Adicet Bio ACET continues to make steady progress with prula-cel/prulacabtagene leucel (formerly known as ADI-001),the company’s lead product candidate and primary clinical value driver in autoimmune diseases. It is a first-in-class investigational allogeneic gamma delta CAR T cell therapy currently being developed in early-stage studies for multiple indications such as lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) and rheumatoid arthritis (RA).
The FDA previously granted prula-cel Fast Track Designation for the treatment of relapsed/refractory class III or class IV LN, refractory SLE with extrarenal involvement and SSc.
The company expects to report an updated phase I clinical dataset in the third quarter of 2026 from patients with LN and SLE, including participants with at least 12 months of follow-up.
Adicet Bio, Inc. Price and Consensus
Adicet Bio, Inc. price-consensus-chart | Adicet Bio, Inc. Quote
Adicet held productive discussions with the FDA regarding the overall design of a potential pivotal study in LN. The company is advancing the start-up activities with the pivotal program expected to commence in the second half of 2026, subject to regulatory clearance, with further details anticipated in the third quarter of 2026.
Beyond LN and SLE, Adicet plans to provide additional clinical updates for prula-cel in SSc during the second half of 2026.
The phase I study of prula-cel in RA is evaluating two lymphodepletion regimens, cyclophosphamide alone and cyclophosphamide combined with fludarabine. An update from the study is expected in the second half of 2026.
These developments could broaden the potential addressable market for prula-cel if clinical results continue to support its approach.
Year to date, shares of Adicet have risen 9.2% compared with the industry’s 11.1% growth.
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ADI-212 Adds Solid-Tumor Potential
ACET’s pipeline is not solely dependent on autoimmune disease. ADI-212, a next-generation, gene-edited and armored cell therapy candidate targeting metastatic castration-resistant prostate cancer (mCRPC), represents another potential value driver. The company expects to submit a regulatory filing in the third quarter of 2026 and begin phase I enrollment in the fourth quarter of 2026, subject to regulatory clearance. ADI-212 is designed with multiple mechanisms intended to enhance antitumor activity within the solid-tumor microenvironment, giving ACET exposure to another large therapeutic opportunity.
In Vivo CAR-T Platform Creates Additional Upside
The company is developing a differentiated in vivo CAR-T platform targeting both hematologic malignancies and solid tumors. Adicet plans to provide a comprehensive update on the platform and pipeline in the second half of 2026. Successful development could broaden the company's pipeline beyond its current programs and create additional long-term value-creation opportunities.
ACET's Zacks Rank & Estimates
Adicet currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 30 days, estimates for ACET’s 2026 loss per share have narrowed from $8.61 to $6.76, while 2027 estimates for loss per share have widened from $3.71 to $5.64.
Other Stocks to Consider
Some other top-ranked stocks in the biotech sector are Amneal Pharmaceuticals AMRX and Precigen PGEN, currently sporting a Zacks Rank #1(Strong Buy) each, while AC Immune ACIU carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings per share estimates for Amneal Pharmaceuticals have increased from $1.00 to $1.02 for 2026. Over the same period, estimates for earnings per share increased from $1.12 to $1.21 for 2027. AMRX shares have risen 42.1% year to date.
Amneal Pharmaceuticals beat earnings in each of the trailing four quarters, delivering an average surprise of 32.82%.
Over the past 30 days, estimates for Precigen’s 2026 loss per share have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have increased 72.3% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 30 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have declined 7.7% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
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