On December 29, 2025 Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully-integrated commercial stage biotechnology company, reported it has entered into a securities purchase agreement with Point72 for the purchase and sale of 615,025 shares of its common stock at an offering price of $16.26 per share and, in lieu of shares of common stock, pre-funded warrants to purchase up to an aggregate of 615,025 shares of common stock at a purchase price of $16.259 per pre-funded warrant, which equals the offering price per share of the common stock less the $0.001 per share exercise price of each pre-funded warrant. The closing of the offering is expected to take place on or about December 30, 2025, subject to the satisfaction of customary closing conditions.

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The gross proceeds of the offering will be approximately $20.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering to fund the commercialization of its marketed products, the development of its product pipeline, and general working capital and corporate purposes.

TD Cowen is acting as sole placement agent for the offering. A.G.P./Alliance Global Partners is acting as a financial advisor.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-287965) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected].

This press release shall 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 other 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 other jurisdiction.

(Press release, TONIX Pharmaceuticals, DEC 29, 2025, View Source [SID1234661640])

On December 29, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that the New Drug Application ("NDA") for fanregratinib (HMPL-453) for the treatment of adult patients with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma ("ICC") with fibroblast growth factor receptor ("FGFR") 2 fusion/rearrangement who have previously received systemic therapy has been accepted and granted priority review by the China National Medical Products Administration ("NMPA").

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Fanregratinib (HMPL‑453) is a novel, selective, oral inhibitor targeting FGFR 1/2/3. ICC is a highly aggressive malignancy arising from the intrahepatic biliary epithelium. It accounts for 8.2-15.0% of primary liver cancers, and consequently it is the second most common type after hepatocellular carcinoma. In recent years, the incidence of ICC has continued to rise, with a 5-year overall survival rate of approximately 9%.[1] Approximately 10-15% of ICC patients globally have tumors harboring FGFR2 fusions or rearrangements.

This NDA is supported by data from a single-arm, multi-center, open-label, Phase II registration study in China. The study has met its primary endpoint of objective response rate (ORR). Results from the secondary endpoints including progression-free survival (PFS), disease control rate (DCR), duration of response (DoR) and overall survival (OS) also support the primary endpoint findings. Full results will be submitted for presentation at an upcoming scientific conference. Additional details may be found at clinicaltrials.gov using identifier NCT04353375.

About Fanregratinib
Fanregratinib (HMPL‑453) is a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3. Aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis and resistance to anti-tumor therapies. Abnormal FGFR gene alterations are believed to be the drivers of tumor cell proliferation in several solid tumor settings. HUTCHMED currently retain all rights to fanregratinib worldwide.

(Press release, Hutchison China MediTech, DEC 29, 2025, View Source [SID1234661639])

On December 29, 2025 Genmab A/S (Nasdaq: GMAB) reported that it will discontinue further clinical development of acasunlimab. This decision was made as part of Genmab’s strategic focus on the most value‑creating opportunities in its late‑stage portfolio and following a thorough assessment of the evolving competitive landscape. While the clinical profile observed to date has been encouraging, Genmab will concentrate resources on programs with the highest potential impact, including EPKINLY (epcoritamab), petosemtamab and rinatabart sesutecan (Rina‑S), which are advancing in late‑stage development. This decision is consistent with Genmab’s disciplined portfolio prioritization and capital allocation framework.

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"After careful consideration, we have decided to discontinue the acasunlimab program. Although the data have been encouraging, the compelling opportunities we see in our late‑stage pipeline led us to focus our investments where we believe we can deliver the greatest benefit for patients and shareholders. We are highly energized by the momentum of EPKINLY, petosemtamab and Rina‑S, and we remain committed to executing these programs with speed and rigor," said Jan van de Winkel, Ph.D., Chief Executive Officer, Genmab.

This decision does not impact Genmab’s full‑year 2025 financial guidance.

(Press release, Genmab, DEC 29, 2025, View Source [SID1234661638])

On December 28, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported that it has submitted two separate Investigational New Drug (IND) applications to the National Medical Products Administration (NMPA) for its allogeneic BCMA-targeted CAR-T cell therapy product, CT0596. The applications seek to initiate two corresponding Phase Ib/Ⅱ clinical trials for the treatment of relapsed/refractory multiple myeloma (R/R MM) and primary plasma cell leukemia (pPCL), respectively.

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CT0596 is an allogeneic CAR T-cell therapy targeting BCMA, developed based on CARsgen’s proprietary THANK-u Plus platform. Through the knockout of genes such as NKG2A, TRAC, and B2M, CT0596 is designed to reduce the risk of graft-versus-host disease (GvHD) and host immune rejection. Additional gene editing further blocks host natural killer (NK) cell-mediated rejection, thereby aiming to enhance the product’s efficacy and safety profile.

