Welcome to our dedicated page for Biolinerx news (Ticker: BLRX), a resource for investors and traders seeking the latest updates and insights on Biolinerx stock.
BioLineRx Ltd. develops oncology and rare-disease therapies, with recurring updates centered on GLIX1, APHEXDA (motixafortide), and motixafortide development in solid tumors.
Company news covers GLIX1 clinical development for glioblastoma and other solid tumors under its Hemispherian collaboration, intellectual-property developments tied to GLIX1, financial results, and corporate updates. APHEXDA is approved in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma and is commercialized by partners, while BioLineRx has retained motixafortide rights for solid-tumor programs including metastatic pancreatic cancer.
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.
BioLineRx Ltd. (NASDAQ: BLRX) announced a registered direct offering of 13,636,365 American Depositary Shares (ADSs) and warrants at a price of $1.10 per ADS, projected to raise gross proceeds of $15 million. The offering is expected to close around September 21, 2022. The funds will support the commercial launch of Motixafortide for multiple myeloma and other corporate needs, including clinical trials. The warrants have an exercise price of $1.15 per ADS and expire five years post-issuance.
BioLineRx Ltd. (NASDAQ: BLRX) announced a $40 million non-dilutive debt financing agreement with Kreos Capital to support the U.S. commercial launch of Motixafortide. The initial $10 million tranche is available now, while the remaining $30 million will be released upon achieving specific milestones by October 2024. The financing will incur a fixed interest rate of 9.5% per annum, plus royalties on Motixafortide sales. The funds will be utilized for the aggressive launch of the drug for stem cell mobilization in multiple myeloma patients, pending FDA approval.
BioLineRx Ltd. (NASDAQ: BLRX) announced the submission of its New Drug Application (NDA) for Motixafortide to the FDA for stem cell mobilization in autologous bone marrow transplantation for multiple myeloma patients. This submission is based on positive results from the GENESIS Phase 3 trial, which met all endpoints with high statistical significance (p0.0001). Approximately 90% of patients who received Motixafortide proceeded to transplantation after one administration, indicating significant clinical benefits. The FDA's review decision is expected in November 2022, with a potential PDUFA date in mid-2023.
BioLineRx Ltd. (NASDAQ: BLRX) has made significant advancements in its pipeline, with the submission of a New Drug Application (NDA) for Motixafortide in stem cell mobilization expected within 4-6 weeks. The company appointed Holly May as Chief Commercial Officer to enhance its commercial strategy. It also announced a collaboration with GenFleet Therapeutics for a Phase 2b trial in pancreatic cancer. As of June 30, 2022, BioLineRx reported $43.2 million in cash, sufficient to fund operations into H1 2024. The company experienced a net loss of $7.4 million for Q2 2022, up from $6.8 million in Q2 2021.
BioLineRx Ltd. (NASDAQ: BLRX) will release its unaudited financial results for Q2 2022 on August 16, 2022, before US market opens. Following this, a conference call will be held at 10:00 a.m. EDT, featuring remarks from CEO Philip Serlin. The call can be accessed via the company's Investor Relations page, with dial-in options available. BioLineRx focuses on oncology, with its lead program, Motixafortide, in various trials including one for pancreatic cancer. The company is also developing AGI-134, aimed at multiple solid tumors.
M.S.Q. Ventures announced that its client, BioLineRx (NASDAQ/TASE: BLRX), has entered into a co-development agreement with GenFleet Therapeutics for the cancer treatment Motixafortide in pancreatic ductal adenocarcinoma (PDAC). The agreement involves a Phase 2b clinical trial in China with around 200 patients, aiming to assess the efficacy of Motixafortide combined with anti-PD-1 and chemotherapy. Results from the preceding Phase 2a study suggest potential benefits, and this collaboration is expected to expedite PDAC treatment development.