On January 14, 2026 GT Medical Technologies, a company focused on improving the lives of patients with brain tumors, reported that the first patients have been enrolled in the Beginning Radiation Immediately with GammaTile at Glioblastoma Excision versus Standard of Care (BRIDGES) U.S. clinical trial for newly diagnosed glioblastoma (GBM). The BRIDGES trial is an innovative randomized study evaluating whether implanting GammaTile at the time of surgery can improve the survival outcomes for patients with newly diagnosed GBM.

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Per Langoe, CEO of GT Medical Technologies, stated "GT Medical Technologies is proud to announce that the first patients have been enrolled in the BRIDGES trial, a groundbreaking study that will examine the ability of GammaTile to increase survivability for patients with newly diagnosed GBM. Patients who are newly diagnosed with GBM face an unacceptably poor prognosis, demonstrating a significant need for disruptive therapies that can improve the standard of care. With the recent completion of our ROADS trial for newly diagnosed brain metastases, we are very encouraged going into the BRIDGES trial."

The first BRIDGES patient enrollment was achieved at Westchester Medical Center in Valhalla, NY, by neurosurgeon Dr. Simon Hanft. "All of us at Westchester Medical Center are excited about giving our patients access to the BRIDGES trial and what it could mean for our patients suffering from GBM," stated Dr. Hanft. "We have utilized GammaTile successfully for a number of years, and we look forward to a significant contribution to the BRIDGES trial in an effort to lead the exploration of new advancements in care for patients with GBM."

Dr. Clark C. Chen, Professor and Director of the Brain Tumor Program, Brown University Health, Providence, RI, explained "Although glioblastoma remains a challenging disease, meaningful progress is underway. The BRIDGES trial exemplifies this momentum, offering patients access to the most advanced therapies available in modern neuro-oncology. At Brown Health, we are proud to make this trial available to our patients."

"GammaTile therapy is designed to be implanted at the time of GBM tumor resection, enabling radiation treatment to begin immediately rather than weeks after surgery," said Dr. Michael Garcia, Chief Medical Officer at GT Medical Technologies. "This represents a fundamental shift from the traditional care paradigm, where time between surgery and radiation allows for the tumor to start growing back. By delivering radiation from day one—when tumor burden is at its lowest—GammaTile offers a new way to rethink postoperative radiation. This approach underpins the promise of the BRIDGES trial and its potential to transform how GBM is treated."

(Press release, GT Medical Technologies, JAN 14, 2026, View Source [SID1234662049])

On January 14, 2026 Samsung Epis Holdings (KRX: 0126Z0) reported corporate progress and updates at the 44th J.P. Morgan Healthcare Conference.

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"2026 is a monumental year for us, as we enter into a new chapter for our company. Today, we are announcing six additional candidates in our biosimilar pipeline, including vedolizumab and dupilumab. We are making great progress to secure 20 biosimilars in our portfolio by 2030," said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. "We also received the investigational new drug application (IND) clearance for the first novel therapeutic candidate developed by Samsung Bioepis, and plan to advance our clinical program this year. As we broaden our portfolio beyond biosimilars, we will continue our development efforts in antibody-drug conjugates (ADCs), leveraging our innovative research and development platform to expand viable treatment options for patients with unmet needs."

Samsung Bioepis Biosimilar Updates

Samsung Bioepis currently has 11 biosimilars for 10 unique biological molecules approved and launched in more than 40 countries.1 The company has pembrolizumab biosimilar undergoing Phase 1 and 3 clinical studies, and plans to secure 20 biosimilars in its portfolio by 2030.
The new pipeline will include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab.
Novel Therapeutics Updates

In December 2025, the FDA has cleared the IND Application for SBE303. SBE303 is Samsung Bioepis’ first novel ADC engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including urothelial cancer, lung cancer, and breast cancer.2 The Phase 1 first-in-human clinical trial, aiming to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of SBE303 in participants with advanced refractory solid tumors, is set to begin this year.
Samsung Bioepis plans to have one novel therapeutic candidate enter into clinical study every year.
Epis NexLab, the new subsidiary under Samsung Epis Holdings, has launched a project to develop a peptide-based drug delivery platform.
Samsung Bioepis Biosimilars Portfolio

