On January 7, 2026 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported corporate updates and highlighted upcoming milestones for 2026.

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"Heading into 2026, we are proud of the strong execution across our pipeline. Since reporting data in October from our prula-cel Phase 1 program in autoimmune diseases, enrollment has more than doubled with over 20 patients as of December 31, 2025. We have also reached regulatory alignment with the FDA to enable outpatient dosing of SLE and LN patients receiving prula-cel and are advancing our Phase 1 study in treatment-refractory RA comparing prula-cel following cyclophosphamide alone versus cyclophosphamide/fludarabine conditioning. Taken together, these accomplishments set the stage for a meaningful data readout expected in the first half of 2026," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "In parallel, we continue to advance our broader pipeline, including ADI-212, our next-generation, gene-edited and armored solid tumor candidate, which is advancing towards a regulatory filing in the first half of 2026. These achievements strongly position us as we prepare for a pivotal study and continue to advance our pipeline."

Recent Pipeline Progress and Operational Progress:

Autoimmune Diseases Clinical Programs

The prula-cel Phase 1 program is enrolling patients across seven different autoimmune diseases: LN, SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS), AAV and treatment-refractory RA. Prula-cel has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of relapsed/refractory class III or class IV LN, refractory SLE with extrarenal involvement, and SSc.
In November 2025 the Company reached alignment with the FDA to allow LN and SLE patients to be dosed with prula-cel in the outpatient setting in ongoing and future clinical trials.
In October 2025, Adicet announced the dosing of the first treatment-refractory RA patient in a Phase 1 study. The study will evaluate two conditioning regimens: cyclophosphamide alone and cyclophosphamide with fludarabine. The primary objectives of the study are to evaluate the safety and tolerability of prula-cel. Secondary objectives include measuring cellular kinetics, pharmacodynamics, and disease activity scores.
In October 2025, the Company reported positive preliminary safety and efficacy data from the Phase 1 clinical trial of prula-cel in patients with LN and SLE. The data highlighted rapid and sustained reductions in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score and Physician’s Global Assessment (PGA), improved renal function, and favorable safety and tolerability profile as of the August 31, 2025 data cut-off date.
Solid Tumor Clinical Programs

Adicet is continuing to advance preclinical development of ADI-212, a next-generation gene-edited and armored clinical candidate designed to target prostate-specific membrane antigen. ADI-212 is engineered to express a novel CAR binder designed to support enhanced tolerability and tumor-specific recognition. It integrates membrane-tethered IL-12 armoring and CRISPR/Cas9 mediated disruption of subunit 12 of the mediator complex (MED12) to enhance potency in solid tumors and deliver multiple anti-tumor mechanisms of action within the tumor microenvironment.
In October 2025, Adicet presented preclinical data from ADI-212 at the 32nd Annual Prostate Cancer Foundation Scientific Retreat supporting its design elements and functional enhancements in multiple models of disease.
Corporate Updates

In October 2025, Adicet successfully raised approximately $74.8 million in net proceeds through an underwritten registered direct offering of equity securities, extending its cash runway into the second half of 2027.
Strategic Priorities and Anticipated Key Milestones for 2026

Present new and updated clinical data from the Phase 1 study evaluating prula-cel throughout 2026.

Adicet remains on track to share a clinical update in LN, SLE, and SSc in the first half of 2026.
The Company also expects to share another clinical update from the study in the second half of 2026.
Gain alignment with the FDA on a path to registration for prula-cel.

Adicet plans to request a meeting with the FDA in the second quarter of 2026 to inform potential pivotal trial design. Subject to regulatory clearance to proceed, the Company expects to initiate a pivotal study in LN or LN and SLE patients in the second half of 2026.
Advance innovations designed to enhance patient experience and expand access.

The Company is actively enrolling patients with treatment-refractory RA in its Phase 1 study of prula-cel evaluating the potential to reduce the need for conditioning.
Adicet expects to provide a clinical update on the Phase 1 RA study in the second half of 2026.
Initiate clinical development of ADI-212 in mCRPC.

Adicet expects to submit a regulatory filing for ADI-212 for the treatment of mCRPC in the first half of 2026.
Subject to regulatory clearance to proceed with a clinical trial, the Company expects to initiate clinical startup activities in the second quarter of 2026.

(Press release, Adicet Bio, JAN 7, 2026, View Source [SID1234661828])

On January 7, 2026 Emergent BioSolutions Inc. (NYSE: EBS) reported that Joe Papa, president and chief executive officer, will provide a company presentation during the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026 at 5:15 PM PST.

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The audio link for Emergent’s session may be accessed here and will be live for up to 30 days.

The Company’s slides will be made available at the time of the presentation on the Investors section of the Emergent website.

(Press release, Emergent BioSolutions, JAN 7, 2026, View Source [SID1234661798])

On January 7, 2026 Soley Therapeutics ("Soley") reported a $200 million Series C financing to advance its proprietary cell stress sensing platform and pipeline of novel therapeutics into the clinic. Proceeds will support IND-enabling work and clinical trials for two first-in-class internally discovered and developed oncology assets, in addition to advancement of the non-oncology stress-reducing drug candidates for neurodegenerative disorders and metabolic diseases, and continued platform scale-up.

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New investors in this round included Surveyor Capital as primary investor, joined by HRTG Partners, RWN Management, and others. Existing Soley investors, including Doug Leone Family Fund, Breyer Capital, and GordonMD Global Investments LP, and other undisclosed investors also participated.

The Soley platform captures time-resolved responses across thousands of features in human cells, then uses proprietary computer vision and AI to convert those features into compact, structured signatures. It screens hundreds of thousands of compounds per week, generates reproducible data at scale in-house using first-in-class automation and robotics, and trains proprietary AI/ML models, to accelerate hit finding, mechanistic insights, and molecule design.

"We built Soley to measure how living human cells, in health and disease, respond to drug exposure and determine their fate. We then translate this cellular information into a robust portfolio of novel drug candidates across a broad range of disease areas and indications," said Yerem Yeghiazarians, M.D., Co-founder and CEO of Soley Therapeutics. "We are thrilled by the strong investor support from life sciences and technology focused funds as we advance our lead programs into the clinic and expand our platform to continue building a first-in-class pipeline."

(Press release, Soley Therapeutics, JAN 7, 2026, View Source [SID1234661813])

On January 7, 2026 Curadel Pharma, a pioneer in zwitterionicity and innovator in advanced radiotherapies and imaging drugs, reported that CPI-008 (cRGD-ZW800-1), a novel integrin-targeted, zwitterionic imaging drug for margin detection of pancreatic cancer during surgery, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

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"Receiving orphan designation from both the FDA and the EMA is a profoundly important milestone for Curadel, granting us valuable incentives to fuel our development efforts," said John V. Frangioni, MD, PhD, Curadel founder and CEO. "As a pioneering company working to introduce significant advances in surgical imaging, the efficiencies of fee exemptions, credits, along with the potential for market exclusivity are vital tools to help us smartly deploy our resources and focus on delivering value to the surgical community."

In the U.S., FDA grants ODD to therapeutic candidates for conditions affecting fewer than 200,000 people in the U.S. This designation provides incentives to advance clinical development including exemption from user fees, tax credits for qualified clinical trials, and potential for up to seven years of U.S. market exclusivity if the product is approved for its designated indication. Similarly, EMA’s designation includes incentives including protocol assistance, reduced regulatory fees, and potential for early access conditional approvals, as well as market exclusivity up to 10 years if approved.

Pancreatic cancer remains one of the most challenging cancers to treat, and current imaging tools are not fully effective in helping to identify the full extent of cancerous cells to allow for full removal during surgical procedures. By enhancing surgeons’ ability to accurately visualize cancerous cells, Curadel’s technology could become an important asset in the surgical suite to optimize outcomes not only for pancreatic cancer patients, but potentially for other tumor types as well.

CPI-008 has demonstrated strong imaging capabilities in investigator-initiated Phase 2 studies in multiple cancers including pancreatic cancer, head and neck cancer, and colorectal cancer. As part of its strategic pipeline curation, Curadel is evaluating out-licensing opportunities for the program, offering a highly differentiated technology that potential partners can leverage to expand leadership in the competitive imaging market.

