BLRX - BioLine RX - Promising Biotech with Big upside - LongBLRX
BL-8040 Overview
BL-8040 is a novel, short peptide that functions as a high-affinity antagonist for CXCR4, which BioLineRx is developing for the treatment of solid tumors, acute myeloid leukemia, or AML, and stem-cell mobilization for bone-marrow transplantation.
Solid Tumors:
In January 2016, BioLineRx entered into a collaboration with MSD, known as Merck in the U.S. and Canada, in the field of cancer immunotherapy. Based on this collaboration, in September 2016 BioLineRx initiated a Phase 2a study, known as the COMBAT study, focusing on evaluating the safety and efficacy of BL-8040 in combination with KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy, in up to 30 patients with metastatic pancreatic adenocarcinoma. The study is an open-label, multicenter, single-arm trial designed to evaluate the clinical response, safety and tolerability of the combination of these therapies as well as multiple pharmacodynamic parameters, including the ability to improve infiltration of T cells into the tumor and their reactivity. Partial results will be presented at the 2018 ASCO Gastrointestinal Cancers Symposium (ASCO GI) in January 2018, with top-line results expected in the second half of 2018.
September 2016, BioLineRx entered into a collaboration with Genentech , Inc., a member of the Roche Group , in the framework of which both companies would carry out Phase 1b/2 studies investigating BL-8040 in combination with atezolizumab (TECENTRIQ®), Genentech’s anti-PDL1 cancer immunotherapy, in various solid tumors and hematologic malignancies. Genentech commenced a Phase 1b/2 study for the treatment of pancreatic cancer in July 2017, as well as a Phase 1b/2 study in gastric cancer in October 2017. Genentech expects to commence an additional Phase 1b/2 study in lung cancer by early 2018. In September 2017, BioLineRx initiated a Phase 1b/2 study under this collaboration in acute myeloid leukemia (AML). These studies will evaluate the clinical response, safety and tolerability of the combination of these therapies, as well as multiple pharmacodynamic parameters.
n March 2015, BioLineRx reported successful top-line safety and efficacy results from a Phase 1 safety and efficacy trial for the use of BL-8040 as a novel stem-cell mobilization treatment for allogeneic bone marrow transplantation at Hadassah Medical Center in Jerusalem.
In March 2016, BioLineRx initiated a Phase 2 trial for BL-8040 for allogeneic stem-cell transplantation, conducted in collaboration with the Washington University School of Medicine, Division of Oncology and Hematology. Initial results of this study announced in March 2017 show that a single injection of BL-8040 mobilized sufficient amounts of cells required for transplantation at a level of efficacy similar to that achieved by using 4-6 injections of G-CSF, the current standard of care. Topline results of this study are now expected in mid-2018, as a result of certain delays in study recruitment in connection with the addition of two sites to the study and the regulatory filings associated therewith.
In August 2017, following a successful meeting with the FDA , BioLineRx announced the filing of regulatory submissions required to commence a randomized, controlled Phase 3 registrational trial of BL-8040 for the mobilization of hematopoietic stem cells, or HSCs, for autologous transplantation in patients with multiple myeloma. The trial is expected to commence by the end of 2017.
In November 2017, BioLineRx disclosed preclinical data supporting BL-8040 as robust mobilizer of hematopoietic stem cells, or HSCs, associated with long-term engraftment. The data will be presented as an oral presentation at the 59th American Society of Hematology (ASH) Annual Meeting and Exhibition in Atlanta, GA, taking place in December 2017.
Pre-Clinical Data
In vitro and in vivo data show that BL-8040 binds to CXCR4 at the low nanomolar range (1-10nM) and occupies it for prolonged periods of time (>24h). Characterization of the CXCR4 antagonism action of BL-8040 in comparison to other CXCR4 antagonists revealed that, unlike other compounds from the same class, BL-8040 acts as an antagonist as well as an inverse agonist. This activity leads to decreased autonomous signaling of CXCR4 and suggests activity against constitutively active variants.
BL-8040 inhibits the growth of various tumor types including multiple myeloma, non-Hodgkin’s lymphoma, leukemia, non-small cell lung carcinoma, neuroblastoma and melanoma. BL-8040 significantly and preferentially stimulated apoptotic cell death of malignant cells (multiple myeloma, non-Hodgkin’s lymphoma and leukemias). Significant synergistic and/or additive tumor cell killing activity has been observed in-vitro and in-vivo when tumor cells were treated with BL-8040 together with Rituximab, Bortezomib, Imatinib, Cytarbine, BCL-2 inhibitor ABT-199 and the FLT-3 inhibitor AC-220 (in NHL, MM, CML, AML, and AML-FLT3-ITD models, respectively). BL-8040 also mobilizes cancer cells as well as neutrophils and progenitor cells from the bone marrow to the peripheral blood.
