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Clarity signs a large-scale Manufacturing Supply Agreement for copper-64 with Theragenics

On March 25, 2026 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 signing of a large-scale Manufacturing Supply Agreement for copper-64 with Theragenics.

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The agreement relates to Theragenics’ 134,000 square foot production facility with a fleet of 14 cyclotrons close to Atlanta, Georgia, a major US transport hub, for centralised, large-scale copper-64 (Cu-64 or 64Cu) production ahead of anticipated 64Cu-SAR-bisPSMA commercial launch upon successful completion of Clarity’s Phase III registrational trials with this product, AMPLIFY1 and CLARIFY2, and subsequent US Food and Drug Administration (FDA) New Drug Application (NDA) approval.

Theragenics have substantial cyclotron expertise with 40 years of routine radiometal production and considerable experience in production of radioisotopes for medical use. Combined with a sizeable fleet of high-current cyclotrons, this constitutes an opportunity for large-scale copper-64 manufacturing at the site. Theragenics have capacity to produce around 100Ci (3.7 TBq) of copper-64 per day on a single cyclotron, which translates into around 2,000 patient doses per day on each cyclotron at 200 MBq per dose with a 48-hour shelf life. Together with Clarity’s existing copper-64 supply agreements with SpectronRx and Nusano, this agreement with Theragenics further enhances Clarity’s broad network of high-volume copper-64 manufacturers in distinct US geographies. The network is designed to support commercial-scale demand across multiple large oncology indications with secure, seamless and abundant supply of this diagnostic isotope, made possible with the 12.7-hour half-life of copper-64, which is unique in the radiopharmaceutical commercial space.

Mark Pugh, CEO of Theragenics, commented, "We are excited to enter into this Manufacturing Supply Agreement for copper-64 with Clarity. Having a current commercial sales force in prostate cancer, we have a deep insight into this field and have seen the excitement from key opinion leaders around 64Cu-SAR-bisPSMA. This agreement continues our expansion into the contract manufacturing organisation (CMO) isotope market, and we see Clarity as an ideal partner to advance this vision. Clarity is in a unique position with two diagnostic Phase III trials nearing completion, three Fast Track Designations (FTDs) from the US FDA and impressive data generated to date. With our core expertise and experience in producing radiometals for commercial medical purposes at Theragenics, together we can expand access to radiopharmaceuticals and bring a next-generation platform to patients in need of better diagnostics in the US."

Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, commented, "Clarity is closer than ever to commercialisation of 64Cu-SAR-bisPSMA, with outstanding data recently released from the head-to-head Co-PSMA investigator-initiated trial3 and our announcement on achieving our target number of participants in the Phase III AMPLIFY trial just months since imaging the first patient4.

"The growing body of scientific evidence, along with the FTDs from the FDA are providing great momentum for 64Cu-SAR-bisPSMA. Building out a secure, reliable and abundant supply and manufacturing strategy is now coming into play, ensuring a solid base for our commercial launch and accelerated market expansion, subject to FDA approval. Our team is committed to continue working closely with our vendors, clinicians, participating clinical trial sites, regulatory agencies and supply and manufacturing facilities to get 64Cu-SAR-bisPSMA to patients in need as soon as possible, at scale to meet the future demand.

"The longer half-life of copper-64 (12.7 hours vs. less than 2 hours for the radionuclides currently used in prostate-specific membrane antigen [PSMA] positron emission tomography [PET], i.e. gallium-68 and fluorine-18) translates into a shelf-life of up to 48 hours for 64Cu-SAR-bisPSMA. As such, copper-64 offers greater flexibility for supply and scheduling of patients, overcoming various limitations of the short half-life isotopes currently used in radiodiagnostics. This represents a unique opportunity to implement a multi-tiered service approach comprising of large, local, centralised manufacturing with broad geographic distribution. Importantly, we have the opportunity to avoid the excessive costs, waste and inefficiencies associated with the supply and manufacture of short half-life isotopes. Our goal is to take the industry in a new direction of scalability and profitability while delivering universal access to radiodiagnostics for physicians and the patients they serve.

"Theragenics has decades of experience in the commercial production of radiometals for medical purposes and valuable insight into the prostate cancer field based on their existing brachytherapy business. We look forward to working with them as we prepare to take the next steps in our development."

