On December 24, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported the acceptance of an abstract on the Co-PSMA (NCT06907641)1 Investigator-Initiated Trial (IIT), led by Prof Louise Emmett at St Vincent’s Hospital Sydney, for oral presentation at the upcoming European Association of Urology (EAU) Congress 2026, Europe’s biggest urological conference, to be held 13-16 March 2026 in London, UK2.

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Co-PSMA’s official study title is "Comparative performance of 64Copper [64Cu]-SAR-bisPSMA vs. 68Ga-PSMA-11 PET CT for the detection of prostate cancer recurrence in the setting of biochemical failure following radical prostatectomy". This Phase II IIT evaluated the performance of Clarity’s diagnostic product, 64Cu-SAR-bisPSMA, in a head-to-head comparison to standard-of-care (SOC) 68Ga-PSMA-11 in 50 patients with low prostate-specific antigen (PSA) who were candidates for curative salvage therapy. Eligible patients were required to have had radical prostatectomy with no salvage therapy and a PSA level between 0.2 and 0.75 ng/mL.

The results to be presented by Prof Emmett at the EAU Congress 2026 will expand on the earlier findings that the trial met its primary endpoint, demonstrating that 64Cu-SAR-bisPSMA positron emission tomography (PET) / computed tomography (CT) detected significantly more lesions per patient than the SOC, 68Ga-PSMA-11 PET/CT3. These results further build on the growing body of evidence showing that 64Cu-SAR-bisPSMA improves the detection of prostate cancer, compared to the current SOC prostate-specific membrane antigen (PSMA) PET agents which are known to have low sensitivity, especially in patients with low PSA levels4,5.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "64Cu-SAR-bisPSMA has been purposely developed at the benchtop to overcome the many shortfalls of the current SOC PSMA imaging agents. With the molecule only being invented some 7 years ago, we have already demonstrated at the cellular level, in animal models and now in multiple clinical trials, that 64Cu-SAR-bisPSMA is clearly differentiated from the competitors. In a very short amount of time, we have moved from invention to two registrational Phase III trials, both to complete recruitment next year, continuing to build on strong evidence generated to date of the improved diagnostic performance of our product through various clinical trials and real-world evidence (compassionate use supply). We reported earlier that our optimised agent detects more lesions in this IIT head-to-head comparison against the SOC product3. We also know that 64Cu-SAR-bisPSMA identifies more as well as smaller lesions and was able to do so earlier than SOC PSMA PET agents in our Phase II COBRA trial6. The full results from Co-PSMA will again reinforce the mounting data showing how 64Cu-SAR-bisPSMA can outperform SOC PSMA PET products.

"We are committed to a rigorous scientific and clinical development process, which has delivered exceptional results to date. The acceptance of the Co-PSMA data by this world-leading urology conference for an oral presentation is a testament to its strength and quality. This recognition not only highlights the impact of this research but also underscores the significant potential of 64Cu-SAR-bisPSMA to advance PSMA imaging and improve prostate cancer management. The abstract summary will be announced in mid-February, followed by the oral presentation in mid-March 2026.

"Prof Emmett is a global key opinion leader in the field of urologic nuclear medicine, with a strong track record of highly regarded scientific publications as well as extensive clinical experience. We are honoured to continue working together on our registrational AMPLIFY7 and CLARIFY8 trials and trust that her unique expertise and commitment to providing the best available patient care will help us to get closer to our mutual goal of improving detection and treatment paradigm for prostate cancer patients.

"With two US Food and Drug Administration (FDA) Fast Track Designations for 64Cu-SAR-bisPSMA and two ongoing registrational trials, we are extremely excited to enter the USD 2 billion PSMA PET imaging market as it is further expected to grow to over USD 3 billion by 2029 with not only a clearly differentiated agent, but also a product with substantial logistical benefits over the current competitors."

(Press release, Clarity Pharmaceuticals, DEC 24, 2025, View Source [SID1234661608])

On December 23, 2025 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies based on its proprietary Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, reported a program update on its ongoing Phase 1 study evaluating JANX008, its EGFR-targeted TRACTr, in multiple solid tumor indications.

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JANX008 is being evaluated in an ongoing Phase 1 study (NCT05783622) designed to assess safety, pharmacokinetics/pharmacodynamics, and evidence of clinical activity. The Phase 1a dose-escalation portion of the study has been completed, and the program has initiated expansion cohorts to enable further evaluation and support continued dose optimization across selected solid tumor settings.

Janux expects to provide additional updates on JANX008 as the study progresses and data continue to mature.

(Press release, Janux Therapeutics, DEC 23, 2025, View Source [SID1234661618])

On December 23, 2025 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported it will participate in the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, with a presentation at 7:30 am PST.

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Live webcasts of these events can be accessed from the investors section of the Company’s website at View Source, View Source, View Source Archived replays will be available on the Company’s website.

