On December 18, 2025 Niowave Inc., a U.S.- based global leader in medical radioisotope production, reported the expansion of its existing supply agreement with AstraZeneca, a global biopharmaceutical company, to a 10-year commitment to deliver Actinium-225 (Ac-225), following AstraZeneca’s decision to exercise its option to increase capacity. The agreement secures a reliable and scalable supply of this critical isotope to advance AstraZeneca’s growing portfolio of radioconjugates (RCs). RCs are a type of cancer treatment that use radioactive particles to target and destroy cancer cells.

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"Our expanded agreement with AstraZeneca underscores Niowave’s central role in scaling high-quality production of medical radioisotopes for the development of targeted cancer treatments," said Mike Zamiara, CEO of Niowave. "We are pleased to play a role in ensuring that AstraZeneca’s promising pipeline of radioconjugates have the isotope supply they need."

Ac-225 is one of the most promising radioisotopes in oncology as its emitted alpha particles deliver highly potent, DNA-damaging energy, enabling precise destruction of tumor cells while limiting harm to surrounding healthy tissue with targeted modalities like RCs. Despite its potential, global supply of Ac-225 remains limited. Niowave’s proprietary superconducting linear accelerator technology and radiochemistry provide sustainable, U.S.-based production to address this need.

As AstraZeneca advances RCs for prostate and other difficult-to-treat cancers, the agreement highlights the critical importance of securing dependable isotope supply.

(Press release, AstraZeneca, DEC 18, 2025, View Source [SID1234661543])

On December 18, 2025 Cartography Biosciences, Inc., a biotechnology company advancing a differentiated pipeline of antibody-based cancer therapies, reported that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application for its lead program, CBI-1214. This approval enables Cartography Bio to initiate a Phase I clinical trial for CBI-1214, a T-cell engager being developed for the treatment of colorectal cancer (CRC).

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In addition to the IND approval, Cartography Bio also announced that CBI-1214 has been granted Fast Track designation by the FDA. This status is designed to facilitate the development and expedited review of drugs that treat serious conditions and fill an unmet medical need, underscoring the potential of CBI-1214 and the urgent, unmet need among patients with CRC. These milestones mark the next steps forward in bringing a potential new, highly specific, tumor antigen therapy to patients with CRC. Cartography anticipates initiating its Phase I clinical trial in the first quarter of 2026.

Kevin Parker, Cartography Bio CEO, said, "Receiving IND approval and Fast Track designation for CBI-1214 represent two important steps forward for Cartography, further validation of our ATLAS and SUMMIT discovery platforms, a tribute to the hard work and ingenuity of our entire team and crucial progress toward addressing the unmet needs of colorectal cancer patients."

Dirk Nagorsen, MD, Cartography’s CMO, added, "This IND approval allows us to advance CBI-1214, our novel T-cell engager, rapidly into clinical development. The Fast Track designation further validates the significant unmet need we are targeting in CRC and the potential impact of our approach. We look forward to expeditiously advancing our Phase I trial."

CBI-1214, Cartography’s lead program, is a T-cell engager molecule that targets LY6G6D, an emerging and highly specific tumor antigen for treating CRC patients. The target, which has minimal expression on healthy cells, is uniquely expressed within the microsatellite stable (MSS) and microsatellite instability-low (MSI-L) subtypes of CRC, which represent the vast majority of CRC patients and remains a major area of unmet medical need. CBI-1214 has protein engineering features that are specifically designed to optimize anti-tumor activity.

About Colorectal Cancer

Colorectal cancer (CRC) is the third most common cancer diagnosed in both men and women in the United States, and the second leading cause of cancer-related deaths globally. According to the American Cancer Society, an estimated 153,020 new cases of colorectal cancer are diagnosed annually in the U.S., leading to approximately 52,550 deaths. Despite advances in treatment, many patients face significant challenges, particularly in advanced stages, highlighting the urgent need for innovative and more effective therapeutic options.

(Press release, Cartography Biosciences, DEC 18, 2025, View Source [SID1234661528])

On December 18, 2025 SkylineDx reported the release of new data from two complementary, peer-reviewed publications that reinforce the clinical value of the Merlin CP-GEP Test for melanoma risk stratification. Together, these studies demonstrate that prospectively validated genomic tools are essential to improve clinical decision-making and reduce both under- and overtreatment in early-stage melanoma.

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The Merlin CP-GEP Test, validated in the largest prospective gene expression profiling study in melanoma (MERLIN_001), demonstrated that a High-Risk result identifies patients with a threefold increased risk of SLNB positivity compared to Low-Risk, and consistently above the 10% threshold referenced in major guidelines.

Despite 75% of melanoma being diagnosed at an early T1 stage1, the disease still accounts for a disproportionate share of skin cancer mortality with more than half of melanoma-related deaths coming from patients who initially presented with "early-stage" disease. These findings reinforce a growing consensus across oncology: accurate, prospectively validated risk-assessment tools must be incorporated into standard-of-care, just as they are in breast, prostate, and thyroid cancer.

