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.

Jazz Pharmaceuticals Announces Positive Results From Phase 3 TONES 3 and TONES 4

March 20, 2017: Jazz Pharmaceuticals announced positive efficacy results from two global multicenter studies in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA). JZP-110 demonstrated highly statistically significant differences in the co-primary efficacy endpoints in the TONES 3 study at the 300 mg, 150 mg, 75 mg and 37.5 mg dose arms and in the TONES 4 study in the combined JZP-110 treatment arm (300 mg, 150 mg, and 75 mg doses) compared to placebo. Based on the preliminary safety analysis, the most commonly reported adverse events (AEs) in these studies were consistent with those previously described in the Phase 2 clinical studies evaluating JZP-110 in narcolepsy.

The Treatment of OSA and Narcolepsy Excessive Sleepiness (TONES) Phase 3 program is comprised of four studies, two in OSA, one in narcolepsy and one open-label, long-term safety and maintenance of efficacy study. The two Phase 3 OSA studies enrolled 652 total patients.
Efficacy Results of TONES 3 Study The TONES 3 study, or 14-003, is a 5-arm, parallel-group study evaluating four doses of JZP-110 (300 mg, 150 mg, 75 mg and 37.5 mg) and placebo for a 12-week period. The study enrolled 476 patients and was powered to detect differences between placebo and the 300 mg and 150 mg dose arms.

In TONES 3, JZP-110 demonstrated highly statistically significant improvement in the co-primary endpoints of Maintenance of Wakefulness test (MWT) and Epworth Sleepiness scale (ESS) at all doses. In addition, the key secondary endpoint of Patient Global Impression of Change (PGIc) scale demonstrated a highly statistically significant improvement in the 300 mg, 150 mg and 75 mg doses versus placebo. On the co-primary endpoints of MWT and ESS, the study demonstrated that treatment with JZP-110 significantly increased the patients’ ability to stay awake and significantly decreased patients’ subjective levels of sleepiness, respectively, compared to placebo. These effects were maintained throughout the course of the study.
Efficacy Results of TONES 4 Study The TONES 4 study, or 14-004, is a six-week study in which eligible subjects received four weeks of open-label treatment, and at the end of week 4, 126 patients who reported “much” or “very much” improvement on the PGIc scale and who had numerical improvements on the MWT and ESS at week 4 were then randomized 1:1 to receive either the same dose of JZP-110 received in the stable dose phase, or placebo, for two weeks in the randomized withdrawal phase.

In TONES 4, patients randomized to continue on JZP-110 maintained efficacy, while those randomized to placebo experienced a loss of efficacy, as measured by the co-primary and key secondary endpoints.

Preliminary Safety Results of TONES 3 and TONES 4 Studies Based on a preliminary safety analysis, the most commonly reported adverse events were headache, nausea, decreased appetite, dry mouth, anxiety, dizziness, insomnia, nasopharyngitis, and palpitations. There were six patients with serious adverse events (SAEs), two patients on placebo and four on JZP-110. None of these was deemed a treatment-related adverse event as assessed by the investigators. Additional safety information will be available based on the final analyses of the JZP-110 program, including results of the open-label, long-term safety and maintenance of efficacy study.

January 18, 2017: Leerink reiterates their Outperform rating on Jazz Pharmaceuticals and sets a price target of $182 after yesterday evenings FDA updates regarding a generic Xyrem (naracolepsy) application appear to be a net-positive for JAZZ as the FDA concurrently ruled (in a citizens petition [CP]) that it won’t allow generic substitutes to carve-out safety/dosing language that is patent protected. At a minimum, firm expects the approved generic will need to successfully litigate the Xyrem formulation (ends mid-2020E) and DDI patents (expires 2033E) before launching as they believe an at-risk launch against two battletested patent families would be financial catastrophic. Ultimately, todays update provides much needed visibility into how the FDA views the safety risk of omitting divalproex DDI (drug-drug interaction) and dosing language from the Xyrem package insert. Some investors believed generic companies’ ability to “carve out” the DDI information from their labels would allow them to argue they didn’t infringe the DDI patents. Based on last night’s ruling, it would appear this generic noninfringement strategy on the DDI patents is foreclosed. Further, with JAZZs DDI patents withstanding the invalidity challenge in multiple inter partes reviews (IPR) relating to the obviousness of those patents, those patents now appear much stronger and likely to withstand two central arguments they’d anticipate when the patent dispute moves to the district court in May 2017 (lead case). Based on the above considerations, firm believes the generic companies will be more likely to accept JAZZ’s likely settlement offer to launch in late 2025E since the risk of getting blocked until 2033E looks increasingly probable.

