Sell Anavex Life Sciences For a Huge 40% Win

April 30, 2017: Sell Anavex Life Sciences for a huge 40% win and congratulations if you made money on this trade.

January 8, 2017: Institutional traders are accumulating biotechnology firm Anavex Life Sciences according to recent 13F filings. The institutional traders who bought the most shares of Anavex Life Sciences are:

BlackRock Fund Advisors = bought 843,994 shares according to 11-11-2016 filing
BlackRock Institutional Trust = bought 284,540 shares according to 11-11-2016 filing
State Street Corp = bought 218,377 shares according to 11-14-2016 filing
Bank of New York Mellon = bought 129,276 shares according to 11-12-2016 filing
Black Rock Investment Management = bought 127,022 shares according to 11-11-2016 filing
D. E. Shaw & Co = bought 105,080 shares according to 11-14-2016 filing
SUSQUEHANNA International Group = bought 102,685 shares according to 11-14-2016 filing
GEODE CAPITAL Management = bought 46,739 shares according to 11-11-2016 filing
VANGUARD GROUP INC = bought 30,148 shares according to 11-14-2016 filing
California State Teachers Retirement System = bought 68,464 shares according to 11-11-2016 filing
NORTHERN TRUST CORP = bought 58,307 shares according to 11-12-2016 filing
TIAA CREF INVESTMENT MANAGEMENT = bought 25,129 shares according to 12-12-2016 filing

November 22, 2016: Anavex Life Sciences announces data on 41-Week treatment of ANAVEX 2-73 for patients with Alzheimer’s Disease; Investigational treatment suggests to curb cognitive and functional decline. At 41 weeks, Alzheimers patients taking a daily oral dose of ANAVEX 2-73 in the exploratory, not yet dose optimized Phase 2a clinical trial, showed a stabilization of cognitive and functional measures. This data of stabilization is promising since Alzheimers disease is a progressive disease where current therapeutics are only able to temporarily slow the worsening of dementia symptoms and not stop the disease from progressing.

At 41 weeks, oral daily dosing between 10mg and 50mg, ANAVEX 2-73 was well tolerated, and no patients discontinued treatment due to adverse events. There were no clinically significant treatment-related adverse events, and no serious adverse events.

Pre-specified exploratory analyses included the cognitive (MMSE) and the functional (ADCS-ADL) changes from baseline. A continued stabilization of both cognitive (MMSE) and functional (ADCS-ADL) measures in patients treated with ANAVEX 2-73 was observed. This correlation was positive with all measured scores (MMSE, ADCS-ADL, Cogstate, HAM-D and EEG/ERP).

About the ANAVEX 2-73 Phase 2a Study

The multicenter Phase 2a clinical trial of ANAVEX 2-73 consists of two parts and a total of 32 mild-to-moderate Alzheimers patients. PART A is a simple randomized, open-label, two-period, cross-over between oral (30mg/50mg) and IV (3mg/5mg) administration, adaptive trial lasting up to 5 weeks for each patient. PART B is an open-label extension for an additional 52 weeks. Initially planned for 26 weeks, PART B was extended to 52 weeks as a result of requests from patients and caregivers.

The primary endpoint of the Phase 2a trial is to establish safety, tolerability and maximum tolerated dose (MTD) of ANAVEX 2-73, which had shown potential in preclinical studies to prevent, halt and/or reverse the course of the disease. Secondary endpoints include dose response, bioavailability, and exploratory cognitive as well as functional measures using Mini Mental State Examination (MMSE) and evaluation of Alzheimers Disease Co-operative Study Activities of Daily Living Inventory (ADCS-ADL), as well as Cogstate test battery and EEG/ERP.

Anavex Life Sciences Corp. is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer.

Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean safety profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial.

Sell Catalyst Pharmaceuticals For a 47% Gain

April 16, 2017: Sell Catalyst Pharmaceuticals for a 47% gain in 60 days and congratulations if you made money on the trade.

