Findings suggest motixafortide alone, and in combination with natalizumab, could support the collection of the large number of stem cells required by gene therapies for sickle cell disease within a single apheresis cycle - Data from proof-of-concept study shows that motixafortide was safe and well tolerated Oral presentation at ASH 2024 on Saturday, December 7, 2024 in San Diego, California TEL AVIV, Israel and WALTHAM,... Read More

Patient survey currently underway in partnership with the HealthTree Foundation; data expected in Q1 2025 TEL AVIV, Israel and WALTHAM, Mass. , Sept. 17, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced the launch of Mobilization Matters , a digital resource for people with multiple... Read More

Secured APHEXDA ® formulary placement among top 80 transplant centers representing ~37% of stem cell transplant procedures performed, surpassing stated goal for quarter; on-track to reach goal of ~60% by end of Q4 Doubled the number of centers ordering APHEXDA during the second quarter Entered into clinical trial agreement with St. Jude Children's Research Hospital to evaluate motixafortide for hematopoietic stem cell... Read More

Management to Hold Conference Call at 8:30 a.m. EDT TEL AVIV, Israel , Aug. 8, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that it will release its unaudited financial results for the second quarter ended June 30, 2024 on Thursday, August 15, 2024 , before the U.S. markets open.... Read More

Steady growth in APHEXDA® adoption in first full quarter post-approval Among top 80 transplant centers, secured APHEXDA formulary placement to date at institutions representing ~26% of stem cell transplant procedures performed - on track to reach stated goal of ~35% by end of Q2 Announced new data in abstract accepted at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting on pilot phase of ongoing Phase 2b... Read More

New analysis of biopsy samples demonstrated a significant increase in CD8+ T-cell density in tumors from all 11 patients treated 7 of 11 patients in the pilot phase experienced a partial response, with 6 confirmed; 10 of 11 patients experienced disease control Poster Presentation on Saturday, June 1, 2024 in Chicago , Illinois TEL AVIV, Israel , May 24, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a... Read More

Management to Hold Conference Call at 8:30 a.m. EDT TEL AVIV, Israel , May 22, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that it will release its unaudited financial results for the quarter ended March 31, 2024 on Tuesday, May 28, 2024 , before the U.S. markets open. The Company... Read More

TEL AVIV, Israel , May 17, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) ("BioLineRx" or the "Company"), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that it has received a notification letter from the Nasdaq Stock Market LLC ("Nasdaq"). The letter notifies the Company that it is not in compliance with the minimum bid price... Read More

Presentation Today, Monday, May 6, 2024 in Atlanta , Georgia TEL AVIV, Israel , May 6, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that new economic model data will be presented on APHEXDA® (motixafortide) for CD34+ hematopoietic stem cell (HSC) mobilization in patients with... Read More

TEL AVIV, Israel , April 17, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced a poster presentation on apheresis center efficiency and CXCR4 antagonists including APHEXDA (motixafortide) in patients with multiple myeloma. The poster will be presented at the American Society for... Read More

Proceeds to be used to further accelerate uptake of APHEXDA® in stem cell mobilization, life-cycle expansion activities in sickle cell disease, and motixafortide metastatic pancreatic cancer program TEL AVIV, Israel , April 10, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that it has... Read More

TEL AVIV, Israel , April 1, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) ("BioLineRx" or the "Company"), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that it has entered into definitive agreements with several institutional investors for the issuance and sale in a registered direct offering of 7,500,000 of the Company's... Read More

Reported significant commercial progress for APHEXDA® -- secured payer coverage representing ~95% of covered lives in the U.S.; continued progress on formulary approvals at targeted major transplant centers; received Healthcare Common Procedure Coding System (HCPCS) J-Code to facilitate Medicare reimbursement Announced first patient dosed in randomized Phase 2b clinical trial evaluating motixafortide in first-line pancreatic... Read More

