A Phase 1b/2a, Double-blind, Placebo-controlled, Three Arm, Randomized Study Evaluating a Single Intravenous Push Followed by a Continuous Infusion of Certepetide Over 4 Hours When Added to Standard of Care (SoC) Versus Two Intravenous Pushes of Certepetide When Added to SoC, Versus SoC Alone in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (FORTIFIDE)

The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in people with metastatic pancreatic ductal adenocarcinoma.
The main questions it aims to answer are:
* is the new drug plus standard treatment safe and tolerable
* is the new drug plus standard treatment more effective than standard treatment
Participants will:
* Visit the clinic three times every 28 days for treatment and tests
* Have CT or MRI scans every 8 weeks while on treatment

Start Date01 Jan 2030

Sponsor / Collaborator

Lisata Therapeutics, Inc.

NCT06498648

/ SuspendedPhase 1/2IIT

Phase I/II Study to Evaluate the Feasibility and Efficacy of Sequential Abemaciclib and Gemcitabine Treatment in Patients With Retinoblastoma (Rb)+ Sarcomas

This phase I/II trial tests the side effects and best dose of abemaciclib when added to gemcitabine and compares the effectiveness of that treatment to the usual treatment of gemcitabine with docetaxel for the treatment of patients with soft tissue sarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) (phase 1) or patients with leiomyosarcoma or dedifferentiated liposarcoma (phase 2). Abemaciclib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Giving abemaciclib with gemcitabine may be safe and effective when compared to treatment with gemcitabine and docetaxel for patients with advanced or metastatic soft tissue sarcoma or leiomyosarcoma or dedifferentiated liposarcoma.

Start Date14 Oct 2026

Sponsor / Collaborator

National Cancer Institute

NCT06822010

/ Not yet recruitingPhase 2IIT

A Phase II Trial of SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (SUMMIT)

This Phase II clinical trial, titled "A Phase II Trial of Sequential Gemcitabine and Mitomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (SUMMIT)," aims to evaluate the safety and effectiveness of a combination chemotherapy treatment for patients with favorable papillary high-grade upper tract urothelial carcinoma (UTUC). The study focuses on sequential administration of two drugs, gemcitabine and Jelmyto (a gel-based form of mitomycin), to potentially preserve kidney function and avoid nephroureterectomy (kidney removal), which is the current standard of care for participants with non-endoscopically resectable tumors.

Start Date01 Jun 2026

Sponsor / Collaborator

Rutgers State University of New Jersey

100 Clinical Results associated with Gemcitabine Hydrochloride

100 Translational Medicine associated with Gemcitabine Hydrochloride

100 Patents (Medical) associated with Gemcitabine Hydrochloride

15,137

Literatures (Medical) associated with Gemcitabine Hydrochloride

01 Nov 2025·CURRENT OPINION IN UROLOGY

Novel intravesical delivery systems for nonmuscle invasive bladder cancer

Review

Author: Ramos, Felix-Guerrero ; Xylinas, Evanguelos ; Katzendorn, Olga ; Pradere, Benjamin ; Khene, Zine Eddine ; Uleri, Alessandro

Purpose of review:

Nonmuscle invasive bladder cancer (NMIBC) represents approximately 75% of bladder cancer cases at diagnosis and poses a significant management challenge due to high recurrence rates and risk for progression. Conventional intravesical therapies face limitations including suboptimal drug delivery, mucosal exposure time and significant adverse events. This review provides a timely assessment of novel intravesical delivery systems developed to overcome these limitations and improve oncological outcomes for patients with NMIBC.

Recent findings:

Several innovative delivery systems show promising results. Hyperthermic intravesical chemotherapy (HIVEC) demonstrates its efficacy in selected high-risk NMIBC. Intravesical drug-releasing systems (iDRS) like TAR-200 showed complete response rates up to 84% in BCG-unresponsive disease, while TAR-210 shows promise for FGFR-altered NMIBC. UGN-102, a reverse thermal gel containing mitomycin C, achieves 65–79% complete response rates in low-grade intermediate-risk NMIBC. Oncofid-P-B, combining paclitaxel with hyaluronic acid, demonstrates efficacy in BCG-unresponsive CIS.

Summary:

Novel intravesical delivery systems show to enhance drug retention, improve tissue penetration, and potentially reduce adverse events. While traditional chemotherapy or BCG remain the gold-standard adjuvant treatments for NMIBC, these novel approaches offer promising alternatives for selected patients pending on ongoing clinical validation.

10 Oct 2025·JOURNAL OF CLINICAL ONCOLOGY

Erratum: TAR-200 for Bacillus Calmette-Guérin–Unresponsive High-Risk Non–Muscle-Invasive Bladder Cancer: Results From the Phase IIb SunRISe-1 Study

Article

Author: Jacob, Joseph M. ; Casco, Nelson Canales ; Cahn, David ; Stromberg, Katharine ; Necchi, Andrea ; Daneshmand, Siamak ; Lotan, Yair ; Pieczonka, Christopher M. ; Cutie, Christopher J. ; Kawahara, Takashi ; Martin, Jason ; Shukla, Abhijit ; Bertzos, Kristi ; Bögemann, Martin ; Zainfeld, Daniel ; Hampras, Shalaka ; Murray, Katie S. ; Xylinas, Evanguelos ; Spiegelhalder, Philipp ; Sweiti, Hussein ; Guerrero-Ramos, Felix ; Van der Heijden, Michiel S. ; Simone, Giuseppe

03 Oct 2025·Expert Opinion On Drug Safety

Signal mining and gender differences analysis of adverse events in NMIBC treatment with gemcitabine and BCG bladder instillation based on the FAERS database

Article

Author: Wang, Jia-Hao ; Wang, Ben ; Wang, Li ; Xia, Long ; Jiang, Bing-Lei ; Zhu, Ping-Yu ; Yang, Lin ; Liu, Ying ; Bao, Er-Hao

OBJECTIVE:

To explore safety differences and perform a gender-based analysis of adverse events related to gemcitabine and Bacillus Calmette-Guérin (BCG) vaccine using the U.S. FDA Adverse Event Reporting System (FAERS) database.

