Yeji
NDA/BLA filedconf 0.85

nexiguran ziclumeran — NDA/BLA filed

$NTLA · Intellia Therapeutics, Inc. · Neuromuscular Disease
Event date
January 27, 2026
130 days ago
Sponsor runway
10 mo
$376.0M liquid

Evidence

On January 27, 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-2 Phase 3 clinical trial of nexiguran ziclumeran ("nex-z") for patients with hereditary transthyretin ("ATTR") amyloidosis with polyneuropathy ("ATTRv-PN").
Source: 8-K filed 2026-01-27View on EDGAR ↗0001193125-26-023387

Comparable historical nda/bla fileds· last 5 years · same event type

TickerDrugDateOutcome
$AXSM2025-12-31unknown
$RCKTkresladi2025-10-14unknown
$ALDXreproxalap2025-07-17unknown
$ETONet-6002025-07-08unknown
$BCRXorladeyo (berotralstat)2025-05-14unknown
$CORTrelacorilant2025-03-03unknown
$ALDXreproxalap2024-11-01unknown
$AXSMaxs-072024-09-04unknown
$RCKTkresladi2023-10-02unknown
$GERNimetelstat2023-08-21unknown

Recent insider activity· ±90 days

8 insiders · 1 buys · 12 sells
Pre-catalyst buying:Cohen Fred E bought $1.40M in the 30 days before this event
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