The U.S. Food & Drug Administration (FDA) has granted an Orphan Drug Designation to BL-8040 as a therapeutic for the treatment of AML as well as for stem cell mobilization
BL-8040 is being developed by BioLineRx under a worldwide, exclusive license from Biokine Therapeutics.
1.
Conclusion: The current data demonstrate that BL-8040 induces mobilization of AML blasts from the BM and has sustained receptor occupancy. In addition, a direct effect on AML blast viability has been observed in samples obtained during BL-8040 monotherapy. Importantly, the data suggest a differential effect of BL-8040 monotherapy on AML blasts vs. normal progenitors. BL-8040 was found to be safe and well tolerated at all doses tested to date. The updated results of the dose escalation phase of this ongoing study will be presented.
Source: www.bloodjournal.org
2.
The FDA approved the first immunotherapy drug recently, but the field dates back to 1891, when William Coley, a physician and cancer researcher, observed that some cancer patients infected by Streptococcus bacteria experienced a dramatic and spontaneous improvement. He began injecting the bacteria into his patients, with mixed results.
The treatment was nearly abandoned amid skepticism from Coley’s peers and the advent of radiotherapy and improved surgical techniques.
Today, however, new avenues of immunotherapy research are underway, and the field is considered among the most promising new approaches to cancer treatment, according to Jill O’Donnell-Tormey, CEO and director of scientific affairs at CRI.
Source: www.jta.org
3.
"activated with human interleukin 2, or activated against patients own tumor cells in the laboratory, when such are available – have been extremely successful in killing every last cancer cell in the patients. The theory is the same, in that the cells are trained to act as honing devices."
“It’s fantastic because they all were expected to have been dead long ago,” Slavin told ISRAEL21c. “When the laboratory-treated and separated NK cells are infused into a patient, they go immediately to work because they were already trained in the laboratory to become professional killer cells capable of recognizing and destroying foreign cells.”
"The new procedure has little or no side effects, is done during fifteen-minute outpatient intravenous infusion and has already showed promising results in high risk patients with metastatic or resistant cancer."
"In order for the procedure to be government-approved, a much larger number of patients must successfully undergo treatment."
"The reason I am optimistic is because we use mother nature’s tool – immune-system-cells to fight off disease. Normally too, it is the immune system that can recognize cancer cells as undesirable, and under normal circumstances, it will go on an attack until the single abnormal cell, which can grow to a bitter enemy, is gone. In patients with cancer, the patient’s own immune system failed to recognize the enemy and this is why we use the immune system cells from another individual that can easily recognize and destroy such tumor cells escaping the attention of patient’s immune system,” said Slavin."
Summary Source: seekingalpha.com
In two January ASCO presentations, BL-8040 showed robust infiltration of anti-tumor T-cells into liver metastases in pancreatic cancer and primes the tumor micro-environment to enhance the effectiveness of immunotherapy agents.
New oncology asset AGI-134 induced complete tumor regression in 50% and 67% of two mice melanoma preclinical studies. The company plans to start Phase 1/2a clinical trials in 1H 2018.
BiolineRx is funded to 2020 with $55M in cash, no debt. However cash balance might be higher since it's likely company was selling against a $30M ATM since November.
The company has plans to deliver up to a dozen high-potential catalysts in 2018 following a busy January (4 conferences, and 4 clinical data).
Institutional ownership has increased from 20% to almost 60% in a year. Five analysts have a consensus Buy rating with $3.5/share price target.
Chart Screenshots:
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Will update.
-AB
Pharmaceuticals
PGNX POTENTIAL LONG PGNX POTENTIAL LONG
1W Chart:
* on the weekly chart if you look at recent data it is displaying the fact that the recent buyers are a lot stronger than the sellers
*one candle up from the buyer took out 6 candles down from the sellers
1D Chart:
*on this chart it is displaying the fact that the recent buyer had pushed price up above 4H structure and seems to be holding above this level
*the momentum on the daily chart also favors the buyers, giving us a higher probability for the long side trades
4H Chart:
* on this chart it is displaying that price has broken recent significant structure and has been holding above this level
* yesterdays candles display a weak re-test by the sellers into that recent 4H structure point
1H Chart:
*use this time frame for accuracy of entry as well as risk (stop loss)
ALWAYS have a strategic trading plan when approaching the markets. You want to stay disciplined to your plan no matter what the conditions are. ALWAYS remember trading is about probabilities, nobody knows with 100% certainty what the market will do next but with good probabilities on your side as well as proper risk management it could lead to a profitable and consistent path of trading.
