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biolinerx Q4 2023 Earnings Preview
Mar. 25, 2024 1:31 PM ETBioLineRx Ltd. (BLRX) Stock
By: Vansh Agarwal, SA News Editor
biolinerx (NASDAQ:BLRX) is scheduled to announce Q4 earnings
results on Tuesday, March 26th, before market open.
The consensus EPS Estimate is -$0.22 (-633.3% Y/Y)
and the consensus Revenue Estimate is $0.17M.
FWIW
Have fingers and toes crossed!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Closes up 17.5%!
1.3100+0.1100 (+9.1667%)
As of 11:29AM EDT. Market open.
Volume 483,923
Avg. Volume 288,336
Perhaps good news expectations?
My Granddaughter is over in Israel(Tel Aviv)
I have been buying BLRX over the last two weeks hoping that they release a decent annual report on the 26 March. I bought shares also in OTRK and got killed. Oh well, can't win them all. My Granddaughter is over in Israel(Tel Aviv) she brought a Hillel group over. She is a Hillel Leader paid by the University of Maryland.
BioLineRx to Report 2023 Annual Financial Results on March 26, 2024
https://finance.yahoo.com/news/biolinerx-report-2023-annual-financial-110000667.html
TEL AVIV, Israel, March 20, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced it will release its audited financial results for the year ended December 31, 2023 on Tuesday, March 26, 2024, before the U.S. markets open.
The Company will host a conference call at 08:30 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer.
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until March 28, 2024; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
I have already done that I will buy back in after things settle down over in China. They have some kind of election coming up.
but my buddies in that world told me they would cover my loss if there happened to be one.
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
https://finance.yahoo.com/news/biolinerx-strengthens-intellectual-property-estate-120000297.html
- 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.
In addition to a broad range of U.S. and international patents covering various aspects of motixafortide, including composition of matter, methods of synthesis, methods of use and combinations, BioLineRx was granted seven years of Orphan Drug market exclusivity beginning on September 8, 2023, the day APHEXDA® (motixafortide) was approved by the FDA, in combination with G-CSF, for use by multiple myeloma patients undergoing autologous stem cell transplantation. Additionally, motixafortide was granted five years of market exclusivity across all indications as a New Chemical Entity (NCE). The NCE exclusivity also commenced on September 8, 2023.
"This is a very meaningful addition to our IP portfolio as we look to scale up the production of motixafortide to support both the commercial demand for APHEXDA for stem cell mobilization in multiple myeloma patients as well as the numerous ongoing clinical trials underway in other indications, including metastatic pancreatic cancer and for gene therapies in sickle cell disease," stated Philip Serlin, Chief Executive Officer of BioLineRx. "When combined with the seven years of Orphan Drug Designation market exclusivity that we were granted upon FDA approval of APHEXDA beginning last September, and five years of exclusivity across all indications as a New Chemical Entity, we have a broad set of IP protections that we believe will allow us to maximize the value of this important molecule for our company and shareholders for years to come."
Motixafortide has also been granted Orphan Drug Designation in the U.S. and Europe for the treatment of pancreatic cancer, as well as in the U.S. for the treatment of acute myeloid leukemia (AML).
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The company's first approved product is APHEXDA® (motixafortide) with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma. BioLineRx is advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with operations in the U.S., the company is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside.
Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on Twitter and LinkedIn.
