Intellia's 'Lonvo-Z' Enters FDA Priority Review — Bids to Become World's First In Vivo CRISPR Therapy — BigGo Finance

Intellia Therapeutics (NTLA) secured a $400M credit facility with OrbiMed, drawing $75M initially. The remaining $325M is contingent on milestones. The facility has a 9.15% minimum interest rate. NTLA has $628.4M in cash but reported a $106.6M Q2 net loss. The financing supports potential U.S. launch of lonvo-z and other programs.

Intellia Therapeutics (NTLA) announced the FDA accepted and granted priority review to its BLA for lonvoguran ziclumeran, a CRISPR-based therapy for hereditary angioedema (HAE). A decision is expected by March 2027. The therapy showed an 87% reduction in attacks in a phase III study. NTLA shares have risen 41.7% year-to-date. The company also has another CRISPR therapy, nexiguran ziclumeran, in development with Regeneron (REGN).

Intellia Therapeutics announced FDA acceptance of its BLA for lonvo-z, a CRISPR-based therapy, with a Priority Review and PDUFA action date of March 10, 2027. The FDA does not plan to hold an advisory committee. If approved, lonvo-z would be the first in vivo CRISPR therapy, supported by Phase 3 data showing an 87% reduction in mean monthly attacks and a 62% attack-free rate.

Intellia Therapeutics (NTLA) shares rose after the FDA granted priority review for its CRISPR-based therapy lonvo-z, targeting hereditary angioedema. The company's P/S ratio is 24.91, below its historical median, suggesting market expectations of future growth. GuruFocus' GF Value™ estimates NTLA is 4.8% undervalued at $12.63 per share, with a GF Score™ of 70/100.

Intellia Therapeutics (NTLA) stock rose 4.1% in pre-market trading after the FDA accepted its Biologics License Application for lonvoguran ziclumeran and granted Priority Review. The FDA set a target action date of March 10, 2027, and indicated no advisory committee meeting is planned. The application is based on Phase 3 trial data showing an 87% reduction in monthly HAE attacks. Citizens analysts reiterated a $30.00 price target, citing significant value in the HAE opportunity.

Intellia Therapeutics (NTLA) received FDA Priority Review for lonvo-z, a CRISPR-based therapy for hereditary angioedema, with a decision expected by March 2027. The company's P/S ratio is 25.13, below its historical median of 32.3x, and its GF Value™ suggests it is 4.0% undervalued. Insider activity shows net selling, while six top gurus hold the stock, with mixed recent activity.