Biolinerx Stock Price, News & Analysis

BioLineRx (NASDAQ: BLRX) announced positive initial results from a Phase 1 clinical trial evaluating motixafortide for stem cell mobilization in sickle cell disease (SCD) gene therapies. The study showed that motixafortide, both alone and combined with natalizumab, was safe and well-tolerated, potentially enabling collection of required stem cells in a single apheresis cycle. Motixafortide alone mobilized 198 CD34+ cells/μl median, while the combination achieved 231 CD34+ cells/μl. Notably, patients experienced 2.8-fold greater stem cell mobilization with motixafortide alone and 3.2-fold greater with the combination compared to current standard plerixafor.

BioLineRx (NASDAQ/TASE: BLRX) has received a Notice of Allowance from the USPTO for a new Composition of Matter patent on motixafortide (APHEXDA®/BL-8040). This patent strengthens BioLineRx's intellectual property estate and extends patent protection for motixafortide in the U.S. through December 2041.

The patent reflects the unique attributes of motixafortide as a mobilization agent for multiple myeloma patients undergoing autologous stem cell transplantation, as well as its potential in other indications like pancreatic cancer and gene therapies for sickle cell disease.

BioLineRx also has Orphan Drug market exclusivity for APHEXDA® until September 2030 and five years of data exclusivity as a New Chemical Entity. Motixafortide has Orphan Drug Designation in the U.S. and Europe for pancreatic cancer treatment and in the U.S. for acute myeloid leukemia treatment.

BioLineRx (NASDAQ: BLRX) has launched 'Mobilization Matters', a digital resource for multiple myeloma patients preparing for stem cell collection. The platform, launched on Apheresis Awareness Day, offers patient stories, educational resources, and a discussion guide to support patients undergoing this critical treatment phase.

In partnership with the HealthTree Foundation, BioLineRx is conducting the Mobilization Matters Stem Cell Collection Survey to gather patient insights about their experiences with stem cell collection and apheresis. Survey results are expected in Q1 2025. The initiative aims to enhance understanding and improve care strategies for multiple myeloma patients undergoing stem cell collection.

BioLineRx (NASDAQ: BLRX) reported its Q2 2024 financial results and recent updates. Key highlights include:

- Secured APHEXDA® formulary placement among top 80 transplant centers representing ~37% of stem cell transplant procedures, surpassing Q2 goal

- Doubled the number of centers ordering APHEXDA during Q2

- Entered clinical trial agreement with St. Jude Children's Research Hospital for motixafortide in sickle cell disease

- Q2 revenue: $5.4 million, including $1.8 million from APHEXDA sales

- Net income: $0.5 million, compared to net loss of $18.5 million in Q2 2023

- Cash position: $40.1 million as of June 30, 2024, expected to fund operations into 2025

BioLineRx (NASDAQ: BLRX), a commercial stage biopharmaceutical company focusing on oncology and rare diseases, will announce its second quarter 2024 financial results on August 15, 2024, before the U.S. markets open.

The company will host a conference call at 8:30 a.m. EDT on the same day, featuring remarks by CEO Philip Serlin. Investors can join the call by dialing +1-888-281-1167 (U.S.) or +972-3-918-0685 (international).

A live webcast and replay of the call will be available on the company's website. The replay can also be accessed by dialing +1-888-295-2634 (U.S.) or +972-3-925-5904 (international) until August 19, 2024.

BioLineRx (NASDAQ: BLRX, TASE: BLRX) announced a Phase 1 clinical trial in collaboration with St. Jude Children's Research Hospital to evaluate motixafortide for mobilizing CD34+ hematopoietic stem cells (HSCs) in gene therapies for sickle cell disease (SCD). This study includes experts from St. Jude and two other clinical sites, focusing on new mobilization options due to the limitations of current strategies, like plerixafor, which require multiple cycles. Enrollment is set to start in a few months, and initial data from a related trial at Washington University is expected in late 2024. Motixafortide, BioLineRx's leading candidate, was FDA-approved in September 2023 for HSC mobilization in multiple myeloma patients.

BioLineRx (NASDAQ: BLRX) reported its Q1 2024 financial results and recent corporate updates. The company highlighted steady growth in APHEXDA® adoption, securing formulary placement at institutions representing ~26% of stem cell transplant procedures, targeting 35% by end of Q2. Key developments include new data presented at ASCO 2024 from a Phase 2b pancreatic cancer trial, and the approval of a motixafortide HSC mobilization study in China. Financials showed $6.9 million in total revenue and a net loss of $0.7 million, a significant improvement from a $12.2 million loss in Q1 2023. The company completed $26 million in debt and equity financing to support U.S. commercialization of APHEXDA.

BioLineRx (BLRX) announced new data from its Phase 2 CheMo4METPANC trial evaluating motixafortide in combination with cemiplimab and standard chemotherapies for first-line pancreatic cancer. The trial, presented at ASCO 2024, showed increased CD8+ T-cell density in tumors from all 11 patients. Of these, 64% experienced partial responses and 91% had disease control, surpassing historical rates of 23% and 48%, respectively. Preliminary median progression-free survival was 9.6 months, compared to 5.5 months historically. Based on these results, the trial has been expanded from 30 to 108 patients.

BioLineRx (NASDAQ: BLRX), a biopharmaceutical company focused on oncology and rare diseases, will release its unaudited first-quarter financial results for 2024 on May 28, 2024, before U.S. market hours. A conference call will be held at 8:30 a.m. EDT, hosted by CEO Philip Serlin. Access to the call is available via several international dial-ins, with a live webcast and replay accessible on the company's website. Dial-in replays will be available until May 30, 2024.