On January 2, 2026 Hoth Therapeutics (NASDAQ: HOTH), a clinical-stage biopharmaceutical company developing innovative therapies for underserved medical needs, reported the filing of two U.S. provisional patent applications that significantly expand the Company’s intellectual property portfolio and establish a new oncology-focused dermatology platform targeting treatment-induced skin toxicity from modern cancer therapies.

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The first provisional patent application, titled covering the topical treatment of radiation-induced skin toxicity in oncology patients.

The second provisional patent application, titled addressing dermatologic toxicities associated with emerging targeted cancer therapies, including second and third menin inhibitors.

Together, these dual filings secure priority intellectual property rights around the use of HT-001 to treat dermatologic toxicities across multiple oncology treatment modalities, including radiation therapy and next-generation targeted agents. As cancer treatments become more effective and patients remain on therapy longer, managing treatment-limiting skin toxicities has become a critical and growing unmet need in oncology care.

Radiotherapy-induced dermatitis and dermatologic adverse effects from targeted oncology therapies frequently result in pain, inflammation, severe pruritus, infection risk, reduced quality of life, and treatment interruption or discontinuation, which can negatively impact patient outcomes. Despite their prevalence, current treatment options remain largely supportive, with few mechanism-driven therapies designed to address the underlying biological drivers of these conditions.

Hoth’s patent filings seek to protect the use of HT-001, a receptor antagonist with a well-established pharmacologic profile, to target neurogenic and inflammatory pathways implicated in therapy-induced skin injury. The Company believes this approach may represent a novel and potentially first-in-class strategy within the rapidly expanding oncology supportive-care and oncodermatology markets.

"These filings represent a meaningful expansion of our intellectual property estate into an increasingly important area of oncology care," said Robb Knie of Hoth Therapeutics. "As cancer therapies advance, the ability to manage treatment-related toxicities is becoming essential. We believe this emerging platform highlights our strategy of identifying differentiated, mechanism-driven opportunities that can address significant unmet needs while creating long-term shareholder value."

The Company believes these provisional patents support the development of a scalable oncology-adjacent platform with potential applications across radiation oncology, targeted cancer therapies, dermatology, and inflammatory skin disorders, while leveraging an established compound in novel therapeutic contexts, formulations, and routes of administration. The filings also provide flexibility to pursue additional preclinical development, formulation optimization, and future U.S. and international patent protection.

Hoth Therapeutics continues to execute its strategy of building a diversified, IP-centric development portfolio focused on large, underserved markets, with an emphasis on therapies designed to improve patient outcomes and quality of life.

(Press release, Hoth Therapeutics, JAN 2, 2026, View Source [SID1234661689])

On January 1, 2026 ImmunoForge Co., Ltd. (Co-CEOs Sung-Min Ahn and Kiho Chang), a clinical-stage biopharmaceutical company specializing in rare diseases, reported that its leadership team will be in San Francisco during the 43rd Annual J.P. Morgan Healthcare Conference (January 12–15, 2026) to conduct strategic 1-on-1 meetings with global pharmaceutical companies and investors.

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Instead of a formal stage presentation, ImmunoForge is focusing on high-level private partnering sessions to discuss the clinical progression and licensing of its key pipelines. The company’s primary objective is to secure strategic partners capable of spearheading U.S. clinical trials for its Phase 2 assets.

Key Highlights for Partnering:

Monthly long-acting ELP (Elastin-Like Polypeptide) platform: Peptide conjugation and Protein fusion possible
BBB penetrating ELP (Elastin-Like Polypeptide) platform: BBB shuttle platform fusing ELP to make monthly CNS drugs
PF1801 (Polymyositis/Dermatomyositis, DMD & Sarcopenia): Currently in a Phase 2 study in South Korea. With U.S. FDA Phase 2 IND clearance already secured for both indications, the asset is primed for an immediate U.S. clinical launch by a global partner.
PF1804 (DMD Cardiomyopathy): This promising asset also received FDA Phase 2 IND clearance, standing ready for clinical execution.
PF1807 (Sarcopenia): A monthly sarcopenia therapy based on use patent for the prevention and treatment of myositis and sarcopenia.
KF1601 (CML): While domestic rights have been successfully licensed out ahead of a Phase 1 launch in Korea next year, global licensing rights (excluding Korea) are open for discussion, offering a validated opportunity for international partners.
"Our goal for JPM 2026 week is to meet with potential partners who can leverage our FDA-cleared INDs to rapidly bring these therapies to the U.S. market," said a representative from ImmunoForge. "As a lean biotech, we have focused on de-risking our assets through regulatory clearances; we are now looking for the right global collaborators to take these programs through the next phase of clinical development and to the commercial markets. In addition to licensing deals with global pharmaceutical companies, we are also actively willing to pursue NewCo models led by investors. In line with this strategy, we intend to expand our development capabilities by introducing our diverse pipeline to global companies, including our established long-acting ELP platform and the newly developed BBB-penetrating ELP platform technology."

Schedule for Meeting
ImmunoForge is currently accepting meeting requests for the week of JPM 2026. To schedule a session with our executive team in San Francisco.

