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HC Wainwright& Co. analyst Joseph Pantginis maintains BioLine Rx (NASDAQ:BLRX) with a Buy and raises the price target from $19 to $21.
HC Wainwright & Co. Maintains Buy on BioLine Rx, Raises Price Target to $21
6:11 am ET September 15, 2023 (Benzinga
Bon chance! It will not be a smooth ride,
but long term you stand to gain imo.
Just bought another 3,300 shares.
A positive write up......hoping it plays out well. Still up even after the recent price slaughter. :)
Summary
BioLineRx reported its second piece of material good news in as many weeks with FDA approval of Aphexda for stem cell mobilization in multiple myeloma patients. The approval of the drug delivers additional credibility to BioLineRx’ other motixafortide programs and provides a tailwind to commercialization efforts in Asia. We expect to see IIA approval for the Asia deal in the next few months and could see first ex-US revenues shortly after. Other highlights for the company include the start of the Columbia University-sponsored Phase II PDAC trial, Washington University’s work on sickle cell disease and efforts advancing AGI-134 in solid tumors. The US commercialization team has been hard at work preparing for Aphexda’s approval and could have first sales in the next few weeks. Based on the approval of Aphexda, we increase our valuation to $7.00 per share reflecting an increase in the probability of regulatory success to 100%.
BLRX: …Go!
https://finance.yahoo.com/news/blrx-093600390.html
By John Vandermosten, CFA
FDA Approval of Aphexda
On September 11th, BioLineRx Ltd. (NASDAQ:BLRX) announced FDA approval of Aphexda, its stem cell mobilization product for autologous transplantation in multiple myeloma. The product was the 36th novel drug approved for 2023. Based on the strong data generated in the Phase III GENESIS trial, we had high expectations for approval and were not disappointed. Management made a considerable effort to prepare for commercialization of Aphexda and has assets in place to build relationships with payors and providers including a medical affairs scientific exchange, preparation for journal publication and medical service liaison (MSL) engagement.
Management provided additional detail on pricing for the product, with a targeted list of $5,900 per vial. The amount of product required is based on weight and, on average, two vials are expected to be required for each patient’s collection with an administration of Aphexda sufficient to produce stem cells for a second apheresis session if needed. Now that the label has been finalized, product packaging is taking place. Quality assurance checks will be performed and shipping to a third-party logistics center will occur as Aphexda makes its way to transplant centers.
The commercialization team is in discussions with payors for coverage and reimbursement and BioLineRx is engaging leading physicians in the specialty to educate the community. The team has identified the top centers around the United States which represent more than 85% of autologous transplants. Customer targeting has been even more refined based on local need which could be based on apheresis unit capacity and low yields to identify those most receptive to the product and the benefits it brings. Centers that were involved in the GENESIS trial will also be among the first to see the product given their familiarity with it.
Valuation
Upon FDA approval of Aphexda, we increase our probability of success of Aphexda commercialization in the United States to 100% from 85%. Pricing is adjusted to reflect management’s guidance of $5,900 per vial and the use of an average of ~2 vials per treatment. We maintain our probabilities in the EU until approval in that region and will add contributions from Asia after approval for the deal is granted by the Israeli Innovation Authority (IIA). We maintain our values for the motixafortide PDAC and AGI-134 programs. The result of our adjustment supports an increase in the valuation to $7.00 per share.
We are keeping our eye on the next valuation-driving catalyst, which is the approval of the license agreement with Guangzhou Gloria Biosciences Co., Ltd., which we discuss in further detail below. As approval for Aphexda was granted before year-end 2023, BioLineRx remains eligible for the higher royalty rates. There are also several jurisdictions in the licensed regions where commercialization may begin when FDA approval is granted, requiring only a minor bridging study and administrating filings. This suggests that first foreign revenues could begin flowing over the next few quarters.
Asia License Agreement
Along with its second quarter earnings release, BioLineRx announced that it had signed an exclusive license agreement to develop and commercialize motixafortide in Asia along with an equity investment from two partners. Features of the arrangement include:
? $15 million upfront payment
? Potential development, regulatory and sales milestones
? Tiered double-digit royalties
? Initiation of a registrational study in stem-cell mobilization in China
? Initiation of a randomized Phase II/III study in first line pancreatic cancer
? Equity investment of $14.6 million
The equity investment was made at $2.136 per American Depository Share (ADS) and did not include warrants. This represents 6,829,137 shares. Other closing conditions of the transaction include the requirement that it be approved by the Israeli Innovation Authority within four months. While only select financial details were made public, this appears to be a standard agreement for a strong candidate and if successful will open up one of the largest markets in the world to motixafortide in multiple indications. We expect to update our valuation model to reflect this following FDA approval and launch of motixafortide in the United States.
