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 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 TransThera Sciences Nanjing, Inc. (the "TransThera") reported that the new drug application for Tinengotinib tablets has been accepted by the Center for Drug Evaluation ("CDE")of the National Medical Products Administration ("NMPA") of the PRC. It is intended for the treatment of adults with unresectable advanced or metastatic cholangiocarcinoma (CCA) who have received at least one prior systemic treatment and FGFR inhibitor treatment. Previously, Tinengotinib tablets have been included in the List of Products for Priority Review and the List of Breakthrough Therapy Designation for this indication.

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About Tinengotinib

Tinengotinib is an internally discovered, NDA stage, multi-kinase inhibitor that exerts antitumor effects by targeting FGFRs and VEGFRs, mitotic kinases Aurora A/B and Janus kinases (JAK). Ongoing clinical trials conducted globally have revealed the potential of tinengotinib to be efficacious in various solid tumors, such as cholangiocarcinoma, prostate cancer, breast cancer, and liver cancer. It was granted the Orphan Drug Designation (ODD) and Fast Track Designation (FTD) by the FDA for the treatment of CCA, the Orphan Drug Designation (ODD) for the treatment of biliary tract cancer by the European Medicines Agency (EMA), the Priority Review and Approval Procedure and the Breakthrough Therapy Designation (BTD) by the National Medical Products Administration (NMPA) in China for the treatment of CCA.

(Press release, TransThera Biosciences, DEC 18, 2025, View Source [SID1234661542])

On December 18, 2025 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted the Company Fast Track Designation for BGB-B2033, its GPC3x4-1BB bispecific antibody for the treatment of adult patients with hepatocellular carcinoma (HCC) with disease progression on or after prior systemic treatment.

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"The FDA awards Fast Track Designation to therapies that show potential to address an unmet medical need in serious or life-threatening conditions. The FDA’s decision reflects the encouraging profile of BGB-B2033 in advanced hepatocellular carcinoma, where patients continue to face limited treatment options," said Julie Lepin, Senior Vice President and Chief Regulatory Affairs Officer at BeOne.

BeOne is currently conducting a global, multi-center Phase 1 clinical trial (NCT06427941) to explore the safety and anti-tumor activity of BGB-B2033, both alone and in combination with PD-1 inhibitor TEVIMBRA (tislelizumab).

About Hepatocellular Carcinoma

Hepatocellular Carcinoma (HCC) is the sixth most common cancer worldwide and the fourth leading cause of cancer-related death.1 HCC accounts for 80% of all primary liver cancers, with the number of new cases expected to double between 2022 and 2050.2 The rising burden of HCC is primarily attributed to the high prevalence of the hepatitis B and hepatitis C viruses (HBV/HBC) and lifestyle factors such as obesity, tobacco, and alcohol consumption.3 With approximately 80% of patients diagnosed in advanced stages and five-year survival rates for this patient population lower than 20%, new treatment options are needed beyond currently available systemic therapy.

About BGB-B2033

BGB-B2033 is a bispecific antibody targeting GPC3 (glypican 3), a tumor-specific antigen highly expressed in HCC5, and 4-1BB, a co-stimulatory receptor associated with T-cell activation and tumor reactivity in HCC.6 The molecule has been designed with reduced antibody-dependent cellular cytotoxicity (ADCC) to prevent systemic toxicity.

(Press release, BeOne Medicines, DEC 18, 2025, View Source [SID1234661541])

On December 18, 2025 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease, reported that it is commencing an underwritten public offering of shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and accompanying warrants to purchase shares of common stock. In addition, Cue Biopharma intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15% of the shares of its common stock and/or warrants to purchase shares of common stock offered in the public offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. All of the securities are being offered by Cue Biopharma.

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H.C. Wainwright & Co. is acting as sole book-running manager for the proposed offering. Newbridge Securities Corporation is acting as co-manager for the proposed offering.

The securities are being offered pursuant to an effective shelf registration statement on Form S-3 (File No. 333-271786) that was filed with the Securities and Exchange Commission (the "SEC") on May 9, 2023, and declared effective on May 26, 2023. The offering will be made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may also be obtained by contacting: H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [email protected].

This press release does not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Cue Biopharma, DEC 18, 2025, View Source [SID1234661540])