Forward Looking Statement
Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management's expectations, beliefs and intentions regarding, among other things, expectations and commercial potential of motixafortide, as well as its potential investigational uses. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials, and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; whether BioLineRx's collaboration partners will be able to execute on collaboration goals in a timely manner; whether the clinical trial results for APHEXDA will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors; BioLineRx's ability to establish, operationalize and maintain corporate collaborations; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing, including any unexpected costs or delays in the commercial launch of APHEXDA; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; statements as to the impact of the political and security situation in Israel on BioLineRx's business; and the impact of the COVID-19 pandemic, the Russian invasion of Ukraine, the declared war by Israel against Hamas and the military campaigns against Hamas and other terrorist organizations, which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 22, 2023. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
Contacts:
United States
John Lacey
BioLineRx
IR@biolinerx.com
Israel
Moran Meir
LifeSci Advisors, LLC
moran@lifesciadvisors.com
Logo - https://mma.prnewswire.com/media/2154863/4165445/BioLineRx_Ltd_Logo.jpg
Cision
Cision
View original content:https://www.prnewswire.com/news-releases/biolinerx-strengthens-intellectual-property-estate-with-notice-of-allowance-for-us-patent-covering-method-of-manufacturing-motixafortide-bl-8040-suitable-for-large-scale-production-302078254.html
SOURCE BioLineRx Ltd.
midastouch017
I had a great day between BLRX and GOTU. Got into GOTU in a small amount of 1500 shares in the mid $5 range which is a high range for me. closed today at $8.09, I do not like China stocks but my buddies in that world told me they would cover my loss if there happened to be one. They are expecting it to go to possibly $20.00 or more by year-end. I told each of them I would give them a finders fee if it did. 3 of the five guys were born over there.
Do not go into this stock without researching it. I did plenty. Since these guys have nothing to do with the company I made the move. As they are risk investors. My kind of people.
By the way, I just finished reading the book UNBREAKABLE INVESTOR by Charles V. Payne (great read)
1.3999+0.0699 (+5.2556%)
As of 01:04PM EST. Market open.
Methinks the word has been brought
to His ears and attention!
From your mouth to G-D's ears
Perhaps:
Gulam Manji, MD, PhD, of Columbia University to present encore pilot phase data at the Immuno-Oncology (IO) 360° Summit on February 29 -
Nice trading day. Do it again tomorrow PLEASE!!!!!!!
BioLineRx Announces First Patient Dosed in Randomized Phase 2 Combination Clinical Trial Evaluating Motixafortide in First-Line Pancreatic Cancer (PDAC)
https://finance.yahoo.com/news/biolinerx-announces-first-patient-dosed-120000825.html
- 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). The investigator-initiated trial is being conducted in collaboration with Columbia University and is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies.
"Pancreatic ductal adenocarcinoma (PDAC) has had limited responses to traditional immunotherapy, resulting in a poor prognosis for patients and an urgent need for new treatment approaches," said Philip Serlin, Chief Executive Officer of BioLineRx. "We are encouraged by our early pilot data and look forward to continuing to advance the expanded, randomized Phase 2 CheMo4METPANC trial for patients living with this cancer."
Findings from the single-arm pilot phase of the CheMo4METPANC trial will be shared by Dr. Manji at the 10th Annual Immuno-Oncology (IO) 360° Summit in Brooklyn, New York on Thursday, February 29, 2024. The findings were previously presented during an oral presentation at the American Association of Cancer Research (AACR) Special Conference on Pancreatic Cancer in Boston, Massachusetts, September 28, 2023. As of July 2023, 7 of the 11 patients (64%) in the pilot phase experienced a partial response (PR) of which 5 (45%) were confirmed PRs at the time of the data cut; one patient experienced resolution of the hepatic (liver) metastatic lesion; and three patients (27%) experienced stable disease, resulting in a disease control rate of 91%.
Motixafortide, BioLineRx's lead therapeutic candidate, was approved by the U.S. Food & Drug Administration (FDA) in September 2023, in combination with filgrastim (G-CSF), to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma, under the brand name APHEXDA®. Motixafortide is also being evaluated in a Phase 1 clinical trial evaluating motixafortide as a monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD).
About CheMo4METPANC Phase 2 Clinical Trial
The multi-center CheMo4METPANC Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04543071) is a randomized, investigator-initiated clinical trial in first line metastatic pancreatic cancer. Sponsored by Columbia University, and supported equally by BioLineRx and Regeneron, the study is evaluating the combination of CXCR4 inhibitor motixafortide, PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in 108 patients. The trial's primary endpoint is progression free survival (PFS). Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit and overall survival.