Management to Hold Conference Call at 08:30 a.m. EDT TEL AVIV, Israel , March 20, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced it will release its audited financial results for the year ended December 31, 2023 on Tuesday, March 26, 2024 , before the U.S. markets open. The Company... Read More

New patent, when issued, will be valid until December 2041 Additional IP complements U.S. market exclusivity awarded to BioLineRx upon FDA approval of APHEXDA® (motixafortide) in September 2023 as a result of its Orphan Drug and New Chemical Entity designations TEL AVIV, Israel , March 4, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in... Read More

Conducted in Collaboration with Columbia University , the CheMo4METPANC Phase 2 trial is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies compared to chemo alone Gulam Manji , MD, PhD, of Columbia University to present encore pilot phase data at the Immuno-Oncology (IO) 360° Summit on February 29 TEL AVIV, Israel , Feb. 28, 2024 /PRNewswire/ --... Read More

Results include pharmacokinetic and pharmacodynamic data, and post-hoc subgroup analyses of the Phase 3 GENESIS trial Presentations on Thursday, February 22, 2024 in San Antonio, Texas TEL AVIV, Israel , Feb. 16, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that new post-hoc subgroup... Read More

Proof-of-concept study is initial step toward goal of identifying more efficient CD34+ HSC mobilization regimen for patients with sickle cell disease choosing gene therapy TEL AVIV, Israel , Dec. 21, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that the first patient has been dosed... Read More

Received FDA Approval of APHEXDA® (motixafortide) in Combination with Filgrastim (G-CSF) to Mobilize Hematopoietic Stem Cells for Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma Closed Exclusive License Agreement for Motixafortide in Asia Region with Concurrent Strategic Equity Investment Presented Encouraging Data at AACR from Pilot Phase of Randomized Phase 2 Combination Trial with... Read More

Management to Hold Conference Call at 10:00 a.m. EST TEL AVIV, Israel , Nov. 13, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced it will release its unaudited financial results for the quarter ended September 30, 2023 on Monday, November 20, 2023 , before the U.S. markets open. The... Read More

NEW YORK , Oct. 31, 2023 /CNW/ -- M.S.Q. Ventures ("MSQ") is pleased to announce that its client, BioLineRx Ltd. ("BioLineRx") (NASDAQ/TASE: BLRX), has entered into an exclusive license agreement with Guangzhou Gloria Biosciences Co., Ltd. (GloriaBio) and an associated investor for the development of motixafortide across all indications in Asia. The license agreement provides for a $15 million upfront payment and an equity... Read More

License agreement includes $15 million upfront, up to $50 million in potential development and regulatory milestones; up to ~$200 million in potential commercial milestones, and tiered double-digit royalties on sales Gloria Biosciences expected to begin bridging study to support potential approval and commercialization of motixafortide in the territory in stem cell mobilization Gloria Biosciences expected to initiate... Read More

6 of 11 Patients in the Pilot Phase Experienced a Partial Response, with 4 Confirmed; One Patient Experienced Resolution of the Hepatic Metastatic Lesion Data Presented at AACR Special Conference on Pancreatic Cancer Multi-Center, Randomized Phase 2 Study Currently Enrolling TEL AVIV, Israel , Sept. 28, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX ) (TASE: BLRX) , a commercial stage biopharmaceutical company pursuing... Read More

APHEXDA is the first innovation in stem cell mobilization for multiple myeloma to be approved in the U.S. in a decade One dosage of APHEXDA plus filgrastim enabled a majority of patients to achieve the collection goal of ≥ 6 million hematopoietic stem cells among a contemporary population of multiple myeloma patients Management to hold conference call on Tuesday, September 12, 2023 at 8:00 a.m. U.S. EDT TEL AVIV, Israel ,... Read More

