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.
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.