Code Name (Brand Name3)

Non-proprietary Name

Reference Product

Status4

SB5

(IMRALDI, HADLIMA, ADALLOCE)

Adalimumab

Humira

Launch

SB4

(BENEPALI, BRENZYS, ETOLOCE)

Etanercept

Enbrel

Launch

SB2

(FLIXABI, RENFLEXIS, REMALOCE)

Infliximab

Remicade

Launch

SB3

(ONTRUZANT, SAMFENET)

Trastuzumab

Herceptin

Launch

SB8

(AYBINTIO)

Bevacizumab

Avastin

Launch

SB11

(BYOOVIZ, AMELIVU)

Ranibizumab

Lucentis

Launch

SB12

(EPYSQLI)

Eculizumab

Soliris

Launch

SB15

(OPUVIZ, AFILIVU)

Aflibercept

Eylea

Launch

SB16

(OBODENCE, OSPOMYV)

Denosumab

Prolia

Launch

SB16

(XBRYK)

Denosumab

Xgeva

Launch

SB17

(PYZCHIVA, EPYZTEK)

Ustekinumab

Stelara

Launch

SB27

Pembrolizumab

Keytruda

Phase 1 and 3

Samsung Bioepis Biosimilar Candidates in Early Stage Development

Non-proprietary Name

Reference Product

Dupilumab

Dupixent

Guselkumab

Tremfya

Ixekizumab

Taltz

Vedolizumab

Entyvio

Ocrelizumab

Ocrevus

Fam-trastuzumab deruxtecan-nxki

Enhertu

(Press release, Samsung Epis Holdings, JAN 14, 2026, View Source [SID1234662050])

On January 13, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported it has received a new independent assessment for the absence of cardiotoxicity in subjects treated with Annamycin, bringing the total number of Annamycin treated subjects reviewed by its independent expert to 90. Data from the most recently completed clinical trials’ subjects were made available to an expert in chemotherapy who is affiliated with a leading cancer research institute in assessing cardiotoxicity. After review of certain data, the independent expert concluded that there was no evidence of cardiotoxicity. This data is across five clinical trials treating acute myeloid leukemia (AML) and soft tissue sarcoma (STS) with Annamycin as a monotherapy and in combination with cytarabine and across multiple sites in the United States (US) and the European Union (EU). Most of these subjects were treated above the recommended lifetime maximum for other anthracyclines.

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The data made available to the expert included, but was not limited to, data from serial 12-lead ECGs, transthoracic echocardiography with centralized global longitudinal strain (GLS) analysis, and cardiac biomarker (troponins I and T) concentration measurements by a central lab using validated assays. Cardiac health biomarkers such as blood troponin levels are considered an indicator of potential long-term heart damage.

"As we closely approach almost 100 subjects that have received Annamycin (also known by the name "naxtarubicin") which have been reviewed by our expert, we continue to be encouraged by the potential of Annamycin. This additional independent report of additional datasets provides further validation of the absence of cardiotoxicity," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "Annamycin continues to demonstrate an absence of cardiotoxicity, even in subjects who have received far more than the lifetime maximum cumulative anthracycline exposure established by the US Food and Drug Administration (FDA). In fact, 65 of the 90 subjects evaluated have been taken over the FDA’s lifetime maximum of 550 mg/m2 and with one of them being taken over 6500 mg/m2. Our growing body of positive data for Annamycin continues to bolster our confidence in our belief that Annamycin is truly a ‘next generation’ anthracycline, especially in light of the growing efficacy data that we have previously reported in the treatment of AML and STS. We remain focused on advancing our Annamycin development programs and ultimately, addressing the medical unmet needs of people with difficult to treat cancers."