METHODS:

Using the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) methods, adverse events associated with gemcitabine and BCG were mined from FAERS database reports spanning from Q1 2004 to Q3 2023.

RESULTS:

The study extracted 37,855 reports with gemcitabine and 5,455 reports with BCG as the primary suspected drugs. Adverse events were more prevalent in males (male-to-female ratio: gemcitabine 1.10, BCG 4.25). Differences in high-frequency adverse events among the top 20 signals were detected for both drugs. Both drugs affected similar organ systems, including potential pulmonary, ocular, and renal toxicity, with gemcitabine showing a broader range of adverse events. Gender analysis revealed fewer adverse reactions to gemcitabine in females, while males had fewer adverse reactions to BCG.

CONCLUSION:

Differences in high-frequency adverse events between gemcitabine and BCG, including some not listed on drug labels, were observed. Both drugs affect similar organ systems, with gemcitabine showing a broader range of adverse events. Gender differences in adverse events were notable.

806

News (Medical) associated with Gemcitabine Hydrochloride

24 Nov 2025

·ir.biolinerx.com

BioLineRx Reports Third Quarter 2025 Financial Results and Provides Corporate Update

- Establishes joint venture with Hemispherian AS to advance GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma and other cancers - - Phase 1/2a clinical trial of GLIX1 expected to commence in Q1 2026 - - Management to host conference call today, November 24 th, at 8:30 am EST - TEL AVIV, Israel , Nov. 24, 2025 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the quarter ended September 30, 2025 , and provided a corporate update. "The clear highlight of the third quarter was our announcement in September that we established a joint venture with Hemispherian, expanding our development pipeline into additional high-need cancer indications, leading with glioblastoma, in addition to our ongoing PDAC program," stated Philip Serlin , Chief Executive Officer of BioLineRx . "Hemispherian's lead asset, GLIX1, is a versatile molecule with a novel mechanism of action that targets the DNA repair mechanism in cancer cells and has demonstrated compelling efficacy in numerous pre-clinical models. Importantly, the development path is straightforward and efficient, and we are eager to initiate a Phase 1/2a first-in-human study in the first quarter of next year while also advancing pre-clinical activities in support of future potential trials of GLIX1 in other cancers." "At the same time, the ongoing CheMo4METPANC Phase 2b clinical trial of motixafortide in metastatic pancreatic cancer, which is being led by Columbia University and supported by both Regeneron and BioLineRx , continues to progress, giving us a second opportunity to leverage our drug development expertise to bring true innovation to patients with difficult-to-treat cancers," Mr. Serlin concluded. Corporate Updates Announced formation of a joint venture to advance privately held Hemispherian's small molecule cancer therapeutic, GLIX1 GLIX1, a Phase 1-ready candidate that is being developed as a potential treatment for glioblastoma, estimated to be a greater than $3.7 billion global addressable market by 2030 that has seen little innovation since the current standard of care was developed in 2005. The compound is also expected to be evaluated in other cancers, with preclinical work beginning in 2026. Announced that it has received Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a key patent covering GLIX1 for cancers in which cytidine deaminase (CDA) is not over-expressed beyond a specific threshold, estimated to be 90% of all cancers. Patent preserves BioLineRx's ability to evaluate GLIX1 in other cancers beyond glioblastoma, including both hematological and solid tumor cancer types. Patent further broadens and strengthens GLIX1's patent protection until 2040, with a possible patent-term extension of up to five years. GLIX1, a Phase 1-ready candidate that is being developed as a potential treatment for glioblastoma, estimated to be a greater than $3.7 billion global addressable market by 2030 that has seen little innovation since the current standard of care was developed in 2005. The compound is also expected to be evaluated in other cancers, with preclinical work beginning in 2026. Patent preserves BioLineRx's ability to evaluate GLIX1 in other cancers beyond glioblastoma, including both hematological and solid tumor cancer types. Patent further broadens and strengthens GLIX1's patent protection until 2040, with a possible patent-term extension of up to five years. Financial Updates With $25.2 million on its balance sheet as of September 30, 2025 , BioLineRx is maintaining its cash runway guidance into the first half of 2027. Clinical Updates GLIX1 Continued to advance preparations for initiation of a Phase 1/2a clinical trial of GLIX1 in recurrent and newly diagnosed glioblastoma in the first quarter of 2026. World leading investigators in the field of glioblastoma, Dr. Roger Stupp and Dr. Ditte Primdahl of the Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center at Northwestern University , will serve as principal investigators for the study. The Phase 1 part of the trial aims to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy. The Phase 2a expansion part of the trial is planned to include three population cohorts: (1) GLIX1 as monotherapy in recurrent GBM, (2) GLIX1 on top of standard of care in newly diagnosed GBM patients (likely a "window of opportunity" study, with biopsies before and after treatment for PD assessment), and (3) GLIX1 in combination with PARP inhibitors in other solid