Yeji
FDA approvalconf 0.85

nexiguran ziclumeran — FDA approval

$NTLA · Intellia Therapeutics, Inc. · Neuromuscular Disease
Event date
March 2, 2026
96 days ago
Sponsor runway
10 mo
$376.0M liquid

Evidence

“On March 2, 2026, Intellia announced that the U.S. Food and Drug Administration ("FDA") has removed the clinical hold on the investigational new drug application ("IND") for the MAGNITUDE Phase 3 clinical trial of nexiguran ziclumeran ("nex-z") for patients with transthyretin ("ATTR") amyloidosis with cardiomyopathy ("ATTR-CM").”
Source: 8-K filed 2026-03-02View on EDGAR ↗0001193125-26-084309

Comparable historical fda approvals· last 5 years · same event type

100% hit rate (10/10)
TickerDrugDateOutcome
$INCYzynyz2026-05-18success
$INCYjakafi xr2026-05-01success
$AXSMauvelity2026-04-30success
$INCYzynyz2026-03-30success
$BIIBspinraza2026-03-27success
$CORTlifyorli2026-03-25success
$RYTMimcivree2026-03-19success
$ASNDyuviwel2026-02-27success
$BMRNpalynziq2026-02-27success
$ETONdesmoda2026-02-25success

Recent insider activity· ±90 days

8 insiders · 1 buys · 12 sells
Sell
2026-03-02
BASTA JAMES
EVP, General Counsel
1,211 @ $13.78$17K
Sell
2026-03-02
Clark Eliana
EVP, Chief Technical Officer
607 @ $13.78$8K
Grant
2026-03-01
BASTA JAMES
EVP, General Counsel
65,829 @ ——
Grant
2026-03-01
Schultes Birgit C
EVP, Chief Scientific Officer
39,200 @ ——
Grant
2026-03-01
Schultes Birgit C
EVP, Chief Scientific Officer
56,000 @ ——
Grant
2026-03-01
Dube Michael P
VP, Chief Accounting Officer
17,250 @ ——
Grant
2026-03-01
BASTA JAMES
EVP, General Counsel
46,080 @ ——
Grant
2026-03-01
Clark Eliana
EVP, Chief Technical Officer
7,353 @ ——
Grant
2026-03-01
Clark Eliana
EVP, Chief Technical Officer
10,505 @ ——
Grant
2026-03-01
Lebwohl David
EVP, Chief Medical Officer
9,943 @ ——
Grant
2026-03-01
Lebwohl David
EVP, Chief Medical Officer
14,204 @ ——
Grant
2026-03-01
Dulac Edward J III
EVP, Chief Financial Officer
61,280 @ ——
Grant
2026-03-01
Dulac Edward J III
EVP, Chief Financial Officer
87,543 @ ——
Grant
2026-03-01
LEONARD JOHN M
President and CEO
156,400 @ ——
Grant
2026-03-01
LEONARD JOHN M
President and CEO
225,400 @ ——
Sell
2026-01-05
Dube Michael P
VP, Chief Accounting Officer
2,989 @ $9.21$28K
Sell
2026-01-05
Schultes Birgit C
EVP, Chief Scientific Officer
8,508 @ $9.21$78K
Sell
2026-01-05
Clark Eliana
EVP, Chief Technical Officer
9,515 @ $9.21$88K
Sell
2026-01-05
LEONARD JOHN M
President and CEO
34,146 @ $9.21$314K
Sell
2026-01-05
Lebwohl David
EVP, Chief Medical Officer
11,903 @ $9.21$110K
Sell
2026-01-05
BASTA JAMES
EVP, General Counsel
10,397 @ $9.21$96K
Sell
2026-01-05
Dulac Edward J III
EVP, Chief Financial Officer
6,379 @ $9.21$59K
Buy
2026-01-05
Cohen Fred E
Director
150,000 @ $9.35$1.40M
Exercise10b5-1
2025-12-12
LEONARD JOHN M
President and CEO
8,557 @ $6.83$58K
Exercise10b5-1
2025-12-11
LEONARD JOHN M
President and CEO
49,959 @ $6.83$341K
Sell10b5-1
2025-12-11
LEONARD JOHN M
President and CEO
49,959 @ $9.49$474K
Sell10b5-1
2025-12-11
LEONARD JOHN M
President and CEO
32,832 @ $9.47$311K
Sell10b5-1
2025-12-11
LEONARD JOHN M
President and CEO
5,355 @ $9.59$51K
← All catalysts for $NTLA