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FDA clears Beam Therapeutics IND for PKU gene editing therapy

Thu, 18 Jun 2026 07:00:11 -0400

Beam Therapeutics Inc. (Nasdaq: BEAM) announced that the U.S. Food and Drug Administration has cleared its investigational new drug application for BEAM-304, a base editing therapy for phenylketonuria (PKU), a rare inherited metabolic disorder affecting approximately 20,000 people in the United States.

BEAM-304 is a liver-targeting lipid nanoparticle formulation designed to correct mutations in the phenylalanine hydroxylase gene that cause PKU. The therapy is delivered via intravenous infusion and aims to reduce toxic phenylalanine levels to within recommended guidelines while allowing patients to normalize their diet.

The company plans to initiate a Phase 1/2 open-label trial that will initially evaluate safety, tolerability,

Beam Therapeutics Announces Clearance of Investigational New Drug Application for BEAM-304 for the Treatment of Phenylketonuria (PKU) by the United States (U.S.) Food and Drug Administration

Thu, 18 Jun 2026 07:00:00 -0400

BEAM-304 Development Approach Has Potential to Create Transformative, One-time Therapies for the Majority of Patients with PKU

BEAM-304 Program Designed as Platform-based Approach Reflecting Emerging FDA Guidance for Accelerated Development of Genome Editing Therapies

New Preclinical Data for BEAM-304 to be Presented at FASEB Genome Engineering: Research and Applications Conference

CAMBRIDGE, Mass., June 18, 2026 (GLOBE NEWSWIRE) -- Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced that the United States (U.S.) Food and Drug Administration (FDA) has cleared the investigational

Beam Therapeutics Announces Clearance of Investigational New Drug Application for BEAM-304 for the Treatment of Phenylketonuria (PKU) by the United States (U.S.) Food and Drug Administration

Thu, 18 Jun 2026 07:00:00 -0400

BEAM-304 Development Approach Has Potential to Create Transformative, One-time Therapies for the Majority of Patients with PKU

BEAM-304 Program Designed as Platform-based Approach Reflecting Emerging FDA Guidance for Accelerated Development of Genome Editing Therapies

New Preclinical Data for BEAM-304 to be Presented at FASEB Genome Engineering: Research and Applications Conference

Beam Therapeutics Announces Clearance of Investigational New Drug Application for BEAM-304 for the Treatment of Phenylketonuria (PKU) by the United States (U.S.) Food and Drug Administration

Thu, 18 Jun 2026 07:00:00 -0400

BEAM-304 Development Approach Has Potential to Create Transformative, One-time Therapies for the Majority of Patients with PKU

BEAM-304 Program Designed as Platform-based Approach Reflecting Emerging FDA Guidance for Accelerated Development of Genome Editing Therapies

New Preclinical Data for BEAM-304 to be Presented at FASEB Genome Engineering: Research and Applications Conference

Beam Therapeutics Announces Clearance of Investigational New Drug Application for BEAM-304 for the Treatment of Phenylketonuria (PKU) by the United States (U.S.) Food and Drug Administration

Thu, 18 Jun 2026 07:00:00 -0400

BEAM-304 Development Approach Has Potential to Create Transformative, One-time Therapies for the Majority of Patients with PKU

BEAM-304 Program Designed as Platform-based Approach Reflecting Emerging FDA Guidance for Accelerated Development of Genome Editing Therapies

New Preclinical Data for BEAM-304 to be Presented at FASEB Genome Engineering: Research and Applications Conference

Form 8-K Beam Therapeutics Inc. For: Jun 03

Mon, 08 Jun 2026 16:05:00 -0400

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Form 8-K Beam Therapeutics Inc. For: Jun 03

Mon, 08 Jun 2026 16:05:00 -0400

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Form 4 Beam Therapeutics Inc. For: Jun 03 Filed by: Fishman Mark