Investigator-initiated trials (IIT) for CT0596 have already been conducted in China to explore its clinical potential in treating R/R MM and pPCL. Data from the first-in-human study, presented at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, demonstrated a favorable safety profile and encouraging efficacy signals for CT0596. As of August 31, 2025, all 8 patients with R/R MM who received CT0596 infusion were evaluable for efficacy, with a median follow-up of 4.14 months. Six patients achieved a partial response (PR) or better: 3 achieved complete response/stringent complete response (CR/sCR) (all received full-dose lymphodepletion), 1 achieved very good partial response (VGPR), and 2 achieved PR. Four patients experienced Grade 1 cytokine release syndrome (CRS), with no Grade 2 or higher CRS observed. No immune effector cell-associated neurotoxicity syndrome (ICANS), GvHD, dose-limiting toxicities, treatment discontinuations, or deaths were reported.

Previously, the company also disclosed preliminary clinical data for CT0596 in relapsed/refractory pPCL. Two heavily pretreated pPCL patients with high disease burden and rapid progression both achieved sCR after receiving CT0596 treatment.

The IND applications mark the commencement of the registration clinical development phase for CT0596, which holds the potential to offer a new treatment option for patients with R/R MM and pPCL.

About CT0596

CT0596 is an allogeneic BCMA-targeted CAR-T therapy developed using CARsgen’s proprietary THANK-u Plus platform. It is currently being evaluated in investigator-initiated trials for relapsed/refractory multiple myeloma (R/R MM) or primary plasma cell leukemia (pPCL). CT0596 demonstrated preliminary favorable tolerability and encouraging efficacy signals. Further investigation is planned in additional plasma cell malignancies and autoimmune diseases mediated by plasma cells.

(Press release, Carsgen Therapeutics, DEC 28, 2025, View Source [SID1234661634])

On December 28, 2025 Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, reported that it has entered into a long-term strategic collaboration with Yantai Lannacheng Biotechnology Co., Ltd. ("Lannacheng"). The two parties will leverage their respective resources and strengths to jointly advance the development of next-generation radionuclide drug conjugates (RDCs).

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Compared with conventional radiotherapy, RDCs utilize tumor antigen–specific ligands to deliver radionuclides directly to tumor lesions for targeted radiotherapy, thereby effectively reducing damage to surrounding healthy tissues. In contrast to antibody–drug conjugates (ADCs), the radionuclides in RDCs can also exert cytotoxic effects on neighboring tumor cells and the tumor microenvironment, even if those cells do not express the target antigen. This mechanism offers a potential advantage in overcoming tumor heterogeneity and drug resistance. In addition, this technology holds the potential to achieve theranostics—integrating both diagnosis and treatment.

With its advanced technology platforms and deep expertise, Harbour BioMed has built a solid foundation in antibody discovery and development. The company’s proprietary Harbour Mice platform enables the generation of fully human monoclonal antibodies in both conventional (H2L2) and heavy chain-only (HCAb) formats, eliminating the need for additional engineering or humanization. The HCAb technology, in particular, produces unique, fully human heavy chain-only antibodies that are approximately half the size of conventional IgGs, offering significant advantages for next-generation antibody therapeutics. In the development of RDCs, fully human antibodies—characterized by low immunogenicity, superior tissue penetration, and high specificity and stability—can significantly enhance the efficiency of targeted delivery, thereby improving therapeutic efficacy while effectively reducing drug-related toxicity and side effects.

Founded in 2021, Lannacheng is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of integrated theranostic radiopharmaceuticals for oncology. The company’s R&D engine, enhanced by its proprietary pharmacokinetic optimization and dual-targeting drug development platforms, combines target validation, radioisotope selection, and linker design to improve pharmacokinetic profiles and advance the development of dual-targeting radiopharmaceutical candidates. Its strengths are further solidified through end-to-end integration of capabilities supported by its controlling shareholder, Dongcheng Biochem, including R&D resources, a stable supply of radioisotopes, and a GMP production facility currently under construction in Yantai. Together, these elements ensure a sustainable, scalable, and rapidly innovating radiopharmaceutical pipeline.

Jingsong Wang, MD, PhD, Founder, Chairman, and CEO of Harbour BioMed, commented: "We are very pleased to establish a long-term strategic collaboration with Lannacheng to jointly advance the development of next-generation RDCs. Harbour BioMed is committed to providing efficient and highly differentiated antibody solutions for innovative therapies through our globally leading Harbour Mice fully human antibody platform. This collaboration will deeply integrate Harbour BioMed’s expertise in antibody discovery with Lannacheng’s strengths in radiopharmaceutical R&D and commercialization, accelerating the development of more precise, effective and safe cancer therapies and bringing new hope to patients worldwide."

Wu Xiaoming, General Manager of Lannacheng, stated: "We are delighted to establish a long-term strategic collaboration with Harbour BioMed to jointly advance the R&D and translation of next-generation radiopharmaceuticals. Lannacheng is committed to leveraging our systematic radiopharmaceutical technology platform, comprehensive industrial capabilities, and global collaboration network to provide efficient, innovative, and differentiated integrated solutions for tumor diagnosis and treatment. This collaboration will fully combine Lannacheng’s strengths in radiopharmaceutical R&D and commercialization and Harbour BioMed’s deep expertise in antibody discovery. Together, we aim to accelerate the development of more precise, effective, and safe cancer treatment therapies, bringing new hope to patients worldwide."

(Press release, Harbour BioMed, DEC 28, 2025, View Source [SID1234661633])