Cheers! Keep an eye out! PLEASE like and follow me here on TradingView for more setups!
Teva still positive but...$Teva is still positive in the uptrend although the candle of yesterday has turned some indicators in bearish position. Over the mid term bullish trend is still strong. Having said that next candles have to be monitored because on a monthly basis there is a potential dragon fly bearish, thus a prompt recover toward the upper edge of the bullish flag is important for further climb. I will keep the chart under observation in the next days.
$BHC almost a buy: under the radarI am waiting for an entry long in $BHC but positive signs are already there especially RSI is giving an insight, MA 200 is almost close and it might be probable a new test. Monthly RSI is down and on a weekly basis price is approcing the pullback of the third bullish wave.
For the time being, given the positive earnings release a bullish trend continuation is highly probable but I would not exclude somewhat time to complete the flag in order to reach the main trendline in red. If it is not like that a bullish signal will be given ....only.... when the price breaks the upper edge of the flag.
For aggressive traders an entry long might be done even today with really tight SL.
ENDP - SHORT-TERM SHORT & LONG-TERM BUY - Endo Pharma ENDP
Endo International plc is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines through excellence in development, manufacturing and commercialization. Through our operating companies – Endo Pharmaceuticals, Par Pharmaceutical and Paladin Labs – Endo is dedicated to serving patients in need. Endo commenced operations in 1997 by acquiring certain pharmaceutical products, related rights and assets from The DuPont Merck Pharmaceutical Company.
The Crash: Revenue Is In Free Fall
Endo Pharmaceuticals: The Free Fall Continues
Mar. 26, 2018
Summary
Revenue from ENDP's core Generics business is in decline and other business segments appear in disarray.
Its $8B debt load is at 7.5x run-rate EBITDA. If operating income continues to slide, it could hurt ENDP's ability to service its debt.
ENDP ENDP trades at 9x EBITDA, but it is uncertain if potential legal exposures pursuant to opioids are priced in.
Sell ENDP.
This idea was discussed in more depth with members of my private investing community, Shocking The Street.
There is a war being fought over drug prices. Lawmakers have hit back at price gougers and opioid manufacturers, and Endo Pharmaceuticals (ENDP) is in the middle of it. A few months ago, I thought Endo was at an inflection point and there was a good probability it could turn things around. However, its slide continues.
What: The bottom dropped out from under shares of Endo International plc (NASDAQ:ENDP), the specialty pharma famous for selling "uncrushable" opioids and agreeing to enormous legal settlements. After management revealed disturbing revisions of its 2016 full-year estimates, the stock plummeted 41.4% last month, according to data from S&P Global Market Intelligence.
Logical? Sold because they sell opiates? Are opiated still needed/critical to US Healthcare?
NO!
BIG Consolidation period: 4 Years (2014-2018)
The First CYCLE WAVE Completed.
Now, in the middle of the SECOND WAVE (Correction)
Key Levels for Retrace: 1, 1.382, & 1.618
Look for retrace back to around $13.00 ENDP
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Most Recent News:
Endo International Plc (ENDP) on Wednesday said it is lifting a temporary stay of its litigation against the U.S. Food and Drug Administration that seeks a declaration the agency's interim policy on compounding using bulk drug substances is contrary to law.
Endo International Plc (ENDP) on Wednesday said it is lifting a temporary stay of its litigation against the U.S. Food and Drug Administration that seeks a declaration the agency's interim policy on compounding using bulk drug substances is contrary to law.
Analysts at RBC Capital upgraded Endo International PLC (NASDAQ:ENDP) from Sector Perform to Outperform. Endo shares rose 2.56 percent to $16.05 in pre-market trading.
Will update.
-Stay humble America,
-AB
MYL: wedge about to be completed$MYL: Bullish wedge is about to be completed as yesterday we have seen rising bullish pressure, actually price wasn't able to break out the upper edge and we have seen a sharp intraday pullback (about 3%). Today buyers are coming in, thus price is heading upper edge. Volumes are rising, MACD on a weekly basis turn positive. Test of mid and long term support as previously described positive too. Target prices highlighted in blue.
Novartis almost a buyPharmaceutical stocks represents a defensive asset when a positive market cycle is about to finish or when it is foreseen a cycle less positive than the previous one. In such context pharma stocks should have an advantage because of inelastic demand for such goods.
