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BioWorld - Sunday, June 14, 2026
Home » Topics » Regulatory » IND

IND
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Art concept for monoclonal antibodies
Immuno-oncology

FDA clears IND for Pilatus’ metabolic checkpoint therapy PLT-012

Dec. 16, 2025
No Comments
Pilatus Biosciences Inc. has obtained IND clearance from the FDA for PLT-012, a first-in-class anti-CD36 monoclonal antibody, for the treatment of solid tumors. Pilatus plans to initiate a first-in-human phase I trial with this metabolic checkpoint antibody in the first quarter of next year.
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Multiple sclerosis

Formation loads new Bleecker division with Lynk’s TYK2 inhibitor

Dec. 16, 2025
By Marian (YoonJee) Chu
No Comments
Formation Bio Inc. acquired ex-China rights to Lynk Pharmaceuticals Co. Ltd.’s oral TYK2-inhibitor, LNK-01006, for up to $605 million. The phase I-ready central nervous system (CNS) candidate will be developed at Formation’s newly formed subsidiary, Bleecker Bio.
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Multiple sclerosis

Formation loads new Bleecker division with Lynk’s TYK2 inhibitor

Dec. 11, 2025
By Marian (YoonJee) Chu
No Comments
Formation Bio Inc. acquired ex-China rights to Lynk Pharmaceuticals Co. Ltd.’s oral TYK2-inhibitor, LNK-01006, for up to $605 million. The phase I-ready central nervous system (CNS) candidate will be developed at Formation’s newly formed subsidiary, Bleecker Bio.
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Cancer

Ideaya seeks IND clearance for KAT6/7 dual inhibitor IDE-574

Dec. 10, 2025
No Comments
Ideaya Biosciences Inc. has submitted an IND application to the FDA for IDE-574, a KAT6/7 dual inhibitor with potential to treat hormone receptor-positive breast cancer and lung adenocarcinoma. A phase I trial of IDE-574 monotherapy is expected to begin in the first quarter of next year.
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Immuno-oncology

Avencell’s AVC-203 cleared for clinic for B-cell malignancies

Dec. 5, 2025
No Comments
Avencell Therapeutics Inc. has received clinical trial clearances from the FDA and EMA to conduct a phase I/II trial (Quadvance) of AVC-203 for the treatment of relapsed or refractory B-cell malignancies.
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Woman measuring her body fat with caliper
Endocrine/metabolic

FDA approves IND for CSPC’s SYH-2069 for obesity

Dec. 5, 2025
No Comments
CSPC Pharmaceutical Group Ltd. has obtained IND clearance from the FDA to conduct clinical trials in the U.S. with SYH-2069 for weight management in individuals with obesity or overweight and at least one weight-related comorbidity.
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Brain and neural networks
Neurology/psychiatric

Lynk’s allosteric TYK2 inhibitor LNK-01006 gains IND clearance

Dec. 3, 2025
No Comments

Lynk Pharmaceuticals Co. Ltd. has received IND clearance from the FDA for LNK-01006, an allosteric TYK2 inhibitor with potential to treat neurodegenerative diseases.


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Degradation of motor neurons
Neurology/psychiatric

Vectory’s VTX-002 gains IND clearance for ALS

Dec. 3, 2025
No Comments
Vectory Therapeutics BV has obtained IND clearance from the FDA for a phase I/II trial (PIONEER-ALS) of VTX-002, a first-in-class vectorized antibody targeting TDP-43 pathology in amyotrophic lateral sclerosis (ALS). VTX-002 delivers an engineered antibody designed to selectively target toxic species of TDP-43.
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Art concept for gene therapy research
Neurology/psychiatric

FDA clears Latus Bio’s LTS-101 to enter clinic for CLN2 disease

Dec. 3, 2025
No Comments
Latus Bio Inc. has reported IND clearance by the FDA for LTS-101, a gene therapy candidate to treat the CNS manifestations of late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease. The FDA has also granted orphan drug, rare pediatric disease and fast track designations to LTS-101.
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Concept art for targeting cancer
Cancer

Ideaya’s IDE-034 gains IND clearance for solid tumors

Dec. 1, 2025
No Comments
Ideaya Biosciences Inc. has received IND clearance from the FDA for the initiation of a phase I trial to evaluate IDE-034, a bispecific B7H3/PTK7 TOP1 antibody-drug conjugate.
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