On January 8, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel payloads, reported that Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics will present at the 2026 Biotech Showcase being held from January 12-14, 2026 in San Francisco, CA.

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Presentation details are as follows:

Date/Time: Tuesday, January 13, 2026 at 9:30 AM PST

Location: Yosemite A (Ballroom Level)

In addition to the presentation, management will be available to participate in in-person one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

(Press release, Akari Therapeutics, JAN 8, 2026, View Source [SID1234661843])

On January 8, 2026 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported corporate updates and highlights from its ZYNLONTA clinical program.

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"During 2025, we delivered meaningful progress across our ZYNLONTA clinical program and extended our expected cash runway at least to 2028," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "This year, we look forward to multiple clinical catalysts including full results from our LOTIS-5 and LOTIS-7 2L+ DLBCL trials, as well as potentially from the ongoing Phase 2 indolent lymphoma IITs. Assuming positive results, we anticipate potential compendia inclusion for each in the first half of 2027 with LOTIS-5 regulatory approvals to follow. Taken together, we anticipate we will see an acceleration in net product revenue growth beginning in 2027."

Recent Highlights and Developments

Preliminary unaudited 2025 selected financial results. ZYNLONTA net product revenue is expected to be approximately $73 million for full year 2025 compared with $69.3 million for full year 2024. Fourth quarter 2025 ZYNLONTA net product revenue is expected to be approximately $22 million, as compared to $16.4 million in the fourth quarter of 2024, primarily reflecting variability in customer ordering. Underlying demand for ZYNLONTA in the current 3L/3L+ DLBCL indication remained broadly stable year-over-year. The Company ended 2025 with cash and cash equivalents of approximately $261 million which, based on current plans, is expected to provide a cash runway at least to 2028.

Reported updated data from LOTIS-7 in December 2025. Updated data from the LOTIS-7 Phase 1b clinical trial evaluating the safety and efficacy of ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) demonstrated an 89.8% best overall response rate (ORR) and a 77.6% complete response rate across 49 efficacy evaluable patients with a minimum of 6 months follow-up. Enrollment in the LOTIS-7 trial is ongoing, with complete enrollment of approximately 100 patients at the selected 150 µg/kg dose expected during the first half of 2026. The Company plans to share full data at a medical meeting and through publication by the end of 2026. In addition, the Company plans to assess regulatory and compendia strategies in the first half of 2027.

LOTIS-5 topline results anticipated in 2Q 2026. The Company expects to provide topline data in 2Q 2026 from the LOTIS-5 Phase 3 confirmatory trial of ZYNLONTA in combination with rituximab in patients with 2L+ DLBCL once the pre-specified number of approximately 262 progression-free survival (PFS) events is reached and data are available. Publication of the full results is anticipated by the end of 2026. Assuming positive results, a supplemental Biologics License Application (sBLA) submission to the U.S. FDA will follow, with potential compendia inclusion in the first half of 2027 and confirmatory approval in 2L+ DLBCL in mid-2027.

Investigator-initiated trials (IITs) of ZYNLONTA in indolent lymphomas ongoing. Initial data from the Phase 2 clinical trial evaluating ZYNLONTA in combination with rituximab to treat relapsed or refractory (r/r) follicular lymphoma (FL) and the Phase 2, single-arm, open-label, multicenter trial of ZYNLONTA to treat r/r marginal zone lymphoma (MZL) led by the Sylvester Comprehensive Cancer Center at University of Miami have shown promising efficacy and manageable safety results. The Company anticipates publication of both data sets as early as the end of 2026. Assuming positive data, the Company plans to assess regulatory and compendia strategies.

IND-enabling activities completed for PSMA-targeting ADC. IND-enabling activities for the Company’s exatecan-based, prostate-specific membrane antigen (PSMA)-targeting ADC were completed at the end of 2025. The Company continues to explore partnership opportunities.

(Press release, ADC Therapeutics, JAN 8, 2026, View Source [SID1234661842])

On January 7, 2026 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage oncology company, reported that management will provide an update on 2026 priorities and program milestones during the Company’s presentation at the 44th Annual J.P. Morgan Healthcare Conference on January 12th, 2026 at 3:45pm in San Francisco, CA.