The Manufacturing Supply Agreement is effective as of 25 March 2026. Cancellation and extension provisions are aligned with industry standard rates.

(Press release, Clarity Pharmaceuticals, MAR 25, 2026, View Source [SID1234663861])

WuXi Biologics Reports Record 2025 Annual Results

On March 24, 2026 WuXi Biologics (Cayman) Inc. ("WuXi Biologics" or "the Group", stock code: 2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions for biologics discovery, development and manufacturing, reported audited results for the year ended December 31, 2025 ("Reporting Period").

Financial Highlights

Revenue: Revenue increased 16.7% YoY to RMB21.8 billion, driven by continued execution of the Group’s "Follow and Win the Molecule" strategy, rising demands for complex biologics modalities including bispecific antibodies and ADCs, growing Research Services partnerships, and higher utilization of existing and newly expanded manufacturing capacity, including the ramp-up of the Group’s European facility.

Gross Profit and Gross Profit Margin: IFRS gross profit increased 30.9% YoY to RMB10.0 billion, with gross margin expanding 500 bps to 46.0%. Adjusted gross profit rose 25.5% YoY to RMB10.6 billion, with adjusted gross margin of 48.8%. Margin expansion was primarily driven by favorable business mix, higher capacity utilization, and efficiency gains from WBS and digitalization initiatives.

EBITDA and EBITDA Margin: EBITDA grew 38.1% YoY to RMB9.0 billion, while adjusted EBITDA increased 22.8% YoY to RMB9.8 billion. EBITDA margin reached 41.5%, with adjusted EBITDA margin expanding to 45.1%.

Net Profit and Net Profit Attributable to Owners of the Company: IFRS net profit rose 45.3% YoY to RMB5.7 billion, while net profit attributable to owners of the Company grew 46.3% to RMB4.9 billion. These increases were primarily driven by the higher gross profits and the gains from the Group’s investment portfolio.

Adjusted Net Profit and Adjusted Net Profit Attributable to Owners of the Company: Adjusted net profit increased 22.0% YoY to RMB6.6 billion, while adjusted net profit attributable to owners of the Company rose 17.9% YoY to RMB5.6 billion.

Earnings Per Share (EPS): Basic EPS rose 48.8% to RMB1.22 (2024: RMB0.82). Diluted EPS advanced 48.7% to RMB1.16 (2024: RMB0.78)

Adjusted Earnings Per Share (Adjusted EPS): Adjusted basic EPS increased 19.7% to RMB1.40 (2024: RMB1.17), while adjusted diluted EPS reached RMB1.33, up 18.8% from RMB1.12 in the prior year.

Business Highlights

Integrated Project Adds
The Group added a record-high of 209 new integrated projects in 2025, bringing the total pipeline to 945 programs. Approximately half of the new additions originated from U.S. clients, reflecting strong momentum from the U.S. biopharma sector. With 74 late-stage and 25 commercial projects, the Group is well positioned to drive sustained manufacturing revenue growth.

Of the 209 new additions, 23 programs were post-IND wins under the Group’s "Win-the-Molecule" strategy, including 6 late-stage programs, bringing total "Win-the-Molecule" projects to 112 since 2018.

Research
Research Services delivered another phenomenal year in 2025, generating record-high upfront and total payments, and securing potential milestone and royalties over US$4 billion.

CD3 T-cell engager (TCE) partnerships continued to expand during the year, reflecting growing industry adoption of the Group’s leading CD3 platform. The platform has been adopted by many leading biopharma companies, including Vertex, Merck, GSK and Sino Biopharmaceutical.

As of year-end 2025, Research Services supported 50+ active programs eligible for milestone payments and sales royalties, providing a growing base of high-margin long-term revenue potential.

Development
The Group supported 156 IND filings in 2025, and expanded capacity to 200 INDs and 20 BLAs/MAAs annually. It also added a record number of new development projects in 2025. Bispecifics and ADCs accounted for 2/3 of new additions, with each modality growing by approximately 30% to 196 and 252 programs, respectively. Complex modalities now represent more than half of the entire project portfolio, reflecting sustained momentum in next-gen biologics and the Group’s leading market position.

