Altimmune Provides an Update on its Investigational New Drug Application for a Phase 1 AdCOVID™ Clinical Trial
By Dr. Matthew Watson
GAITHERSBURG, Md., Dec. 23, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a clinical hold on the Company’s Investigational New Drug (IND) application for AdCOVID, a single-dose intranasal COVID-19 vaccine candidate. The Agency requested certain protocol modifications and the submission of additional Chemistry, Manufacturing and Controls (CMC) data. Altimmune has responded to the Agency’s clinical hold letter received on December 22, 2020 and, at this time, does not anticipate a significant impact on the overall clinical development timeline as the Company has agreed to each of the FDA’s requests.
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Altimmune Provides an Update on its Investigational New Drug Application for a Phase 1 AdCOVID™ Clinical Trial
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December 24th, 2020
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