Adicet Bio Stock Price, News & Analysis

Adicet Bio, Inc. (Nasdaq: ACET) is a clinical-stage biotechnology company focused on discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. According to company disclosures, Adicet is advancing a pipeline of "off-the-shelf" gamma delta T cells engineered with chimeric antigen receptors (CARs) to support durable activity in patients.

Business focus and therapeutic approach

Adicet describes its core approach as developing allogeneic gamma delta CAR T cell therapies that can be administered as one-time, off-the-shelf treatments. Its programs are designed to target B cells and tumor-associated antigens, with the goal of addressing serious autoimmune conditions and solid tumors. The company reports that its therapies are intended to combine the attributes of gamma delta T cells with CAR engineering to provide targeted activity.

Key clinical program: prulacabtagene leucel (prula‑cel, formerly ADI‑001)

The company’s lead program is prulacabtagene leucel (prula‑cel, formerly ADI‑001), described as an investigational allogeneic gamma delta CAR T cell therapy targeting B cells via an anti‑CD20 CAR. Adicet reports that prula‑cel/ADI‑001 is being evaluated in a Phase 1 program across multiple autoimmune diseases, including lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS), anti‑neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV) and treatment‑refractory rheumatoid arthritis (RA).

Company communications state that prula‑cel/ADI‑001 has received Fast Track Designation from the U.S. Food and Drug Administration for the potential treatment of relapsed/refractory class III or class IV LN, refractory SLE with extrarenal involvement, and SSc, and that Fast Track Designation has also been granted for RA. In Phase 1 data reported for LN and SLE patients, Adicet highlighted rapid and sustained reductions in SLEDAI‑2K and Physician’s Global Assessment scores, improved renal function in LN patients, and a safety profile characterized by no observed Immune Effector Cell‑Associated Neurotoxicity Syndrome (ICANS) and only Grade 1 cytokine release syndrome in a subset of patients, as of an August 31, 2025 data cut.

The company further reports that all LN and SLE patients in the initial Phase 1 cohort discontinued immunosuppressants and either discontinued or tapered corticosteroids to physiological levels after a single dose of ADI‑001, and that the therapy demonstrated hallmarks of an immune reset with emergence of naïve and previously undetected B cell repertoires.

Autoimmune disease development strategy

Adicet’s disclosures describe a Phase 1 autoimmune program with four arms enrolling LN and SLE, SSc, IIM and SPS, and AAV, with a separate Phase 1 study in treatment‑refractory RA. The primary objectives across these studies are to evaluate safety and tolerability of ADI‑001/prula‑cel, with secondary objectives that include cellular kinetics, pharmacodynamics, changes in autoantibody titers, and disease activity scores. The company has also reported alignment with the FDA to enable outpatient dosing of SLE and LN patients in ongoing and future clinical trials.

In RA, Adicet is conducting a Phase 1 study evaluating two conditioning regimens, cyclophosphamide alone and cyclophosphamide with fludarabine, to explore how conditioning may affect the overall therapeutic experience. The company indicates that this RA study is part of a broader initiative to develop a portfolio of therapies for autoimmune patients, including preclinical gene‑edited CAR T and in vivo CAR T programs targeting B cells with the potential to reduce or eliminate the need for conditioning.

Oncology and solid tumor programs

Beyond autoimmune indications, Adicet reports work in oncology. Its disclosures describe ADI‑212 as a next‑generation, gene‑edited and armored gamma delta CAR T clinical candidate designed to target prostate‑specific membrane antigen (PSMA) in metastatic castration‑resistant prostate cancer (mCRPC). ADI‑212 is engineered to express a novel CAR binder intended to support tumor‑specific recognition and tolerability, and to integrate membrane‑tethered IL‑12 armoring together with CRISPR/Cas9‑mediated disruption of subunit 12 of the mediator complex (MED12). According to the company, these design elements are intended to enhance potency in solid tumors and deliver multiple anti‑tumor mechanisms of action within the tumor microenvironment.

Adicet has presented preclinical data for ADI‑212 at a prostate cancer scientific meeting, stating that the data support the candidate’s design and functional enhancements in multiple disease models. The company has also disclosed plans to advance ADI‑212 into regulatory review for mCRPC.

In addition, Adicet previously advanced ADI‑270, described as an armored gamma delta CAR T product candidate targeting renal cell carcinoma and other CD70+ malignancies. Company filings state that ADI‑270 was evaluated in a Phase 1 trial in clear cell renal cell carcinoma (ccRCC) and showed a disease control rate and evidence of tumor exposure and expansion, with a favorable tolerability profile. However, Adicet has announced a strategic pipeline prioritization under which development of ADI‑270 has been discontinued, with resources redirected to ADI‑001 and ADI‑212.

Corporate and capital markets context

Adicet Bio’s common stock trades on the Nasdaq Capital Market under the symbol ACET. The company has reported actions related to its listing status, including a Nasdaq notice regarding minimum bid price requirements and a transfer from the Nasdaq Global Market to the Nasdaq Capital Market, as well as a board‑approved reverse stock split intended to support compliance with listing standards. Adicet has also disclosed registered direct offerings of common stock and pre‑funded warrants, with net proceeds used to extend its cash runway and support ongoing clinical and preclinical programs.

Company communications describe workforce reductions and strategic pipeline prioritization measures, including the discontinuation of ADI‑270, as part of efforts to focus resources on assets that Adicet believes have the greatest potential for clinical and commercial success, notably ADI‑001/prula‑cel in autoimmune diseases and ADI‑212 in oncology.

Regulatory filings and governance

Through its SEC filings, including Form 8‑K reports and a definitive proxy statement, Adicet provides information on material events such as clinical data announcements, financing transactions, listing status updates, and corporate actions like reverse stock split proposals. The proxy statement for a special meeting of stockholders describes proposals to approve an amendment to the company’s certificate of incorporation to effect a reverse stock split within a specified range and, if needed, to adjourn the meeting to solicit additional proxies.

These filings also outline voting procedures for stockholders of record and beneficial owners, the use of virtual shareholder meeting platforms, and the mechanics of submitting and revoking proxies. Together, they provide insight into Adicet’s corporate governance practices and its approach to engaging with stockholders on capital structure decisions.

Position within the biotechnology landscape

According to its own descriptions, Adicet Bio is focused on gamma delta CAR T cell science applied to both autoimmune disease and oncology. Its work centers on allogeneic, off‑the‑shelf cell therapies that target B cells and tumor antigens, with an emphasis on clinical programs in LN, SLE, SSc, IIM, SPS, AAV, RA and mCRPC. The company’s disclosures highlight a combination of early clinical data, regulatory designations, and preclinical engineering strategies such as gene editing and cytokine armoring as key elements of its development efforts.