The license agreement has been made between BioLineRx and two separate entities. The first is Guangzhou Gloria Biosciences Co., Ltd., a company organized under the laws of the People’s Republic of China. The second company is Hong Seng Technology Limited, a company organized under the laws of the Special Administrative Region of Hong Kong.
Additional detail in the Form 6-K filing show more specific detail including that BioLineRx is further entitled to $49 million based on reaching development and regulatory milestones in China and Japan and up to $197 million in sales milestones based upon defined sales targets. Royalties will range from 10-20% of revenues. Further discussion of the arrangement is available in the filing.
Upcoming 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 in Sickle Cell Disease – 2H:23
? Motixafortide in SCM target action (PDUFA) date – September 2023
? US launch of motixafortide in SCM – 3Q:23
? Approval of Asia Licensing Agreement (Gloria) by Israeli Innovation Authority – 4Q:23
? Potential initiation of randomized Phase 2 study of AGI-134 – 2023
Summary
BioLineRx reported its second piece of material good news in as many weeks with FDA approval of Aphexda for stem cell mobilization in multiple myeloma patients. The approval of the drug delivers additional credibility to BioLineRx’ other motixafortide programs and provides a tailwind to commercialization efforts in Asia. We expect to see IIA approval for the Asia deal in the next few months and could see first ex-US revenues shortly after. Other highlights for the company include the start of the Columbia University-sponsored Phase II PDAC trial, Washington University’s work on sickle cell disease and efforts advancing AGI-134 in solid tumors. The US commercialization team has been hard at work preparing for Aphexda’s approval and could have first sales in the next few weeks. Based on the approval of Aphexda, we increase our valuation to $7.00 per share reflecting an increase in the probability of regulatory success to 100%.
I wish you best of luck with
$BCLI in 2 weeks time!
A PDUFA delay would have driven
the stock to 50 cents.
What is causing the downfall is this:
BioLineRx Announces $15 Million Registered Direct Offering
September 19, 2022
TEL AVIV, Israel, Sept. 19, 2022 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, today announced that it has entered into definitive agreements with several institutional investors for the issuance and sale in a registered direct offering of 13,636,365 of the Company's American Depositary Shares (ADSs) and warrants to purchase up to an aggregate of 13,636,365 ADSs, at a combined purchase price of $1.10 per ADS and associated warrant. Each ADS represents fifteen (15) ordinary shares, par value NIS 0.10 per share, of BioLineRx. The offering is expected to close on or about September 21, 2022, subject to satisfaction of customary closing conditions.
The warrants will have an exercise price of $1.15 per ADS and will be exercisable at any time upon issuance and will expire five years from the date of issuance.
You’d think we had gotten a PDUFA delay or something based on this price action!
Sheesh!
Tanking again on 250k shares
But keep listening to gamblers talk about how many teslas they’re leasing because of this stock.
Steady tank since approval. Only hope is buyout and that’s basically a lottery ticket.
If these drug stocks don’t pop hard at approval, they’re done.
Stocktwits is also informative.
Wish I heard about this board in February.
I found out about this stock when it was at $1.66.
$GMDA "we have onboarded 12 transplant centers and have 8 additional transplant
centers currently in the onboarding process against the goal of 10 to 15 for the year. "
$BLRX:"Company to accelerate availability to patients and maximize value through
independent commercialization to well-defined U.S. transplant center community. "
Why not share? why not cooperate?
adamp
I recommended on this very board to buy at
late Feb 2023, the price then was ~$0.55
https://tradingeconomics.com/blrx:us
Many of those who bought at this price level probably
sold out along the way.
With FDA approval achieved, agreements, collaborations
etc, the long term strongly suggests a positive outlook.
Hang on, come visit in 6 months time, find out who had
it right.
lol... don't get used to it
For anyone who bought this recently this thing is a stinker. I could care less how things went with this stock years ago. For anyone holding this now, this one is a liability. There is NO reason to buy this now. We are, what, months from any revenues from this drug? Meanwhile other projects will drain 10s to 100s of millions of dollars putting more pressure on the pps. From 13M+ shares traded and no movement, to 2.59M the next day. It's over. We have months to get revenue reports from this drug, in the meantime, nothing but sellers and shorters to drive this below a dollar. If you're so wise, tell everyone how this one recovers without buyers, because they are effectively gone. I saw this with MCRB, I saw this with PRVB who got lucky with a buyout for their bogus drug. If you're such a 'wise' trader, then you're shorting the hell out of this thing at this point.
adamp
Correction to my previous post to you. I have taken from my gain on BLRX $62,000 to put aside to buy instead to lease my a 2024 Tesla model 3. I have given my 5 grand children $5000 each to pay for books when they are ready for college and still have just under 100,000 shares left that will make my wife and me very comfortable along with her pention from teaching for 35 years and my reserves from running my own business plus both our social security. Just so you understand I have series 6 and 66 licenses from when I studied the market and studied for the series 7 license to become a broker but never took the test. I decided I could not be a broker and have to take money from people I knew could not afford to lose those dollars. You see son I am some 35 years older then you and seem to have a lot more wisdom. ENOUGH SAID. Oh and last point I have been been in the market for 53 years and have spent only the markets money the last 40 years.
Son learn to treat people the same as you want to be treated IT WORKS!!!!
Lol… one day? You’re an idiot I’ve see.n this play out many times before. Lose all your money. Seres Mcrb died after fda approval and keeps dying. I can name many others. This one is doomed. I hope you’re still around when it reverse splits. Only a buffoon keeps faith in a company that tanks like this after approval
One day bad showing and you throw in the towel on them. What has changed. just wait for the string of good financial news and you will be crying in your glass of water,What a weakie you have to learn how to play this market. It always is the case buy up to the news then sell on the news. Let's see what the end of the week looks like. Oh you sold out sucks to be you. Study the stock so you can understand the company. Better yet understand the market or don't play where you don't belong.
Buyers are done. Nothing but sellers, starting tomorrow.
There’s nothing here. A meaningful fda approval should have shot us up 300%
Buyers are done. Nothing but sellers, starting tomorrow.
There’s nothing here. A meaningful fda approval should have shot us up 300%
adamp
Let's take a look at what BLRX has done for me so far. So far I have put away $62,000 thanks to this company for re-leasing another Tesla model 3 in 2024. much more shares still under the wing . So how did your short position do
FDA approval and this thing just tanks. Praying that we can get back down to $1.40 so I can dump my straddle. What a total POS. I feel bad for everyone who got super bullish on this. Try again next time, I guess.
warrants people. warrants. they are just about done exercising
Bought another 5000 this morning
I just bought some 2.15s
No one is going to touch a stock that performs so poorly after fda approval. All the buyers are done, they’ve all set stop losses, and all those stops will be triggered within 2 trading days. I’ve seen this all play out before. The stock either pops or it dies. This one looks like it’s going to die. Between day traders selling on news, big firms shorting relentlessly, and companies dumping diluted shares into any run, there’s just too much to overcome with a disinterested buyer base
Fraction of a penny increments… company is shooting their own feet here.
We’re doomed. Fda approval and this is going nowhere. Company probably dumping shares into the news. Over 7M shares traded with little movement. Fda approval doesn’t mean anything anymore. Nov $2.50 calls have no volume
Hot damn! That is some friggin' great news to wake up to!!! Congrats eveyone!
Interesting article:
BioLineRx Announces FDA Approval of APHEXDA™ (motixafortide) in Combination with Filgrastim (G-CSF) to Mobilize Hematopoietic Stem Cells for Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
https://finance.yahoo.com/news/biolinerx-announces-fda-approval-aphexda-110000569.html
- APHEXDA is the first innovation in stem cell mobilization for multiple myeloma to be approved in the U.S. in a decade -
- One dosage of APHEXDA plus filgrastim enabled a majority of patients to achieve the collection goal of ≥ 6 million hematopoietic stem cells among a contemporary population of multiple myeloma patients -
- Management to hold conference call on Tuesday, September 12, 2023 at 8:00 a.m. U.S. EDT [Why not today - i wonder?]
TEL AVIV, Israel, Sept. 11, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company focused on certain cancers and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved APHEXDA™ (motixafortide) 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. APHEXDA is administered by injection, for subcutaneous use.
Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9174951-biolinerx-fda-approval-aphexda/
Multiple myeloma is the second most-common hematologic malignancy. Autologous stem cell transplantation (ASCT) is part of the standard of care treatment paradigm for multiple myeloma and delivers prolonged survival for patients with this cancer type.1 The success of ASCT depends on adequate mobilization of stem cells during the treatment process. The American Society for Transplantation and Cellular Therapy (ASTCT) guidelines recommend a collection target of 3-5 x 106 CD34+ cells/kg.2 Additionally, collection of a sufficient number of stem cells to perform two transplantations is recommended.2-5 Historically, depending on induction regimens and mobilization strategies, up to 47% of patients have had challenges collecting target numbers of hematopoietic stem cells for ASCT after one apheresis session.6-7
"Greater numbers of patients with multiple myeloma are candidates for autologous stem cell therapy; however, achieving target collection goals can be difficult in some patients given modern barriers, including the treatment of older patients and use of contemporary induction regimens," said John DiPersio, MD, PhD, primary investigator for the GENESIS trial and
Professor of Medicine, Pathology and Immunology and Director of the Center for Gene and Cellular Immunotherapy at Washington University School of Medicine in St. Louis. "Innovation in this area of medicine has been needed, and today's approval of APHEXDA addresses the demand for new therapies that can meet today's challenges by delivering more reliability in stem cell mobilization, versus filgrastim alone, with fewer days of apheresis sessions and fewer doses of filgrastim for people living with this cancer."
The FDA approval of APHEXDA is based on results from the 2-part, 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, 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.8
The assessment of CD34+ cells was performed by central and local laboratories. Central laboratory assessments were used for the efficacy results. Local laboratory results were used for clinical treatment decisions. APHEXDA plus filgrastim enabled 67.5% of patients to achieve the stem cell collection goal of ≥ 6 × 106 CD34+ cells/kg within two apheresis sessions, versus 9.5% for the placebo plus filgrastim regimen, as measured by central laboratory.9 Additionally, 92.5% of patients reached the stem cell collection goal in up to two apheresis sessions in the APHEXDA arm and 21.4% in the placebo arm, as measured by local laboratories.9 Local laboratory data were used for a sensitivity analysis. The data are descriptive and were not statistically powered nor prespecified. The information should be cautiously interpreted.
In GENESIS, the safety was evaluated in 92 patients with multiple myeloma who received APHEXDA 1.25 mg/kg subcutaneously plus filgrastim, and 42 patients who received placebo plus filgrastim. Serious adverse reactions occurred in 5.4% of patients receiving APHEXDA plus filgrastim. These reactions included vomiting, injection site reaction, hypersensitivity reaction, injection site cellulitis, hypokalemia and hypoxia. The most common adverse reactions occurring in GENESIS (incidence >20%) were injection site reactions (pain, erythema and pruritus), pruritus, flushing, and back pain.9
"Given the strong efficacy data shown in the GENESIS trial, which included patients who are representative of the current multiple myeloma patient population, we believe APHEXDA will play a critical role in addressing unmet needs and introduce a new treatment paradigm for this challenging cancer," said Philip Serlin, Chief Executive Officer of BioLineRx Ltd. "The company is working relentlessly to make this important innovation in stem cell mobilization available to appropriate patients, their physicians and transplant teams."
"FDA approval of APHEXDA, the company's first approved therapeutic, is a tremendously exciting and important moment in our history and validates our drug development programs," said Ella Sorani, PhD, Chief Development Officer of BioLineRx Ltd. "We would like to thank all of the patients and families who have contributed to the research and development of APHEXDA."
Increased age, as well as exposure to lenalidomide-containing induction regimens, including 3-4 drug combination regimens, have been associated with impaired stem cell mobilization.2-3 The GENESIS study included patients considered representative of the typical multiple myeloma population undergoing ASCT, with a median age of 63 years and with ~70% of patients in both arms of the trial receiving lenalidomide-containing induction therapy.8 In this contemporary population, patients in the APHEXDA plus filgrastim arm were able to mobilize more than four times the amount of stem cells with a single dose over a 24-hour period compared with placebo plus filgrastim.8
BioLineRx expects to make APHEXDA available later this month. For further information about APHEXDA, please see the Important Safety Information below and the full Prescribing Information, and visit www.APHEXDA.com.
