IND

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).

FDA clears IND for Harbour Biomed’s HBM-7004

Fri, 08 May 2026 09:00:00 -0400

Harbour Biomed has gained IND clearance from the FDA for HBM-7004, enabling the initiation of a first-in-human phase I trial in subjects with advanced solid tumors.

Arrivent’s MUC16/NaPi2b-targeted ADC gains IND clearance

Fri, 08 May 2026 09:00:00 -0400

Arrivent Biopharma Inc. has obtained IND clearance from the FDA for ARR-002 (AV-P138-ADC), an antibody-drug conjugate (ADC) with an initial focus in ovarian and endometrial cancers and broader therapeutic potential across solid tumors. A phase I trial is expected to open in the second half of the year.

Laguna Biotherapeutics’ LGNA-100 gains IND clearance

Thu, 30 Apr 2026 09:00:00 -0400

Laguna Biotherapeutics Inc. has obtained IND clearance from the FDA for its cancer immunotherapeutic LGNA-100 (QUAIL-100). The planned first-in-human phase I study will evaluate LGNA-100 in pediatric and young adult participants with high-risk acute leukemias and myelodysplastic syndromes following αβ-depleted hematopoietic stem cell transplantation (HSCT) to prevent leukemic relapse.

Taiho and Araris announce IND clearance for ARC-02

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

Taiho Oncology Inc., Taiho Pharmaceutical Co. Ltd. and Araris Biotech AG have announced completion by the FDA of the IND review period for ARC-02, enabling initiation of a phase I trial by Taiho Oncology.

FDA clears IND for Naturecell’s Astrostem-AU for autism

Thu, 16 Apr 2026 09:00:00 -0400

Naturecell Co. Ltd.’s U.S. subsidiary, Naturecell America, has received IND clearance from the FDA for Astrostem-AU, an autologous adipose-derived mesenchymal stem cell therapy for adults with autism spectrum disorder (ASD).

‘Immune reset’ is ambition of Tr1x’s allogenic Tr1 cell therapy

Tue, 14 Apr 2026 12:00:00 -0400

Tr1x Inc. was founded with a simple but ambitious goal: to change how autoimmune and inflammatory diseases are treated, moving away from chronic treatment and toward durable cures. “We are trying to flip the script on regulatory T cells (Tregs),” Tr1x CEO David de Vries told BioWorld. “The goal is to reset the immune system rather than continuously suppress it, and we believe we have a unique technology to do that.”

Canwell gains IND clearance for ADC CAN-016

Tue, 07 Apr 2026 09:00:00 -0400

Canwell Pharma Inc. has obtained IND approval from the FDA for CAN-016, a novel antibody-drug conjugate (ADC). The company will initiate a phase I study in patients with HER2-expressing solid tumors who have experienced disease progression following prior ADC therapies.

Telomir Pharmaceuticals submits IND in U.S. for Telomir-1 in TNBC

Wed, 01 Apr 2026 09:00:00 -0400

Telomir Pharmaceuticals Inc. has submitted an IND application to the U.S. FDA for its lead candidate, Telomir-1 (Telomir-Zn), for the treatment of advanced and metastatic triple-negative breast cancer (TNBC). Telomir-1 is a first-in-class metal-modulating epigenetic agent designed to restore transcriptional control in tumor cells by targeting intracellular iron-zinc homeostasis.

Otsuka to acquire PTSD drugmaker Transcend in $1.2B deal

Tue, 31 Mar 2026 12:00:00 -0400

Otsuka Pharmaceutical Co. Ltd. is taking a neuroplastogen approach to posttraumatic stress disorder (PTSD) through its planned $1.22 billion acquisition of Transcend Therapeutics Inc. The deal gives Tokyo-headquartered Otsuka access to Transcend’s lead asset, TSND-201, an oral neuroplastogen that has begun patient recruitment for a phase III study in the U.S.

Aktis Oncology’s AKY-2519 gains IND approvals

Tue, 31 Mar 2026 09:00:00 -0400

Aktis Oncology Inc. has obtained IND approvals from the FDA enabling the company to proceed to a phase Ib trial with AKY-2519, a miniprotein radioconjugate targeting B7-H3-expressing tumors, including prostate, lung and other solid tumors. Specifically, the IND clearances relate to [64Cu]Cu-AKY-2519 for imaging and [225Ac]Ac-AKY-2519 for therapeutic use.

Otsuka to acquire PTSD drugmaker Transcend in $1.2B deal

Mon, 30 Mar 2026 12:00:00 -0400

Endocyclic’s ENDO-205 gains IND clearance for endometriosis

Tue, 24 Mar 2026 09:00:00 -0400

Endomet Biosciences Inc. (dba Endocyclic Therapeutics) has obtained IND clearance from the FDA for its lead program, ENDO-205, a first-in-class, nonhormonal targeted peptide therapeutic for endometriosis.