January 4, 2017: The popular SeekingAlpha blogger Hawkinvest, with over 5,000 followers, posted a positive article on Catalyst Pharmaceuticals today that got the stock moving higher. Hawkinvest writes

Biotech and healthcare stocks underperformed in 2016 and that means this is a sector that could offer value and rebound potential in 2017. With all of this in mind, I have been looking for “hidden gems” in the biotech sector. I have recently found a couple of very interesting investment opportunities that offer an excellent risk to reward ratio and one of the stocks I am bullish on now is Catalyst Pharmaceuticals, Inc

Catalyst Pharmaceuticals, Inc., a biopharmaceutical company, focuses on the development and commercialization of therapies for people with rare debilitating diseases. Its lead product candidate is Firdapse, a proprietary form of amifampridine phosphate, which completed Phase III clinical trial for the treatment of patients with Lambert-Eaton Myasthenic syndrome; and is in small blinded clinical trial to treat Congenital Myasthenic syndromes, as well as is in Phase II/III clinical trial for the treatment of MuSK-antibody positive myasthenia gravis.

Sell Portola Pharmaceuticals For a 45% Win!

April 10, 2017: Sell Portola Pharmaceuticals for a 45% win and congratulations if you made money on the trade.

December 27, 2016: Portola Pharmaceuticals price target raised to $29 from $20 at Credit Suisse, reiterates Neutral rating.

December 26, 2016: Biotechnology firm Portola Pharmaceuticals had revenue of $12.1 million in 2015. For 2016, revenue is on track to more than double to $26.2 million.

December 23, 2016: Portola Pharmaceuticals reports that the FDA accepts NDA for priority review for betrixaban, a prophylaxis of venous thromboembolism (VTE) Granting priority review for betrixaban, an oral, once-daily Factor Xa inhibitor anticoagulant, for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE. A priority review shortens the FDA review timeline to six months from the standard review period of 10 months. The application for betrixaban, an FDA-designated Fast Track investigational drug, was deemed sufficiently complete to permit a substantive review and has been given a Prescription Drug User Fee Act (PDUFA) action date of June 24, 2017. Additionally, Portola announced that the European Medicines Agency (EMA) had validated its Marketing Authorization Application (MAA) for betrixaban for extended-duration prophylaxis of VTE in adults with acute medical illness and risk factors for VTE. The EMAs Committee for Medicinal Products for Human Use (CHMP) is reviewing the application under a standard 210-day review period.

December 19, 2016: Portola Pharmaceuticals announced it had signed a $50 million loan agreement with Bristol-Myers Squibb Company and Pfizer Inc. that provides additional funding toward development and clinical studies of AndexXa (andexanet alfa), an investigational compound that is a potential antidote for Factor Xa inhibitors. Under the terms of the agreement, Bristol-Myers Squibb and Pfizer will each loan Portola $25 million. The principal and interest will be repaid primarily through royalties on AndexXa commercial sales. No shares, warrants, options or other equity components were or will be issued in connection with the loan. The non-secured loan does not involve any transfer of patent ownership or licenses.

December 15, 2016: Heavy call activity detected in Portola Pharmaceuticals of 1500 Jan 20 calls traded at $1.15.

Portola Pharmaceuticals is a biopharmaceutical company developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases.

Sell Global Blood Therapeutics For a Huge 91% Win!

March 4, 2017: Sell Global Blood Therapeutics for a monster 91% win in 41 days! Congratulations if you were able to make money on the trade.

January 4, 2017: JPMorgan Chase initiates coverage of biotechnology firm Global Blood Therapeutics with an Overweight rating and a price target of $25. JPMorgan thinks GBT440 is a promising wholly owned asset targeting a broad and underserved market, as such current levels could provide an attractive entry point despite the relative lack of critical upcoming data.

