Altimmune (ALT) - Get Report shares fell sharply after the biopharmaceutical company announced the Food and Drug Administration put a clinical hold on its Investigational new drug application for AdCOVID, a single-dose intranasal Covid-19 vaccine candidate.
The FDA wants protocol changes and more data. But Altimmune is unbowed by the action.
“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,” Altimmune said in a commentary.
“We look forward to working with the FDA and will continue preparing to commence our planned Phase 1 clinical trial of AdCOVID,” the company added.
Altimmune shares traded at $11.40, down 9.67% in premarket trading Thursday. The stock has skyrocketed 555% year to date through Wednesday amid enthusiasm about the Covid vaccine.
Just like the company, analysts weren’t too concerned about the action from the FDA. It’s “very easily addressable,” said Piper Sandler analyst Yasmeen Rahimi. The stock’s 66% drop since July 20 represents a buying opportunity, he said.
Rahimi reiterated his overweight rating and $80 price target for the stock. AdCOVID’s Phase 1 commencement is on schedule for January 2021, with topline data coming in the first quarter, he said.
Jefferies analyst Kelechi Chikere also sees the FDA hold as just a minor delay that shouldn’t prevent a release of data in the first quarter. He reiterated his buy rating on the stock and $24 price target.