Alligator is continuing preparations for trial initiation in line with regulatory input.","length":384,"tagName":"p"},{"type":"text","content":"This regulatory feedback represents another key milestone in the late-stage development of mitazalimab and complements the recently announced confirmation by the U.S. Food and Drug Administration (FDA) of the Phase 3 dose .","length":223,"tagName":"p"},{"type":"blockquote","items":[{"val":[{"type":"text","content":""We are very pleased with EMA's endorsement of our Phase 3 trial design and mitazalimab's Phase 3 readiness, confirming its path to regulatory approval in Europe," said Søren Bregenholt, CEO of Alligator Bioscience. "This advice from EMA aligns very well with previous input from FDA thus enabling a single global Phase 3 study leading to mitazalimab's potentialregistration as a new treatment for patients with metastatic pancreatic cancer in these major territories."","length":501,"tagName":"p"}]}],"isPullQuote":false,"pullquoteImage":null,"source":"","length":501},{"type":"text","content":"For further information, please contact:","length":40,"tagName":"p"},{"type":"text","content":"Søren Bregenholt, CEOE-mail: [email protected]: +46 (0) 46 540 82 00","length":98,"tagName":"p"},{"type":"text","content":"The information was submitted for publication, through the agency of the contact person set out above, at 8:45 a.m. CEST on 17 June 2025.","length":137,"tagName":"p"},{"type":"text","content":"About Alligator Bioscience","length":26,"tagName...

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