GBT440-001 is a randomized, placebo-controlled, double-blind, single and multiple ascending dose study. This ongoing Phase 1/2 study is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of GBT440 in both healthy subjects and adults with SCD. The study is being conducted in three parts: Part A (single dose administration), Part B (multiple dose administration, daily for 15 days in healthy subjects and 28 days in SCD patients) and Part C (multiple dose administration, daily for 90 days in SCD patients). Some patients in Part C have taken GBT440 for up to 6 months.

Results presented at ASH showed:

– All 41 SCD patients receiving GBT440 for up to six months have demonstrated a profound and durable reduction in hemolysis (red blood cell destruction) as assessed by hemoglobin, reticulocytes, and/or bilirubin.

– All patients taking GBT440 showed profound and durable reductions in irreversibly sickled cells compared with those taking a placebo.

Results from Part C (dosing for at least 90 days) demonstrate that among the 13 GBT440-treated patients:

– Patients treated with GBT440 for at least 90 days showed a clinically significant increase in hemoglobin (greater than 1 g/dL increase) compared with 14 placebo patients (46 percent vs. 0 percent; p=0.006).

Patients treated with GBT440 had a sustained reduction in irreversibly sickled cells compared with placebo-treated patients (-76.6 percent vs. +9.7 percent; p<0.001).- GBT440 was well tolerated up to six months of dosing. The most common treatment-related adverse events were Grade 1/2 headache and gastrointestinal disorders and occurred at similar rates in the placebo and GBT440 arms. There were no drug-related serious or severe adverse events. No sickle cell crises events occurred in study participants while on GBT440. Exercise testing data showed normal tissue oxygen delivery (no change in oxygen consumption compared to placebo).

– Absorption, Metabolism and Excretion of GBT440 a Novel Hemoglobin S (HbS) Polymerization Inhibitor for the Treatment of Sickle Cell Disease (SCD), in Healthy Male Subjects (Abstract #2487)

– Results of a study evaluating the pharmacokinetics, metabolism, and excretion of GBT440 given orally to healthy subjects showed that the drug was completely excreted from the body, with a half-life of approximately three days. This is much shorter than the lifespan of a red blood cell (about 120 days) of a healthy subject, suggesting that the binding of GBT440 to hemoglobin is a reversible process. The data also suggests that the pharmacokinetics of GBT440 are unlikely to be affected in patients with renal disorders.

Global Blood Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to discovering, developing and commercializing novel therapeutics to treat grievous blood-based disorders with significant unmet need.

GBT440 is Global Blood Therapeutics leading drug candidate which targets the underlying mechanism of red blood cell sickling and offers the potential to treat sickle cell disease (SCD) rather than only its symptoms.

Wells Fargo Gives Buy On Juno One Day, Downgrades the Next!

February 23, 2017: Wells Fargo initiated coverage of JUNO on February 22, 2017 with an Outperform rating. Then, one day later on February 23, 2017, Wells Fargo downgraded JUNO to market perform! Was this a rotational dump at $24 and we just provided Wells Fargo the liquidity they needed? I don’t know but my trust in Wells Fargo analyst ratings is seriously damaged. Wells Fargo is normally solid in their analyst ratings so I think somebody messed inside Wells Fargo. I’m out of JUNO for a small loss around market open today. Ain’t nobody got time for WF analyst ratings stupidity. No worries, we’ll get Wells Fargo back on another trade.

February 22, 2017: Juno had a huge volume surge on February 22, 2017. Volume was 700% higher than 3 month volume average. Wells Fargo just initiated coverage of JUNO with an Outperform rating and a price target of $34 to $36. I decided to pick up some Juno today in my personal trading account.

January 18, 2017: Hearing takeover rumors circulating about Juno Therapeutics. Vague rumors and could not confirm the source.

December 20, 2016: JUNO and CELG announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to investigational drug JCAR017 for the treatment of patients with relapsed/refractory (r/r) aggressive large B-cell non-Hodgkin lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL), not otherwise specified (de novo or transformed from indolent lymphoma), Primary Mediastinal B-cell Lymphoma (PMBCL) or Grade 3B Follicular Lymphoma. In addition, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) have granted JCAR017 access to the Priority Medicines (PRIME) scheme for r/r DLBCL.