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"Last year was transformative for Terns as we completed our transition to an oncology company anchored by our allosteric BCR-ABL inhibitor, TERN-701, for CML. Following compelling TERN-701 data at ASH (Free ASH Whitepaper) in December, and our subsequent capital raise, we are in a strong position to advance TERN-701 towards pivotal trial initiation. Based on accelerating momentum in our CARDINAL trial, our goal for pivotal trials is to enroll patients more quickly than historical precedents in CML and to generate data that further strengthen the position of TERN-701 as a potential best-in-disease therapy across all lines of CML treatment," said Amy Burroughs, chief executive officer of Terns. "We believe that reaffirming clinical differentiation and advancing to product launch rapidly will be key factors to maximize the therapeutic and commercial potential of TERN-701," added Ms. Burroughs.

Anticipated 2026 Priorities and Key Milestones

TERN-701: Oral, allosteric BCR-ABL tyrosine kinase inhibitor (TKI) for chronic myeloid leukemia (CML)

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Anticipated 2026 milestones for TERN-701 include:

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Selection of pivotal dose in mid-2026

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End of Phase 2 regulatory interaction with U.S. FDA in mid-2026

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Updated and expanded CARDINAL data by second half of 2026

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Initiation of first pivotal trial (2L+ population) in late 2026 / early 2027

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Preliminary study design anticipates evaluation of TERN-701 vs control arm of investigator’s choice 2 nd generation TKI (dasatinib, nilotinib, bosutinib) with major molecular response (MMR) at six months as the primary endpoint

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New cohort added to the ongoing CARDINAL Phase 1/2 study to evaluate TERN-701 500mg QD in approximately 20 patients with BCR-ABL resistance mutations including T315I, M244V, F359I/C/V and others

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At the 67th ASH (Free ASH Whitepaper) Annual Meeting in December 2025, Elias Jabbour, MD, Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, presented unprecedented safety and efficacy data from the CARDINAL trial

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CARDINAL enrolled a predominantly 3L+ patient population with 38% of patients having received prior asciminib of whom 75% discontinued due to lack of efficacy

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TERN-701 showed an encouraging safety profile (N=63)

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87% (55/63) of patients remained on treatment as of the data cutoff

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No dose-limiting toxicities were observed in dose escalation, and a maximum tolerated dose was not reached

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The majority of treatment-emergent adverse events (TEAEs) were low grade with no apparent dose relationship

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Grade 3 or higher TEAEs were all less than 10%, most commonly neutropenia (8%) and thrombocytopenia (8%)

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Unprecedented efficacy with MMR achievement rate by 24 weeks of 75% (18/24) in evaluable patients enrolled at the recommended phase 2 dose range of >320mg QD, trending 2-3X higher than asciminib in Phase 1 and Phase 3 studies evaluating a 3L+ patient population

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Deep molecular response (DMR) achievement rate by 24 weeks of 36% (10/28)

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Encouraging MMR rates in patients with prior asciminib (n=10)

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Overall MMR rate of 60% (6/10), with 43% (3/7) achieving MMR and 100% (3/3) maintaining MMR

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Enrollment has accelerated with 85+ patients enrolled as of December 8, 2025

Other Pipeline Programs

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Discovery efforts are underway on undisclosed targets for oncology indications

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Terns is seeking a strategic partner to advance the TERN-501 and TERN-801 legacy metabolic programs

Corporate Updates

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In December 2025, Terns completed an upsized public offering of 18,687,500 shares of its common stock, generating gross proceeds of approximately $747.5 million before deducting underwriting discounts and commissions and other offering expenses

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Unaudited cash, cash equivalents and marketable securities for the year ended December 31, 2025, of approximately $1.0 billion expected to provide cash runway into 2031, including the first potential approval and launch of TERN-701

A live webcast of the Company’s J.P. Morgan Healthcare Conference presentation will be available on the investor relations page of Terns’ website at View Source A replay of the webcast will be archived on Terns’ website for at least 30 days following the presentation.

(Press release, Terns Pharmaceuticals, JAN 7, 2026, View Source [SID1234661903])

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 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])