About Pancreatic Cancer
Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. In the United States in 2024, an estimated 66,000 adults will be diagnosed with the disease, which accounts for approximately 3% of all cancers in the U.S. and about 7% of all cancer deaths.1 Worldwide, an estimated 496,000 people were diagnosed with the disease in 2020. In the U.S., if the cancer is detected at an early stage when surgical removal of the tumor is possible, the 5-year relative survival rate is 44%. About 12% of people are initially diagnosed at this stage. If the cancer has spread to surrounding tissues or organs, the 5-year relative survival rate is 15%. For the 52% of patients who are initially diagnosed with metastatic cancer, the 5-year relative survival rate is 3%.2 In particular, hepatic (liver) metastases are a critical risk factor driving poor prognoses for patients with metastatic PDAC. These data highlight the need for the development of new therapeutic options.
About Motixafortide in Cancer Immunotherapy
Motixafortide inhibits CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including pancreatic ductal adenocarcinoma (PDAC). Motixafortide leverages the expression of the CXCR4 receptor on different immune cells and potentiates the immune system against the tumor. Among CXCR4-expressing immune cells, some exhibit anti-tumoral activity, such as effector T cells and some exhibit pro-tumoral activity and support tumor growth. By blocking the CXCR4 receptor, motixafortide was shown in a Phase 2 study in pancreatic cancer patients to enhance anti-tumoral activity and to ameliorate the pro-tumoral activities by modulating the effector/suppressor cell ratio towards a proinflammatory profile.
We maintain our valuation of $7.60 per share which recognizes BioLineRx’ commercialization success around the globe for motixafortide in stem cell collection and in various cancer indications.
BLRX: Poster Presentations
https://finance.yahoo.com/news/blrx-poster-presentations-132700179.html
Mon, February 26, 2024 at 3:27 PM GMT+2
By John Vandermosten, CFA
NASDAQ:BLRX
Subgroup Analyses of Genesis Trial Data at ASTCT & CIBMTR
Washington University School of Medicine’s Zachary Crees, MD and BioLineRx’ (NASDAQ:BLRX) Ella Sorani, PhD descended on San Antonio, Texas last week to participate in poster presentations for the 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). The tandem meetings took place February 21-24, 2024. Dr. Crees presented a poster entitled Motixafortide Enables Consistent, Robust Hematopoietic Stem Cell Collection (HSC) across Populations with Increased Impaired HSC Mobilization: A Sub-Group Analysis of the Genesis Study. Dr. Sorani shared findings from another poster labeled Prolonged CXCR4 Receptor Occupancy By Motixafortide Following a Single Subcutaneous Injection Is Associated with Extended Mobilization of CD34+ Cells in Peripheral Blood for > 24 Hours. Continue reading for a summary of findings presented at the transplant conferences.
ASCT Stem Cell Collection
Successful autologous hematopoietic stem cell transplant (ASCT) requires a sufficient number of stem cells from peripheral blood to be collected. In many cases, stem cell collection may be difficult due to a number of patient characteristics including age, presence of cytopenias and radiation exposure among other factors. To address problematic collection, the Genesis trial was launched. The Phase III study sought to determine the efficacy of motixafortide and G-CSF combination therapy with G-CSF alone for the mobilization of hematopoietic stem cells.
The primary endpoint of mobilizing more than 6 x 106 CD34+ cells per kg in two apheresis sessions was achieved by 92.5% of subjects in the motixafortide arm compared with 26.2% in the G-CSF arm. The results for patients that presented complicating factors was even more stark between the two arms. Below we provide a comparison of patients with risk factors for poor mobilization who reached collection targets in one apheresis session:
Extended Mobilization of CD34+ Cells
BioLineRx conducted a study to measure in-vitro receptor occupancy, clinical pharmacokinetics and pharmacodynamics of peripheral blood CD34+ cells after motixafortide administration. The assessment was conducted in healthy volunteers and in patients with multiple myeloma. Further aims of the study were to assess associations between apheresis timing and apheresis yield.