JCAR017 uses a defined CD4:CD8 cell composition and 4-1BB as the costimulatory domain, which differentiates it from other CD19-directed CAR T product candidates in clinical development. Earlier this month, data from multiple phase I studies with JCAR017 in non-Hodgkin lymphoma and pediatric acute lymphoblastic leukemia were presented at the 58th American Society of Hematology Annual Meeting.

December 19, 2016: The biotechnology company Juno Therapeutics defeats Kite Pharma’s challenge to CAR T-Cell patent. Juno Therapeutics announced that it has defeated an attempt to invalidate a patent exclusively licensed by Juno that covers, among other things, a chimeric antigen receptor (CAR) T-cell used for the treatment of B-cell malignancies, and that it is suing Kite Pharma, Inc., seeking a declaratory judgment that Kite’s lead product candidate, KTE-C19, will infringe the patent when commercially produced.

In August 2015, Kite Pharma, Inc. filed an inter partes review in the U.S. Patent & Trademark Office in an attempt to invalidate U.S. Patent No. 7,446,190 by challenging all of its claims. Juno exclusively licenses the ‘190 patent, titled “Nucleic Acids Encoding Chimeric T Cell Receptors,” from Sloan-Kettering Institute for Cancer Research, an affiliate of Memorial Sloan-Kettering Cancer Center. The patent covers, among other things, a construct for a CD-19 targeted CAR T cell treatment that employs a CD28 costimulatory domain.The U.S. Patent & Trademark Office instituted a review of the patent, and on December 16, 2016, issued a final written decision upholding all the claims of the patent.

The lawsuit is being filed in the U.S. District Court for the District of Delaware. Juno and the Sloan Kettering Institute are represented by Irell & Manella LLP in both the IPR and the litigation.

December 6, 2016: Juno provided an update of key data from studies of its investigational chimeric antigen receptor (CAR) T-cell product candidates, presented at the 58th American Society of Hematology (ASH) Annual Meeting in San Diego, December 3-6, 2016.

We are encouraged by the safety and efficacy results we see with JCAR017 and JCAR014 in several B-cell malignancy settings, including in non-Hodgkin lymphoma, chronic lymphocytic leukemia, and pediatric acute lymphoblastic leukemia, and the possibilities suggested by early data in treating patients with CD19-negative disease, said Hans Bishop, Junos President, and CEO. We are also learning more about factors that contribute to efficacy and managing the toxicities associated with CAR T therapy and will apply what we learn to our broader development pipeline.

Pediatric Acute Lymphoblastic Leukemia (ALL): JCAR017Final results from the Phase I Pediatric Leukemia Adoptive Therapy-02 (PLAT-02) study with JCAR017 in children and young adults with relapsed or refractory (r/r) CD19-positive ALL were presented in an oral session by Rebecca Gardner, M.D., of Seattle Children’s Research Institute (Abstract #219), on Saturday, December 4. JCAR017 uses a defined CD4: CD8 cell composition and 4-1BB as the costimulatory domain, which differentiates it from other CD19-directed CAR T product candidates in clinical development.

The presentation updated data previously presented at ASCO in June 2016. It included 43 pediatric and young adult patients treated with JCAR017 who were evaluable for response.

Key results:40/43 (93%) patients experienced a minimal residual disease (MRD)-negative complete remission (CR).

In patients who received preconditioning with fludarabine/cyclophosphamide (flu/cy) lymphodepletion, the overall response (OR) rate was 14/14 (100%) patients. The estimated 12-month event-free survival is 50.8% (95%CI 36.9, 69.9) and overall survival (OS) is 69.5% (95%CI 55.8, 86.5).Severe cytokine release syndrome (sCRS) was observed in 10/43 (23%) patients.