Leveraging its integrated R-D-M capabilities, bi- & multi-specifics have emerged as the Group’s fastest growing modality, contributing nearly 20% of total revenue in 2025 and delivering 120%+ YoY growth. To support continued pipeline growth, the Group has expanded regulatory submission capacity to support approximately 200 INDs and 20 BLAs/MAAs annually.

During the Reporting Period, the Group introduced WuXia TrueSite, a targeted-integration CHO cell line platform that enables 6-month DNA-to-IND timelines, while delivering 8+ g/L mAb titers and >99% expression stability across 60 generations. The Group also expanded its high-dose drug delivery capabilities for clinical and commercial applications, including WuXiHighTM high-throughput formulation development, hyaluronidase co-formulation, and large-volume device solutions, further broadening their addressable commercial opportunities.

Manufacturing
In 2025, the Group supported 74 Phase III projects and 25 commercial manufacturing projects, completed 28 PPQs (process performance qualification), and has 34 PPQs scheduled for 2026 based on contracts as of Dec 31, 2025. The Group maintained a 100% PPQ campaign success rate, demonstrating consistent execution and a robust large-scale manufacturing quality system.

To support the expanding commercial pipeline and enhance global supply resilience, the Group continues to advance its "Global Dual Sourcing" strategy, scaling integrated CRDMO capabilities across geographies, while expanding its manufacturing footprint globally.

U.S.: Construction of MFG11 in Worcester, MA is progressing. Upon completion, the facility will feature six 6,000L single-use bioreactors, a dedicated downstream line, and extensive automation. MFG18 in Cranbury, NJ is also being upgraded to add commercial manufacturing capabilities in response to the strong local demands.
Singapore: Construction of a new modular drug product (DP) facility has commenced and is expected to be one of the largest modular biologics DP facilities globally, significantly enhancing the Group’s end-to-end DP service capabilities. The design of a modular drug substance (DS) facility is also underway. In addition, WuXi XDC’s Singapore site achieved mechanical completion in June 2025.
Qatar: In December 2025, the Group signed a MOU with the Qatar Free Zones Authority (QFZ), advancing plans to establish the Qatar site as a strategic hub within its global CRDMO network and extend its geographic presence into the Middle East.

Backlog
As of December 31, 2025, total backlog stood at US$23.7 billion, including US$11.5 billion service backlog and US$12.2 billion potential milestones. Backlog within 3 years reached US$4.5 billion, providing strong visibility into near-term revenue growth.

Quality
The Group maintains a comprehensive global quality management system to support clients’ regulatory and compliance requirements. From 2017 to 2025, the Group has completed 46 regulatory inspections by major national authorities, including 22 by the U.S. FDA and EU EMA, with no critical issues and zero data integrity findings.

As of December 31, 2025, the Group maintains a 100% pass rate for FDA Pre-License Inspection (PLI) and has passed more than 1,800 client GMP audits, including 230+ conducted by EU Qualified Persons, demonstrating consistent quality and compliance standards across global operations.

(Press release, WuXi Biologics, MAR 24, 2026, View Source [SID1234669264])

Callio Therapeutics Doses First Patient in Phase I Clinical Trial of Dual-Payload ADC CLIO-8221 in Advanced HER2-Expressing Solid Tumors

On March 24, 2026 Callio Therapeutics, a biotherapeutics company advancing dual-payload antibody-drug conjugates (ADCs) with a targeted, multi-mechanism approach to cancer treatment, reported that the first patient has been dosed in a Phase I clinical trial evaluating CLIO-8221 in patients with advanced HER2-expressing solid tumors. CLIO-8221 is a novel, first-in-class dual-payload ADC targeting HER2, engineered for targeted delivery of two payload classes: a topoisomerase 1 (Topo1) inhibitor and an ATR inhibitor, to HER2-expressing tumors.

The Phase I clinical trial (NCT07300943) is ongoing in Australia and the U.S., with Callio Therapeutics having received IND clearance from the U.S. Food and Drug Administration (FDA) this month. The IND is also under review by the China National Medical Products Administration (NMPA), and the trial is expected to expand to multiple sites in China.