Novartis ($NVS,$NOVN) is one of the candidate to break up as the price is moving in a triangle since 2015. the stock doesn't not have an high volatility as other stocks but is one of the main represented of INDEX STOCK HEALTH CARE. There are nice technical indications on the chart that a breakout might happen in the next weeks. At the moment I am expecting a price pullback, where at the end it will be possible to go for an entry long.
Conclusions
At the moment price is consolidating and some other days to reduce RSI value will be needed. It's possible either to open positions at the end of the pullback or when price breaks out the downtrend (2015). Possibility to have it in CHF or $.
($celg) Celgene: not so fastCelgene helped by the company's buyback has turned positive after a complicated year. Despite this in terms of foundamentals two drugs are on the way to be developped but such developments will be revealed in the next year so patient is a must for those who wants to invest of something concreate. On a technical point of view yesterday price faild to cross MA 200. This is an importante resistence and a tp for those who bought shares in the last weeks as the RSI is overbought, thus a little pullback is expected in the next days.
Levels to watch are the followings as reported: 89.20, 86.27.
MYL first signs of strenght for Mylan nice occasionsin the chart I highlighted the last bounce from the "hystorical support" at 35,40 dollars. I drew also the main downtrend line since 12/2015. This is an interesting point because 2 solid supports pass thorugh it and price is conferming this bullish area. Earnings are expected to come in two weeks but in any case this is a tempting occasion to go long with tight SL slighlty under 35,40 dollars.
BHC Bausch Health: possible opportunity in the next daysAlthough earnings are releasing next week, the today's session for $BHC will be critical: a trend inversion might be possible on a daily basis, yesterday price formed a dragon fly bullish as the arrow shows.
This must be confirmed with a black (green) candle today in order to develop minimum of swing, otherwise there will be no signs for an inversion in the short term.
Ground seems to be ready even because RSI (oscillator) is near the range of 30-40 which means that it is charged enough to support a bullish trend.
Conclusions
For aggressive traders entry long might be done today with tight SL. Price actually flows over a solid support around 21.50 dollars.
For conservative traders: watch and wait at least today.
Alexion waiting for pull back and second entry($ALXN) I have already flagged up alexion when price was around 112-115 dollars saying there was a good opportunity for an entry long.
Recently we have had an important sign because the price broke the hystorical downtrend since july 2015. We had some indicators overbought but thank to this pullback we can wait for a second entry long position.
A suitable level would be around 128 dollars whilst another one would be around 124.
I keep an eye pealed on MACD because last candle was quite dramatic so when the indicator turns toward the bullish mode in conjunction with the level mentioned above, It will be possible to open a long position.
Celgene ($celg) if tomorrow...if only tomorrow....Weekly chart: we have the downtrend channel clearly defined on a weekly basis. On a monthly basis we have already had a minimum of swing with a dragon fly bullish, on a daily chart some signs of an incoming uptrend as described in the latest posts...but tomorrow...tomorrow is where we play the game with the last resistence in place at 86.72 dollars. Once we get out of the channel and we leave this solid resistance it will mean that Celgene will be ready to come back to war.
I will be long in case the price breaks such thresold because signs of long will get really clear.
TEVA is recharging the battery waiting next earnings release ($TEVA) was accelerating the uptrend but since some days it has come back on its path inside a bullish flag. It is important to note that next week earnings will be released so high volatility should be expected. Masch is about to turn on bullish mode RSI is quite down and vortex is neutral.
I might expect that some investors will get long before the earnings pushing the price up but it is just an hypothesis. So far we are still inside the range with lower and upper edges showed on the chart.
LONG TERM LONG ON OTSUKA PHARMA!I will not go into details on this one. Bottom line is, I am impressed with Otsuka's vision and its recent developments - and many other things which I will not explain here. I will be entering a long position soon, watching the action at these levels. This is will be one of the stocks I would recommend to add to your stocks portfolio.
-Keep it Real-
Alexion (AXLN): new entry longTime to raise up the head has come for ALexion pharmaceuticals. After some years in a trading range and a never ending downtrend since 2015 (black line) price has broken it up reaching recently 135.87 dollars. As showned in the graph we have an important technical signal which is the cross between MA 50 and MA 200. We have also the RSI confirming tghe momentum and an entry buy from vortex.
Volume is neither low nor high but enough to confirm the uptrend, given trendlines and the mix of the other indicators. Price has borken the dynamic resistence at 128.41, the short term trading range YTD.