On Track for September 9, 2023 PDUFA Target Action Date on NDA for Motixafortide in Stem Cell Mobilization (SCM) for Autologous Transplantation in Multiple Myeloma (MM) Signed Exclusive License Agreement to Motixafortide in Asia Region with Concurrent Equity Investment Announced Initiation of Investigator-Initiated Randomized Phase 2 Combination Trial with Motixafortide in First Line PDAC in Collaboration with Columbia... Read More

Management to Hold Conference Call at 10:00 a.m. EDT TEL AVIV, Israel , Aug. 22, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a pre-commercial stage biopharmaceutical company pursuing life-changing therapies for certain cancers and rare diseases, announced today it will release its unaudited financial results for the quarter ended June 30, 2023 on Wednesday, August 30, 2023 , before the U.S. markets open. The... Read More

TEL AVIV, Israel , July 17, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial stage biopharmaceutical company pursuing life-changing therapies for certain cancers and rare diseases, today announced the initiation of a randomized, investigator-initiated Phase 2 clinical trial in first line metastatic pancreatic cancer based on preliminary data from the single-arm pilot phase. The combination... Read More

On Track for September PDUFA Target Action Date on NDA for Motixafortide in Stem Cell Mobilization (SCM) for Autologous Transplantation in Multiple Myeloma (MM) Rapidly Advancing U.S. Commercial Activities in Support of Potential September Launch Announced Publication in Nature Medicine of GENESIS Phase 3 Clinical Trial Data Evaluating Motixafortide and G-CSF in SCM for Autologous Transplantation in MM Management to hold... Read More

Management to Hold Conference Call at 10:00 a.m. EDT TEL AVIV, Israel , May 17, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, announced today that it will release its unaudited financial results for the quarter ended March 31, 2023 on Wednesday, May 24, 2023 , before the U.S. markets open. The Company will host a conference call on... Read More

TEL AVIV, Israel , April 25, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, today announced that it has received formal notice from The Nasdaq Stock Market, LLC ("Nasdaq") stating that the Company has regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2). BioLineRx is now in compliance with all... Read More

GENESIS trial achieved statistical significance (p<0.0001) across all primary and secondary endpoints Nature Medicine publication describes how GENESIS trial included patients representative of current multiple myeloma population undergoing autologous HSCT, including older patients and those who received lenalidomide-containing induction therapies – factors associated with impaired HSPC mobilization Motixafortide plus G-CSF... Read More

Announced FDA Acceptance of APHEXDA® (motixafortide) New Drug Application (NDA) in Stem Cell Mobilization with Prescription Drug User Fee Act (PDUFA) Target Action Date of September 9, 2023 - Named Tami Rachmilewitz, M.D., as new Chief Medical Officer and Completed Formation of U.S. Commercial Leadership Team with Extensive Drug Launch and Sales Experience Entered into Clinical Trial Collaboration with Washington University... Read More

Management to Hold Conference Call at 10:00 am EDT TEL AVIV, Israel , March 15, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, announced today that it will release its audited financial results for the year ended December 31, 2022 on Wednesday, March 22, 2023 , before the U.S. markets open. The Company will host a conference call on... Read More

Clinical trial part of long-term growth strategy for motixafortide across multiple potential therapeutic areas TEL AVIV, Israel , March 6, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, today announced a collaboration with Washington University School of Medicine in St. Louis to advance a Phase 1 clinical trial that will evaluate the... Read More

Experienced Drug Developer Brings Over 15 Years of Clinical Development Industry Knowledge across Multiple Therapeutic Areas and Modalities TEL AVIV, Israel , Jan. 4, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, today announced that it has appointed Tami Rachmilewitz, M.D., as Chief Medical Officer. Dr. Rachmilewitz will report to the... Read More

Study Met Primary Endpoint for Safety and Tolerability First-in-Human, Single-Agent Study Demonstrated Immune Activity Across Multiple Biomarkers Company to Seek Publication of Complete Data Analysis in 2023 TEL AVIV, Israel , Dec. 20, 2022 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, today announced results from the Phase 1/2a study of... Read More