(Press release, Curadel Pharma, JAN 7, 2026, View Source [SID1234661829])

On January 6, 2026 Convergent Therapeutics Inc., a clinical-stage biotechnology company focused on the development of next-generation radiopharmaceuticals for the treatment of cancer, and NorthStar Medical Radioisotopes (NorthStar), a leading radiopharmaceutical company, reported an expanded agreement under which Convergent will support its drug development and clinical batch production with dedicated manufacturing suites on NorthStar’s Beloit, Wisconsin campus.

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Co-locating Convergent’s manufacturing at NorthStar establishes an integrated and reliable supply chain for CONV01-α drug product production with Ac-225, relieving supply constraints for alpha-based radiotherapies and supporting Convergent’s ongoing clinical trials through to commercial production.

"The relationship with NorthStar enables us to fully realize the potential of our leading radioantibody program as we demonstrate the advantages of alpha emitters in addressing metastatic castration-resistant prostate cancer (mCRPC) and the significant need for new, safer, and more effective therapies for patients. With secured Ac-225 supply, clinical proof-of-concept, and potential best-in-class efficacy and tolerability, CONV01-α is well-positioned to advance mCRPC treatment," said Convergent CEO and Co-Founder Philip Kantoff, M.D. "Our strategic investment in manufacturing will support late-stage monotherapy studies of CONV01-α, and additional trials to assess CONV01-α in earlier stages of prostate cancer and in combination with other therapeutics."

CONV01-α, Convergent’s lead program for mCRPC and other radiopharmaceuticals in its pipeline, leverage the power and precision of alpha-emitting isotopes. NorthStar recently announced it now produces alpha radioisotopes for therapeutic applications at scale, with Convergent as a key customer for Ac-225. Reliable Ac-225 supply further supports Convergent’s ability to deliver the next generation of alpha-based radiotherapies, building on the precision and tolerability advantages demonstrated in clinical trials to date with CONV01-α.

"We are pleased to expand our partnership with Convergent," said Frank Scholz, President and CEO of NorthStar Medical Radioisotopes, LLC. "This agreement underscores the value of our integrated campus designed to reduce complexity and create a robust, reliable supply chain to deliver patient-ready drugs."

In August 2024, NorthStar and Convergent announced a strategic contract manufacturing services agreement to provide Convergent with Ac-225 for use in CONV01-α and to utilize NorthStar’s new state-of-the-art contract development and manufacturing facility to manufacture CONV01-α for Convergent’s clinical trials and perform research and development activities.

"Having drug product and Ac-225 supply co-located on the NorthStar campus provides a unique advantage for our supply chain, enabling greater efficiencies, flexibility, and cost savings, as we leverage NorthStar’s extensive track record in radiopharmaceutical manufacturing," said Caitlyn Harvey, Head of Manufacturing at Convergent. "Their leadership in producing alpha emitters for radiotherapies ensures critical production capabilities and access to Ac-225 are in place for pivotal studies through commercial launch and beyond."

About CONV01-α
CONV01-α is a PSMA-targeted Ac-225 radioantibody that pairs antibody precision with the localized potency of alpha radiation. CONV01-α, which is being developed to improve the treatment of metastatic castration-resistant prostate cancer (mCRPC), uses a humanized monoclonal antibody directed at prostate-specific membrane antigen (PSMA), a well-established and highly expressed antigen in prostate cancer. CONV01-α is differentiated by its ability to precisely deliver Actinium-225 (Ac-225) through this PSMA-targeting antibody, enabling short-range, high-energy alpha particle radiation that creates focused DNA damage within tumor cells while limiting exposure to surrounding tissues. Initial studies in more than 120 patients have established clinical proof-of-concept for CONV01-α, showing consistent antitumor activity and a differentiated safety profile. This selectivity, combined with strong tumor retention and minimal salivary and renal uptake, supports the potential of CONV01-α to be a clinically impactful therapy for PSMA-positive cancers.

(Press release, Convergent Therapeutics, JAN 6, 2026, https://convergentrx.com/convergent-therapeutics-and-northstar-medical-radioisotopes-announce-expanded-partnership-to-support-convergents-late-stage-alpha-emitting-radioantibody-program/ [SID1234661750])