The study observed that complete CXCR4 receptor occupancy by motixafortide was observed starting at concentrations as low as 3 nanomolar (nM), with increasing concentrations generating longer receptor occupancy of over 72 hours. Further findings from an examination demonstrated that there was no correlation between the timing of the apheresis procedure and the yield of CD34+ cells within the recommended collection window.
Poster conclusions identified high CXCR4 receptor affinity and slow dissociation rate of motixafortide which result in long receptor occupancy leading to an extended pharmacodynamic effect. CD34+ cells are rapidly mobilized after motixafortide injection, and peak from 12 – 16 hours post administration. 86.3% of patients were able to collect over 6 x 106 CD34+ cells per kilogram in one leukapheresis session. Despite the peak at 12 – 16 hours, there was no correlation between timing of apheresis and cell yield in the 10-hour to 16-hour timepoint following motixafortide injection. The extended pharmacodynamic effect of motixafortide may enable a flexible administration window that allows for leukapheresis to be performed more than 24 hours post administration.
Milestones
? Motixafortide, Phase II (Columbia) PDAC study data release – 2023
? Presentation of GENESIS data at medical meetings & conferences – 2023
? Data published for Phase II PDAC trial – 2H:23
? Motixafortide, Phase I launch in Sickle Cell Disease – 2H:23
? Motixafortide in SCM target action (PDUFA) date – September 2023
? US launch of motixafortide in SCM – 3Q:23
? Gloria Biosciences strategic equity investment – October 2023
? Approval of Asia Licensing Agreement (Gloria) by Israeli Innovation Authority – 4Q:23
? ASH poster presentation: Aphexda in Transplant Centers – December 10, 2023
? Start of Gloria Biosciences’ stem cell mobilization bridge study – 2024
? Start of Gloria Biosciences’ 1st line pancreatic cancer study (motixafortide & zimberelimab) - 2024
? Launch motixafortide and anti-PD-1 combination study - 2024
? Potential initiation of randomized Phase 2 study of AGI-134 – 2024
? Sickle Cell Disease Phase I readout – 2H:24
Summary
BioLineRx presented two posters in San Antonio, Texas at the tandem transplant conferences ASTCT and CIBMTR. The posters provided additional analysis of the Genesis trial and other data which evaluated the use of motixafortide in multiple myeloma patients and healthy volunteers that required an autologous stem cell transplant. The research found that motixafortide was able to produce a high proportion of stem cells especially in patients with risk factors that may otherwise limit collection. A second study was able to show that motixafortide produces durable receptor occupancy at relatively low concentrations of drug which allow for collection over a multi-hour period post motixafortide administration.
While the data provide additional supportive data for motixafortide, the drug’s ability to safely and effectively collect sufficient cells for stem cell transplantation in multiple myeloma patients has been recognized by the FDA, resulting in the product’s approval. BioLineRx is now commercializing motixafortide branded as Aphexda in the United States.
We maintain our valuation of $7.60 per share which recognizes BioLineRx’ commercialization success around the globe for motixafortide in stem cell collection and in various cancer indications.
Nice market reaction:
1.3000+0.1200 (+10.1695%)
As of 10:40AM EST. Market open.
3 Top Penny Stocks for 5,000% Upside in 2024 and Beyond
Only extreme speculators need apply
https://investorplace.com/2024/02/3-top-penny-stocks-for-5000-upside-in-2024-and-beyond/
15h ago · By Josh Enomoto, InvestorPlace Contributor
If you want the ultimate in extreme penny stocks, this list should do it.
BioLine (BLRX): BioLine drug discovery specialty aligns with a wide addressable market.
BioLine (BLRX)
A drug development company, BioLine (NASDAQ:BLRX) utilizes its acumen to power novel drug ideas past the bench. From the clinical development process to approval and commercialization, BioLine helps deliver meaningful therapeutics that address critical needs. Per its website, the company seeks to accelerate innovative ideas into the hands of the people who need them most: desperate patients seeking answers to their conditions.