"Dosing the first patient in the Phase I trial in Australia and receiving IND clearance from the U.S. FDA are significant steps in our commitment to advancing dual-payload ADCs for patients with cancer," said Piers Ingram, Ph.D., Chief Executive Officer of Callio Therapeutics. "CLIO-8221 is the first program from Callio’s dual-payload ADC pipeline to enter the clinic, achieved in just a year from our launch. We believe this dual-payload ADC approach represents a promising new modality for multi-mechanism targeted cancer treatment."

"CLIO-8221 uses a potent combination of two complementary anti-cancer payloads to address a common mechanism that causes resistance to single-payload ADCs. In preclinical models, CLIO-8221 demonstrated compelling anti-tumor activity, with a single dose leading to tumor regression in both Topo1 inhibitor-insensitive and -refractory models and was significantly more effective than single-payload ADCs," said Jerome Boyd-Kirkup, Ph.D., Chief Scientific Officer of Callio Therapeutics. "Callio is actively developing a pipeline of promising dual-payload ADCs with rationally selected payload combinations. We are excited to move this pipeline into clinical trials in the upcoming months."

"We are committed to improving treatment options for patients and are excited to take this step with CLIO-8221," said Naomi Hunder, M.D., Chief Medical Officer of Callio Therapeutics. "CLIO-8221 represents a major advance in ADC technology, combining the validated cytotoxic payload exatecan with an ATR inhibitor payload. For patients whose cancers have become resistant or do not respond to existing Topo1 inhibitor-based ADCs, this dual-payload approach offers a new potential treatment option. Patients may also benefit from improved safety, as our next-generation linker platform is designed to reduce toxicities, consistent with the broad therapeutic window observed in preclinical studies."

About CLIO-8221

HER2 is a clinically validated target for antibody-drug conjugates (ADCs), with multiple approved therapies demonstrating meaningful benefit across tumor types, however, most patients eventually progress on treatment despite retaining HER2 expression. Mechanistic resistance to cytotoxic payloads has emerged as a key reason for treatment failure. CLIO-8221 is a novel, first-in-class dual-payload ADC targeting HER2, designed to address this challenge.

CLIO-8221 delivers two mechanistically complementary payloads, a topoisomerase 1 (Topo1) inhibitor and an ATR inhibitor, directly to HER2-expressing tumors. While Topo1 inhibitors have shown strong clinical activity, activation of the DNA damage response following Topo1 inhibitor-induced replication stress represents a potential major driver of resistance. By simultaneously inhibiting Topo1 and blocking the DNA damage response through ATR inhibition, CLIO-8221 is engineered to overcome payload insensitivity and sensitize tumors to Topo1 inhibition. Developed using proprietary linker and ADC platform technologies, CLIO-8221 aims to maximize anti-tumor activity while reducing systemic toxicity, offering the potential for deeper and more durable responses in patients who have progressed on existing HER2-targeted therapies.

(Press release, Callio Therapeutics, MAR 24, 2026, View Source [SID1234663888])

Radiopharm Theranostics Achieves Primary Endpoint In 90% of Patients At Second Interim Analysis of RAD 101 Phase 2b Imaging Trial in Brain Metastases

On March 24, 2026 Radiopharm Theranostics (ASX: RAD, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, reported the second interim data from twenty patients in its U.S. Phase 2b clinical imaging trial of RAD 101 in brain metastases. RAD 101 is Radiopharm’s novel, small-molecule imaging agent targeting fatty acid synthase (FASN) and radiolabelled with Fluorine-18 for the diagnosis of suspected recurrent brain metastases from solid tumors of different origins.

The second interim analysis showed that 90% (18/20) of the patients dosed with RAD101 achieved concordance between PET imaging and MRI (the primary endpoint). The results showed significant and selective tumor uptake in the brain metastases. Images confirm metabolic activity in brain metastases compared to equivocal MRI findings.

In addition, the first five patients with evaluable six-month follow-up and/or biopsy data show a positive trend for sensitivity and specificity (the secondary objectives). Sensitivity and specificity are two of the fundamental hallmarks of any diagnostic test including in imaging. They measure an imaging test’s ability to correctly identify patients with a disease (sensitivity, true positive rate), as well as patients without the disease (specificity, true negative rate).

