Biotech News

Intellia Therapeutics Announces FDA Acceptance of Biologics License Application with Priority Review for Lonvoguran Ziclumeran (Lonvo-z) for Hereditary Angioedema (HAE)

Intellia (NTLA)IntelliaFDA / regulatory

FDA sets Prescription Drug User Fee Act (PDUFA) date of March 10, 2027 Positions lonvo-z to be the world’s first in vivo CRISPR-based therapy and the only one-time HAE treatment, if approved CAMBRIDGE, Mass., Sept. 08, 2026 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc.

Related news

NTLAIntellia2026-06-13 11:30 EST

Intellia Therapeutics Reports Additional Positive Phase 3 Results for Lonvoguran Ziclumeran (lonvo-z) in Patients with Hereditary Angioedema

NTLAIntellia2026-06-01 11:30 EST

Intellia Therapeutics to Report Additional Phase 3 HAELO Data for Lonvoguran Ziclumeran (lonvo-z) in Late-Breaking Oral Presentation at EAACI 2026

ABEOAbeona Therapeutics2026-09-18 11:30 EST

Abeona Therapeutics® Congratulates Ultragenyx on U.S. FDA Approval of FAYUVI™ Gene Therapy for Sanfilippo Syndrome Type A (MPS IIIA)

GSKGSK plc2026-08-24 07:01 EST

Jemperli (dostarlimab) accepted for priority review by the US FDA for dMMR/MSI-H locally advanced rectal cancer

SRPTSarepta Therapeutics2026-06-30 12:30 EST

Sarepta Announces FDA Acceptance of sNDAs for AMONDYS 45® and VYONDYS 53®

GSKGSK plc2026-04-28 12:00 EST

Bepirovirsen accepted for priority review and granted Breakthrough Therapy Designation by the US FDA

PHARPharming Group2026-06-04 05:00 EST

Pharming announces U.S. FDA acceptance of sNDA resubmission for Joenja® (leniolisib) to treat children aged 4 to 11 years with APDS

PHARPharming Group2026-09-11 18:00 EST

FDA approves Pharming’s Joenja® as first treatment for children with APDS in the U.S.

VYGRVoyager Therapeutics2026-06-01 12:00 EST

Voyager Receives FDA IND Clearance for VY1706, First Gene Therapy Approach to Reducing Tau Production in the Brain for Alzheimer’s Disease

KRYSKrystal Biotech2026-05-18 12:00 EST

Krystal Biotech Announces United Kingdom MHRA Approval of VYJUVEK® for the Treatment of Dystrophic Epidermolysis Bullosa

Intellia

In Vivo CRISPR Gene Editing Intellia Therapeutics develops potentially one-time medicines using CRISPR-based gene editing. Its lead programs edit disease-causing genes directly inside the body through systemically delivered therapies. Hereditary Angioedema Lonvoguran ziclumeran, or lonvo-z, is an in vivo gene-editing candidate designed...

Recent company news

Stock data

Close
12.26 USD
Market cap
1.83B USD
Exchange
NASDAQ
Sector
Biopharma
Location
United States