Jake On for Myles Miter's questions to Intellia Therapeutics Inc (NTLA) leadership • Q1 2025
Question
Jake, on behalf of Myles Miter, asked if recent leadership changes at the FDA's CBER are influencing Intellia's plans for its BLA submission timing or its commercial hiring strategy for NTLA-2002.
Answer
CEO John Leonard stated that the company has not experienced any tangible changes to its FDA interactions or program timelines. He noted that Intellia's strong relationship with the agency is evidenced by three recent RMAT designations. He believes the FDA's focus on robust clinical data from randomized, controlled trials aligns perfectly with Intellia's strategy, keeping their plans on track.