NTLA

Price & events

Pipeline stages · 3 programs

Pipeline · 5 trials · 2 upcoming

Catalyst news & presentations · 30

• by 2028Guided 40%regulatory submissionFiled (NDA/BLA)nexiguran ziclumeran · Anticipates submitting BLA for ATTRv-PN by 2028.SEC 8-K
• by 2028Guided 40%readoutPhase 3nex-z · Complete MAGNITUDE-2 study to support BLA submissionSEC 8-K
• by 2028Guided 40%regulatory submissionFiled (NDA/BLA)nex-z · potential BLA submission supported by MAGNITUDE-2 studySEC 8-K
• early 2027Guided 55%enrollment completesecondaryPhase 3nex-z · Complete enrollment in MAGNITUDE studySEC 8-K
• first half of 2027Guided 55%readoutPhase 3lonvoguran ziclumeran · Anticipates regulatory approval and US launchSEC 8-K
• in 2026readoutPhase 3NTLA-2002 · Report topline data from Phase 3 studySEC 8-K
• second half of 2026Guided 55%regulatory submissionFiled (NDA/BLA)lonvoguran ziclumeran · Plan to complete BLA filing.SEC 8-K
• second half of 2026Guided 55%regulatory submissionFiled (NDA/BLA)NTLA-2002 · Submit BLA for NTLA-2002SEC 8-K
• in 2026readoutPhase 3nexiguran ziclumeran · Report topline data from Phase 3 studySEC 8-K
• 2026-08-06Estimated 45%earningsEarningsEarnings releaseyahoo
• first half of 2026readoutPhase 3lonvoguran ziclumeran (lonvo-z) · Expects to report outcomes of Phase 3 HAELO study.SEC 8-K
• first half of 2026enrollment completesecondaryPhase 3nexiguran ziclumeran · Expect to complete enrollment in Phase 3 MAGNITUDE-2 trial in first half 2026.SEC 8-K
• June 13, 2026readoutPhase 3lonvoguran ziclumeran · Additional positive Phase 3 HAELO results presented at EAACI and published in NEJMSEC 8-K
• April 27, 2026regulatory submissionFiled (NDA/BLA)lonvoguran ziclumeran · Initiated rolling BLA submission to FDA.SEC 8-K
• 2026-04-01rolling reviewlonvoguran ziclumeran · Initiated rolling BLA submissionSEC 8-K
• 2026-03-02fda agreementnexiguran ziclumeran · FDA lifted clinical hold after agreement on mitigation measures including enhanced liver monitoring and exclusion criteria.SEC 8-K
• in 2025readoutPhase 2NTLA-2002 · Report topline data from Phase 2 studySEC 8-K
• in 2025trial initiationsecondaryPhase 3NTLA-2002 · Initiate Phase 3 study in HAESEC 8-K
• in 2025trial initiationsecondaryPhase 3nexiguran ziclumeran · Initiate pivotal Phase 3 study in ATTR-CMSEC 8-K
• second half of 2025conferencedata presentationsecondaryPhase 1/2lonvoguran ziclumeran (lonvo-z) · New and longer-term data from Phase 2 portion of Phase 1/2 study planned for presentation.SEC 8-K
• November 10, 2025conferencedata presentationsecondaryPhase 1nexiguran ziclumeran · Positive longer-term Phase 1 data presented at AHASEC 8-K
• November 8, 2025conferencedata presentationsecondaryPhase 1/2lonvoguran ziclumeran · Positive pooled Phase 1/2 data presented at ACAAISEC 8-K
• 2025-11-05safety signalnexiguran ziclumeran · Patient death due to septic shock; Grade 4 liver transaminase elevations.SEC 8-K
• 2025-10-29clinical holdnexiguran ziclumeran · FDA placed clinical hold on Phase 3 MAGNITUDE and MAGNITUDE-2 trialsSEC 8-K
• third quarter of 2025enrollment completesecondaryPhase 3NTLA-2002 · Complete enrollment in HAELO studySEC 8-K
• September 25, 2025conferencedata presentationsecondaryPhase 1nexiguran ziclumeran · Positive longer-term Phase 1 data presented at the 5th International ATTR Amyloidosis Annual Meeting and published in NEJM.SEC 8-K
• mid-2025conferencedata presentationsecondaryPhase 2NTLA-2002 · Present additional Phase 2 data at medical conferenceSEC 8-K
• first half of 2025conferencedata presentationsecondaryPhase 2nexiguran ziclumeran · Present updated Phase 2 data at medical conferenceSEC 8-K
• first half of 2025regulatory submissionFiled (NDA/BLA)NTLA-2002 · Submit marketing applicationsSEC 8-K
• first half of 2025regulatory submissionFiled (NDA/BLA)nexiguran ziclumeran · Submit marketing applicationsSEC 8-K