(Press release, ImmunoForge, JAN 1, 2026, View Source [SID1234661690])

On December 31, 2025 Delcath Systems, Inc. (Nasdaq: DCTH), ("Delcath" or the "Company") an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported the publication of results from subgroup analyses of the phase 3 FOCUS study. The publication, titled "Subgroup Analyses of the Phase 3 FOCUS Study of Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma" was published in the Journal of Cancer Research and Clinical Oncology. The analysis assessed efficacy and safety in subgroups of patients treated with Delcath’s HEPZATO KIT, a drug/device combination for liver-directed treatment of mUM patients. The HEPZATO KIT is currently the only liver-directed treatment to be approved by the FDA for patients with unresectable mUM. The article provides clinically relevant subgroup analyses of key efficacy endpoints, including overall response rate (ORR), progression-free survival (PFS) and overall survival (OS), and safety categories. Prespecified subgroups included age (<65 or ≥65 years), sex (male or female) geographic region (ex-US or US) extent of tumor liver involvement (1-25% or 26-50%), hepatic tumor burden (above or below median), presence of extrahepatic lesions (yes or no), baseline LDH (low/normal or elevated) and number of prior therapies (0 or 1+).

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This prespecified analysis of clinically relevant subgroups included 91 patients treated in the FOCUS study. Key efficacy and safety findings include:

Consistent tumor response was observed regardless of age, sex, geographic region, presence/absence of extrahepatic lesions, and prior therapy.
ORR: significantly higher ORR for patients with tumor burden below the median (51.1% vs. 22.2%, p=0.008). No significant differences for other subgroups.
PFS: significantly longer median PFS for patients with tumor burden below the median (11.3 vs. 5.8 months, p=0.007). No significant differences for other subgroups.
OS: significantly longer median OS for patients with smaller extent of tumor liver involvement (22.4 vs 16.8 months, p=0.032), tumor burden below the median (26.7 vs 15.4 months, p=0.008) and low/normal LDH (23.4 vs 15.3 months, p=0.019)
Of the 33 patients achieving an objective response (CR or PR), 57.6% (19 patients) responded within the first or second treatment cycle, while one-third (33.3%; 11 patients) of responses were observed in Cycles 4–6, highlighting the importance of continued treatment up to the maximum of 6 cycles to optimize tumor response.
The overall safety profile was similar across subgroups, with no evidence of cumulative toxicity with successive treatment cycles. The incidence of serious adverse events and Grade 3/4 adverse events was consistent with the overall study population, and no treatment-related deaths occurred. "These subgroup analyses provide valuable insights into optimizing treatment with Melphalan/HDS for patients with unresectable metastatic uveal melanoma, underscoring the importance of early intervention in patients with lower tumor burden to maximize clinical benefits," said Vojislav Vukovic, MD, MSc, PhD, Chief Medical Officer of Delcath. "The consistent efficacy and manageable safety profile across diverse patient groups further validate this liver-directed therapy as a key option in managing this challenging disease."
The FOCUS study utilized HEPZATO KIT (HEPZATO (melphalan) for Injection/Hepatic Delivery System), and results from the FOCUS study lead to the approval of HEPZATO by the U.S. Food and Drug Administration (FDA).

(Press release, Delcath Systems, DEC 31, 2025, View Source [SID1234661670])

On December 30, 2025 Alkermes plc (Nasdaq: ALKS) reported that its Chief Executive Officer, Richard Pops, will provide a corporate overview and update at the 44th Annual J.P. Morgan Healthcare Conference. The presentation will take place on Tuesday, Jan. 13, 2026 at 10:30 a.m. PST (1:30 p.m. EST/6:30 p.m. GMT). The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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(Press release, Alkermes, DEC 30, 2025, View Source [SID1234661654])

On December 30, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that the New Drug Application ("NDA") for savolitinib for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma patients with MET amplification who have failed at least two prior systemic treatments has been accepted and granted priority review by the China National Medical Products Administration ("NMPA").

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This NDA is supported by data from a single-arm, multi-center, open-label, Phase II registration study of savolitinib in gastric cancer patients with MET amplification in China. The study has met its primary endpoint of objective response rate (ORR) by the Independent Review Committee (IRC) (RECIST 1.1). Additional details may be found at clinicaltrials.gov using identifier NCT04923932.

Gastric cancer remains one of the most common cancers and leading causes of cancer death in China. MET-driven gastric cancer has a very poor prognosis.[1] It is estimated that MET amplification accounts for approximately 4-6% of gastric cancer patients.[2],[3] The annual incidence of MET amplification gastric cancer is estimated to be approximately 18,000 in China.

The NMPA has granted Breakthrough Therapy Designation to savolitinib for this potential indication in 2023. The NMPA granted this designation to this new treatment that could target a serious condition where clinical evidence demonstrates substantial advantages over existing therapies.

About Savolitinib
Savolitinib is an oral, potent, and highly selective MET tyrosine kinase inhibitor (TKI) being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. MET is a tyrosine kinase receptor that has an essential role in normal cell development.[5] Savolitinib blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

Savolitinib is approved in China and is marketed under the brand name ORPATHYS by our partner, AstraZeneca, representing the first selective MET inhibitor approved in China. It has been included in the National Reimbursement Drug List of China (NRDL) since March 2023.

It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines.

(Press release, Hutchison China MediTech, DEC 30, 2025, View Source [SID1234661655])