APHEXDA Investor Conference Call
The Company will host an investor conference call on September 12, 2023 at 8:00 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 September 14, 2023; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
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 2023, 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.10 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 Autologous Stem Cell Transplantation
Autologous stem cell transplantation (ASCT) is part of the standard treatment paradigm for a number of blood cancers, including multiple myeloma. In the U.S., as many as 8,000 ASCTs are performed each year in patients with multiple myeloma.11 The current ASCT standard of care includes 4-6 cycles of induction therapy (an initial drug-combination regimen to position the patient for as deep a treatment response as possible). To begin the stem cell mobilization process, a patient will receive a daily dose of filgrastim (G-CSF) for four days. Daily doses of filgrastim will continue until the target collection goal is met with the addition of up to four daily doses of plerixafor as needed.12 For patients unable to mobilize sufficient numbers of cells for harvesting during this primary mobilization phase, rescue therapy may be carried out followed by an additional number of apheresis sessions as necessary.2
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.8
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.8
The study met the primary endpoint with a high degree of statistical significance (p<0.0001). The assessment of CD34+ cells was performed by central and local laboratories. Central laboratory assessments were used for the efficacy results. Local laboratory results were used for clinical treatment decisions. APHEXDA plus filgrastim enabled 67.5% of patients to achieve the cell collection goal of ≥ 6 × 106 CD34+ cells/kg in up to two apheresis sessions with a single administration, versus 9.5% for the placebo plus filgrastim regimen, as measured by central laboratory.9 Additionally, 92.5% of patients reached the stem cell collection goal in up to two apheresis sessions in the APHEXDA arm and 21.4% in the placebo arm, as measured by local laboratories.13 Local laboratory data were used for a sensitivity analysis. The data are descriptive and were not statistically powered nor prespecified. The information should be cautiously interpreted.
The safety of APHEXDA was evaluated in 92 patients with multiple myeloma who received APHEXDA 1.25 mg/kg subcutaneously plus filgrastim and 42 patients who received placebo plus filgrastim for mobilization of hematopoietic stem cells for collection and apheresis. Serious adverse reactions occurred in 5.4% of patients receiving APHEXDA plus filgrastim. Serious adverse reactions included vomiting, injection site reaction, hypersensitivity reaction, injection site cellulitis, hypokalemia and hypoxia. The most common adverse reactions occurring in GENESIS (incidence >20%) were injection site reactions (pain, erythema, and pruritus), pruritus, flushing and back pain.9
Please see important safety information below.
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.9
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 for certain cancers 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, the potential benefits of APHEXDA, the timing of the launch of APHEXDA and the plans and objectives of management for future operations and expectations and commercial potential of motixafortide. 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 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 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 and the Russian invasion of Ukraine, 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.
Kumar SK, et al. Blood. 2008;111(5):2516-2520.
Giralt S, et al. Biol Blood Marrow Transplant. 2014;20(3):295-308.
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Crees, ZD, et al. Future Oncology. 2019;15(30):3555-3563.
APHEXDA. Prescribing Information. BioLineRx Ltd; 2023.
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Cision
Cision
View original content:https://www.prnewswire.com/news-releases/biolinerx-announces-fda-approval-of-aphexda-motixafortide-in-combination-with-filgrastim-g-csf-to-mobilize-hematopoietic-stem-cells-for-collection-and-subsequent-autologous-transplantation-in-patients-with-multiple-myeloma-301923206.html
SOURCE BioLineRx Ltd.
Congrats to BioLineRx we longs love you!!!!!!!!!!!!!!
Blrx : we will see news before market opens,
VDRM ; waiting for nupelo approval at any time stock will be north of $0.90 to 1,5,15
Well this is it.Like the eagles game it will come down to the last play at 7AM tomorrow morning.
BEST OF LUCK TO ALL LONGS
102 million shares has been allocated to an investor in Hong Kong from TASE exchange. This is going to get very interesting.
Double digits by Christmas if news is awesome tomorrow.
BLRX investor relations already tweeted on Friday after hours conference with Nurses regarding this indication plus on their website already hiring. The news will likely be premarket Monday.
Would it surprise you if the FDA doesn't meet their required date to report. Hell they only had months to get this done, Our government sucks but to tell the truth it still is the best around and I have traveled enough of this world to say this. If you take the time to study the FDA in my opinion you will learn that they too are a corrupt part of our government. GOD help us to find the people to go into our government and clean up the mess.
This is strictly my opinion and should be taken that way
my guess is Monday before the market opens
So, do you think that the FDA's decision will get posted before the morning bell on Monday or do you think that we will have to wait for the closing bell before we hear the news?
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