Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Problem is FDA has to be positive.
Good Shabbes.
STOCKTWITS posters VERY POSITIVE
Does anyone find it bizarre that there are no financial news stories posted about BLRX today?
Don't forget that BCLI's AdCOM meeting with the Fed is coming up on September 29th. It would be awesome to get positive news from the Fed for BLRX and BCLI. Hopefully, with positive news, my Brainstorm stock will do a 180 and shoot back up to where it was just prior to when the Fed originally rejected their phase 3.
I forgot to mention that the StockTwits post was published in Nature:
To this day, BLRX remains the only biotech whose research was published by Nature.
I think BLRX's chances are a lot better
Lol, reminds me of the crazy
optimistic days of $ORMP!
Quite a realistic estimate!
I will stick with $3.75 close Monday if FDA is favorable.
I prefer to be extremely overoptimistic with a stockprice of $450.
You are somewhat overoptimisic,
however i hope you are spot on.
As long as approval is coming, i
would not care to wait until........
Tuesday.
Uggh...the waiting is just excruciating.
It would suck if the FDA makes us wait 'til Monday.
May we enjoy good FDA tidings today.
Amen.
$3.75 end of regular trading Friday if FDA announces positive.
Hopefully we will get positive news from the FDA tomorrow morning. If that does happen, where do you think the stockprice will end up at by the closing bell?
I guess we need to check back at 3:59 and 59 seconds.
Enjoy the safari, take care from the lions, tigers
and any cannibals you might stumble onto.
Don't watch the news, and may you find out
you became a rich man due to BLRX and GMDA.
Bon Voyage!
Answer to your question is you probably will not hear from me for a month as I go back to Africa for a longer safari. It was a past dream that came true for me once. I am a nature lover. Especially animals. Seeing the Big 5 in person exploded my head. But I grew a new one (HA HA!!!)
I was not thinking of a dis-approval but possibly a temp hold for additional info. Trust me I am not trying to POOP on my parade. Just gun shy on a share price drop like we had to face earlier
Anyway, what will you say when finally FDA approval is announced as i expect? Was
there a leak after all?
Believe what you will, but i can assure you that if
there were a non approval leak decision by FDA,
sp would have dropped to less than $1.00
MHO
I would like to believe that but in this day and age I cannot believe that. I am sorry to have to believe that way but just look at our own government. Even they cannot keep a secret.
SO WOULD I. I don't publically give out my figures anymore. I have shares in my name,kids names and wife's name as well as company name for legal reasons.
Okay did someone close to the company leak some bad news
SO WOULD I. I don't publically give out my figures anymore. I have shares in my name,kids names and wife's name as well as company name for legal reasons.
I would gladly walk away from all my shares for 25 dollars a pop..... I would give me 2.8 million off of a 22k investment
Also locks out future profits. So it swings both ways. If you are in this stock as a long you have to have BALLS.
It was up 7 days straight….
showed weakness this morning logical peeps lock in profits
Okay did someone close to the company leak some bad news$ I cannot find anything on the internet that would cause a drop like this. People hold your shares for now this is not a time to sell right before the announcement. If and it should go our way you will be kicking yourself in the ass (that is if you can turn your foot around to do so). DO NOT LET THE MARKETMAKERS STEAL YOUR SHARES. This of course is my opinion and should not be taken in any decision you might make.
Nothing like a drop in share price to get the blood flowing . I think it may be the market makers trying to scare up the weak to sell so they (market makers) have some shares to sell.
this is going get some serious attention this week:
BioLine RX Price Target Maintained With a $19.00/Share by HC Wainwright & Co.
4:27 am ET August 31, 2023 (Dow Jones) Print
yep excellent post.
this FDA approval is a done deal. once it is officially announced, this stock will rocket to $10.
new analysts price target: $19.
so this is a very big deal.
NIH article expects FDA approval
It says: "motixafortide has completed phase-III clinical trials and is in the pre-submission phase. It is expected to obtain FDA approval" https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10386233/
motixafortide reference:
https://biolinerx.com/motixafortide-in-cancer-immunotherapy/
Let’s go for our $3 break.
Load and hold.
We know the FDA approval is in the bag.
Kinda nuts that the stock was just $1.28 last Monday. My stake is currently 48% in green territory.
$3 is quite possible today. either before closing or in after hours trading.
either way it is trading above $3 tomorrow.
this can hit $2.80 or so in after hours trading.
we should see $3 here tomorrow.
it is game on.
people are buying this in anticipation of the FDA approval which is coming right up.
The stockprice briefly broke past the $2.50 barrier. I'd love to see it explode past that and end up near $3 by the closing bell.
BLRX: On Your Marks, Get Set…
https://finance.yahoo.com/news/blrx-marks-set-100400464.html
By John Vandermosten, CFA
2Q:23 Operational and Financial Results
It had been relatively quiet between the first and second quarter report with only the start of the Phase II metastatic pancreatic cancer trial evaluating motixafortide announced in July. However, along with the second quarter report, BioLineRx Ltd. (NASDAQ:BLRX) revealed an exclusive agreement for development and commercialization in Asia. The arrangement includes an upfront payment and investment in BioLineRx that will materially extend the company’s cash runway and allow for sales throughout China, Japan and other Far East territories.