Fundamentally, BioLine benefits from a massive total addressable market. According to Acumen Research and Consulting, the global drug discovery sector reached a valuation of $81.5 billion in 2022. Further, experts believe that the space could be worth $181.4 billion by 2032. If so, that would translate to a compound annual growth rate (CAGR) of 8.5%.
Given that the market capitalization of BLRX stock is only $96 million, it technically enjoys a robust upside pathway. However, the company will need to print something on the top line eventually to satisfy investors.
Still, H.C. Wainwright’s willing to bet on BioLine, rating shares a “buy” with a $21 target. That comes out to almost 1,594% upside. Therefore, BLRX ranks among the penny stocks to consider.
The increase with robust volume is
indeed a positive sign.
Hope the momentum continues today!
I am smiling as the increase is now showing in the after-hours trading. Yummy - Yummy finally some positive action.
1.2401+0.0901 (+7.8348%)
As of 02:52PM EST. Market open.
Volume 312,266
Avg. Volume 309,441
Smile!
1.2600+0.1500 (+13.5135%)
As of 01:14PM EST. Market open.
Volume 560,076
Avg. Volume 301,411
That's more like it!
The company was also featured in a tipranks article saying it’s a compelling investment due to growing revenue and earnings potential given their recent approval.
That probably is hurting either.
Murocman
Sure seems like market reaction
to the news is somewhat lukewarm.
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®
https://finance.yahoo.com/news/biolinerx-announces-acceptance-two-poster-120000916.html
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.
Results include pharmacokinetics (PK) and pharmacodynamics (PD) data as well as post-hoc subgroup analyses from the Phase 3 GENESIS trial, a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of APHEXDA (motixafortide) plus filgrastim, compared to placebo plus filgrastim (G-CSF), for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients. Phase 1 study results demonstrated an extended PD effect with complete receptor occupancy by motixafortide starting at a concentration of 3nM. In the GENESIS trial, post-hoc subgroup analyses based on baseline characteristics and risk factors for impaired HSC mobilization demonstrated a consistent benefit of motixafortide + G-CSF over placebo + G-CSF mobilization for all patients.
Poster Presentations at the 2024 Tandem Meetings: Transplantation & Cellular Therapy Meetings of the ASTCT and the CIBMTR.
Henry B. González Convention Center, San Antonio, Texas
Poster Session Details
Poster: Number 537. See abstract.
Title: Motixafortide Enables Consistent, Robust Hematopoietic Stem Cell Collection (HSC) across Populations with Increased Impaired HSC Mobilization: A Sub-Group Analysis of the Genesis Study
Presenter: Zachary D. Crees, MD, Washington University School of Medicine in St. Louis
Poster Session: Myeloma - Clinical
Date: Thursday, February 22, 2024
Time: 6:45 PM - 7:45 PM
Poster: Number 535. See abstract.
Title: Prolonged CXCR4 Receptor Occupancy By Motixafortide Following a Single Subcutaneous Injection Is Associated with Extended Mobilization of CD34+ Cells in Peripheral Blood for > 24 Hours
Presenter: Ella Sorani, PhD, BioLineRx Ltd
Poster Session: Myeloma - Clinical
Date: Thursday, February 22, 2024
Time: 6:45 PM - 7:45 PM
About the GENESIS Trial
GENESIS (NCT 03246529) is a 2-part, Phase-3, randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and efficacy of APHEXDA (motixafortide) plus filgrastim (G-CSF), compared to placebo plus filgrastim, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients. Part 1 was a single center, lead-in, open-label study involving 12 patients treated with motixafortide plus filgrastim designed to ascertain the dose. Part 2 involved 122 patients who were randomized 2:1 in a double-blind, placebo-controlled, multicenter study. The primary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize = 6 million CD34+ cells in up to two apheresis sessions. A key secondary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize = 6 million CD34+ cells in one apheresis session.
About Multiple Myeloma Multiple myeloma is an incurable blood cancer that affects some white blood cells called plasma cells, which are found in the bone marrow. When damaged, these plasma cells rapidly spread and replace normal cells in the bone marrow. According to the American Cancer Society, in 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and nearly 13,000 people will die from the disease in the U.S.1 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems, or infections.
