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. (NASDAQ: BLRX) is a commercial-stage biopharmaceutical company based in Modi'in, Israel, with operations extending to the United States. The company specializes in developing life-changing therapies for oncology and rare diseases. BioLineRx's flagship product, APHEXDA® (motixafortide), has gained approval in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma patients.
Currently, the company is advancing a robust pipeline of investigational medicines targeting sickle cell disease, pancreatic cancer, and other solid tumors. One of their notable clinical-stage therapeutic candidates is motixafortide (BL-8040), a novel peptide showing promise in stem-cell mobilization and solid tumors. Another key candidate is AGI-134, an immuno-oncology agent dedicated to treating solid tumors.
BioLineRx recently announced definitive agreements with institutional investors for the issuance and sale of its American Depositary Shares (ADSs) and warrants. This equity transaction, combined with financial resources from an existing debt facility, positions the company well for the commercialization of APHEXDA and the advancement of its other pipeline programs. Additionally, the company is exploring motixafortide's potential in supporting gene therapy for sickle cell disease, collaborating with leaders in the gene therapy field such as St. Jude Children's Research Hospital and Washington University School of Medicine.
BioLineRx has also received recent notifications and presented new data at various esteemed conferences such as the American Society of Clinical Oncology (ASCO) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). These efforts underscore the company's commitment to bringing innovative therapies from the bench to the bedside.
To access more information about BioLineRx, visit their official website or follow them on Twitter and LinkedIn.
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 (p<0.0001). 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.
BioLineRx (NASDAQ: BLRX) has entered a collaboration with GenFleet Therapeutics to conduct a Phase 2b trial of Motixafortide for first-line metastatic pancreatic cancer (PDAC) in China. GenFleet will fund and execute the trial, evaluating Motixafortide combined with anti-PD-1 and chemotherapy against standard chemotherapy. This partnership follows positive results from the Phase 2a COMBAT/KEYNOTE-202 study, which showed improved outcomes in second-line PDAC therapy. BioLineRx retains global rights to Motixafortide and plans to submit a New Drug Application for stem cell mobilization soon.
BioLineRx Ltd. (NASDAQ: BLRX) has appointed Holly W. May as its Chief Commercial Officer, a newly established role, effective June 16, 2022. Ms. May brings extensive experience in commercial strategy, having led 13 product launches, and will focus on the U.S. market for Motixafortide, pending FDA approval. The U.S. market for Motixafortide in stem cell mobilization is projected to be worth $360 million annually. BioLineRx aims to submit a New Drug Application to the FDA in mid-2022, continuing preparations for Motixafortide's launch.
BioLineRx Ltd. (NASDAQ: BLRX) reported its Q1 2022 financial results, highlighting significant progress on Motixafortide's New Drug Application (NDA) for stem cell mobilization, expected to be submitted to the FDA by mid-2022. The company ended Q1 with $50.6 million in cash, sufficient to fund operations into H1 2024. A market assessment estimates a $360 million opportunity in the U.S. for stem cell mobilization. Positive cost-effectiveness results were reported, showing savings of ~$30,000 versus other treatments. The net loss narrowed to $4.9 million from $10.2 million year-over-year.
BioLineRx Ltd. (NASDAQ: BLRX) will announce its unaudited financial results for Q1 2022 on May 11, 2022, before US markets open. A conference call hosted by CEO Philip Serlin is scheduled for the same day at 10:00 a.m. EDT. The call will be accessible via the Company's Investor Relations page. BioLineRx focuses on oncology, with key programs including Motixafortide for cancer therapy and AGI-134, aimed at treating solid tumors. A replay will be available post-call.
BioLineRx Ltd. (NASDAQ: BLRX) announced its 2021 financial results, reporting a net loss of $27.1 million, less than the $30 million loss in 2020. The company holds $57.1 million in cash and equivalents. A significant highlight was the positive outcome of a pharmacoeconomic study for Motixafortide, showing substantial cost savings compared to current treatments. BioLineRx plans to submit an NDA for Motixafortide in mid-2022, targeting a $360 million US market. The company aims for a potential FDA approval and US launch of Motixafortide in 2023.
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