tumors. Pre-clinical activities in support of potential clinical trials of GLIX1 in additional cancers are ongoing. World leading investigators in the field of glioblastoma, Dr. Roger Stupp and Dr. Ditte Primdahl of the Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center at Northwestern University , will serve as principal investigators for the study. The Phase 1 part of the trial aims to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy. The Phase 2a expansion part of the trial is planned to include three population cohorts: (1) GLIX1 as monotherapy in recurrent GBM, (2) GLIX1 on top of standard of care in newly diagnosed GBM patients (likely a "window of opportunity" study, with biopsies before and after treatment for PD assessment), and (3) GLIX1 in combination with PARP inhibitors in other solid tumors. Motixafortide Pancreatic Ductal Adenocarcinoma (mPDAC) Enrollment continues in the CheMo4METPANC Phase 2b clinical trial, which is being led by Columbia University , and supported by both Regeneron and BioLineRx . The CheMo4METPANC trial is evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and standard chemotherapy (gemcitabine and nab-paclitaxel). A prespecified interim analysis is planned when 40% of progression-free survival (PFS) events are observed. Sickle Cell Disease (SCD) & Gene Therapy Announced that a poster featuring final results from a Phase 1 clinical trial (NCT05618301) evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD) was accepted for presentation at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition taking place December 6-9, 2025 , in Orlando, FL. The 10-subject proof-of-concept study, which was conducted in collaboration with Washington University School of Medicine , demonstrated that motixafortide alone, and in combination with natalizumab, were found to be safe and well- tolerated. Common adverse events were transient and included Grade 1-2 injection site and systemic reactions. No Grade 4 adverse events, dose limiting toxicities or complicated vaso-occlusive events occurred. Motixafortide alone, and in combination with natalizumab resulted in robust CD34+ HSC mobilization. Motixafortide alone mobilized a median of 189 CD34+ cells/μl (range 77-690) to the peripheral blood (PB), with a median yield of 4.22x106 CD34+ cells/kg following a single blood volume collection, projecting the collection of 16.9x106 cells/kg in a four-blood-volume apheresis collection session. Motixafortide in combination with natalizumab mobilized a median of 312 CD34+ cells/μl (range 117-447) to the PB, with a median yield of 4.89x106 CD34+ cells/kg following a single blood volume collection, projecting the collection of 19.6x106 CD34+ cells/kg in a four-blood-volume apheresis collection session. The collection yields of motixafortide alone and in combination with natalizumab are encouraging given that hematopoietic stem cell-based gene therapy for sickle cell disease requires sufficient HSCs (16.5-20x106 CD34+ cells/kg) to generate a product. In two subjects with prior plerixafor mobilization, motixafortide alone, and in combination with natalizumab, led to 2.7-2.8 fold higher CD34+ cells/μl mobilization to PB and 2.8-3.2 fold higher CD34+ cells/kg collection yield, respectively, than plerixafor. A second SCD study, sponsored by St. Jude Children's Research Hospital , continues to enroll patients. The study is a multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ HSCs used in the development of gene therapies for patients with SCD. The 10-subject proof-of-concept study, which was conducted in collaboration with Washington University School of Medicine , demonstrated that motixafortide alone, and in combination with natalizumab, were found to be safe and well- tolerated. Common adverse events were transient and included Grade 1-2 injection site and systemic reactions. No Grade 4 adverse events, dose limiting toxicities or complicated vaso-occlusive events occurred. Motixafortide alone, and in combination with natalizumab resulted in robust CD34+ HSC mobilization. Motixafortide alone mobilized a median of 189 CD34+ cells/μl (range 77-690) to the peripheral blood (PB), with a median yield of 4.22x106 CD34+ cells/kg following a single blood volume collection, projecting the collection of 16.9x106 cells/kg in a four-blood-volume apheresis collection session. Motixafortide in combination with natalizumab mobilized a median of 312 CD34+ cells/μl (range 117-447) to the PB, with a median yield of 4.89x106 CD34+ cells/kg following a single blood volume collection, projecting the collection of 19.6x106 CD34+ cells/kg in a four-blood-volume apheresis collection session. The collection yields of motixafortide alone and in combination with natalizumab are encouraging given that hematopoietic stem cell-based gene therapy for sickle cell disease requires sufficient HSCs (16.5-20x106 CD34+ cells/kg) to generate a product. In two subjects with prior plerixafor mobilization, motixafortide alone, and in combination with natalizumab, led to 2.7-2.8 fold higher CD34+ cells/μl mobilization to PB and 2.8-3.2 fold higher CD34+ cells/kg collection yield, respectively, than plerixafor. APHEXDA Performance Update APHEXDA generated sales of $2.4 million in the third quarter of 2025, providing royalty revenue to the Company of $0.4 million . Financial Results for the Quarter Ended September 30, 2025 Total revenues for the third quarter of 2025 were $0.4 million , reflecting the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. Total revenues in 2025 are not comparable to the same period in 2024, which included a portion of the upfront payment from Gloria Biosciences ( $3.2 million ) as well as direct commercial sales by