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Loxo - Bull pennant and upcoming eventsThis is the weekly chart on Loxo Oncology. This biotech focuses on cancer treatments by targeting genetic mutations that create protein chimers that lead to unregulated cellular proliferation. In English, and very simply, imagine a copy machine. When you press 'Copy' you should get one duplicate of the item you want copied. Cells have similar systems where a protein in the cell membrane receives a signal from the outside world telling the cell to divide and make a copy of itself. Now imagine your copy machine crosses circuits with a 'Repeat' button. This will lead to infinite, unchecked copying. In cancer a similar thing occurs. Genetic mutations can cause the growth signalling protein to get joined to other proteins leading to unchecked, infinite cellular proliferation. This is one of the several steps to developing cancer. Loxo has developed and is testing drugs that target these specific mutations. Their leading drug, Lorotrectinib, targets TRK fusion proteins (-tinib as a suffix indicates it inhibits tyrosine kinases) and has shown good efficacy in combating several types of cancer with minimal side effects reported. Notable upcoming events are a data review at an upcoming oncology conference October 19-23, Earnings Report on 11/5/18, and a New Drug Application review PDUFA by the FDA on 11/26/2018. The last date is the most important as Loxo could see Lorotrectinib obtain FDA approval. Other possibilities for the PDUFA are an extension of the review or rejection of the drug. From the research reports I have read so far on Lorotrectinib I am doubtful a rejection/denial will happen. I suspect it will either be approved or the review extended and this will depend upon new data, likely to be presented in October. The chart currently looks bullish to me. There is a clear uptrend long term with us likely in a Wave 2 in Elliot Wave Theory. Mid term price is consolidating in a descending wedge/bull pennant. The safe trade is to buy once price breaks the top of the channel. An aggressive option is to buy when price touches the bottom of the channel. If I buy prior to earnings I will probably trim half my position the day before ER then play the run up to the PDUFA review late November. ***This is not investing advice. I am not an investing professional. Do not invest what you cannot afford to lose. All investors should seek guidance from licensed financial advisers and not random people on the internet.***
LLong
by ruud_one
BLRX-BREAKOUT-UPDATEBLRX had a strong rally today and it's just getting started. In the related idea my price target was $1.34. Today's high was $1.78 Check out the weekly chart: Photo Finish. $1.34 was 1.618 extension level from Waves 1 & 2. Since the price-action broke $1.34 we will have an extended 3rd wave. I expect a very strong rally tomorrow, I will update in the morning before the open to confirm. Target is hard to predict since its impossible to know what level extending waves will terminate. I will keep a close eye on the price-action. Will update. -AB
NASDAQ:BLRXLong
by FibMarketWatch
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: screenshots.firefox.com screenshots.firefox.com screenshots.firefox.com Will update. -AB
NASDAQ:BLRXLong
by FibMarketWatch
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 screenshots.firefox.com screenshots.firefox.com screenshots.firefox.com 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
ELong
by FibMarketWatch
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
NASDAQ:BIIBShort
by UnknownUnicorn2997486
Small Pharma Big Backers and Partners - LONG SNG (Synairgen)Prudent Drug Discovery Company Low market cap ( appox £13m at time of writing ). Issues shares very rarely ( last placing nearly four years ago ). Has material interest in its work from larger partners ( Pharmaxis ). Sold interest in LOXL2 programme for £5m to Pharmaxis in December. Pharmaxis continues to fund and develop LOXL2 inhibitors and Synairgen retains interest across all fibrotic indications at circa 17% of all partnering proceeds. Potential of drug appears across multiple uses now ( not just lung-related ) and indications from Pharmaxis looking very good. Recent interviews from Pharmaxis management suggest a good chance of a deal with major pharma in H2. Low free float in the stock ( 60% in hands of major shareholders ). Major funds holding ( Woodford Investment Management and Lansdowne Partners ). High profile investors holding stakes ( Richard Griffiths and Leonard Licht ). These high profile investors have been raising, rather than reducing their stakes in the company, periodically. For a risky smallcap biotech stock it appears well placed to survive and thrive, regardless of the short term success of a sale/licencing deal of LOXL2 by Pharmaxis, making it considerably less risky than most biotech stocks in the long term. However, the indications and noises being made about LOXL2 by Pharmaxis are looking as positive as you could hope for, and backed up by them putting their money where their mouth is in the first place and increasing their stake for cash.
