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Neoleukin Gets FDA Clinical Hold Letter Related To IND Of NL-201 - Quick Facts

Neoleukin Therapeutics, Inc. (NLTX) has received a clinical hold letter from the FDA related to the company's investigational new drug application to begin a phase 1 clinical program of its immunotherapeutic candidate, NL-201. The FDA has informed Neoleukin that it needs to develop a new assay. The FDA also had additional requests not related to the clinical hold to be addressed by amendment of the IND.

"We believe that we will be able to develop the requested assay and respond within the next several months," said Jonathan Drachman, CEO of Neoleukin.

Shares of Neoleukin Therapeutics were down nearly 20% in pre-market trade on Friday.

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