"It is important to understand that nearly half of all cancers and 60% of childhood cancers are currently treated with cardiotoxic anthracyclines that result in permanent damage to the heart. To quote one study: ‘Some commonly used cancer drugs, such as the anthracyclines, are known to be cardiotoxic. Left undetected and untreated, this cardiotoxicity is progressive and persistent and can lead to cardiomyopathy, clinical heart failure, the need for a heart transplant, or death. In fact, 30 years after diagnosis, the number of cardiac-related deaths among survivors exceeds the number caused by cancer recurrence (emphasis added).’ We believe Annamycin has the potential to become the first ever non-cardiotoxic anthracycline. Coupled with its observed ability in a wide range of tumor animal models to avoid cross-resistance with existing anthracyclines and to demonstrate equal or greater efficacy, we believe the market opportunity for Annamycin is potentially enormous. We are looking forward to adding to this dataset and completing long-term cardiac follow-up with active subjects in our current trials."

(Press release, Moleculin, JAN 13, 2026, https://moleculin.com/moleculin-reports-independent-assessment-confirms-no-cardiotoxicity-of-annamycin-in-90-subjects/ [SID1234662017])

On January 13, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported an update on the Company’s 2026 strategic priorities and clinical development progress. These updates will be discussed as part of the Company’s presentation at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 13, 2026, at 3:00 p.m. PT / 6:00 p.m. ET.

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"Since our founding, we have intentionally built Zai Lab as a dual-engine company – combining a commercially profitable and scaling China business with a global innovation engine that is now reaching a pivotal inflection point," said Samantha Du, Founder, Chairperson, and CEO of Zai Lab. "With Zoci now in Phase 3 and multiple global programs advancing behind it, we are entering our next phase with a highly efficient, globally integrated R&D platform, a strong balance sheet, and the capabilities to execute at scale."

"Our regional business is built around a portfolio of high-impact, first- and best-in-class medicines that are driving durable, multi-year growth," said Josh Smiley, President and Chief Operating Officer of Zai Lab. "This engine provides a strong and growing financial foundation to support our long-term strategic priorities. At the same time, our dual-gateway model and partner-of-choice position enable us to consistently access high-quality innovation and advance those assets efficiently on a global stage."

Zai Lab’s Dual-Engine Strategy

Zai Lab’s differentiated dual-engine model is designed to drive both near-term performance and long-term global value creation. The Company’s commercially profitable and scaling China business provides a strong financial foundation to invest in global innovation. Its fully integrated cross-border R&D platform enables faster, more capital-efficient development of high-quality assets, as demonstrated by Zoci’s rapid advancement from first-in-human studies to global pivotal trials. Together, these two engines uniquely position Zai Lab to build a globally competitive biopharmaceutical company.

Advancing Differentiated Global Programs Across Oncology and Immunology

Zocilurtatug Pelitecan (Zoci or ZL-1310)

Zoci, the Company’s lead global asset and a potential first- and best-in-class DLL3-targeting ADC, is expected to be in three registrational studies by the end of 2026:

2L/3L SCLC (small cell lung cancer): Data demonstrated a 68% overall response rate (ORR) with a favorable safety profile, including low rates of Grade 3+ adverse events and no treatment-related discontinuations at 1.6 mg/kg. A registrational Phase 3 study has been initiated.
1L SCLC: An ongoing Phase 1 combination study with PD-L1 ± chemotherapy is expected to inform the design of a Phase 3 study anticipated to initiate by year-end. A novel combination Phase 1 study is expected to initiate in the first half of 2026.
NEC (neuroendocrine carcinoma): A Phase 1 study is ongoing, with results expected in the first half of 2026. A registration-enabling study is expected to initiate in the second half of 2026.
Other Global Oncology Assets

ZL-6201: A novel LRRC15-targeting ADC designed to disrupt the tumor microenvironment by targeting tumor-associated fibroblasts (TAF), enabling potential for broad applicability across multiple solid tumors (sarcoma, breast cancer, NSCLC). Global Phase 1 initiation is expected in 1Q 2026.
ZL-1222: A next-generation PD-1/IL-12 immunocytokine that has demonstrated strong anti-tumor activity in preclinical models, including in PD-1-sensitive and resistant settings, with an improved systemic safety profile. IND-enabling studies are expected to complete this year.
ZL-1311: A next-generation T-cell engager (TCE) targeting MUC17, a promising and druggable antigen overexpressed in up to ~50% of gastric and gastroesophageal junction cancers. The program represents Zai Lab’s first globally owned TCE and strategically expands our immuno-oncology portfolio while leveraging our established expertise in GI cancers. ZL-1311 is expected to enter global clinical development this year.
Zai Lab is building capabilities in TCEs and exploring additional immunocytokines beyond IL-12, with further details to be provided throughout the year.