A second study presented by Dr. Gardner examined toxicity management in the PLAT-02 trial (Abstract #586). In the study, two cohorts were given either anti-IL6 (tocilizumab) alone or the combination of tocilizumab and the steroid dexamethasone, with the goal of preventing sCRS. Results showed:

Both cohorts experienced similar overall rates of Grade 1-2 CRS following treatment: 21/23 (91%) in cohort 1 and 19/20 (95%) on in the early intervention group. In the tocilizumab arm, 7 of 23 (30%) patients experienced sCRS, versus 3/20 (15%) in the tocilizumab / dexamethasone arm.

Early intervention with immunomodulation appeared to decrease the rates of sCRS while preserving the previously observed high rates of MRD-negative CR.

Long-term persistence of CD19 CAR-T cells is protective against relapse.

Pediatric ALL: JCAR018Nirali N. Shah, M.D., of the National Cancer Institute, presented data from a Phase I study of JCAR018, a CAR T cell product candidate targeting CD22, in 16 pediatric patients with r/r CD19-negative ALL (Abstract #650) on Monday, December 5. The study is the first to evaluate CAR T cell therapy in patients expressing CD22. All of the patients had been previously treated with anti-CD19 CAR T cell therapy and had already undergone at least one allogeneic stem cell transplant.

Key results:

The primary adverse event was grade 1-2 cytokine release syndrome, with no severe or irreversible neurotoxicity. There was one death due to sepsis in a patient after resolution of CRS.

3/9 (33%) patients are in ongoing remission ranging 3-12+ months.

Results showed 7/8 (88%) patients achieved an MRD-negative CR with flu/cy lymphodepletion followed by JCAR018 at dose level 2 (1 x 106 transduced CAR T cells/kg).

The study continues to enroll patients. Juno is currently testing pre-clinical constructs to understand better the optimal way to target these two antigens in the same product.

Diffuse Large B-Cell Lymphoma (DLBCL): JCAR017In a poster presentation on Monday, December 5, Jeremy Abramson, M.D., of Massachusetts General Hospital Cancer Center, presented results from the Phase I TRANSCEND study in patients with r/r DLBCL, follicular lymphoma grade 3B or mantle cell lymphoma (MCL) who were treated with flu/cy lymphodepletion and JCAR017.

Topline results included a 12/20 (60%) complete response in patients with r/r DLBCL (N=19) and follicular lymphoma grade 3B (N=1) treated with a single dose of JCAR017 at dose level 1 (5×107 cells). No sCRS was observed; grade 3-4 neurotoxicity was seen in 3/22 (14%) patients, all of whom received the steroid dexamethasone for neurotoxicity. Also, the side effect profile plus cell persistence suggests the potential for combination therapy.

The Phase I TRANSCEND trial continues, enrolling more patients at dose levels 1 and 2. Juno intends to initiate a pivotal trial in the U.S. in patients with r/r DLBCL in 2017.Chronic Lymphocytic Leukemia (CLL): JCAR014In an oral presentation on Saturday, December 4, Cameron Turtle, M.B.B.S., Ph.D., of the Fred Hutchinson Cancer Research Center, reported on results from a Phase I study of heavily pretreated patients with CLL who failed treatment with ibrutinib, the standard-of-care treatment for CLL. Fifteen of 17 (88%) efficacy-evaluable patients who had bone marrow disease at the start of the trial and treated with flu/cy and the two lowest doses of JCAR014 had a complete marrow response by flow cytometry. Fourteen of the complete bone marrow response patients had a response assessment by the more sensitive method of IgH deep sequencing, with 7/14 (50%) having no detectable disease. All seven of these patients are alive and progression free with follow-up ranging from 3 to 26 months.

Two of 24 (8%) patients developed grade 3-5 sCRS and 6/24 (25%) patients developed grade 3-5 severe neurotoxicity. There was one treatment-related mortality (4%) in the trial in a patient who received flu/cy lymphodepletion, with both grade 5 CRS and cerebral edema.