BioLineRx ( $1.7 million ) prior to the Ayrmid transaction in November 2024 . Cost of revenues for the third quarter of 2025 was immaterial, compared to cost of revenues of $0.8 million for the third quarter of 2024. The cost of revenues in 2025 reflects sub-license fees on royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The cost of revenues in 2024 primarily reflects amortization of intangible assets, royalties on net product sales of APHEXDA in the U.S. and cost of goods sold on product sales. Research and development expenses for the third quarter of 2025 were $1.7 million , a decrease of $0.8 million , or 33.0%, compared to $2.6 million for the third quarter of 2024. The decrease resulted primarily from lower expenses related to motixafortide due to the out-licensing of U.S. rights to Ayrmid, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount. There were no sales and marketing expenses for the third quarter of 2025, compared to $5.5 million for the third quarter of 2024. The decrease resulted primarily from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid out-licensing transaction. General and administrative expenses for the third quarter of 2025 were $0.8 million , a decrease of $0.6 million , or 40.2%, compared to $1.4 million for the third quarter of 2024. The decrease resulted primarily from lower payroll and share-based compensation, primarily due to a decrease in headcount, as well as small decreases in a number of general and administrative expenses. Non-operating income (expenses) for the third quarters of 2025 and 2024 primarily relate to fair-value adjustments of warrant liabilities on the Company's balance sheet, as a result of changes in its share price, offset by warrant offering expenses. Net financial income for the third quarter of 2025 was $0.1 million , compared to net financial expenses of $1.2 million for the third quarter of 2024. Net financial income (expenses) for both periods primarily relate to loan interest paid, partially offset by investment income earned on bank deposits and gains on foreign currency (primarily NIS) cash balances due to the strengthening of the NIS against the US dollar during the period. The significant decrease in financial expenses in the 2025 period results from a substantial paydown of the BlackRock loan balance in November 2024 , following the transaction with Ayrmid. Net loss for the third quarter of 2025 was $1.0 million , compared to net loss of $5.8 million for the third quarter of 2024. As of September 30, 2025 , the Company had cash, cash equivalents, and short-term bank deposits of $25.2 million , sufficient to fund operations, as currently planned, into the first half of 2027. Conference Call and Webcast Information To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until November 26, 2025; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally. About BioLineRx BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The Company's first approved product, APHEXDA® (motixafortide), is indicated in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma, and is being commercialized by Ayrmid Ltd. (globally, except Asia) and Gloria Biosciences (in Asia). BioLineRx has retained the rights to develop motixafortide in metastatic pancreatic cancer (PDAC) and has a Phase 2b PDAC trial currently ongoing under a collaboration with Columbia University. In addition, BioLineRx has established a joint venture with Hemispherian AS to develop GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma and other solid tumors, for which a Phase 1/2a clinical trial is planned to be initiated in the first quarter of 2026. Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on X and LinkedIn.  Forward Looking Statement Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management's expectations, beliefs and intentions regarding, among other things, the commercial potential of motixafortide, expectations with regard to clinical trials of motixafortide and GLIX1, the expected cash runway, and BioLineRx's business strategy. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials, and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials, whether the clinical trial results for APHEXDA will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors; BioLineRx's ability to establish, manage, and maintain corporate collaborations, as well as the ability of BioLineRx's collaborators to execute on their development and commercialization plans; BioLineRx's ability to integrate new therapeutic candidates and new personnel as well as new collaborations; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; BioLineRx's ability to maintain the listing of its ADSs on Nasdaq; and statements as to the impact of the political and security situation in Israel on BioLineRx's business, which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 31, 2025 . In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law. Contacts: United States Irina Koffler LifeSci Advisors, LLC IR@biolinerx.com Israel Moran Meir LifeSci Advisors, LLC moran@lifesciadvisors.com BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION (UNAUDITED) December 31 , September 30 , 2024 2025 in USD thousands Assets CURRENT ASSETS Cash and cash equivalents 10,436 7,914 Short-term bank deposits 9,126 17,298 Trade receivables 2,476 - Prepaid expenses 443 432 Other receivables 1,478 699 Inventory 3,145 2,181 Total current assets 27,104 28,524 NON-CURRENT ASSETS Property and equipment, net 386 168 Right-of-use assets, net 967 724 Intangible assets, net 10,449 10,388 Total non-current assets 11,802 11,280 Total assets 38,906 39,804 Liabilities and equity CURRENT LIABILITIES Current maturities of long-term loan 4,479 4,479 Accounts