On December 23, 2025 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported that it will host a conference call and live webcast at 4:00 p.m. ET on Wednesday, January 7, 2026 to provide an update on 12-month overall survival (OS) from its ongoing Phase 2a clinical trial of atebimetinib + modified Gemcitabine / nab-paclitaxel (mGnP) in first-line pancreatic cancer patients.

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"We are excited to share updated overall survival data from our ongoing Phase 2a trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients," said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. "We are increasingly confident in atebimetinib’s ability to extend and improve the lives of patients with pancreatic cancer."

The conference call will be webcast live and archived in the Investor Relations section of Immuneering’s website at Events & Presentations | Immuneering Corporation.

(Press release, Immuneering, DEC 23, 2025, View Source [SID1234661609])

On December 23, 2025 Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products reported business and financial results for the fiscal year ended September 30, 2025.

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"2025 was a pivotal year for Citius as we successfully launched LYMPHIR following its FDA approval, marking the first new systemic therapy for cutaneous T-cell lymphoma (CTCL) patients since 2018. This milestone reflects our ability to execute and our commitment to delivering impactful treatments for patients with limited options," said Leonard Mazur, Chairman and CEO of Citius Pharma. "With LYMPHIR commercially available as of December 2025, we are focused on its successful launch and adoption in 2026, with even greater opportunities ahead to drive value for patients and shareholders. We are actively engaging with the FDA to advance Mino-Lok, exploring additional indications and markets for LYMPHIR, and working diligently to strengthen our financial and operational foundation to support sustained growth. We look forward to reporting on our continued progress in the coming months."

Fiscal Year 2025 Business Highlights and Subsequent Developments

● Citius Pharma subsidiary, Citius Oncology (Nasdaq: CTOR), launched LYMPHIR (denileukin diftitox-cxdl), a novel IL-2 receptor-directed immunotherapy, in the U.S. in December 2025 for the treatment of adult patients with relapsed or refractory Stage I-III CTCL after at least one prior systemic therapy;

● Citius Pharma drove commercial preparations for LYMPHIR’s launch through its shared management services agreement with Citius Oncology:

- Executed service agreements with the three leading U.S. pharmaceutical wholesalers to distribute LYMPHIR throughout the U.S.;

- Secured access to LYMPHIR in 19 international markets through regional distribution partners via named patient programs (NPPs), which allows access to LYMPHIR where permitted by local law without constituting commercial approval outside the U.S.;

- Ensured production and sufficient supply of LYMPHIR for up to 18 months of estimated commercial demand;

- Secured inclusion of LYMPHIR in the National Comprehensive Cancer Network (NCCN) guidelines and compendia with a Category 2A recommendation, and a unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code (J9161) to aid in obtaining coverage and reimbursement;

- Partnered to deploy an AI-powered sales and marketing platform to enhance commercial targeting, real-time field execution, and provider engagement; and,

- Contracted with a leading provider of global commercialization services to supply medical information, pharmacovigilance, revenue cycle management, program management, data and analytics, and channel management services;

● Raised approximately $61 million in gross proceeds from capital raises:

- Citius Pharma closed $25 million in gross proceeds from strategic financings during and after the fiscal year end; and,

- Citius Oncology closed $36 million in gross proceeds from strategic financings during and after the fiscal year end; and,

● Continued to engage with the FDA on the paths forward for Mino-Lok and Halo-Lido.

Fiscal Year 2025 Financial Highlights

● Cash and cash equivalents of $4.3 million as of September 30, 2025;

● Citius Pharma did not report revenues for the year;

● R&D expenses were $9.2 million for the full year ended September 30, 2025, compared to $11.9 million for the full year ended September 30, 2024;

● G&A expenses were $18.5 million for the full year ended September 30, 2025, compared to $18.2 million for the full year ended September 30, 2024;

● Stock-based compensation expense was $10.8 million for the full year ended September 30, 2025, compared to $11.8 million for the full year ended September 30, 2024; and,

● Net loss was $39.7 million, or ($3.38) per share for the fiscal year ended September 30, 2025 compared to a net loss of $40.2 million, or ($5.97) per share for the full year ended September 30, 2024.

