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BioWorld - Thursday, April 9, 2026
Home » Topics » Regulatory » IND

IND
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3D illustration showing cross section of a human bone
Cancer

Prelude’s JAK2 V617F inhibitor PRT-12396 gains IND clearance

Feb. 4, 2026
No Comments
Prelude Therapeutics Inc. has received IND clearance from the FDA for PRT-12396, a mutant-selective JAK2 V617F inhibitor being developed for the treatment of patients with certain myeloproliferative neoplasms.
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Antibodies attacking cancer cell
Immuno-oncology

ABL Bio files IND application for ABL-209

Feb. 3, 2026
No Comments
ABL Bio Inc. has submitted an IND application to the FDA seeking clearance to begin a phase I trial of ABL-209 (NEOK-002). Pending approval, the trial is expected to begin by mid-year in the U.S.
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Illustration of cancer tumor
Immuno-oncology

Onchilles Pharma’s N-17350 gains IND clearance for solid tumors

Feb. 3, 2026
No Comments
Onchilles Pharma Inc. has obtained IND approval from the FDA for N-17350, enabling initiation of first-in-human studies in patients with advanced solid tumors. The study will enroll patients in the U.S. and Australia with advanced solid tumors.
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Neural network
Diagnostics

IND approval for Trace Biosciences’ nerve imaging agent

Feb. 2, 2026
No Comments
Trace Biosciences Inc. has obtained IND approval from the FDA for LGW16-03 (Nervetrace Dx), the company’s first nerve-specific fluorescent imaging agent. The IND clearance enables Trace to initiate a first-in-human study evaluating the safety and intraoperative performance of LGW16-03 in surgical settings.
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Going public ticker

Eikon Therapeutics seeks up to $317M raise in Nasdaq IPO

Jan. 29, 2026
By Marian (YoonJee) Chu
No Comments
Oncology-focused Eikon Therapeutics Inc. set the terms of its IPO Jan. 28, selling 17.648 million shares at a price range between $16 to $18 per share. At the top of the range, the Millbrae, Calif.-based biopharma company would raise about $317.7 million.
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Illustration of the optic nerve connecting eye to brain
Ocular

Life Biosciences’ ER-100 cleared for clinic in optic neuropathies

Jan. 29, 2026
No Comments
Life Biosciences Inc. has obtained IND clearance from the FDA for ER-100 in optic neuropathies.
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DNA and cancer cells
Cancer

Siren Biotechnology’s glioma program gains IND clearance

Jan. 29, 2026
No Comments
Siren Biotechnology Inc. has obtained IND approval from the FDA enabling the initiation of its first-in-human trial for its lead investigational program SRN-101 in adult patients with recurrent high-grade glioma.
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Korean Won currency symbol made of gray cast iron

1st Biotherapeutics closes $22M series D, preps for IPO

Jan. 27, 2026
By Marian (YoonJee) Chu
No Comments
1st Biotherapeutics Inc. announced the closing of a ₩31.7 billion series D funding round Jan. 26 to advance its lead phase I oncology asset, FB-849, and portfolio of candidates for neurodegenerative diseases.
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Korean Won currency symbol made of gray cast iron

1st Biotherapeutics closes $22M series D, preps for IPO

Jan. 26, 2026
By Marian (YoonJee) Chu
No Comments
1st Biotherapeutics Inc. announced the closing of a ₩31.7 billion series D funding round Jan. 26 to advance its lead phase I oncology asset, FB-849, and portfolio of candidates for neurodegenerative diseases.
Read More
Concept art for "unlocking the secrets of the mind"
Neurology/psychiatric

Insilico Medicine’s ISM-8969 gains IND clearance for Parkinson’s

Jan. 26, 2026
No Comments
Insilico Medicine Cayman Topco has obtained IND approval from the FDA for ISM-8969 for the treatment of Parkinson’s disease, enabling initiation of a phase I trial in healthy volunteers.
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