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BioWorld - Sunday, April 5, 2026
Home » Topics » Regulatory » IND

IND
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Brain clay model
Neurology/Psychiatric

FDA clears IND for Jaguar’s JAG-201 for genetic form of ASD and Phelan-McDermid syndrome

Feb. 1, 2024
Jaguar Gene Therapy LLC’s IND application for JAG-201, a gene therapy for a genetic form of autism spectrum disorder (ASD) and Phelan-McDermid syndrome (PMS; 22q13.3 deletion syndrome), has been cleared by the FDA.
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Human NK cell
Immuno-oncology

23andme’s NK cell activator cleared to enter clinic for solid tumors

Feb. 1, 2024
23andme Holding Co. has received FDA clearance of its IND application for 23ME-01473 (‘1473), a dual mechanism antibody and natural killer (NK) cell activator intended to treat cancer.
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Illustration of the inside of an eye with macular degeneration
Ocular

Ascidian’s RNA exon editor cleared to enter clinic for Stargardt disease

Jan. 30, 2024
Ascidian Therapeutics Inc. has received FDA clearance of its IND application for ACDN-01, an RNA exon editor targeting the genetic cause of Stargardt disease.
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Structure of human CD47 (violet) in complex with human SIRP alpha (green)
Immuno-oncology

Biosion's anti-SIRPα antibody BSI-082 cleared to enter clinic

Jan. 25, 2024
Biosion Inc. has gained FDA clearance of its IND application for BSI-082, a novel anti-SIRPα monoclonal antibody (mAb) candidate.
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Cancer cells
Immuno-oncology

Cytomx receives IND clearances for CX-2051 and CX-801

Jan. 25, 2024
Cytomx Therapeutics Inc. has received clearances from the FDA for IND applications for two conditionally activated Probody therapeutics.
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Immuno-oncology

Harbour’s bispecific antibody HBM-9027 cleared to enter clinic in US for solid tumors

Jan. 24, 2024
Harbour Biomed Ltd. has obtained FDA clearance of its IND application to initiate a first-in-human...
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Neurology/Psychiatric

Vanda receives IND clearance for ASO for Charcot-Marie-Tooth disease type 2S

Jan. 24, 2024
Vanda Pharmaceuticals Inc. has announced FDA approval of its IND application to evaluate VCA...
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Neurology/Psychiatric

Juvena’s JUV-161 awarded US orphan drug designation for myotonic dystrophy type 1

Jan. 24, 2024
The FDA has awarded orphan drug designation to Juvena Therapeutics Inc.’s JUV-161, an...
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3d illustration of ovarian cancer
Immuno-oncology

NK Celltech announces US IND clearance for NK cell therapy NK-010

Jan. 23, 2024
NK Celltech Co. Ltd. has announced FDA clearance for a clinical trial of NK-010, a nongenetically modified allogeneic peripheral blood natural killer (NK) cell drug.
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Immuno-oncology

Strand’s STX-001 receives IND clearance from FDA to treat solid tumors

Jan. 23, 2024
Strand Therapeutics Inc. has received IND clearance from the FDA to initiate a first-in-human phase I trial of STX-001 as a new approach for the treatment of solid tumors.
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