Bioline RX

BioLineRx Ltd. is a clinical stage biopharmaceutical company, which focuses on oncology. Its pipeline includes Motaxafortide (BL-8040), which is used for stem-cell mobilization, solid tumors, and acute myeloid lukemia; and AGI-134, which is a immunotherapy treatment used fro multiple solid tumors. The company was founded in 2003 and is headquartered in Modi'in, Israel.

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BioLineRx Ltd. is a clinical stage biopharmaceutical company, which engages in the research and development of treatments that focus on cancer. Its product pipeline includes Motaxafortide (BL-8040), which is used for stem-cell mobilization, solid tumors, and acute myeloid lukemia; and AGI-134, which is an immunotherapy treatment used for multiple solid tumors. The company was founded in 2003 and is headquartered in Modi'in, Israel.

- 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 oncology and rare diseases, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent, "Process for Manufacturing Peptide," covering a method of manufacturing motixafortide (BL-8040) that is suitable for large scale production.

BioLineRx Strengthens Intellectual Property Estate with Notice of Allowance for U.S. Patent Covering Method of Manufacturing Motixafortide (BL-8040) Suitable for Large Scale Production

- 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/ -- 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 in the randomized CheMo4METPANC Phase 2 combination clinical trial evaluating the company's CXCR4 inhibitor motixafortide, the PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC).

BioLineRx Announces First Patient Dosed in Randomized Phase 2 Combination Clinical Trial Evaluating Motixafortide in First-Line Pancreatic Cancer (PDAC)

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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 analyses and pharmacodynamic data will be presented on APHEXDA® (motixafortide) for CD34+ hematopoietic stem cell (HSC) mobilization in patients with multiple myeloma at the 2024 Tandem Meetings: Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT®) and the Center for International Blood and Marrow Transplant Research (CIBMTR®), taking place February 21-24, 2024, in San Antonio, Texas.

BioLineRx Announces Acceptance of Two Poster Presentations on APHEXDA® (motixafortide) for CD34+ Hematopoietic Stem Cell (HSC) Mobilization in Patients with Multiple Myeloma at the 2024 Tandem Meetings of ASTCT® and CIBMTR®

- 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 in the Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD).

BioLineRx Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating Motixafortide for CD34+ Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease

BioLineRx gains approval for a blood cancer drug that aids in stem cell transplantation. Motixafortide, the flagship drug, shows promising results in mobilizing blood stem cells and in combination with other treatments for pancreatic cancer. Financially, BioLineRx has a limited amount of cash on hand but has secured a licensing deal that provides additional funds.

BioLineRx: Still A Buy, With Some Questions

BioLineRx is a biopharmaceutical company specializing in cancer and rare disease therapies. The company's main product, Aphexda, was FDA-approved for stem cell mobilization in multiple myeloma patients. BioLineRx's low cash reserves and need for additional financing pose risks, but its valuation appears relatively conservative.

BioLineRx: Weighing Aphexda's Breakthrough Against Financial Challenges

BioLineRx Ltd. (NASDAQ:BLRX ) Q3 2023 Earnings Conference Call November 20, 2023 10:00 PM ET Company Participants John Lacey - Head of IR & Corporate Communications Phil Serlin - CEO Holly May - President of BioLineRx USA Mali Zeevi - CFO Conference Call Participants Joe Pantginis - H.C.

BioLineRx Ltd. (BLRX) Q3 2023 Earnings Call Transcript

- 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 Motixafortide in Patients with First Line PDAC - - Began Enrollment of Phase 1 Trial Evaluating Motixafortide for CD34+ Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease - - Management to host conference call today, November 20, at 10:00 a.m. EST - TEL AVIV, Israel , Nov. 20, 2023 /PRNewswire/ -- BioLineRx Ltd.

BioLineRx Reports Third Quarter 2023 Financial Results and Recent Corporate and Portfolio Updates

- Management to Hold Conference Call at 10:00 a.m. EST - TEL AVIV, Israel , Nov. 13, 2023 /PRNewswire/ -- BioLineRx Ltd.

BioLineRx to Report Third Quarter 2023 Results on November 20, 2023

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NEW YORK , Oct. 31, 2023 /PRNewswire/ -- M.S.Q. Ventures ("MSQ") is pleased to announce that its client,  BioLineRx Ltd.

BioLineRx entered Exclusive License Agreement to Motixafortide in Asia, advisored by M.S.Q. Ventures

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- 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 randomized Phase 2/3 first-line pancreatic cancer clinical trial, evaluating motixafortide in combination with PD-1 inhibitor *zimberelimab and standard of care combination chemotherapy - TEL AVIV, Israel , Oct. 12, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced the closing of an exclusive license agreement with Guangzhou Gloria Biosciences Co., Ltd.

BioLineRx Announces Closing of Exclusive License Agreement to Motixafortide in Asia and Concurrent Strategic Equity Investment

- 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.

BioLineRx Announces Encouraging Data from Pilot Phase of Phase 2 Combination Clinical Trial with Motixafortide in First-Line Pancreatic Cancer (PDAC)

Abstracts to be Published on American Association of Cancer Research (AACR) Virtual Meeting Platform at 5:30 pm EDT on Wednesday, September 27, 2023 Oral Presentation on Thursday, September 28, 2023, in Boston, Massachusetts  TEL AVIV, Israel , Sept. 19, 2023 /PRNewswire/ -- BioLineRx Ltd.

BioLineRx Announces Acceptance of Oral Presentation on Pilot Phase Data from Phase 2 Combination Clinical Trial with Motixafortide in First-Line PDAC at AACR Special Conference on Pancreatic Cancer

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BioLineRx has received approval for their stem cell mobilizing compound, motixafortide, for certain forms of blood cancer. The compound has shown impressive results in mobilizing stem cells in patients, with a high success rate in optimal stem cell collection. However, there are concerns about competition from generic versions of a similar drug and the decreasing need for immediate autologous transplants in patients with multiple myeloma.

Assessing BioLineRx As A Buy After Drug Approval

Bioline RX Ltd (NASDAQ:BLRX) shares jumped at the market open on Monday after the US Food and Drug Administration approved the use of Aphexda (motixafortide) in combination with filgrastim for patients with multiple myeloma, a type of bone marrow cancer. The company's Nasdaq-listed shares rose as much as 23% in pre-market trading before opening 10% higher at $2.33.

BioLineRx rallies on FDA approval of Aphexda with Filgrastim

- 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 , Sept.

BioLineRx Announces 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

BioLineRx Ltd. (NASDAQ:BLRX ) Q2 2023 Earnings Conference Call August 30, 2023 7:30 PM ET Company Participants John Lacey - Head of Investor Relations and Corporate Communications Phil Serlin - Chief Executive Officer Mali Zeevi - Chief Financial Officer Holly May - Chief Commercial Officer Conference Call Participants Joe Pantginis - H.C.

BioLineRx Ltd. (BLRX) Q2 2023 Earnings Call Transcript

- 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 University - - Management to host conference call today, August 30, at 10:00 am EDT - TEL AVIV, Israel , Aug. 30, 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 reported its unaudited financial results for the second quarter ended June 30, 2023, and provided corporate and portfolio updates.

BioLineRx Reports Second Quarter 2023 Financial Results and Recent Corporate and Portfolio Updates

- Management to Hold Conference Call at 10:00 a.m. EDT - TEL AVIV, Israel , Aug. 22, 2023 /PRNewswire/ -- BioLineRx Ltd.

BioLineRx to Report Second Quarter 2023 Results on August 30, 2023

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