About APHEXDA® APHEXDA (motixafortide) is a CXCR4 antagonist with long receptor occupancy (greater than 72 hours) that, in combination with filgrastim (G-CSF), enables mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous stem cell transplantation in patients with multiple myeloma.2
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
APHEXDA is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
APHEXDA is contraindicated in patients with a history of serious hypersensitivity reactions to motixafortide.
WARNINGS AND PRECAUTIONS
Anaphylactic Shock and Hypersensitivity Reactions: Anaphylactic shock and hypersensitivity reactions have occurred. Premedicate all patients with a triple drug premedication regimen that includes an H1-antihistamine, an H2 blocker, and a leukotriene inhibitor approximately 30-60 minutes prior to each dose of APHEXDA. Administer APHEXDA in a setting where personnel and therapies are immediately available for treatment of anaphylaxis and other systemic reactions. Monitor patients for 1 hour following APHEXDA administration and manage reactions promptly. Patients receiving negative chronotropic drugs (e.g., beta-blockers) may be more at risk for hypotension in the event of a hypersensitivity reaction and these drugs, when appropriate, should be replaced with non-chronotropic drugs.
Injection Site Reactions: Injection site reactions (73%) including pain (53%), erythema (27%), and pruritus (24%) have occurred. Severe reactions occurred in 9% of patients. Premedicate with an analgesic premedication (e.g., acetaminophen) prior to each APHEXDA dose. Use analgesic medication and local treatments post-dose, as needed.
Tumor Cell Mobilization in Patients with Leukemia: For the purpose of hematopoietic stem cell (HSC) mobilization, APHEXDA may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, APHEXDA is not intended for HSC mobilization and harvest in patients with leukemia.
Leukocytosis: Administering APHEXDA in conjunction with filgrastim increases circulating leukocytes as well as HSC populations. Monitor white blood cell counts during APHEXDA use.
Potential for Tumor Cell Mobilization: When APHEXDA is used in combination with filgrastim for HSC mobilization, tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of potential reinfusion of tumor cells has not been well-studied.
Embryo-fetal Toxicity: Based on its mechanism of action, APHEXDA can cause fetal harm. Advise pregnant women of the potential risk to the fetus. Verify pregnancy status in females of reproductive potential prior to initiating treatment with APHEXDA and advise use of effective contraception during treatment and for 8 days after the final dose.
ADVERSE REACTIONS
The most common adverse reactions (incidence >20%) in patients treated with APHEXDA were injection site reactions [73%, including pain (53%), erythema (27%), pruritus (24%)]; pruritus (38%); flushing (33%); back pain (21%).
USE IN SPECIFIC POPULATIONS
Pregnancy: Please see the important information in Warnings and Precautions under Embryo-fetal Toxicity.
Lactation: There are no data on the presence of motixafortide in human milk, the effects on the breastfed child, or the effects on milk production. Advise females that breastfeeding is not recommended during treatment with APHEXDA and for 8 days after the final dose.
Pediatric Use: The safety and effectiveness of APHEXDA have not been established in pediatric patients.
Please see the accompanying full Prescribing Information.
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The company's first approved product is APHEXDA® (motixafortide) with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma. BioLineRx is advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with operations in the U.S., the company is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside.
Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on Twitter and LinkedIn.
Well raise the flag at least we did not finish in the red today
BarrellofHay
Let's think about your posts. If you had cancer and were in line to die would you be willing to spend more to try to saving your life knowing that the drug that cost more has a better chance than the generic that cost less but does not have as good a chance to keep you alive. Keep in mind the real thing is covered under Medicare. Even if it cost more it is your life at stake.
Anyone know the pricing. Worried about generics regardless of whether its better or not.
Don't speak Yiddish me no understand. Put it into English, please. What do you see as their problem? If it is major it must be reported.
