(Reuters) – Shares of gene editing firm Intellia Therapeutics soared 10% in early trade on Thursday after the U.S. health regulator cleared its application to begin a mid-stage trial for its gene therapy NTLA-2002.
Analysts said the development marked a key milestone for Intellia and the broader gene editing field, as it points to U.S. Food and Drug Administration’s (FDA) increased willingness to allow trials for gene therapies.
“This is an important milestone for Intellia as it is the first-ever Investigational New Drug (IND) application cleared by the FDA for in vivo gene editing,” RBC Capital Markets analyst Luca Issi said in a note.
Intellia is testing its gene therapy NTLA-2002 as a treatment for a rare disorder called hereditary angioedema (HAE). The condition is characterized by recurring and unpredictable inflammation in various organs and impacts less than 50,000 people in the United States, according to government data.
Intellia’s therapy uses the gene-editing tool CRISPR to reduce the level and activity of the inflammation-causing gene, kallikrein B1 (KLKB1).
The FDA’s clearance removes a major overhang for Intellia, even though investors have questioned the company’s decision to file a trial application for NTLA-2002 before the application for its other therapy NTLA-2001, BMO Capital Markets analyst Kostas Biliouris said.
However, some analysts believed the NTLA-2002 application could pave the way for clearing trial application for NTLA-2001. “Today’s (Thursday) update clears the stage for NTLA-2001 IND around mid-2023,” Truist Securities analyst Joon Lee said in a note.
Intellia said it will work quickly to begin enrollment in the mid-stage portion of its study and will present early-stage data for NTLA-2002 later this year.
Shares of the Massachusetts-based company rose 10% to $44.95 in early trade.
(Reporting by Bhanvi Satija in Bengaluru; editing by Uttaresh Venkateshwaran)
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