(Press release, BeOne Medicines, DEC 23, 2025, View Source [SID1234661619])

On December 23, 2025 Henlius reported that the 44th J.P. Morgan Healthcare Conference will take place from January 12 to 15, 2026, in San Francisco, USA. Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius (2696.HK), has been invited to attend and will deliver a keynote presentation on January 15 (PST).

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Recognized as one of the world’s largest and most influential healthcare investment and industry conferences, the J.P. Morgan Healthcare Conference is widely regarded as a bellwether for global pharmaceutical and healthcare innovation and capital trends. The event brings together industry leaders, fast-growing emerging companies, technology innovators, and global investors, with more than 8,000 participants expected to convene in San Francisco to explore cutting-edge developments and partnership opportunities.

At the conference, Dr. Zhu will outline the core competencies Henlius has built throughout its internationalisation journey, share updates on the company’s innovative pipeline and next-generation technology platforms—including antibody-drug conjugates (ADCs) and multispecific T-cell engagers (TCEs)—and present Henlius’ strategic outlook for the next five years. Leveraging an integrated platform spanning R&D, manufacturing, regulatory affairs, and commercialisation, Henlius has evolved from an early-stage biotech into a scaled, globally operating biopharmaceutical company with an established international footprint. Henlius has established dedicated clinical development, operations, and regulatory teams in key markets including the United States and Japan, enabling independent clinical trial execution and direct engagement with global regulatory authorities to accelerate localized development and market access. In addition, the company’s commercial manufacturing facilities have obtained GMP certifications in China, the EU, and the United States, with a global supply network that now spans six continents. Through the coordinated advancement of differentiated innovation assets and diversified technology platforms, Henlius continues to deepen its global market presence while building long-term strategic partnerships with leading multinational pharmaceutical companies, forming a sustainable and scalable global development model.

Looking ahead, Henlius will remain focused on addressing unmet patient needs worldwide. By working closely with global capital markets and industry partners, the company aims to further strengthen its global innovation and operational capabilities and to build a globally competitive, patient-centric biopharma, delivering high-quality and affordable biologic medicines to patients around the world.

(Press release, Shanghai Henlius Biotech, DEC 23, 2025, View Source [SID1234661620])

On December 23, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel payloads reported the initiation of GMP manufacturing activities to support the development of AKTX-101, the Company’s lead ADC program.

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Akari has selected WuXi XDC, the world’s leading ADC contract development and manufacturing organization (CDMO), as its partner for this critical and necessary IND-enabling work to support the initiation of clinical trials. WuXi XDC is globally recognized for its end-to-end ADC development and manufacturing capabilities and deep expertise in producing large numbers of ADCs that are currently in clinical development.

The initiation of this key manufacturing activity marks a significant advancement for AKTX-101, which incorporates Akari’s novel proprietary payload PH1 that works through RNA splicing modulation. The PH1 payload represents a differentiated approach to ADC design and brings a 1-2 punch of cytotoxicity and immuno-oncology action that has the potential to significantly increase the therapeutic impact of ADCs beyond today’s current options.

"Initiating GMP manufacturing of AKTX-101 is an important milestone for Akari and for AKTX-101 as we look to demonstrate the potential of our PH1 ADC payload in treating cancer patients," said Abizer Gaslightwala, President and CEO of Akari Therapeutics. "Advancing this critical project with WuXi XDC reflects our confidence in the science behind AKTX-101 and our path to the clinic. To have WuXi XDC as our key partner adds to our confidence of reaching the clinical trials quickly and efficiently and with the highest quality. This key work lays the foundation for our planned Phase 1 first-in-human study in approximately 12 months."

WuXi XDC also highlighted the importance of the collaboration with Akari and the innovative nature of Akari’s ADC payload, PH1:

"We are excited to work with Akari Therapeutics on the manufacturing of AKTX-101," said Dr. Jimmy Li, CEO of WuXi XDC. "The PH1 payload represents a novel and potentially high impact innovation in the ADC field, and we look forward to leveraging our integrated ADC platform to support the production of high-quality GMP material and help advance this promising program toward the clinic. We believe this first project with Akari could lay the groundwork for multiple ADC programs that utilize this novel payload."

Akari and WuXi XDC are building a strategic partnership around AKTX-101, combining Akari’s innovative ADC design and payload technology with WuXi’s global leadership in ADC development and manufacturing. The resulting GMP-grade drug product is intended to support Akari’s planned Phase 1 first-in-human clinical trial, which the Company expects to initiate in late 2026 or early 2027, subject to regulatory clearance.

This manufacturing milestone underscores Akari’s continued progress in advancing its pipeline and executing on its strategy to develop differentiated ADC therapies using novel payloads that have the potential to significantly improve outcomes for cancer patients.

(Press release, Akari Therapeutics, DEC 23, 2025, View Source [SID1234661605])