payable and accruals: Trade 5,583 3,537 Other 3,131 2,127 Current maturities of lease liabilities 522 297 Warrants 1,691 3,229 Total current liabilities 15,406 13,669 NON-CURRENT LIABILITIES Long-term loan, net of current maturities 8,958 5,599 Lease liabilities 1,081 1,003 Total non-current liabilities 10,039 6,602 COMMITMENTS AND CONTINGENT LIABILITIES Total liabilities 25,445 20,271 EQUITY Ordinary shares 38,097 73,428 Share premium 353,693 327,257 Warrants 5,367 3,686 Capital reserve 17,547 16,195 Other comprehensive loss (1,416) (1,416) Accumulated deficit (399,827) (399,617) Total equity 13,461 19,533 Total liabilities and equity 38,906 39,804 BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (UNAUDITED) Three months ended September 30 , Nine months ended September 30 , 2024 2025 2024 2025 in USD thousands in USD thousands REVENUES: License revenues 3,221 427 12,702 986 Product sales, net 1,722 - 4,489 - Total revenues 4,943 427 17,191 986 COST OF REVENUES (822) (84) (3,174) (190) GROSS PROFIT 4,121 343 14,017 796 RESEARCH AND DEVELOPMENT EXPENSES (2,565) (1,719) (7,284) (5,668) SALES AND MARKETING EXPENSES (5,553) - (18,310) - GENERAL AND ADMINISTRATIVE EXPENSES (1,390) (831) (4,405) (2,029) OPERATING LOSS (5,387) (2,207) (15,982) (6,901) NON-OPERATING INCOME (EXPENSES), NET 756 1,157 13,053 6,950 FINANCIAL INCOME 434 377 1,534 1,161 FINANCIAL EXPENSES (1,625) (304) (4,639) (1,000) NET INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) (5,822) (977) (6,034) 210 in USD in USD EARNINGS )LOSS( PER ORDINARY SHARE - BASIC AND DILUTED (0.00) (0.00) (0.01) 0.00 WEIGHTED AVERAGE NUMBER OF SHARES USED INCALCULATION OF BASIC AND DILUTED EARNINGS (LOSS) PER ORDINARY SHARE 1,199,485,845 2,607,025,540 1,161,448,634 2,399,573,101 BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY (UNAUDITED) Ordinary shares Share premium Warrants Capital reserve Other comprehensive loss Accumulated deficit Total in USD thousands BALANCE AT JANUARY 1, 2024 31,355 355,482 1,408 17,000 (1,416) (390,606) 13,223 CHANGES FOR NINE MONTHS ENDED SEPTEMBER 30, 2024: Issuance of share capital, net 3,056 (3,056) - - - - - Employee stock options exercised 19 56 - (48) - - 27 Employee stock options expired - 523 - (523) - - - Share-based compensation - - - 1,289 - - 1,289 Comprehensive loss for the period - - - - - (6,034) (6,034) BALANCE AT SEPTEMBER 30, 2024 34,430 353,005 1,408 17,718 (1,416) (396,640) 8,505 Ordinary shares Share premium Warrants Capital reserve Other comprehensive loss Accumulated deficit Total in USD thousands BALANCE AT JANUARY 1, 2025 38,097 353,693 5,367 17,547 (1,416) (399,827) 13,461 CHANGES FOR NINE MONTHS ENDED SEPTEMBER 30, 2025 : Issuance of share capital, pre-funded warrants and warrants, net 27,273 (22,260) 501 - - - 5,514 Pre-funded warrants exercised 8,058 (5,876) (2,182) - - - - Employee stock options expired - 1,700 - (1,700) - - - Share-based compensation - - - 348 - - 348 Comprehensive income for the period - - - - - 210 210 BALANCE AT SEPTEMBER 30, 2025 73,428 327,257 3,686 16,195 (1,416) (399,617) 19,533 BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED) Nine months ended September 30 , 2024 2025 in USD thousands CASH FLOWS - OPERATING ACTIVITIES Comprehensive income (loss) for the period (6,034) 210 Adjustments required to reflect net cash used in operating activities (see appendix below) (29,229) (5,084) Net cash used in operating activities (35,263) (4,874) CASH FLOWS - INVESTING ACTIVITIES Investments in short-term deposits (26,350) (29,027) Maturities of short-term deposits 44,626 20,819 Purchase of property and equipment (59) - Net cash provided by (used in) investing activities 18,217 (8,208) CASH FLOWS - FINANCING ACTIVITIES Issuance of share capital, pre-funded warrants and warrants, net of issuance costs 5,358 13,894 Employee stock options exercised 27 - Net proceeds from loan 19,223 - Repayments of loan (2,461) (3,359) Repayments of lease liabilities (380) (399) Net cash provided by financing activities 21,767 10,136 INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS 4,721 (2,946) CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD 4,255 10,436 EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS (140) 424 CASH AND CASH EQUIVALENTS - END OF PERIOD 8,836 7,914 BioLineRx Ltd. APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED) Nine months ended September 30 , 2024 2025 in USD thousands Adjustments required to reflect net cash used in operating activities: Income and expenses not involving cash flows: Depreciation and amortization 2,213 460 Exchange differences on cash and cash equivalents 140 (424) Fair value adjustments of warrants (13,567) (7,544) Share-based compensation 1,289 348 Interest on short-term deposits 126 36 Interest on loan 1,269 - Exchange differences on lease liabilities 67 158 Warrant issuance costs 642 702 (7,821) (6,264) Changes in operating asset and liability items: Decrease (increase) in trade receivables (3,253) 2,476 Decrease in prepaid expenses and other receivables 357 790 Decrease (increase) in inventory (1,591) 964 Decrease in accounts payable and accruals (6,219) (3,050) Decrease in contract liabilities (10,702) - (21,408) 1,180 (29,229) (5,084) Supplemental information on interest received in cash 1,644 874 Supplemental information on interest paid in cash 1,586 1,126 Supplemental information on non-cash transactions: Changes in right-of-use asset and lease liabilities 305 62 Logo - https://mma.prnewswire.com/media/2154863/BioLineRx_Ltd_Logo.jpg View original content:https://www.prnewswire.com/news-releases/biolinerx-reports-third-quarter-2025-financial-results-and-provides-corporate-update-302624413.html SOURCE BioLineRx Ltd. +972-8-6429100

