How Big Is This Setback to Altimmune’s COVID-19 Vaccine Candidate?

By Chris Lange Published Dec 24, 9:40AM EST

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How Big Is This Setback to Altimmune’s COVID-19 Vaccine Candidate? — © DDurrich / iStock via Getty Images

Altimmune Inc. (NASDAQ: ALT) shares dropped on Thursday after the company announced that it had received an update from the U.S. Food and Drug Administration (FDA) regarding its single-dose intranasal COVID-19 vaccine candidate. Obviously, with shares dropping, the news was less than stellar.

The FDA noted that it has issued a clinical hold on the company’s Investigational New Drug (IND) application for AdCOVID. The agency requested certain protocol modifications and the submission of additional Chemistry, Manufacturing and Controls (CMC) data.

Altimmune has responded to the FDA’s clinical hold letter and, currently, does not anticipate a significant impact on the overall clinical development timeline, as the company has agreed to each of the agency’s requests.

Management said that it appreciates the FDA’s support and guidance. Moreover, the firm is looking forward to working with the agency and will continue preparing to commence its planned Phase 1 clinical trial of AdCOVID.

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AdCOVID is a COVID-19 vaccine candidate that has the potential to be administered via an intranasal spray. In addition to activating systemic immunity (neutralizing antibodies and T cell responses), AdCOVID stimulates a type of localized immunity called mucosal immunity, which can act to prevent both SARS-CoV-2 virus infection and transmission.

About a month ago, Altimmune had progressed with a manufacturing agreement for its vaccine candidate. The agreement is with Lonza, which is a leading global biopharmaceutical manufacturing company with facilities in Europe, North America and South Asia.

Excluding Thursday’s move, Altimmune stock had vastly outperformed the broad markets with a gain of about 568% year to date. In the past 52 weeks, the stock was up closer to 613%.

Altimmune stock traded down more than 7% early Thursday to $11.70, in a 52-week range of $1.60 to $35.10. The consensus price target is $41.40.

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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.