IND

IND open for Ractigen’s RAG-1C in proliferative vitreoretinopathy

Mon, 03 Aug 2026 09:00:00 -0400

Ractigen Therapeutics Co. Ltd. has obtained IND approval from the FDA for RAG-1C, a first-in-class small activating RNA (saRNA) drug candidate designed for the prevention and treatment of proliferative vitreoretinopathy.

DYNE-302 gets IND for facioscapulohumeral muscular dystrophy

Tue, 28 Jul 2026 09:00:00 -0400

Dyne Therapeutics Inc. has obtained IND clearance from the FDA for DYNE-302 in facioscapulohumeral muscular dystrophy (FSHD), a rare, genetic disease caused by a mutation in the DUX4 gene. Dyne plans to conduct a phase I trial in ambulatory adults with FSHD.

To viral or not to viral: In vivo CAR T debates delivery tech

Tue, 21 Jul 2026 11:00:00 -0400

The field of cell and gene therapy is moving toward a new phase of scalability and clinical durability, with in vivo chimeric antigen receptor (CAR) T-cell therapeutics emerging as the dark horse in what speakers at BIO Asia-Taiwan 2026 described as CAR T’s second revolution.

To viral or not to viral: In vivo CAR T debates delivery tech

Tue, 21 Jul 2026 09:00:00 -0400

To viral or not to viral: In vivo CAR T debates delivery tech

Mon, 20 Jul 2026 12:00:00 -0400

Atrium’s ATR-1072 gains IND clearance for PRKAG2 syndrome

Wed, 15 Jul 2026 09:00:00 -0400

Atrium Therapeutics Inc. has obtained IND clearance from the FDA for ATR-1072 for the treatment of protein kinase AMP-activated non-catalytic subunit γ2 (PRKAG2) syndrome.

Fate Therapeutics’ FT-839 gains IND clearance

Fri, 10 Jul 2026 09:00:00 -0400

Fate Therapeutics Inc. has obtained IND clearance from the FDA for FT-839, the company’s next-generation, off-the-shelf CAR T-cell product candidate targeting CD19 and CD38 for autoimmune diseases.

Urogen’s UGN-501 gains IND clearance for bladder cancer

Thu, 09 Jul 2026 09:00:00 -0400

Urogen Pharma Ltd. has obtained IND approval from the FDA for UGN-501, a next-generation investigational oncolytic virus. A phase I study evaluating intravesical administration of UGN-501 in patients with non-muscle invasive bladder cancer (NMIBC) is expected to begin in the fourth quarter.

Coregen’s CRG-150 gains IND clearance for solid tumors

Wed, 08 Jul 2026 09:00:00 -0400

Coregen Inc. has obtained IND clearance from the FDA for CRG-150, a novel adoptive cell therapy targeting SRC-3 (steroid receptor coactivator 3).

FDA clears IND for LTZ Therapeutics’ LTZ-232

Wed, 08 Jul 2026 09:00:00 -0400

LTZ Therapeutics Inc.’s LTZ-232 has gained IND clearance from the FDA, enabling initiation of a phase I study in patients with advanced metastatic colorectal cancer and other solid tumors.

Ascletis submits INDs for ASC-36 and ASC-36_35 for obesity

Mon, 06 Jul 2026 09:00:00 -0400

Ascletis Pharma Inc. has submitted two IND applications to the FDA for ASC-36 once-monthly injection and ASC-36_35 once-monthly injection co-formulation for the treatment of obesity.

Brightpath files IND application for BP-2202 for multiple myeloma

Fri, 03 Jul 2026 09:00:00 -0400

Brightpath Biotherapeutics Co. Ltd. has submitted an IND application to the FDA to initiate a phase I trial of BP-2202 in the U.S. (NCT07667868).

FDA clears IND for Ascletis Pharma’s ASC-35 for obesity

Thu, 25 Jun 2026 09:00:00 -0400

Ascletis Pharma Inc. has received IND clearance from the FDA for ASC-35, a once-monthly subcutaneously administered GLP-1 receptor (GLP-1R)/GIP receptor (GIPR) dual peptide agonist, for the treatment of obesity.

Unixell’s UX-DA003 cleared for clinic in US and China

Thu, 25 Jun 2026 09:00:00 -0400

Unixell Biotechnology Co. Ltd. has obtained IND clearance from the FDA for UX-DA003, its allogeneic induced pluripotent stem cell (iPSC)-derived therapy for Parkinson’s disease. IND approval was also gained in China earlier this month, enabling concurrent clinical development in both China and the U.S.

J-Pharma drives first cancer LAT1 to phase III study with FDA nod

Tue, 23 Jun 2026 12:00:00 -0400

J-Pharma Co. Ltd. is progressing the most clinically advanced L-type amino acid transport 1 (LAT1) inhibitor, nanvuranlat (JPH‑203), in a global phase III Beacon-BTC study of biliary tract cancer following U.S. FDA alignment.

Anhorn Medicines gains IND clearance for neuroprotectant AH-008

Tue, 23 Jun 2026 09:00:00 -0400

Anhorn Medicines Co. Ltd. has obtained IND clearance from the FDA for its lead neuroprotective candidate, AH-008, for the prevention of chemotherapy-induced peripheral neuropathy.