"The strength and consistency of these interim results further validate the potential of RAD 101 to address one of the most challenging diagnostic gaps in neuro-oncology," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "With 90% concordance demonstrated to date and encouraging early signals in sensitivity and specificity, we are increasingly confident in RAD 101’s ability to support more accurate and timely treatment decisions for patients with brain metastases. We look forward to the final data readout from the full 30-patient study by June, which will guide our path toward a pivotal trial and, ultimately, toward bringing this important imaging agent to the clinicians and patients who need it."

RAD 101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin, including leptomeningeal disease.

In the U.S. alone, there are more than 300,000 patients diagnosed annually with cerebral metastases. The incidence of Intracranial Metastatic Disease (IMD) continues to increase, in part, due to improvements in systemic therapy resulting in a more durable control of the primary tumor. Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimise patient care.1

WEBINAR DETAILS

AUSTRALIA
Date: Wednesday 25 March 2026
Time: 9:00am AEDT

USA
Date: Tuesday 24 March 2026
Time: 6.00pm EDT

Presenters:

Riccardo Canevari – CEO & Managing Director
Dr Dimitris Voliotis – Chief Medical Officer
Dr. Harshad Kulkarni – BAMF Health, Grand Rapids, MI
Register for the webinar at the link below: View Source

Please submit any questions to: [email protected]

Upon registering attendees will receive an email containing information about joining the webinar. A recording will be available at the above link soon after the conclusion of the live session, with the replay to also be made available via Radiopharm’s website and social media channels.

About the Phase 2 Clinical Trial of RAD101

The U.S. multicenter, open-label, single arm Phase 2b clinical trial is evaluating the diagnostic performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain metastases from solid tumors of different origins. The primary objective of the study is concordance between 18F-RAD101 positive lesions and those seen in conventional imaging (MRI with gadolinium) in participants with suspected recurrent brain metastases. Secondary endpoints are accuracy, sensitivity and specificity of RAD101 in identifying tumor recurrence versus radiation necrosis in previously stereotactic radiosurgery (SRS)-treated brain metastases.

About RAD101

RAD101 is the Company’s novel imaging small molecule that targets fatty acid synthase (FASN), a multi-enzyme protein that catalyses fatty acid synthesis and is overexpressed in many solid tumors, including cerebral metastasis. Targeting FASN activity may allow for the more accurate detection of cancer cells, representing a clinically relevant method for the imaging of brain metastases. Positive data from the Imperial College of London’s Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases (both SRS pre-treated and treatment naïve patients) showed significant tumor uptake that was independent from the tumor of origin. The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall-survival, warranting larger studies.

(Press release, Radiopharm Theranostics, MAR 24, 2026, View Source [SID1234663887])

Calidi Biotherapeutics Announces Partnership with Avance Clinical to Facilitate Australian Regulatory Approval and Accelerate Initiation of CLD-401 Clinical Trials

On March 24, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported a partnership with Avance Clinical, a full-service contract research organization (CRO) with a proven track record and experience in obtaining regulatory approval and clinical trial initiation in Australia. The partnership is focused on rapidly initiating a first-in-human clinical trial for CLD-401 in Australia. In parallel, the Company will pursue an IND filing with the FDA in 2026.

CLD-401 is a genetically modified form of vaccinia virus that is systemically delivered, replicates only in tumor cells, and expresses high levels of IL-15 superagonist (IL-15 SA), an activator of innate and adaptive immune response, in the tumor microenvironment. The planned phase I will investigate the safety, pharmacodynamics, and efficacy of CLD-401 given as monotherapy in patients with solid tumors that have exhausted all other therapeutic options.

"We believe CLD-401 represents a unique mechanism of action in oncology," said Eric Poma, PhD, Chief Executive Officer of Calidi. "We are excited to work with Avance Clinical to initiate clinical studies as quickly as possible and bring this potential treatment option to patients whose disease is resistant to current therapies."

Calidi is currently conducting IND-enabling studies with CLD-401, the first lead candidate from its RedTail platform. The Company continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, MAR 24, 2026, View Source [SID1234663886])