ZL-1503: A Novel Dual-Targeting Approach for Atopic Dermatitis (AD)

ZL-1503 is a first-in-class bispecific antibody dual-targeting IL-13 and IL-31R designed to provide rapid itch relief and broad disease control.

The Company anticipates reporting First-in-Human (FIH) data from healthy volunteers in the second half of 2026, paving the way for Phase 2 development in AD patients.
Key Near-Term Regional Launches to Drive Steady Growth

Today, Zai Lab has eight commercial products in China, forming a diversified and durable commercial portfolio. COBENFY is expected to launch in the first half of 2026 through a focused, high-impact commercial strategy, emphasizing physician education, real-world evidence generation, and preparation for potential NRDL inclusion in 2027. Additional near-term launches, including povetacicept and VRDN-003, are expected to add further layers of growth to the regional business. As China’s regulatory and market access environment continues to evolve, Zai Lab is well positioned to deliver long-term growth.

Catalyst-Rich 2026: Granular Milestones to De-Risk Pipeline and Drive Value

2026 is expected to be a defining year for Zai Lab, with multiple high-impact milestones across its global pipeline. Key catalysts include the continued execution of Zoci’s pivotal program, the advancement of multiple novel oncology and immunology assets into the clinic, several anticipated IND filings, and data readouts designed to further validate the Company’s integrated R&D platform. On the regional front, the expected launch of COBENFY and continued growth of existing product franchises are expected to further strengthen the Company’s financial foundation. Together, these milestones are expected to continue to de-risk the pipeline, accelerate value inflection points, and support Zai Lab’s next phase of global growth.

(Press release, Zai Laboratory, JAN 13, 2026, View Source [SID1234662032])

On January 13, 2026 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation oral macrocyclic MEK inhibitor for the treatment of neurofibromatosis type 1 associated plexiform neurofibromas (NF1-PN), reported updated timelines on its ongoing clinical trials in advanced cancer and adult NF1-PN patients.

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Ongoing Phase 1/1b clinical trial in adult patients with NF1-PN (NCT06961565):

Pasithea has completed enrollment of 12 patients through the first 4 dose cohorts (4, 8, 12 and 18 mg tablets) in Part A of the study.

The Company plans to present data in the second half of 2026, including available efficacy data through the six-month timepoint for both plexiform and cutaneous neurofibromas. The planned data release is also expected to include safety, tolerability and pharmacokinetic (PK) data.
Ongoing Phase 1 clinical trial in advanced cancer patients (NCT06299839):

Pasithea expects to present longer-term follow-up data from patients in Cohort 4 (15mg capsule) through Cohort 8 (45mg capsule) in the second quarter of 2026.
"2025 was a pivotal year for Pasithea, highlighted by early evidence of a differentiated safety and tolerability profile and initial signals of clinical activity in our first-in-human dose escalation advanced cancer study of PAS-004, our potentially best-in-class macrocyclic MEK inhibitor," said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. "In November 2025, we announced encouraging results in patients previously treated with a MEK inhibitor, including a partial response and an initial disease control rate of 71.4% among efficacy evaluable patients with BRAF-mutated tumors and met our planned milestone of providing initial NF1-relevant data through the presentation of pharmacokinetic results in the first two cohorts of our NF1 study. We believe these findings from our advanced cancer study support the development of PAS-004 for the treatment of NF1-PN patients. Additionally, in December 2025, we successfully raised $60 million in gross proceeds through a public offering, enabling us to advance PAS-004 through several key milestones and support operations through at least the first half of 2028. We remain steadfast in our mission to deliver safe, tolerable and effective therapies to patients with significant unmet need, especially in indications requiring chronic dosing."

(Press release, Pasithea Therapeutics, JAN 13, 2026, View Source [SID1234662018])