Biogen Earnings Swing July 2018Biogen's (344.10 at close at the date of this writing) and Eisai's recent success with BAN24O1, an experimental medication for Alzheimer's which is currently in mid-stage clinical trials, in addition to a recent price target raise by Citi, and overall bullish analyst sentiment led to a rally between July 6-9, 2018.
Although the clinical trial's success was certainly reason for bullish sentiment, it ran too far too fast and indicators pointed towards to a sell off. I thus opened put options on July 9, expiring July 13 2018 (currently in the money). We are now only about two weeks away from Biogen's earning report. After studying historical data and charts, I've found that there is often a sell off prior to earnings OR there is a run up then a slight sell off right before the earnings date. I've annotated the chart with periods that indicate this.
In this case, I believe downward momentum will continue followed by a slight rally pre-earnings then a sell off. Opening JUL20 puts may be a smart move at this time.
In the long term, Biogen -0.21% is very scalable and overall is very promising. I agree with Citi's PT of 371.
www.wsj.com
Playing the gap with pharmaceuticals, Lipocine Inc (LPCN)Pharmaceuticals can take nasty falls if their products fail to pass FDA muster. These falls can provide nice opportunities for swing traders to play the gaps that are left by these sharp moves of price action. Lipocine Inc (LPCN) took a nasty dive on the 8th of May, leaving behind a pretty nice 31% gap that will eventually get filled. Since the drop, LPCN has formed a textbook ascending wedge in it's current longer term bearish downtrend, signaling higher prices in the short term. If this wedge continues to hold through it's formation, the gap will be filled where the top of the wedge and the top of the gap intersect (A). Because the ascending wedge is a bearish continuation in an overall downtrend, the price will eventually fall back down (B). However it is also a good possibility that LPCN will fall out of it's wedge before it even fills the gap completely, as price action on average tends to break out ~60% of the way into the wedge, which is well before the gap fill (A).
Celgene is under the radarCelg is under the radar because after an insane downtrend, calm and a bit of optimism is getting back. Price is consolidating in a narrow range and on friday we have seen a first endeavour to break the flag with no success. This has happend because MA 50 has acted like a resistence.
If the price breaks the wall of 80/80.50 with momentum I expect a new buy long with a new uptrend. As showed price has never tried to under 74 dollars since several weeks, plus volatility is really squeezed. I will carefully watch the graph along the next weeks (watch and wait).
TEVA up trend is acceleratingAs showed in the picture trend is accelerating as a sign of streght for TEVA. After some consolidation pauses we have a situation where RSI in pointing up, MACD non really clear as we have had a lateral movement, volatility stop positive.
Red trendline is showing the acceleration. TP around 27 first and 30 dollars after. Despite some up and down of nasdaq, Teva has held the hit continuing the lateral movement rather than going down, another sign of strenght at the moment.
GlaxoSmithKline ShortShort from $42.01.
- Market Cap: $102B
- Beta: 0.83
- P/B: 20.42
- GSK’s consumer healthcare segment sales were down in 2017 due to a slowdown in global growth of its key consumer categories.
- They have also faced pricing pressure from competition and slow down in emerging markets. Although GSK have several candidates in different stages of development, the company has been set back on numerous occasions by the regulators. The largest setbacks in the past few quarters include the phase 3 data on chronic coronary heart disease, Duchenne muscular dystrophy candidate, kydrisa failing to meet the primary end point in a phase 3 study.
- The company phases massive competition from small start-ups to large pharmaceutical corporations. There consumer healthcare segment faces competition from big companies like Johnson & Johnson, Colgate Palmolive, Procter & Gamble and Pfizer.
- Advair, one of GSK’s largest revenue providers is facing intense competition in the asthma and COPD market from AstraZeneca and Merck respiratory drugs.
NeroTree Capital rates GlaxoSmithKline PLC as a SELL with a price target of $38.
$TEVA - Berkshire breakout? Disclaimer, TEVA is in a very bad financial position, with dwindling cashflows and large debt. Buffet has always been the king of "value investing", hence why a position in Teva isn't surprising from him - it's most likely that he sees the company as severely undervalued and is entering into stages of repair.
Buffet's new position in Teva was widely publicised this week:
fortune.com
markets.businessinsider.com
finance.yahoo.com
Just after Buffet disclosed the position, Teva announced the U.S. release of the QVAR Redihaler Inhalation Aerosol.
www.streetinsider.com
-new form of asthma inhalation treatment
-breath actuated
I don't think this is too important. I'd much rather to follow his other position into AAPL rather than TEVA