Plans to study JCAR014 in combination with ibrutinib in CLL are underway, with a cohort expected to begin enrollment in early 2017. Juno is evaluating the use of this data with JCAR014 as a monotherapy and in combination with ibrutinib in support of a potential Juno-sponsored trial with JCAR017 in CLL.

Juno Therapeutics, Inc., a biopharmaceutical company, engages in developing cell-based cancer immunotherapies.

Orexigen Therapeutics Sell For 157% Win!

February 16, 2017: Sell Orexigen Therapeutics for a 157% win in 36 days! Congratulations if you were able to make money on this trade.

January 25, 2017: Orexigen Therapeutics announced that Laboratorios Farmaceuticos Rovi has launched Mysimba in Spain. Mysimba is approved by the European Medicines Agency for the management of weight in adult patients (=18 years) with an initial Body Mass Index (BMI) of = 30 kg/m2 (obese), or = 27 kg/m2 to January 4, 2017: Orexigen Therapeutics, Inc. unveiled “Brains Behind Weight Loss,” a new, national direct-to-consumer advertising campaign demonstrating to patients how the brain plays an important role in weight loss. The campaign will underscore how CONTRAVE (naltrexone HCl/bupropion HCl), an FDA-approved prescription weight-loss medicine, is believed to work on two important areas of the brain the hypothalamus (hunger center) to reduce hunger and the mesolimbic reward system to help control cravings. (The exact neurochemical effects of CONTRAVE leading to weight loss are not fully understood). CONTRAVE is the number one prescribed weight loss brand in the United States.

The CONTRAVE campaign is Orexigen’s first collaboration with Young & Rubicam New York since being tapped as agency of record. Kicking off at the start of the season amidst New Year’s resolutions, the campaign emphasizes the strong connection between the brain and weight loss. The visually intriguing images feature real women who arrange themselves to simulate depictions of the human brain.

December 26, 2016: Orexigen Therapeutics recently announced that its wholly owned subsidiary Orexigen Therapeutics Ireland Ltd. and Biologix FZCO, have executed a commercialization and distributorship agreement in the Middle East for Contrave (naltrexone HCl / bupropion HCl prolonged release) monotherapy for weight management in overweight or obese adult patients.

This agreement covers ten countries in the Middle East: Saudi Arabia, the United Arab Emirates, Kuwait, Oman, Qatar, Bahrain, Lebanon, Jordan, Iraq, and Iran. Under the terms of the agreement, Biologix will be responsible for obtaining regulatory approvals and local product registrations in each of the ten countries and for all commercialization activities. Orexigen will supply Contrave to Biologix at an agreed transfer price. Biologix expects Contrave to be available for patients in some countries starting in the third quarter of 2017.

December 8, 2016: Orexigen Therapeutics announced that its wholly owned subsidiary Orexigen Therapeutics Ireland Ltd. and Consilient Health Ltd. had executed a commercialization and distributorship agreement for Mysimba (naltrexone HCl / bupropion HCl prolonged release) in the UK and Ireland. Mysimba is approved by the European Medicines Agency, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (=18 years) with an initial Body Mass Index (BMI) of = 30 kg/m2 (obese), or = 27 kg/m2 to November 16, 2016: Orexigen Therapeutics announces the presentation of data for OREX-1019, a preclinical candidate for treatment and management of drug addiction Announced the presentation of preclinical data for OREX-1019 (BU10119) at Neuroscience 2016, the 46th annual meeting of the Society of Neuroscience, being held this week in San Diego. OREX-1019 is being evaluated by Orexigen as a treatment for opioid and cocaine addiction and was exclusively licensed by the company in 2015. OREX-1019 is a member of an orvinol compound series developed by Dr. Stephen Husbands, Ph.D. at the University of Bath in the United Kingdom.The data presented this week, “A buprenorphine analog attenuates drug-primed and stress-induced cocaine reinstatement,” was assembled by a team of researchers led by Dr. John Traynor, Ph.D. of the University of Michigan. The biochemical profile of several members of the licensed orvinol compound series, including OREX-1019, demonstrates reduced Mu opioid receptor activity compared to buprenorphine. The presented data provide in vivo evidence for the compound’s therapeutic potential in drug addiction management and suggest a wider use in cocaine addiction.

