Altimmune Announces Successful Pre-IND Meeting with FDA
Altimmune, Inc. (ALT)
NASDAQ:AMEX Investor Relations:
altimmune.com/investors
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Source: GlobeNewswire
GAITHERSBURG, Md., June 10, 2019 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its Phase 2 trial design and manufacturing plans for HepTcell. The FDA did not object to the planned study design and patient populations, as well as plans for manufacturing and product testing, and did not recommend any additional studies in preparation for an IND submission and initiation of Phase 2 trials. A recently completed Phase 1 study in chronically infected subjects was performed in the United Kingdom and South Korea. Altimmune intends to conduct a Phase 2 study in the United States and the pre-IND meeting was held to obtain feedback from the FDA on our intended development path. “We are pleased to have completed the pre-IND meeting with the FDA and will move forward with our plans to file the IND
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Sec Filings
- 11/14/24 - Form SC
- 11/12/24 - Form 4
- 11/12/24 - Form 3
- ALT's page on the SEC website