LSE:SNGLong
by richthenewbie
3
Biotech BasketGenerally speaking we're all pretty aware that a "Buy & Hold" strategy works well. Yet, we find outselves "trading". Despite the evidence indicating this is unwise. In a snapshot view we can take a look at the daily chart (nearly a years worth) and view our 3 stocks in the Biotech basket - and we can pick up some obvious patterns. These stocks are very much sentiment based. They swing wildly, before Earnings calls - but less after. These stocks move with extreme volatility. This is typical of sentiment driven stocks. These stocks offer plenty of activity for a swing trader, or scalper, and show trade-able features. I'd like to talk about rebalancing . The items I mentioned before are true, and seem as though they add up to a perfect suite of scenario's for a trader to load up on downtrends midcycle before an earnings call. I wouldn't argue with that type of play, I think it'd probably make quite a bit of money. Especially if you were doing it with derivatives. That is a great strategy. There are many that could be applied. Today, we're going to explore a boring one: Re-balancing. Selecting a basket. This is no small feat. Many people would pull up a screener and begin going to town on fundamentals, reading news, and generally looking for data which would show a stock in our Biotech sector to either be developing "an un-fair advantage" or to "be significantly mispriced". That's ok. You SHOULD do that. Thats called research, and it should be the majority of what you do as a trader. It should be be even more-so as an investor. Today we cheated. Thats right. We took a look at the Portfolio of Orbimed's top ten holdings, and decided to look at three stocks which in the last quarter Orbimed was bullish on. Orbimed chose to increase holdings of 3 companies. REGN , CI , NASDAQ:VRTX , and we will use these 3 stocks as our basket today. Why? Because they're good stocks. Prove it? Done. Now what is re-balancing and why does a trader care? Rebalancing is a tool most commonly used by Investors . It is useful because it keeps an Investors Risk Management in correlation with their Risk Appetite. This is important, especially for long term holders. In a group as volatile as Biotech, it is even more important - as it lends well to to explosive compounding and can lead to wildly unbalanced portfolios in a relatively short time. One of my favorite examples of rebalancing (and the only one we will discuss here) is practiced by selling and buying based on risk thresholds. A threshold is set like so: Define a risk appetite (percentage of holdings to go into a given asset class) Define a risk factor (percentage of individual positions of a given sector of holdings) Manage risk (buy or sell from a position to meet the percentage guidance originally set) I.E 33% REGN , 33% CI , 33% VRTX Keep in mind you can overweight or underweight any position you choose. Afterall, it is your portfolio, and you are a trader! Why do you care? Following this set of principles gives the trader Long-term-guidance . This is one of the most overlooked portions of a traders strategy. There must be some form of long term guidance. This is why a trader should care. We looked at the stocks aforementioned and pointed out many points for which a trader could buy, or sell, to seemingly outperform the market. Likely, a good trader with good indicators trading in between earnings calls would indeed do well. Now lets take a look at the long term. To Be Continued....
NYSE:CI
by blessmywork
4
INSY Target $23 FDA Cannabidiol Fast trackFDA Grants INSYS Therapeutics ‘Fast Track’ Designation for Cannabidiol (CBD) Oral Solution as INSYS Therapeutics, Inc. (NASDAQ:INSY), announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s cannabidiol (CBD) oral solution for the treatment of Prader-Willi syndrome, a rare and complex genetic disorder characterized by insatiable appetite in children that often leads to obesity and type 2 diabetes. “FDA’s Fast Track designation will enable an expedited regulatory review process for our proprietary formulation of CBD in the treatment of pediatric patients with Prader-Willi syndrome, a debilitating condition which currently does not have any approved products available,” said Steve Sherman, senior vice president of regulatory affairs for INSYS Therapeutics. “We plan to start the clinical development program for this promising therapy in late first quarter of 2018.” The most common known genetic cause of life-threatening obesity in children, Prader-Willi syndrome has a prevalence of approximately 1 in 15,000, according to the Prader-Willi Syndrome Association, occurring in males and females equally and in all races. “We are very encouraged by the FDA’s decision to put CBD for Prader-Willi on the Fast Track and believe it is good news for these young patients, their families and clinicians,” said Saeed Motahari, president and chief executive officer of INSYS Therapeutics. “This special regulatory designation represents a significant milestone in the company’s R&D program, which is focused on developing and delivering safe, effective and novel treatment options using cannabinoids and novel drug delivery technology for unmet medical needs.” About INSYS INSYS Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve patients’ quality of life. Using proprietary spray technology and capabilities to develop pharmaceutical cannabinoids, INSYS is developing a pipeline of products intended to address unmet medical needs and the clinical shortcomings of existing commercial products. Forward-Looking Statements This news release contains forward-looking statements including regarding (i) our belief that FDA’s Fast Track designation will enable an expedited regulatory review process for our proprietary formulation of CBD in the treatment of pediatric patients with Prader-Willi syndrome, (ii) our belief that Prader-Willi syndrome currently does not have any approved products available and that our proprietary CBD formulation has potential to be a viable treatment option and (iii) our plan to start the clinical development program for this promising therapy in late first quarter of 2018. These forward-looking statements are based on management’s expectations and assumptions as of the date of this news release; actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. These factors include, but are not limited to, risk factors described in our filings with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended Dec. 31, 2016 and subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this news release, and we undertake no obligation to publicly update or revise these statements, except as may be required by law.
ILong
by StockPicksNYC98
ITUS stock climbs after news of new patentItus Corporation, a company that develops, aquires, and licenses emerging technologies in the areas of biotechnology, is in the stages of developing technology that can detect cancer at an earlier rate through a blood test. The company saw its stock jump by 85 percent upon releasing news of the patent issuance of the new technology, this was on Sept. 18. The biotechnology industry has grown by 7 percent in the past three months, and in an expanding economy, I would think that this industry has room to continue growing. The S&P continues to grow, gaining 4 points (it is to note that this move was on lower than average volume) at the time of writing this. 90 percent of the market saw new highs today, showing good sentiment. However, the possibility of interest rate hikes still looms over the market, as well as climbing oil prices and President Trumps proposed tax reforms. ITUS has rebounded off support at the 2.50 level and could hit a target of 5.00. It currently sits at 3.33, 51 percent from its 52-week high. Volume is increasing and RSI is showing bullish strength. I am long, having entered at 2.75. Risk is controlled to 3 percent of my account, should the trade go the other way. With earnings coming out, a good report could send the stock up to its target very quickly. There is still a chance to jump in at 3.50 or better.
ILong
by Brandon50115