I do not want the PR morons to float out fluff what they could say is as an update things are moving as we expect them to. We expect to have further comments as we move toward our upcoming quarterly report. This is calming by saying nothing the SEC would jump on. I did PR work in my younger years for a company that was on the OTC-BB
As much as i am disappointed it is not
the companys duty to comment on
share price movements.
The company is obliged to inform only
whenever material events occur.
I am troubled by the robust volume:
Volume 947,453
Avg. Volume 315,706
I am so pissed off I could scream. Where are our PR morons to calm this thing down. No fluff just a few sentences to take the blood out of the water? Unless there is a real problem. OH just leave us hanging from a rope around a tree limb!!!!! SHAME ON OUR PR PEOPLE WHO GET PAID TO DO THEIR JOB.
I am at complete loss of words. I have no idea
of the downfall in sp. At first i thought it had to
do with the ongoing war and that foreign investors
hurried to get rid of any Israel stock although
there is a general negative sentiment towards
Israeli stocks in general.
What is going on with this stock? It is getting hammered.
midastouch017
bought back a little over 6000 shares of BLRX today and thought it was a decent price. Now it is dropping more. Any whispers I should know about? Will probably go for another 3 to 6,000 more if it drops more tomorrow. Hope the first patient on the dosage did not die on them.
Looks like we are in a rut at this time. My feelings are we stay here till closer to next quarter report time. They will have to show some sales or the rut will get deeper. My opinion is they will.
Met with the CEO of PASG as the company is a little under 20 miles from my house. He was down to earth and told me his company is looking forward to big things beginning at the end of this year into mid-2025. Pipeline is big but he also said a lot can happen both ways in that amount of time. Their office is in a downtown high-rent area. I bought shares but still have an eye-watching BLRX. Passage Bio Inc. numbers are not good currently but time will tell. It is a wait and see situation with hope on the other end.
midastouch017
I sold out my BLRX last week with a very nice gain. I put a chunk into BCLI as a holding pattern till I get a feeling toward the next quarter on BLRX. I want to see some earnings not another GMDA. I remain bullish on BLRX but I want to see some internal movement in sales.
1.4400-0.0700 (-4.6358%)
As of 02:03PM EST. Market open.
Very disappointing!
Your friend over here worries that the man running our country has no balls. Worse than that his brain is dead but next in line Kamala would be worse as she has no balls either. HA HA!!! but not funny. Her brain is alive but non -functioning. Trump was a panic but at least he kept us out of any wars. I would think killing the deputy chief of Hamas would be a good news point in your country.
Israeli stocks were hammered down due to this news piece:
Israeli drone kills deputy Hamas chief in Beirut
midastouch017
I bought 5000 shares of CGEN today in 1000 shares at a time to average my price down to $2.02cents per share. I like that they have a lot of irons in the fire and that they are dealing with major Bio companies. BLRX right now is standing in quicksand. At least they are standing and not sinking. NASDAQ got bombed today was not a good start for them or me. Thought after the end-of-year tax loss selloff things would turn around today. Man was I wrong. Did decide not to move on selling anything though. My Israel stocks had better come through for me this year. The volume on BLRX was terrible today I was surprised.
Management does a very POOR JOB in promoting our little company.
Bioline, which developed a drug to mobilize stem cells for bone marrow transplants,
received approval in September and is launching these days.
The product has been incorporated into the treatment protocol of the NCCN network
of cancer centers, which is a good start in the American market.
Bioline itself is responsible for marketing.
As of the end of the third quarter, the company has enough cash until the year 2025.
Happy New Year BLRX shareholders. With tax loss selling now over let's hope that we trend upward for a while. If the Israeli market today was any indication we should finish up tomorrow. I have a final buy order in at $1.54 thinking the open should start at a downward movement to deal with some of the leftover trades that did not make the close on Friday. If it does not trend down at the open I will pull my trade. I am really looking forward to an announcement of some early sales numbers as well as some type of indication as to some European movement. Finally, I sure hope that 2024 leads to a more open IR relationship with us the investors in this company. Management does a very POOR JOB in promoting our little company.
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