January 17, 2017: The U.S. Food and Drug Administration (FDA) has approved Jazz’s Xyrem, the first generic version of Xyrem (sodium oxybate) Oral Solution, to treat cataplexy and excessive daytime sleepiness in patients with narcolepsy, which is a potentially debilitating disease. Cataplexy is a primary symptom of narcolepsy where patients suddenly lose muscle tone, including voluntary muscle control, while awake. Muscle weakness or paralysis associated with cataplexy may cause a person to collapse. Approximately 70 percent of people with narcolepsy have cataplexy. Sodium oxybate is the only medication approved to treat cataplexy in patients with narcolepsy.

The use of Xyrem has been associated with serious side effects including seizures, trouble breathing, changes in alertness, coma, and death. Additionally, the active ingredient in Xyrem (and in the newly approved generic) is sodium oxybate. Sodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB). GHB has not been approved for any medical use and has the potential for abuse, such as in cases of sexual assault.

Because of the potential risks associated with Xyrem, it is subject to strict safety controls on prescribing and dispensing under a program called a Risk Evaluation and Mitigation Strategy (REMS). FDAs approval of generic sodium oxybate is subject to a REMS with strict safety controls that are comparable to those currently required for Xyrem.

Specifically, under both the Xyrem REMS and the generic sodium oxybate REMS, sodium oxybate can be prescribed only by a certified prescriber, and dispensed only to an enrolled patient by a certified pharmacy. Only a certified pharmacy that ships directly to patients can dispense sodium oxybate. Sodium oxybate will not be available in retail pharmacies.

In approving this generic version of Xyrem, the FDA is maintaining strict safety requirements for sodium oxybate, while providing patients with access to a generic medication option for narcolepsy. Source: http://www.fda.gov/Drugs/DrugSafety/ucm537281.htm

January 9, 2017: At the JP Morgan conference, Jazz said it plans to expand via M&A and partnerships this year; Affirms FY16 $9.90-10.30 versus $10.02 estimate; Revenue $1.5 billion versus $1.49 billion estimates.

December 15, 2016: Cantor Fitzgerald initiates JAZZ with an Overweight rating and a price target of $187.

Jazz Pharmaceuticals plc is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing important products that address unmet medical needs. The company has a diverse portfolio of products and product candidates with a focus in the areas of sleep and hematology/oncology.

As part of our unwavering commitment to improving patients’ lives, we are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise. We do this through a growth strategy of growing sales of the existing medicines in our portfolio; acquiring commercial products or product candidates that are in late-stage development, and pursuing focused development of our pipeline of differentiated therapies.

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.

CRISPR’s Brave New World

stock-market-videos MZqkHs - CRISPR's Brave New WorldJust a handful of technologies deserve to be called “game changers”—and CRISPR-Cas9, the new gene-editing tool, is one of them. Discovered just three years ago, CRISPR is sweeping through labs around the world and researchers are already using it to experiment on diseases like cancer and AIDS, engineer new sources of clean energy, and create hardier plants and animals with the goal of wiping out world hunger. This Salon gathers bioengineers and medical researchers to take a hard look at the monumental changes hovering on the horizon.

Salon: Game Change – CRISPR’s Brave New World

The Big Ideas Series is supported in part by the John Templeton Foundation. Additional support provided by The Jackson Laboratory.

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Original Program Date: June 4, 2016
MODERATOR: Robert Benezra
PARTICIPANTS: Ellen Jorgensen, Ben Matthews, Neville Sanjana, Jacob S. Sherkow, Stephen Tsang

Robert Benezra Introduction 00:05

Participant Introductions 00:57

How was CRISPR discovered? 3:31

Is it surprising how quickly CRISPR has been embraced? 8:34

What are the significant ways scientists are using CRISPR? 12:25

Do we want to manipulate the human genome? 22:50

What are the ethics that come with CRISPR? 30:17

How would we release a gene drive into the world 35:22

The first retinal gene therapy trial 41:44

Can CRISPR be used to replace dopaminergic neurons? 49:07

As CRISPR becomes more available could it suffer from under or over regulation? 1:00:47

How much can CRISPR cost? 1:06:25

Will CRISPR be the breakthrough for treating disorders? 1:17:36

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.

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.