Intellia Therapeutics Starts Rolling FDA Application After Phase 3 Angioedema Trial Meets Primary Endpoint
Idag, 14:56
Idag, 14:56
08:56 AM EDT, 04/27/2026 (MT Newswires) -- Intellia Therapeutics (NTLA) said Monday its phase 3 clinical trial for a single-dose gene-editing therapy for hereditary angioedema met its primary and all key secondary endpoints.
The experimental medication reduced swelling episodes by 87% versus placebo during a six-month evaluation period, the company said.
The company reported favorable safety and tolerability data, with no serious adverse events observed in the treatment arm.
Management initiated a rolling biologics license application with the US Food and Drug Administration and anticipates a US launch in the first half of 2027, if approved, it said.
Shares of the company were up 4.7% in Monday premarket activity.
Idag, 14:56
08:56 AM EDT, 04/27/2026 (MT Newswires) -- Intellia Therapeutics (NTLA) said Monday its phase 3 clinical trial for a single-dose gene-editing therapy for hereditary angioedema met its primary and all key secondary endpoints.
The experimental medication reduced swelling episodes by 87% versus placebo during a six-month evaluation period, the company said.
The company reported favorable safety and tolerability data, with no serious adverse events observed in the treatment arm.
Management initiated a rolling biologics license application with the US Food and Drug Administration and anticipates a US launch in the first half of 2027, if approved, it said.
Shares of the company were up 4.7% in Monday premarket activity.
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