J-Pharma drives first cancer LAT1 to phase III study with FDA nod

Thu, 18 Jun 2026 12:00:00 -0400

FDA clears IND for Cenna’s 8M2D for Alzheimer’s disease

Thu, 18 Jun 2026 09:00:00 -0400

Cenna Biosciences Inc. has obtained IND clearance from the FDA for 8M2D, a first-in-class peptide for the treatment of Alzheimer’s disease. A phase Ia/Ib trial of 8M2D in healthy volunteers and patients with early Alzheimer’s disease is expected to begin dosing late this year.

Beam Therapeutics’ BEAM-304 gains IND clearance for PKU

Thu, 18 Jun 2026 09:00:00 -0400

Beam Therapeutics Inc. has obtained IND clearance from the FDA for BEAM-304 for the treatment of phenylketonuria (PKU). BEAM-304 is a liver-targeting lipid-nanoparticle (LNP) formulation of base editing reagents designed to correct mutations in the phenylalanine hydroxylase (PAH) gene that cause PKU.

Amphista’s BRD9 degrader gains IND clearance for AML

Mon, 08 Jun 2026 09:00:00 -0400

Amphista Therapeutics Ltd. has obtained IND clearance from the FDA for AMX-883, an orally bioavailable degrader of BRD9, for the treatment of acute myeloid leukemia (AML). A phase I trial in patients with relapsed or refractory AML and high-risk myelodysplastic syndrome is expected to begin in the second half of this year.

FDA approves IND for Iovance’s TIL therapy IOV-5001

Tue, 02 Jun 2026 09:00:00 -0400

Iovance Biotherapeutics Inc. has received IND clearance from the FDA for IOV-5001, a next-generation interleukin-12 (IL-12)-tethered tumor-infiltrating lymphocyte (TIL) therapy.

Voyager’s tau-targeted gene therapy VY-1706 gains IND approval

Tue, 02 Jun 2026 09:00:00 -0400

Voyager Therapeutics Inc. has obtained IND clearance from the FDA for VY-1706, the company’s investigational gene therapy for the treatment of Alzheimer’s disease.

FDA accepts IND for Rest Therapeutics’ early PTSD candidate

Fri, 29 May 2026 09:00:00 -0400

The FDA has accepted the IND application from Rest Therapeutics SAS for RST-101, the company’s lead investigational candidate for the early treatment of post-traumatic stress disorder (PTSD).

Newcelx submits pre-IND package for NCEL-101 to FDA

Wed, 27 May 2026 09:00:00 -0400

Newcelx Ltd. has submitted a pre-IND briefing package to the U.S. FDA to support a proposed first-in-human trial of NCEL-101 in combination with tegoprubart, an investigational anti-CD40L monoclonal antibody being developed by Eledon Pharmaceuticals Inc.

FDA clears Qihan Biotech’s CAR T therapy QT-019C for clinic

Thu, 21 May 2026 09:00:00 -0400

Hangzhou Qihan Biotech Co. Ltd. has obtained IND clearance from the FDA for QT-019C, a universal allogeneic CAR T-cell therapy for autoimmune diseases. QT-019C cell injection is an off-the-shelf allogeneic CAR T-cell therapy engineered from healthy donor leukapheresis products to stably express two distinct CARs targeting CD19 and BCMA.

Matter Bio files IND for Lm-LLO-TT for PDAC

Wed, 20 May 2026 09:00:00 -0400

Matter Bio has submitted its first IND application to the FDA for Lm-LLO-TT, the company’s lead therapeutic candidate, seeking to initiate a first-in-human phase I/IIa trial in patients with pancreatic ductal adenocarcinoma (PDAC).

Mekanistic’s PI3K/EGFR inhibitor MTX-531 gains IND clearance

Wed, 20 May 2026 09:00:00 -0400

Mekanistic Therapeutics Inc. has obtained IND clearance from the FDA for MTX-531, the company’s lead oncology candidate. A phase I study will be conducted in patients with advanced solid tumors characterized by dysregulated EGFR and/or PI3K signaling, including head and neck and endometrial cancers. Dosing is expected to begin in the third quarter.

MD Anderson gains IND nod for CD94-targeted CAR T therapy

Mon, 18 May 2026 09:00:00 -0400

The University of Texas MD Anderson Cancer Center has received IND clearance from the FDA to initiate a phase I trial of a novel CAR T-cell therapy, JV-394, for patients with relapsed or refractory CD94-positive T/natural killer (NK) cell lymphomas.

KHN-921 gains IND clearance for MYBPC3-associated HCM

Thu, 14 May 2026 09:00:00 -0400

Chengdu Origen Biotechnology Co. Ltd. and Vanotech Ltd. have announced IND clearance by the FDA for KHN-921 for the treatment of hypertrophic cardiomyopathy (HCM) associated with MYBPC3 mutations.

Mabwell’s 9MW5211 gains IND clearance for IBD

Mon, 11 May 2026 09:00:00 -0400

Mabwell (Shanghai) Bioscience Co. Ltd. has obtained IND clearance from the FDA for 9MW5211 for the treatment of inflammatory bowel disease (IBD).