Phase 1Phase 2Drug ApprovalFinancial StatementASH

17 Nov 2025

·www.globenewswire.com

TME Pharma announces receipt of agreements in principle to extend certain bond agreements

TME Pharma announces receipt of agreements in principle to extend certain bond agreements Berlin, Germany, November 17, 2025, 08.00am CET – TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company specializing in the development of novel therapies for cancer and eye diseases, announced today that certain holders of the bonds issued in May and August, 2025 have agreed in principle to extend the maturity of the bonds for a one year period. These bond holders, Diede van den Ouden (CEO) and 2 members of the Supervisory Board, hold 29% of the regular bonds issued in May and August 2025 for a total face value amount of €718,946. TME Pharma will also discuss with other lenders who participated in the May and August 2025 bond issuance to try to procure similar extensions of their debt. TME Pharma believes now may be the right time, as the Company has gained traction with its newly implemented strategy and has seen its transition to a low-cost company successfully completed. A successful extension of the entire May and August bonds would extend the Company’s financial visibility to more than twelve months, into in Q2 2027. Taking into account the current reduction in costs to approximately €110k per month (where possible, costs will continue to be cut) and the cash position of around €2.1M at November 14, 2025. Current financial visibility ends at May 28, 2026 with the existing bond maturity dates. Under the bond extensions under discussion, the main conditions of the loans would not change, except for the extension by one year bringing the new maturity date to May 28, 2027, and the increase in total loan reimbursement amount, which would have to be repaid at 104.7% of the nominal value of the bond in cash at the new maturity date (as compared to 93.5% of the bond nominal value at May 28, 2026) or at 112% of the nominal value of the bond in the case of conversion to shares (formerly 100% of the bond nominal value). TME Pharma emphasizes that its primary goal remains to unlock the value of its biotech assets. The additional activities the Company is envisaging serves to support that goal. A sound operational foundation should help TME Pharma to find partners and limit the risk of shareholder dilution. Diede van den Ouden, CEO of TME Pharma, said: “Ever since I started working for TME Pharma, I've said I want to help the company move forward. I’m a shareholder myself, and I've done everything, and will do everything I can to limit shareholder dilution. Extending this debt could prevent dilution for even a much longer period. We are building a healthy future with TME Pharma and I think it is a positive sign that individuals closely involved with the Company are now once again willing to show their confidence in the Company’s future. I believe this will help us convince other bondholders as well, allowing us to visibly extend the financial performance and attract new investors interested in the complementary strategy.” For more information, please contact: TME Pharma N.V.Diede van den Ouden, CEOir@tmepharma.com About TME Pharma TME Pharma is a clinical-stage biotechnology company specializing in the development of novel therapies for cancer and eye diseases. The Company’s lead compounds have been designed to act on the tumor microenvironment (TME) and the cancer immunity cycle by breaking tumor protection barriers against the immune system and blocking tumor repair. The Company’s two lead assets are: NOX-A12 (olaptesed pegol, an anti-CXCL12 L-RNA aptamer), which is being studied (GLORIA Phase 1/2 clinical trial) in newly-diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy. The US FDA and the German BfArM have approved the design of a randomized Phase 2 trial in glioblastoma, and TME Pharma was awarded Fast Track Designation by the FDA for NOX-A12 in combination with radiotherapy and bevacizumab for use in the treatment of the aggressive adult brain cancer, glioblastoma. NOX-A12 in combination with radiotherapy had also previously received orphan drug designation (ODD) for glioblastoma in the United States and glioma in Europe. NOX-E36 (emapticap pegol, L-RNA aptamer inhibiting CCL2 and related chemokines), which is being evaluated in ophthalmic diseases with a high need for well-tolerated therapies with anti-fibrotic effect. The Company, under the leadership of its new CEO, Diede van den Ouden, who joined in the June 2025, is currently undertaking a strategic restructuring with the goal of providing the financial resources to unlock the value of NOX-A12 and NOX-E36. These steps include: Raising funds from alternative sources (€1.7 million raised in May 2025, including €500,000 from the new CEO)Pursuing stable, cash-generating business opportunities to achieve positive operational cash flow for the CompanyLeveraging tax loss carry forwardsPotentially gaining exposure to digital assets Further information can be found at: www.tmepharma.com. About the GLORIA Study GLORIA (NCT04121455) is TME Pharma’s dose-escalation, Phase 1/2 study of NOX-A12 in combination with radiotherapy in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy). GLORIA further evaluates safety and efficacy of NOX-A12 in the expansion arm in which NOX-A12 is combined with radiotherapy and bevacizumab. About the OPTIMUS Study OPTIMUS (NCT04901741) is TME Pharma’s planned open-label two-arm Phase 2 study of NOX-A12 combined with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic cancer patients. Disclaimer Translations of any press release into languages other than English are intended solely as a convenience to the non-English-reading audience. The company has attempted to provide an accurate translation of the original text in English, but due to the nuances in translating into another language, slight differences may exist. This press release includes certain disclosures that contain "forward-looking statements.” Forward-looking statements are based on TME Pharma’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, the risks inherent in oncology drug development, including clinical trials and the timing of and TME Pharma’s ability to obtain regulatory approvals for NOX-A12 as well as any other drug candidates. Forward-looking statements contained in this announcement are made as of this date, and TME Pharma undertakes no duty to update such information except as required under applicable law. Management will now iParallel to its core biotechnology activities, the company is exploring potential acquisitions and partnerships in stable, profitable businesses. These efforts are aimed at creating a fundamentally profitable corporate structure in which revenues from non-core activities will support and strengthen the further development of its patented drug candidates, which remain the company's flagship products, NOXA12 and NOX-E36. Attachment ENG_TME Pharma announces receipt of agreements in principle to extend certain bond agreements