(Press release, Citius Pharmaceuticals, DEC 23, 2025, View Source [SID1234661607])

On December 23, 2025 Bio-Techne Corporation (NASDAQ: TECH) reported that Kim Kelderman, President and Chief Executive Officer, will present at the 2026 J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, at 9:00 a.m. PST. A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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(Press release, Bio-Techne, DEC 23, 2025, View Source [SID1234661606])

On December 23, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel payloads reported the initiation of GMP manufacturing activities to support the development of AKTX-101, the Company’s lead ADC program.

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Akari has selected WuXi XDC, the world’s leading ADC contract development and manufacturing organization (CDMO), as its partner for this critical and necessary IND-enabling work to support the initiation of clinical trials. WuXi XDC is globally recognized for its end-to-end ADC development and manufacturing capabilities and deep expertise in producing large numbers of ADCs that are currently in clinical development.

The initiation of this key manufacturing activity marks a significant advancement for AKTX-101, which incorporates Akari’s novel proprietary payload PH1 that works through RNA splicing modulation. The PH1 payload represents a differentiated approach to ADC design and brings a 1-2 punch of cytotoxicity and immuno-oncology action that has the potential to significantly increase the therapeutic impact of ADCs beyond today’s current options.

"Initiating GMP manufacturing of AKTX-101 is an important milestone for Akari and for AKTX-101 as we look to demonstrate the potential of our PH1 ADC payload in treating cancer patients," said Abizer Gaslightwala, President and CEO of Akari Therapeutics. "Advancing this critical project with WuXi XDC reflects our confidence in the science behind AKTX-101 and our path to the clinic. To have WuXi XDC as our key partner adds to our confidence of reaching the clinical trials quickly and efficiently and with the highest quality. This key work lays the foundation for our planned Phase 1 first-in-human study in approximately 12 months."

WuXi XDC also highlighted the importance of the collaboration with Akari and the innovative nature of Akari’s ADC payload, PH1:

"We are excited to work with Akari Therapeutics on the manufacturing of AKTX-101," said Dr. Jimmy Li, CEO of WuXi XDC. "The PH1 payload represents a novel and potentially high impact innovation in the ADC field, and we look forward to leveraging our integrated ADC platform to support the production of high-quality GMP material and help advance this promising program toward the clinic. We believe this first project with Akari could lay the groundwork for multiple ADC programs that utilize this novel payload."

Akari and WuXi XDC are building a strategic partnership around AKTX-101, combining Akari’s innovative ADC design and payload technology with WuXi’s global leadership in ADC development and manufacturing. The resulting GMP-grade drug product is intended to support Akari’s planned Phase 1 first-in-human clinical trial, which the Company expects to initiate in late 2026 or early 2027, subject to regulatory clearance.

This manufacturing milestone underscores Akari’s continued progress in advancing its pipeline and executing on its strategy to develop differentiated ADC therapies using novel payloads that have the potential to significantly improve outcomes for cancer patients.

(Press release, Akari Therapeutics, DEC 23, 2025, View Source [SID1234661605])

On December 22, 2025 Alphamab Oncology (stock code: 9966.HK) reported that that the clinical trial application for the independently developed TROP2/HER3 bispecific antibody-drug conjugate (ADC) JSKN016, in combination with InventisBio’s oral selective estrogen receptor degrader (SERD) D-0502, has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The trial (Study Number: JSKN016-204) is for the treatment of locally advanced or metastatic HR-positive, HER2-negative (HR+/HER2-) breast cancer.

