Get started

PHARMA

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
ATNX to retest Support high 17's to mid 18'sATNX may be a tad over extended for now and will likely retrace to it's 18.50 or high 17's support area. May look for a buy in here. ANTX recently named Timothy Cook as senior vice president of global commercial oncology. This is recent add to an all star team in the oncology pharma space. I see a bright future for this asset. ***Any information represented here is my opinion only and not intended to be used for financial gain. None of the information posted here is to be considered financial advice. Information posted here is strictly for entertainment purposes only. Please consult your financial professional before making any kind of investment. Investments can be very risky and any investor should educate themselves before investing by enlisting the help of a financial professional. Past results are not indicative of future results in any construable way.***
A
by algocowboy2030
$TEVA - Berkshire breakout? Disclaimer, TEVA is in a very bad financial position, with dwindling cashflows and large debt. Buffet has always been the king of "value investing", hence why a position in Teva isn't surprising from him - it's most likely that he sees the company as severely undervalued and is entering into stages of repair. Buffet's new position in Teva was widely publicised this week: fortune.com markets.businessinsider.com finance.yahoo.com Just after Buffet disclosed the position, Teva announced the U.S. release of the QVAR Redihaler Inhalation Aerosol. www.streetinsider.com -new form of asthma inhalation treatment -breath actuated I don't think this is too important. I'd much rather to follow his other position into AAPL rather than TEVA
NYSE:TEVA
by UnknownUnicorn2421992
1
SGYP Is Setting Up for A Big Move!SGYP seems to be setting up for a big big move. The Squeeze Momentum Indicator has been forming a triangle which is now about to close and the crosses in the indicator have been black for some time meaning that a release of the squeeze should be about to manifest. My guess is that spike will be to the upside, and it could go as high as 3.60$ (90%+ appreciation), which is the 0.382 retracement level of 17's highs and the 1.618 retracement level of this year's highs.
SLong
by ArthaVidya
1
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
ASX Star Combo Pharma Star Combo Pharma has just started trading last week. It has a good run up to above $2. I believe this is Wave 1 of Elliot. The price has dropped a bit at writing and if I am not wrong, corrective wave 2 will probably hit between 0.5 to 0.618 in the next few days. If i were to trade, i would look for entry below $1.30 between 0.5 to 0.618 fibonacci. At writing, there was a bounce at 0.384 fib @ about $1.40. If my charts are correct, we are looking at corrective wave B of 2 then C down to 0.618 fib. We shall see. ABOUT THE COMPANY --- extracted from: www.afr.com A company that acquired the Living Healthy vitamins and health supplements brand from pharmacy chain Terry White Chemmart last year wants to make a big shift from being a contract manufacturer to launching its own brand. Star Combo Pharma has raised $7 million in an initial public offering at an issue price of 50¢, and will list on the ASX on Wednesday, with chairman Richard Allely outlining ambitious growth plans. The company signed a three-year distribution deal with Terry White Chemmart as part of the acquisition where the Living Healthy vitamins brand will be on the shelves of 450 of the group's pharmacies. Mr Allely said Star Combo currently generated about 70 per cent of its revenues through contract manufacturing for other vitamins companies in western Sydney. About 30 per cent of its revenues come from its own brands, which include Costar, Amax and J&K. Those three brands are largely sold in gift stores and duty free stores. The Living Healthy brand had undergone a rebadging and repackaging, and Star Combo was aiming to accelerate its growth. Between 20 and 30 individual product lines, known as stock-keeping units, would be on the shelves of Terry White Chemmart outlets around Australia. Star Combo was also eyeing a big push into China, to try to emulate in a smaller way the success of big players such as Blackmores and Swisse. At the issue price of 50¢, Star Combo has an indicative market capitalisation of $38 million. Mr Allely said the IPO had been oversubscribed and the company had been forced to scale back applications. The company made a net profit of $1.48 million in 2016-17 from revenues of $9.84 million. Net profit in 2015-16 was $1.59 million from revenues of $9.4 million.
ASX:S66Long
by paper_value
CELG Q1 2018 Earnings on 5/4 - Are Traders Rotating In or Out?What a tumultuous market. Celgene reports earnings on 5/4. Earnings play aside, are traders and investors rotating into or out of pharmaceuticals? The market doesn't know what to do with itself right now. With a Fed meeting taking place over the next couple days, Caterpillar's CFO claiming we've seen a "high water mark" with Q1 earnings, rate concerns, trade concerns, and historic geopolitical uncertainty (especially regarding Iran's nuclear program), some traders claim we've already seen April and May's strongly anticipated earnings rally. If that's true, 1. what a squishy rally, and 2. where do we go from here? Thanks in advance for lending me your attention! Pharmaceuticals are a wild card among the classical winners (usually, financials, materials, and energy) and losers (REITs, utilities, etc.) in a late-cycle rotation. It can be argued a lot of Wall Street cash has sought the arguably greener pastures of cryptocurrencies. But could we see prices move upward along the right side of the chart in pharmaceutical companies? CELG reports earnings on 5/4. Celgene took a dive on 4/30 on troubling news about a drug in its development pipeline. Did that drop make Celgene a bargain buy? CELG's drop on bad news has put it at technical support. The uncertainty of its earnings report and the market overall has it arguably priced cheap. Is Celgene a cheap buy in this market with a possible earnings surprise on 5/4 and upside potential with a rotation into pharma? Please like, follow, and share, and maybe we can have fun and do great things together. Thanks again! See it on the site: holsturr.com/category/markets/charts/ ** For speculative and research purposes only - good luck! **
CLong
by holsturr