Phase 2Orphan DrugFast Track

13 Nov 2025

·ir.acrivon.com

Acrivon Therapeutics Reports Third Quarter 2025 Financial Results and Business Highlights

Advancement of ACR-368 in registrational-intent Phase 2b trial for the treatment of patients with endometrial cancer Preparing for initial clinical data disclosure for ACR-2316 from the Phase 1 trial in AP3-prioritized solid tumor types Expanding power of Generative Phosphoproteomics AP3 supersedes conventional target-centric drug discovery, yielding differentiated compounds with desired pathway effects Cash, cash equivalents and marketable securities of $134.4 million as of September 30, 2025, expected to fund operations into the second quarter of 2027 WATERTOWN, Mass., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform designed to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased and actionable manner, today reported financial results for the third quarter ended September 30, 2025 and reviewed recent business highlights. “Our team continues to efficiently advance our AP3-enabled pipeline of targeted agents, maintaining strong momentum over the past quarter,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and co-founder of Acrivon. “With our prospective biomarker-driven registrational intent Phase 2b trial of ACR-368 in endometrial cancer we aim to address a high unmet need in relapsed patients. Additionally, we are pursuing another opportunity in endometrial cancer with a biomarker-unselected Phase 2b arm in patients with limited prior lines of therapy using low dose gemcitabine as a sensitizer to ACR-368 based on insights by the AP3 platform. We also recently showcased three presentations at the AACR-NCI-EORTC International Conference highlighting the ability of our innovative AP3 generative ensemble model (KaiSR) to accurately assess compound-induced pathway effects, thereby enabling rational drug design aimed at superior activity, as demonstrated by robust preclinical data for ACR-2316. We look forward to sharing initial Phase 1 data for ACR-2316 later this year, expanding upon the early safety and initial clinical activity observed during dose escalation, with tumor shrinkage and a confirmed partial response across several AP3-prioritized solid tumor types.” Recent Highlights ACR-368: CHK1 and CHK2 Inhibitor Continued advancement of the ongoing, registrational-intent, multicenter Phase 2b trial of ACR-368 in patients with recurrent high-grade endometrial cancer who have all received prior platinum-based chemotherapy and immune checkpoint inhibitor treatment regimens Enrollment and dosing ongoing in the third arm of the study, which does not require a pre-treatment biopsy for biomarker assessment. This arm is designed to evaluate ACR-368 with ultra-low dose gemcitabine (ULDG) as a tumor sensitizer in patients with endometrial cancer with limited prior lines of therapy who have all received prior treatment with chemotherapy and anti-PD-1 Enrollment and dosing ongoing in the third arm of the study, which does not require a pre-treatment biopsy for biomarker assessment. This arm is designed to evaluate ACR-368 with ultra-low dose gemcitabine (ULDG) as a tumor sensitizer in patients with endometrial cancer with limited prior lines of therapy who have all received prior treatment with chemotherapy and anti-PD-1 ACR-2316: WEE1/PKMYT1 Inhibitor Continued dosing patients in the Phase 1 monotherapy dose-escalation trial for certain high unmet need, AP3-prioritized solid tumor types Initial clinical activity with tumor shrinkage, and a confirmed partial response, observed across several solid tumor types Presented data at the AACR-NCI-EORTC conference demonstrating: ACR-2316 was rationally designed using AP3 to achieve superior activity through potent WEE1 inhibition with concomitant suppression of WEE1 inhibitor-induced PKMYT1 resistance mechanisms, while triggering robust activation of CDK1, CDK2, and PLK1 to induce potent tumor cell death In cancer xenograft models, ACR-2316 induces complete regression, while treatment with benchmark WEE1 inhibitors or a PKMYT1 inhibitor results in only stable disease at maximum tolerated/formulable doses Initial clinical activity with tumor shrinkage, and a confirmed partial response, observed across several solid tumor types ACR-2316 was rationally designed using AP3 to achieve superior activity through potent WEE1 inhibition with concomitant suppression of WEE1 inhibitor-induced PKMYT1 resistance mechanisms, while triggering robust activation of CDK1, CDK2, and PLK1 to induce potent tumor cell death In cancer xenograft models, ACR-2316 induces complete regression, while treatment with benchmark WEE1 inhibitors or a PKMYT1 inhibitor results in only stable disease at maximum tolerated/formulable doses Generative Phosphoproteomics AP3 Platform Also at the AACR-NCI-EORTC conference, presented data showing that the company’s AP3 generative AI KaiSR model accurately predicts and expands unbiased understanding of actionable global pathway activity states, enabling novel therapeutic target identification and the assessment of compound effects on the entire intracellular protein signaling network for optimal drug design and precision medicine development Anticipated Upcoming Milestones Provide update on registrational-intent trial and confirmatory trial design for ACR-368 in the second half of 2025 Report initial clinical data from the Phase 1 clinical study of ACR-2316 in the second half of 2025 Advance a new potential first-in-class cell cycle drug discovery program for an undisclosed target towards development candidate nomination in 2025 Third Quarter 2025 Financial Results Net loss for the quarter ended September 30, 2025 was $18.2 million compared to a net loss of $22.4 million for the same period in 2024. Research and development expenses were $13.6 million for the quarter ended September 30, 2025, compared to $18.9 million for the same period in 2024. The difference was driven by fewer scheduled and incurred milestones in the current period, combined with the prioritization of endometrial cancer over other tumor types in the ACR-368 clinical trial. General and administrative expenses were $6.0 million for the quarter ended September 30, 2025, which is materially consistent with $6.3 million for the same period in 2024. As of September 30, 2025, the company had cash, cash equivalents and investments of $134.4 million, which is expected to fund operating expenses and capital expenditure requirements into the second quarter of 2027. About Acrivon Therapeutics Acrivon is a clinical stage biopharmaceutical company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 platform. The platform allows the company to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased manner, yielding terabytes of proprietary data and delivering rapid, actionable insights. The Generative Phosphoproteomics AP3 platform is comprised of a growing suite of powerful, internally-developed tools, including the AP3 Data Portal, converting multimodal data into structured data for generative AI analyses, the AP3 Kinase Substrate Relationship Predictor and the AP3 Interactome. These distinctive capabilities enable the company to go beyond the limitations of traditional drug discovery, as well as current AI-based target-centric drug discovery, and rapidly design highly differentiated compounds with desirable pathway effects through intracellular protein network analyses and advance these agents into the clinic for streamlined development. Acrivon is currently advancing its lead program, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 trial for endometrial cancer. The company has received Fast Track designation from the Food and Drug Administration, or FDA, for the investigation of ACR-368 as a monotherapy based on OncoSignature-predicted sensitivity in patients with endometrial cancer. The FDA has granted a Breakthrough Device designation for the ACR-368 OncoSignature assay for the identification of patients with endometrial cancer who may benefit from ACR-368 treatment. In addition to ACR-368, Acrivon is also leveraging its proprietary Generative Phosphoproteomics AP3 platform for the development of its co-crystallography-driven, internally discovered pipeline programs. These include ACR-2316, the company’s second clinical stage asset, a novel, potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity through strong activation of not only CDK1 and CDK2, but also of PLK1 to drive pro-apoptotic cell death, as observed in preclinical studies against benchmark inhibitors. The Phase 1 trial of ACR-2316 is advancing with enrollment in the first three dose-escalation cohorts completed. Drug target engagement was observed at DL1 and 2 using the company’s clinical mass-spectrometry-based AP3 profiling, with evidence of approximate dose proportionality based on plasma pharmacokinetic analyses, and initial clinical activity with tumor shrinkage observed at DL3. In addition, the company is advancing a preclinical program directed against an undisclosed cell cycle regulatory target. Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our preclinical and clinical results, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on Acrivon’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled “Risk Factors” in our reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and Acrivon undertakes no duty to update such information except as required under applicable law. Investor and Media Contacts: Adam D. Levy, Ph.D., M.B.A.alevy@acrivon.com Alexandra Santos asantos@wheelhouselsa.com

Phase 1Fast TrackPhase 2AACRFinancial Statement

100 Deals associated with Gemcitabine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01155	Gemcitabine Hydrochloride	L01BC05	DB00441