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Breast cancer is the most prevalent malignancy among Chinese women, with the HR+/HER2- subtype accounting for approximately 70% of all breast cancer cases. The current first-line standard of care involves endocrine therapy combined with CDK4/6 inhibitors. However, primary or acquired resistance often leads to disease progression, resulting in a significant unmet clinical need in later-line treatment. Therefore, it is crucial to explore novel-mechanism drugs and combination therapies.

JSKN016 is a novel bispecific ADC that simultaneously targets TROP2 and HER3 on the surface of tumor cells. It blocks the corresponding signaling pathways while enhancing cellular endocytosis and release of topoisomerase I inhibitors, enabling precise tumor killing. Early phase clinical studies have shown promising antitumor activity and a favorable safety profile in various solid tumors, including breast cancer. D-0502 is a novel, oral SERD independently developed by InventisBio. Early phase clinical studies have demonstrated its antitumor activity and good tolerability as monotherapy. The combination of both drugs is expected to achieve multiple synergistic effects, which may lead to prolonged disease control and improved survival outcomes for patients.

JSKN016-204 is a multicenter, open-label, randomized controlled phase Ib/II clinical study. It aims to evaluate the safety, tolerability, dose-limiting toxicity (DLT), preliminary antitumor activity, and pharmacokinetics (PK)/pharmacodynamics (PD) of JSKN016 in combination with D-0502 in patients with locally advanced or metastatic HR+/HER2- breast cancer who have been previously treated with CDK4/6 inhibitor in combination with endocrine therapy.

Ms. Yang Liu, Chief Operating Officer of Alphamab Oncology, stated: "Oral SERDs, including InventisBio’s D-0502, have recently demonstrated superior efficacy in HR+ breast cancer. Currently, there are no global precedents for combining an ADC with an oral SERD. Our JSKN016 has shown excellent efficacy and safety in later-line HR+ breast cancer. By combining with D-0502, we hope to further extend the progression-free survival for HR+ breast cancer patients after front-line therapy resistance and translate it into high-quality, long-term survival benefits. We greatly look forward to this collaboration."

Dr. Ling Zhang, Chief Medical Officer of InventisBio, stated: "We are very pleased that the clinical trial application for the combination therapy of D-0502 and JSKN016 has been approved. Drug resistance in HR+/HER2- breast cancer remains a major clinical challenge, with limited treatment options in later lines. D-0502, an oral SERD with a favorable safety profile and high bioavailability, in combination with the ADC JSKN016, is expected to synergistically inhibit tumor growth through a dual mechanism of action, offering new hope for patients with refractory disease."

About JSKN016

JSKN016 is a TROP2/HER3 targeting bispecific ADC developed using the proprietary single-domain antibody and bispecific antibody platforms. It is conjugated via site-specific glycosylation to generate a homogeneous and stable ADC with a drug-to-antibody ratio (DAR) of 4. Upon binding to TROP2 and/or HER3 on the tumor cell surface, JSKN016 blocks the corresponding signaling pathways and enhances cellular endocytosis to release topoisomerase I inhibitors, thereby exerting anti-tumor effects.

JSKN016 has demonstrated promising antitumor activity and a favorable safety profile across multiple solid tumors. Dose optimization and dose confirmation have been completed, and it is poised to advance into Phase III clinical studies.

About D-0502 (Taragarestrant)

D-0502 is a novel, oral selective estrogen receptor degrader (SERD) independently developed by InventisBio, intended for the treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Compared to existing injectable SERDs, its oral administration offers greater convenience for patients. D-0502 has demonstrated favorable antitumor activity and a promising safety profile in both preclinical studies and clinical trials. In October 2021, the Center for Drug Evaluation (CDE) granted approval to initiate a registrational Phase III clinical trial in China for D-0502. This trial is designed as a head-to-head comparison against standard of care in patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer. The first patient was successfully enrolled in this registrational Phase III trial in September 2022, and the trial is currently proceeding as planned.

(Press release, Alphamab, DEC 22, 2025, View Source [SID1234662085]).