November 8, 2016: Orexigen Therapeutics announces commercialization and distributorship agreement with Valeant for Contrave (naltrexone HCl / bupropion HCl extended release) in Australia and New Zealand Announced that Valeant Pharmaceuticals International, Inc. (Valeant), through a wholly-owned subsidiary, will commercialize Contrave (naltrexone HCl / bupropion HCl extended release) in Australia and New Zealand. Under the terms of the agreement between Valeant and Orexigen’s wholly owned subsidiary, Orexigen Therapeutics Ireland Ltd., Valeant will be responsible for obtaining regulatory approvals and for all commercialization activities. Orexigen will supply Contrave tablets to Valeant for an agreed transfer price and certain potential sales milestone payments. Orexigen expects Valeant to file for regulatory approvals in both countries in the first half of 2017.

Orexigen and Valeant Pharmaceuticals International, Inc. previously announced commercialization agreements for Mysimba (naltrexone HCl / bupropion HCl prolonged release) in 20 countries in Central and Eastern Europe and Contrave in Canada and South Africa.

Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. Orexigen developed Contrave (naltrexone HCl and bupropion HCl extended-release), which is approved in the United States. Orexigen’s strategy for Contrave is to pursue marketing authorizations worldwide and pharmaceutical partnerships for global commercialization.

Protalix Biotherapeutics For a Monster 180% Win!

February 11, 2017: Sell Protalix Biotherapeutics for a monster 180% win! This is our biggest winner to date. Long upper shadow and Inverted Hammer candlestick are usually good take profit signals. Congratulations if you made money on the trade.

December 27, 2016: Protalix Biotherapeutics announced today the confirmation of the recent letter of intent to purchase alfataliglicerase to treat Gaucher patients in Brazil by the Brazilian Ministry of Health. The Brazilian Ministry’s order consists of a number of shipments during 2017 for a total of approximately $24.3 million. Shipments are to start in mid-2017 and continue through the end of the year, in increasing volumes. The size of the final shipment of this order represents annual revenues of approximately $42 million.

Gaucher disease is a rare lysosomal storage disorder. Alfataliglicerase is a plant cell-expressed form of the glucocerebrosidase enzyme that was approved by the Brazilian National Health Surveillance Agency in March 2013 for the long-term treatment of adults with Type I Gaucher disease and in November 2016 for the long-term treatment of children four years of age and above with Type I Gaucher disease.

The Company owns all rights to alfataliglicerase in Brazil.

December 14, 2016: Protalix Biotherapeutics announced today that the Company received a letter from Fundao Oswaldo Cruz (Fiocruz), an arm of the Brazilian Ministry of Health (the Brazilian Ministry), detailing intended purchases by the Brazilian Ministry of alfataliglicerase to treat Gaucher patients in Brazil. The letter requests three shipments of alfataliglicerase; the first shipment to be made in the middle of 2017, and the last at the end of 2017. The Company estimates total revenues from these shipments to be approximately $24 million in aggregate.

Gaucher disease is a rare lysosomal storage disorder. Alfataliglicerase is a plant cell-expressed form of the glucocerebrosidase enzyme that was approved by the Brazilian National Health Surveillance Agency in March 2013 for the long-term treatment of adults with Type I Gaucher disease and in November 2016 for the long-term treatment of children four years of age and above with Type I Gaucher disease.The Company owns all rights to alfataliglicerase in Brazil.

November 29, 2016: The price target on Protalix Biotherapeutics was raised to $4 from $3.50 at H.C. Wainwright/Rodman & Renshaw. H.C. Wainwright also reiterates their Buy rating on Protalix Biotherapeutics.

Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®. Protalix’s unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner.