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Biopharmaceutical firm Neoleukin Therapeutics Inc (NASDAQ: NLTX) received a clinical hold letter from the US Food and Drug Administration (FDA) relating to its Investigational New Drug (IND) Application to begin a Phase 1 clinical trial of its immunotherapeutic candidate, NL-201 the company said on Friday.
Neoleukin shares fell over 20% on the news. They are currently sitting at the $13.88 level, down 12.04%.
A clinical hold letter is issued by the FDA to suspend or delay a clinical trial or investigation. Once Neoleukin has submitted a response to the FDA, they will then evaluate the response and decide whether to lift the hold.
The FDA told the company it needs to develop a new assay that more precisely measures the amount of protein being administered and demonstrate with this assay that dose and administration procedures will accurately deliver the intended dose of NL-201.
“We will work diligently to address the FDA’s questions as quickly as possible,” said Jonathan Drachman, CEO of Neoleukin.
“We believe that we will be able to develop the requested assay and respond within the next several months,” added Drachman.
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