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BioWorld - Friday, April 3, 2026
Home » Topics » Regulatory » IND

IND
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Illustration of antibodies attacking neurons
Immune

Biogen’s IND for BIIB-142 accepted by FDA

Sep. 5, 2025
No Comments
Biogen Inc.’s IND application for BIIB-142 has been accepted by the FDA. BIIB-142 is a degrader of IRAK-4 that Biogen intends to explore for therapeutic use in patients with autoimmune diseases.
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Lung cancer illustration
Cancer

Ideaya submits IND for PRMT5 inhibitor

Sep. 4, 2025
No Comments
Ideaya Biosciences Inc. has submitted an IND application to the FDA for IDE-892, an MTA-cooperative inhibitor of PRMT5.
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Skyvaricella

South Korea INDs: Pimedbio, Sillajen, Genosco, SK Bio, Ami

Sep. 3, 2025
By Marian (YoonJee) Chu
No Comments

Several South Korean biotech and biopharmaceutical companies completed IND submissions or won nods to start clinical trials in either the U.S. or South Korea, including SK Bioscience Co. Ltd., Genosco Inc., Pimedbio Inc., Sillajen Inc. and Ami Pharm Co. Ltd.


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Immuno-oncology

Avenzo gains IND clearance for AVZO-103

Sep. 3, 2025
No Comments
Avenzo Therapeutics Inc. has obtained IND clearance by the FDA for AVZO-103 (formerly VAC-103), a nectin-4/TROP2 bispecific antibody-drug conjugate (ADC).
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Illustration for inflammatory bowel disease
Gastrointestinal

IND open for Shattuck’s SL-325 for inflammatory bowel disease

Aug. 22, 2025
No Comments
Shattuck Labs Inc. has reported that its IND from the U.S. FDA for SL-325 for the treatment of inflammatory bowel disease is now in effect. The company expects to commence a phase I trial in healthy volunteers in the third quarter of this year.
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Heart and lungs
Cardiovascular

VTB-10 gets IND clearance for pulmonary arterial hypertension

Aug. 20, 2025
No Comments
Vasthera Co. Ltd. has received IND clearance from the U.S. FDA, enabling it to initiate a phase I trial for VTB-10 for pulmonary arterial hypertension (PAH). Vasthera identified a deficiency of the enzyme peroxiredoxin (PRX) in PAH lesions and used its Redoxizyme platform to develop VTB-10, a small-molecule enzyme that precisely replicates PRX function.
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Eye and DNA
Ocular

Opus Genetics’ OPGx-BEST1 cleared to enter clinic

Aug. 19, 2025
No Comments
Opus Genetics Inc. has obtained IND clearance from the U.S. FDA application for OPGx-BEST1, a gene therapy for the treatment of bestrophin-1 (BEST1)-related inherited retinal disease (IRD).
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CAR T cell with implanted gene strand
Immune

Qihan Biotech’s QT-019B gains US IND clearance for lupus

Aug. 19, 2025
No Comments
Hangzhou Qihan Biotech Co. Ltd. has gained IND approval by the FDA for QT-019B, a universal, dual-target CAR T-cell therapy for refractory systemic lupus erythematosus (SLE). A phase I/II trial will be conducted in the U.S.
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3D illustration of T cells fighting cancer
Immuno-oncology

Evolveimmune’s EVOLVE-104 gains IND clearance for solid tumors

Aug. 14, 2025
No Comments
Evolveimmune Therapeutics Inc. has gained IND clearance from the U.S. FDA for EVOLVE-104, a novel trispecific T-cell engager for the treatment of solid tumors. The company will begin a phase I trial this year.
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Test tube, dropper, DNA illustration
Cancer

K36 Therapeutics gains IND clearance for NSD2 inhibitor KTX-2001

Aug. 8, 2025
No Comments
K36 Therapeutics Inc. has obtained IND clearance from the U.S. FDA for KTX-2001, a selective, oral, small-molecule inhibitor of nuclear receptor-binding SET domain protein 2 (NSD2), a histone methyltransferase and oncogene that activates gene expression in some cancers.
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