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Non-Muscle Invasive Bladder Neoplasms	United States	Janssen Biotech, Inc.	09 Sep 2025
Locally Advanced Lung Non-Small Cell Carcinoma	Australia	Sandoz Pty Ltd.	02 Dec 2008
Locally Advanced Pancreatic Adenocarcinoma	Australia	Sandoz Pty Ltd.	02 Dec 2008
metastatic non-small cell lung cancer	Australia	Sandoz Pty Ltd.	02 Dec 2008
Pancreatic adenocarcinoma metastatic	Australia	Sandoz Pty Ltd.	02 Dec 2008
Recurrent ovarian cancer	Australia	Sandoz Pty Ltd.	02 Dec 2008
Transitional Cell Carcinoma	Japan	Eli Lilly & Co.	25 Nov 2008
Bladder Cancer	Brazil	Libbs Farmacêutica Ltda.	26 May 2008
Biliary Tract Neoplasms	Japan	Eli Lilly & Co.	31 Aug 2001
Lymphoma	Japan	Eli Lilly & Co.	31 Aug 2001
Ovarian Cancer	Japan	Eli Lilly & Co.	31 Aug 2001
Breast Cancer	United States	Eli Lilly & Co.	15 May 1996
Metastatic breast cancer	United States	Eli Lilly & Co.	15 May 1996
Non-Small Cell Lung Cancer	United States	Eli Lilly & Co.	15 May 1996
Pancreatic adenocarcinoma	United States	Eli Lilly & Co.	15 May 1996
Pancreatic Cancer	United States	Eli Lilly & Co.	15 May 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced biliary tract cancer	Phase 3	Taiwan Province	InnoPharmax, Inc.	01 Jul 2025
Recurrent Bladder Cancer	Phase 3	United States	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	China	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Japan	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Argentina	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Belgium	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Brazil	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	France	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Germany	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Italy	Janssen Research & Development LLC	09 Apr 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04640623 (SunRISe-1, Pubmed \| J Clin Oncol)	Phase 2	Non-Muscle Invasive Bladder Neoplasms	208	TAR-200 plus cetrelimab	cvdpnudrxz(ctggmtqtcp) = quxsuylkjk niuwnfxurh (ryujzpddhq, 72.6 - 89.8) View more	Positive	20 Nov 2025
				TAR-200 monotherapy	cvdpnudrxz(ctggmtqtcp) = kqdumoxcmk niuwnfxurh (ryujzpddhq, 53.7 - 80.1) View more
ESMO2025	Not Applicable	Adrenocortical Carcinoma Second line	45	Gemcitabine-capecitabine (GemCap)	hafrildfei(mietiguadc) = swkpljkpyu lvxzfqyfpk (qrildeqxlg, 7.0 - 18.0) View more	Positive	17 Oct 2025
				Gemcitabine-docetaxel (GemDoc)	hafrildfei(mietiguadc) = llgcsmfdge lvxzfqyfpk (qrildeqxlg, 7.0 - 18.0) View more
NCT04640623 (SunRISe-1, ESMO2025)	Phase 2	Non-Muscle Invasive Bladder Neoplasms TP53 \| TERT \| ERBB2 ... View more	108	TAR-200 monotherapy	athraqmtsy(chbfpuhvux) = srqmzejqwx bmqabpfyzm (zsrzoepeae, 63.9 - 95.5) View more	Positive	17 Oct 2025
ChiCTR2300077907 (ESMO2025)	Phase 2	Advanced Pancreatic Ductal Adenocarcinoma First line	20	Icaritin combination with Gemcitabine and Nab-pacitaxel	jnodkreyyf(mfyivinclo) = izimihwppp cxtcaimijr (suqnmvbvcq, 174 - NA) View more	Positive	17 Oct 2025
NCT02539537 (NEOPAN, ESMO2025)	Phase 3	Pancreatic Cancer	2,224	FOLFIRINOX (FFX)	kvqplidify(kovwqjcyfu) = gxomgubwkp ldwhqorwij (zlrztvboey ) View more	Positive	17 Oct 2025
				Gemcitabine (Gem)	kvqplidify(kovwqjcyfu) = mixbuxnftl ldwhqorwij (zlrztvboey ) View more
ESMO2025	Not Applicable	PD-L1 negative Triple Negative Breast Cancer First line PD-L1-negative	929	cyclophosphamide+doxorubicin-based regimens	ghkrrrzkak(kvhvnpvafg) = the majority of pts (55.5%) received only 1 line of therapy (LOT) for a median duration of 3.3 months. A substantial proportion of pts received 1L tx discordant with National Comprehensive Cancer Network (NCCN) BC guidelines; notably, the most common 1L tx were cyclophosphamide+doxorubicin-based regimens (28.1%). Other common 1L regimens included capecitabine (12.7%) and paclitaxel (10.4%). Among pts with ≥2 LOT (44.5%), the most common 2L regimens were capecitabine (16.2%), sacituzumab govitecan (14.8%), and carboplatin+gemcitabine (7.7%). mpspafqsgz (lzgaanvpkg )	Negative	17 Oct 2025
GeNeS1S (ESMO2025)	Phase 2	Pancreatic Cancer	30	gemcitabine+nab-paclitaxel+S-1	mbnquinczi(wrmympmxwm) = qalkdjxmwa phekktdkjh (ekpliaqrng ) View more	Positive	17 Oct 2025
				gemcitabine+nab-paclitaxel+S-1 (primary tumor)	mbnquinczi(wrmympmxwm) = dhmybvakky phekktdkjh (ekpliaqrng )
NCT02879318 (CCTG PA.7, ESMO2025)	Phase 2	Metastatic Pancreatic Ductal Adenocarcinoma MTA \| SAM	173	gemcitabine/nab-paclitaxel+durvalumab+tremelimumab	ihnvxvvbzx(twsvenxohm) = ivgxtrmcmp hvmxkdfymm (wkwnocskaa ) View more	Positive	17 Oct 2025
				gemcitabine/nab-paclitaxel	ihnvxvvbzx(twsvenxohm) = mhgpftgylu hvmxkdfymm (wkwnocskaa ) View more
ESMO2025	Not Applicable	Advanced biliary tract cancer	319	Cisplatin + Gemcitabine + Durvalumab (Intermediate-risk group (score 6-10))	nbgynudjrn(njsglkclkb) = hbdqkregud svhgfzhmlb (pzvqpvicwe ) View more	Positive	17 Oct 2025
NCT03750669 (Pubmed) Manual	Phase 3	Pancreatic Cancer Neoadjuvant	324	Neoadjuvant nab-paclitaxel plus gemcitabine followed by modified FOLFIRINOX	rkxacomteo(vvixaavxlb) = trnecsaxer twzzmpclur (umdjbqixpw, 12.6 - 19.3) View more	Positive	09 Oct 2025
				Surgery	rkxacomteo(vvixaavxlb) = vqtkjckwkr twzzmpclur (umdjbqixpw, 9.1 - 13.5) View more

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