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Home » Topics » Regulatory » IND

IND
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Neurology/psychiatric

Damona’s α5-GABAAR-targeting PAM gains IND clearance to treat cognitive deficits in brain disorders

Nov. 5, 2024
Damona Pharmaceuticals Inc. has obtained IND clearance from the FDA for DPX-101 for the treatment of cognitive deficits in brain disorders, including major depressive disorder.
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RNA strand
Ear, nose & throat

Ribox’s RXRG-001 cleared to enter clinic for radiation-induced xerostomia and hyposalivation

Oct. 28, 2024
Ribox Therapeutics Ltd. has obtained IND clearance from the FDA for the company’s circular RNA therapy, RXRG-001.
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3D illustration of cancer in crosshairs
Cancer

WRN inhibitor IDE-275 gains IND clearance for phase I study in MSI-high tumors

Oct. 28, 2024
Ideaya Biosciences Inc. has announced FDA clearance of an IND application for IDE-275 (GSK-959), a small-molecule inhibitor of Werner helicase (WRN) discovered by Ideaya in collaboration with GSK plc.
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Cancer

Accent Therapeutics’ ATX-559 cleared to enter clinic

Oct. 25, 2024
Accent Therapeutics Inc. has gained IND clearance from the FDA for ATX-559, a first-in-class DHX9 inhibitor.
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AI drug developer Aigen Sciences raises ₩12B series A

Oct. 22, 2024
By Marian (YoonJee) Chu
Backed by AI technology, Aigen Sciences Inc. raised ₩12 billion (US$8.8 million) in a series A financing round to further advance its cancer and rare disease drug pipelines.
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Antibodies attacking cancer cell
Immuno-oncology

FDA clears IND for Adcentrx’s ADC targeting STEAP1

Oct. 22, 2024
Adcentrx Therapeutics Inc. has received FDA clearance of its IND application for ADRX-0405 for the treatment of select advanced solid tumors. A first-in-human phase Ia/b trial of ADRX-0405 in patients with select advanced solid tumors, including metastatic castration-resistant prostate cancer, will begin enrollment and dosing this quarter.
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AI drug developer Aigen Sciences raises ₩12B series A

Oct. 16, 2024
By Marian (YoonJee) Chu
Backed by AI technology, Aigen Sciences Inc. raised ₩12 billion (US$8.8 million) in a series A financing round to further advance its cancer and rare disease drug pipelines.
Read More
Illustration of pancreas, close up of islet
Endocrine/metabolic

Seraxis gains IND clearance for islet replacement therapy

Oct. 16, 2024
Seraxis Inc. has obtained IND clearance from the FDA for a phase I/II study of its novel islet replacement therapy SR-02 for type 1 diabetes. SR-02 is comprised of allogeneic pancreatic endocrine cell clusters that, when implanted to the omentum, form a functional endocrine pancreas outside of the native pancreas.
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Respiratory

Kymera’s oral STAT degrader KT-621 gains IND clearance from FDA

Oct. 10, 2024
Kymera Therapeutics Inc. has received IND clearance from the FDA for KT-621, an investigational first-in-class, once-daily, oral STAT6 degrader.
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Tape measure wrapped around scale
Endocrine/metabolic

Antag’s GIP receptor antagonist cleared to enter clinic in US

Oct. 9, 2024
Antag Therapeutics ApS has received IND clearance from the FDA for lead molecule, AT-7687. A phase I trial will evaluate AT-7687 in healthy lean and healthy obese subjects, including as monotherapy and in combination with semaglutide in the healthy obese individuals.
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