Analysis Clarifies Misleading Benchmarks in Competitor’s Prior Comparison

In a peer-reviewed publication2, SkylineDx investigators conducted a rigorous analysis of a comparative assessment3 used to support DecisionDx-Melanoma. When patient cohorts were harmonized and improper exclusions were corrected, the Merlin CP-GEP Test demonstrated superior metastatic-risk stratification and more accurate prediction of SLNB outcomes across real-world disease prevalence ranges. The analysis revealed that earlier comparisons relied on methodologically flawed cohorts and selectively chosen performance benchmarks, leading to conclusions that were not scientifically valid. When evaluated under aligned and transparent conditions, the Merlin CP-GEP Test consistently delivered higher clinical utility.

New T1a Publication Shows Merlin CP-GEP Test Identifies High-Risk Patients That Were Missed by Traditional Adverse Features

A newly published analysis4 in Journal of American Academy of Dermatology about early-stage T1a melanoma showed that Merlin CP-GEP High-Risk reliably identifies patients with >10% risk of SLNB metastasis, suggesting these individuals should be prioritized for surgical oncology consultation. The study highlights that Merlin CP-GEP Test outperforms using traditional high-risk features for assessment, including age, lymphovascular invasion, and mitotic rate, supporting the Test’s use as an additional high-risk tool in guiding SLNB decision-making.

"Melanoma clinicians need tools that are not only innovative but proven through rigorous, prospective, and blinded clinical validation," said Alexander Meves, MD, Mayo Clinic. "The Merlin CP-GEP Test has demonstrated an improvement over traditional clinicopathologic features and showed in the MERLIN_001 trial that High-Risk patients carry a significantly elevated risk—above key guideline thresholds. Tools with this level of evidence should be integrated into clinical pathways to support more individualized and accurate decision-making for our patients."

(Press release, SkylineDx, DEC 18, 2025, View Source [SID1234661544])

On December 18, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), reported that Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics, will present at the 44th Annual J.P. Morgan Healthcare Conference being held in San Francisco, CA on Tuesday, January 13, 2026 at 9:45 a.m. Pacific Time.

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To access the live audio-only webcast, click here. The archived webcast will also be accessible on the Events & Presentations page in the Investors section of the Crinetics’ website at www.crinetics.com/events.

If you are interested in arranging a 1×1 meeting with management, please contact your conference representative.

(Press release, Crinetics Pharmaceuticals, DEC 18, 2025, View Source [SID1234661529])

On December 18, 2025 Curasight A/S ("Curasight" or "the Company" – TICKER: CURAS) reported the successful and safe dosing of the first patient in the Phase 1 trial using uTREAT in brain cancer (high grade gliomas). The news marks the initiation of the first clinical trial under the company’s therapeutic platform uTREAT, investigating it as a potential treatment option for glioblastoma.

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The start of the phase 1 study with uTREAT means that Curasight is now in the clinical phase with both parts of its theranostic platform aimed at improving treatment and diagnosis of certain cancers. The company’s diagnostic platform uTRACE is currently in a Phase 2 trial for prostate cancer under the strategic partnership with Curium Inc.

"The dosing of the first patient with uTREAT in this Phase 1 trial marks an important step in the development of the therapeutic arm of our theranostic platform, making Curasight a clinical stage therapeutic company". Said Curasight’s CEO Ulrich Krasilnikoff. "I very much look forward to seeing the data and would like to take this opportunity to thank the patient and doctors involved in this trial in supporting our efforts to develop uTREAT ".

About the Phase 1 trial with uTREAT in brain cancer

The trial aims to investigate Curasight’s uTREAT as a new type of targeted radiopharmaceutical therapy in glioblastoma patients. Participants in the trial are patients with newly diagnosed verified or suspected GBM. The trial design is informed from research and earlier studies with uTRACE as well as protocol discussions with Key Opinion Leaders.

About the uPAR theranostic platform

Curasight’s uPAR theranostic platform combines two key technologies – uTRACE and uTREAT both targeting the uPAR receptor. uTRACE is designed to deliver sensitive imaging for diagnosis, while uTREAT offers a targeted radiopharmaceutical solution. Together, they form an integrated approach to improving the diagnosis and treatment of cancers that express uPAR. Curasight’s ambition is to develop both uTRACE and uTREAT to improve diagnosis and treatment of uPAR-expressing cancers.

About high grade glioma

Treatment of glioblastoma and other high-grade gliomas (WHO grades 3 or 4) presents a significant unmet medical need, necessitating innovative and effective treatments. A total of approx. 65,000 patients are diagnosed with primary brain tumors and more than 30,000 patients are diagnosed annually with the most aggressive form, glioblastoma, in the US and EU. Approximately 10 % of the patients are children. The prognosis for individuals with glioblastoma is very poor as approximately 50% of the patients die within 14 months and after five years from diagnosis only 5% are still alive. External beam radiation is a cornerstone in the therapy of brain cancers. uTREAT could potentially replace or reduce the use of external beam radiation and thereby lower side effects to the healthy brain due to more specific tumor tissue targeting.

(Press release, Curasight, DEC 18, 2025, View Source [SID1234661545])