Second quarter earnings were announced on August 30, 2024 concurrent with intense background work to prepare for the anticipated FDA approval of motixafortide for stem cell mobilization in multiple myeloma patients. A conference call was held with management along with the filing of Form 6-K providing additional information. First and foremost in investors’ minds is the target action date of September 9, 2023 for motixafortide, or Aphexda as it is branded, for stem cell mobilization in multiple myeloma patients.
In this report, we will review the latest news reported as well as 2Q:23 operational and financial results. Since our previous update, BioLineRx has oriented its efforts towards pre-commercialization activities. A discussion of BioLineRx’ plans to commercialize Aphexda can be found in a previous report entitled BLRX: Self-Commercialization in the US. It discusses the company’s plans, reviews Aphexda’s mechanism of action and addresses the real-world benefits of an improved approach to stem cell mobilization.
Below we summarize financial results for the three-month period ended June 30, 2023, compared to the same period ending June 30, 2022:
? Research and development expenses totaled $3.0 million, down 44% from $5.4 million, on account of lower expenses related to the new drug application (NDA) supporting activities related to motixafortide and lower expenses associated with the completed AGI-134 study;
? Sales and marketing expenses were $5.6 million, up 384% from $1.2 million on account of initiation of pre-commercialization activities related to motixafortide;
? General and administrative (G&A) expenses were $1.3 million, up 24% from $1.0 million due to a rise in payroll and related expenses due to an increase in headcount and share-based compensation, as well as small increases in a number of G&A expense categories;
? Non-operating expense was ($7.7) million reflecting changes in fair-value adjustments of warrant liabilities on the balance sheet as the company’s share price rose;
? Net financial expenses amounted to ($0.9) million which was impacted by interest paid on loans partially offset by interest received from cash balances;
? Net loss was ($18.5) million compared with ($4.9) million, or ($0.01) and ($0.01) per share respectively.
Cash, equivalents and short-term bank deposits as of June 30, 2023 totaled $32.8 million, down from the year end 2022 balance of $51.1 million. Cash burn during 2Q:23 amounted to ($9.8) million and cash used in financing was ($134,000) related to repayment of lease liabilities. The substantial increase in cash burn year to date reflects the aggressive effort to prepare for the approval of motixafortide which is anticipated in a few days. In September 2022, BioLineRx entered into a $40 million loan agreement with Kreos Capital, and $10 million was drawn. The remaining $30 million will be available in two additional tranches upon the achievement of unspecified milestones. BioLineRx’ deal granting rights to two entities in Asia will also contribute to cash balances in the amount of almost $30 million, which is expected to extend the need for more capital by several 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) with no warrants attached. 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 are 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. A caveat is that if FDA approval for motixafortide does not occur by the end of 2023, the development and regulatory milestones will only be partially payable and royalty rates drop to single digits. Further discussion of the arrangement is available in the filing.
Motixafortide Pancreatic Trial
BioLineRx began a Phase II clinical trial in first line metastatic pancreatic cancer as announced in a July 17th press release. The investigator-initiated effort will be evaluating motixafortide based on the success of earlier work done in a single arm pilot study. A clinicaltrials.gov entry (NCT04543071) details the design and endpoints among other pieces of information.
The study, sponsored by Columbia University, will compare treatment with motixafortide combined with a PD-1 inhibitor (cemiplimab) and chemotherapy to chemotherapy alone in 102 subjects. This builds on an adaptive single arm study that allowed for expansion if data was supportive. We anticipate that BioLineRx’ primary development activities will shift to pancreatic ductal adenocarcinoma (PDAC) following approval of motixafortide for stem cell mobilization.
The company provides a description of the agent’s mechanism of action explaining that motixafortide takes advantage of the expression of the CXCR4 receptor on different immune cells and orients 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 II study in pancreatic cancer patients to enhance anti-tumoral activity and inhibit the pro-tumoral activities by modulating the effector/suppressor cell ratio towards a proinflammatory profile.
SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR.
DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.
TechCrunch
i think this has sufficient momentum and interest to hit $6 to $7 leading up to the FDA approval.
analysts have raised the price target to $19.
float is small. it is going to run up quite rapidly.
they also have around $33 million in cash.
so the balance sheet is strong.
ZACK in a early report on BLRX felt that the approval would boost the share price into the low $4's. My personal thoughts on ZACK is that they are usually WRONG. But they feel as sales and revenues start to show up the stock could bubble into double digits. FROM THEIR MOUTH TO GOD'S ears.
BioLine RX Price Target Maintained With a $19.00/Share by HC Wainwright & Co.
4:27 am ET August 31, 2023 (Dow Jones) Print
Ratings actions from Benzinga: https://www.benzinga.com/quote/BLRX/analyst-ratings
2.2800+0.2600 (+12.8713%)
As of 10:37AM EDT. Market open.
Volume 1,605,529
Avg. Volume 504,885
Robust Volume, lots of interest!
I'd be ecstatic if it reached $5 by Friday but 19 bucks is probably outside the realm of reality.
this will triple in price by friday.
new price target: $19
Followers
|
129
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
2829
|
Created
|
09/13/11
|
Type
|
Free
|
Moderators midastouch017 |
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |