On January 5, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau", or the "Company"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT reported the submission of the first module of its pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA), following the FDA’s previous decision to allow the Company to use the more flexible modular approach. The Company submitted the module as part of an application for the use of Alpha DaRT in treating recurrent cutaneous squamous cell carcinoma (cSCC), the second most common form of skin cancer, for patients not indicated for surgery or standard radiation therapy, and for whom no curative systemic treatment is available. This module is focused on comprehensive documentation with respect to non-clinical studies as required under the PMA application.

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Uzi Sofer, CEO of Alpha Tau, stated, "Alpha Tau continues its fast pace of activity, charging forward in our pursuit of potential marketing authorizations across a wide range of tumors, with an eye toward future commercialization. The decision by the FDA to allow us to submit our PMA in a modular form will hopefully allow for ongoing FDA review and feedback as each module is submitted, and we look forward to this dynamic and efficient authorization review process with the FDA."

Yaniv Sagie, VP Quality and Regulatory Affairs, added, "Thank you to our outstanding team for this great accomplishment, our first PMA module submission, and for all of the other achievements working with regulators around the world. I appreciate the support of our advisors who work closely with us and hope to accomplish great things for Alpha Tau together."

Alpha Tau is currently conducting its multi-center pivotal ReSTART study exploring the use of Alpha DaRT in recurrent cSCC, one of five clinical trials currently approved in the U.S., and anticipates completing patient recruitment in Q1 2026. Alpha Tau has received Breakthrough Device Designation from the FDA in this indication as well as for recurrent glioblastoma multiforme (GBM) and recurrent squamous cell carcinoma of the oral cavity with similar criteria, and is also part of the FDA Total Product Life Cycle Advisory Program (TAP) to accelerate market access for the potential treatment of recurrent GBM.

(Press release, Alpha Tau Medical, JAN 5, 2026, View Source [SID1234661707])

On January 5, 2026 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, reported that its management team is scheduled to present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 8:15 a.m. PST / 11:15 a.m. EST.

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The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be archived on the company’s website for at least two weeks following the presentation.

(Press release, Agios Pharmaceuticals, JAN 5, 2026, View Source [SID1234661706])

On January 5, 2026 Orum Therapeutics (Orum or the Company) (KRX: 475830), a biotechnology company pioneering the field of degrader-antibody conjugates (DACs), reported the appointment of Chad May, Ph.D., as Chief Scientific Officer (CSO). Dr. May brings more than 20 years of oncology and immunology research experience with a track record of advancing antibody drug conjugates (ADCs), T-cell engagers, and other next-generation therapeutic platforms from concept to clinical evaluation.

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"Chad has repeatedly demonstrated an ability to take bold scientific concepts and advance them into clinical candidates across multiple therapeutic modalities," said Sung Joo (SJ) Lee, Ph.D., Founder and CEO of Orum. "His leadership experience in ADCs, T-cell engagers, and structure-driven platform design aligns with Orum’s commitment to precision engineering the next generation of degrader-antibody conjugates. Chad’s expertise strengthens our position as a leader in DAC innovation and supports our progress toward meaningful clinical milestones."

As CSO, Dr. May will provide scientific vision and R&D leadership, guiding the strategic direction, discovery, and advancement of Orum’s pipeline, including the continued evolution of the Company’s proprietary DAC platforms and programs. He will oversee scientific strategy across discovery, translational research, and preclinical development and will play a central role in shaping the next stage of Orum’s technology innovation and pipeline growth.

"The opportunity to join Orum at this stage of growth is incredibly compelling," said Dr. May. "The Company’s Dual-Precision Targeted Protein Degradation approach provides a powerful foundation for creating new classes of degraders guided by antibody specificity. I am excited to work closely with the talented scientific and leadership teams to advance Orum’s DAC platforms, expand therapeutic applications across cancer and other serious diseases, and drive the next wave of innovation in degrader-antibody conjugates."

Dr. May joins Orum from Serotiny, where he served as CSO and oversaw the advancement of a novel gene and cell therapy platform through the company’s post-acquisition integration into Johnson & Johnson. Previously, he served as Senior Vice President of Research and Development at Maverick Therapeutics, where he co-founded and built the R&D organization, advanced multiple conditionally active T-cell engager programs into clinical trials, and led the company’s build-to-buy collaboration with Takeda. Earlier in his career, Dr. May held scientific leadership roles at Pfizer, where he led teams developing T-cell engagers and ADCs and advanced several programs into IND-enabling studies and clinical development. His prior work at ImClone Systems involved the design, conjugation, and evaluation of antibody-based therapeutics. Over his career, Dr. May has built and led high-performing scientific teams, contributed to numerous first-in-class program nominations, and authored more than 30 publications and patents.

(Press release, Orum Therapeutics, JAN 5, 2026, View Source [SID1234661695])

On January 5, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that it has initiated the Phase III part of the Phase II/III trial to evaluate the efficacy of the combination of surufatinib, camrelizumab, nab-paclitaxel and gemcitabine as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma ("PDAC") in China. The first patient received the first dose on December 30, 2025.

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PDAC is a highly aggressive form of cancer, representing over 90% of pancreatic cancer cases. Globally, an estimated 511,000 people were diagnosed with pancreatic cancer, leading to approximately 467,000 deaths in 2022, with an average five-year survival rate of less than 10%. In China, an estimated 119,000 people were diagnosed with pancreatic cancer, causing approximately 106,000 deaths in 2022.[1] Treatments such as chemotherapy, surgery and radiation are commonly employed, but have not shown significant improvement in patient outcomes. Under 20% of metastatic pancreatic cancer patients survive for more than a year.

The trial is a multicenter, randomized, open-label, active-controlled Phase II/III study to evaluate the efficacy and safety of surufatinib combined with camrelizumab, nab-paclitaxel and gemcitabine ("S+C+AG") versus nab-paclitaxel plus gemcitabine ("AG") in adults with metastatic pancreatic cancer who have not previously received systemic anti-tumor therapy. A total of 62 patients were enrolled in the Phase II part, with plans to enroll approximately 400 additional patients in the Phase III part. The primary endpoint for the Phase III part is overall survival (OS). Secondary endpoints include progression-free survival ("PFS"), objective response rate ("ORR"), duration of response (DoR), disease control rate ("DCR"), quality of life and safety. Professor Shukui Qin of China Pharmaceutical University Nanjing Tianyinshan Hospital and Professor Jihui Hao of Tianjin Medical University Cancer Institute and Hospital are the leading principal investigators of this study. Additional details may be found at clinicaltrials.gov, using identifier NCT06361888.

Results from the Phase II part were recently presented at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress.[3] As of the data cut-off of July 24, 2025, the median PFS follow-up duration was 8.15 months. The S+C+AG regimen demonstrated a median PFS of 7.20 months compared to 5.52 months for the AG arm (stratified hazard ratio [HR] 0.499, log-rank p=0.0407), representing a 50.1% reduction in the risk of progression or death. Consistent benefits were observed across other key efficacy endpoints, including ORR (67.7% vs 41.9%, p=0.0430) and DCR (93.5% vs 71.0%, p=0.0149). Although overall survival data were immature at the time of analysis, a favorable trend was observed (not reached vs 8.48 months, unstratified HR 0.555), with 9 events in the S+C+AG arm (N=31) and 15 events in the AG arm (N=31). The safety profile was manageable. Treatment-emergent adverse events (TEAEs) of grade 3 or above occurred in 80.6% of patients in the S+C+AG arm compared to 61.3% in the AG arm.

About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (VEGFRs) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA. HUTCHMED currently retains all rights to surufatinib worldwide.

About Camrelizumab
Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the programmed death-1 (PD-1) receptor. Camrelizumab has been approved in China for multiple indications in areas such as lung cancer, liver cancer, esophageal cancer, nasopharyngeal cancer and cervical cancer. Camrelizumab is marketed in China by Hengrui Pharma under the brand name AiRuiKa.

(Press release, Hutchison China MediTech, JAN 5, 2026, View Source [SID1234661694])

On January 4, 2026 Insilico Medicine ("Insilico"), a world-leading artificial intelligence (AI)-driven drug discovery company, reported a multi-year research and development (R&D) collaboration with Servier, an independent international pharmaceutical company governed by a foundation. This strategic alliance is focused on identifying and developing novel therapeutics for challenging targets in the oncology space by leveraging Insilico’s proprietary AI platform, Pharma.AI.

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Under the agreement, Insilico will be eligible to receive up to US$32 million in upfront and near-term R&D payments and will lead the AI-driven discovery and development of potential drug candidates that meet predefined criteria, while Servier will share the R&D expenses and lead clinical validation and commercialization processes.

"This collaboration underscores Servier’s commitment to applying cutting-edge technologies to address unmet medical needs for the benefit of patients and reflects our confidence in Insilico’s internally developed and validated AI platform", said Christophe Thurieau, Executive Director Research at Servier.

"I am excited to see the collaboration—it is yet another strong acknowledgment of our AI capabilities and R&D expertise", said Alex Zhavoronkov, PhD, founder, CEO and CBO of Insilico Medicine. "As we deepen the integration of generative AI into every stage of the pharma value chain, I believe the future of pharmaceutical superintelligence is never so close, where AI agents could actually make decisions and design experiments, driving a virtuous cycle of faster, smarter, and safer drug development."

Insilico has extensive experience in AI-driven oncology drug discovery and development. The company has established a robust oncology pipeline that targets multiple cancer indications, leveraging both moderately novel and well-established mechanisms. Among its most promising assets, the potential best-in-class pan-TEAD inhibitor ISM6331 and the MAT2A inhibitor ISM3412 are both undergoing global, multicenter Phase I clinical trials. Additionally, four other oncology programs have been fully or partially out-licensed to partners, with Phase I clinical trials actively in progress.

Harnessing state-of-the-art AI and automation technologies, Insilico has significantly improved the efficiency of preclinical drug development, setting a benchmark for AI-driven drug R&D. While traditional early-stage drug discovery typically requires an average of 4.5 years, Insilico has nominated 20 preclinical candidates from 2021 to 2024, with an average timeline—from project initiation to preclinical candidate (PCC) nomination—of just 12 to 18 months per program, with only 60 to 200 molecules synthesized and tested in each program.

(Press release, Insilico Medicine, JAN 4, 2026, View Source [SID1234661696])