Biolinerx Stock Price, News & Analysis

BioLineRx Ltd. (NASDAQ:BLRX) has appointed Dr. Tami Rachmilewitz as Chief Medical Officer, effective January 4, 2023. Dr. Rachmilewitz brings over 15 years of clinical development experience, previously holding leadership roles at VBL Therapeutics and other notable companies. Her expertise will support BioLineRx's upcoming initiatives, including the launch of APHEXDA® and the further development of the drug motixafortide across various therapeutic areas. This appointment aims to enhance the company's capabilities in bringing innovative treatments to cancer patients.

BioLineRx Ltd. (NASDAQ: BLRX) announced positive results from its Phase 1/2a study of AGI-134, an investigational cancer vaccine for unresectable metastatic solid tumors. The study met its primary endpoint of safety and tolerability, with no dose-limiting toxicities and a recommended dose of 200mg for further trials. Immune activity was also observed, with 29% of patients achieving stable disease. The company plans to publish full data analysis in 2023 and will consult its advisory board for next steps.

BioLineRx Ltd. (NASDAQ: BLRX) announced its participation in the 12th Annual LifeSci Partners Corporate Access Event occurring from January 9-11, 2023, in San Francisco, CA. Management will be available for one-on-one meetings on January 11, 2023. BioLineRx focuses on oncology, with its lead drug, motixafortide, showing promise in multiple studies, including a Phase 3 trial for multiple myeloma and a Phase 2a trial for pancreatic cancer. The FDA has accepted its NDA submission with a PDUFA date of September 9, 2023.

BioLineRx Ltd. announced the FDA's acceptance of its New Drug Application for APHEXDA® (motixafortide), aimed at mobilizing stem cells for multiple myeloma treatment, with a PDUFA target date of September 9, 2023. The company plans to independently commercialize APHEXDA® in the U.S., naming Holly May as President of BioLineRx USA. BioLineRx completed a $40 million debt financing and a $15 million equity offering to support the product launch. The company reported a net loss of $6.8 million for Q3 2022 and had $57.3 million in cash as of September 30, 2022.

BioLineRx Ltd. (NASDAQ/TASE: BLRX), a biopharmaceutical company focused on oncology, will release its unaudited financial results for Q3 2022 on November 15, 2022, before U.S. markets open. The conference call, featuring CEO Philip Serlin, is scheduled for 10:00 a.m. EST on the same day. Interested parties can join by dialing +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally, or via webcast. A replay will be available two hours post-call. BioLineRx's lead program, motixafortide, has a PDUFA date of September 9, 2023.

BioLineRx Ltd. (NASDAQ: BLRX) announced that the FDA has accepted its New Drug Application (NDA) for APHEXDA® (motixafortide), targeting improved stem cell mobilization in multiple myeloma patients. The NDA is based on the GENESIS Phase 3 trial, which met all endpoints with high statistical significance. A PDUFA action date is set for September 9, 2023. The company is preparing for a robust commercial launch, highlighting a potential to enhance patient outcomes and reduce healthcare resource usage.

BioLineRx Ltd. (NASDAQ/TASE: BLRX) received a notification letter from Nasdaq indicating non-compliance with the minimum bid price requirement, as the closing bid price for its ADSs was below USD $1.00 for 30 consecutive trading days. The company has until May 1, 2023, to regain compliance, with the possibility of an extension if necessary. This notice does not immediately affect the company's listing, and they will continue operations, focusing on the potential launch of APHEXA® for treating multiple myeloma patients.

BioLineRx Ltd. (NASDAQ: BLRX) announced significant findings related to motixafortide, a candidate for stem cell mobilization in multiple myeloma patients. The full pharmacoeconomic study shows cost benefits when using motixafortide with G-CSF compared to plerixafor with G-CSF, demonstrating reduced healthcare resource utilization and higher successful mobilization rates. Additionally, a Phase 1 trial design for using motixafortide in gene therapy for sickle cell disease will also be presented at the ASH Annual Meeting from December 10-13, 2022.

BioLineRx Ltd. (NASDAQ: BLRX) has announced its plan for independent U.S. commercialization of APHEXDA (Motixafortide) for stem cell mobilization in multiple myeloma patients, contingent on FDA approval. Veteran product leader Holly May has been appointed as President, BioLineRx USA. The company aims to build a targeted sales force to engage with transplant centers, projecting a $360 million annual market opportunity. The recent NDA submission follows positive results from the GENESIS Phase 3 trial. A webinar is scheduled for September 28 to discuss the launch strategy.