Clovis Oncology Stock Rising Off Uptrend Channel Line

Clovis Oncology stock is rising off its uptrend channel line as large players volume continues to rise. The uptrend is also supported by the Twiggs Money Flow which is slowly rising. I dipped my toe in the water and purchased a little bit of Clovis Oncology stock today.

Clovis Oncology News

Since the company reported earnings on August 2, 2017, Clovis Oncology shares have lost about -8%. Clovis reported a second-quarter 2017 loss of -$1.29 per share, which was narrower than the year-ago loss of -$2.07 per share. The reported loss was greater than analysts forecast of -$1.27.

Net product revenues, entirely from Rubraca, were approximately $14.6 million in the quarter, up 108.6% sequentially. Revenues beat the consensus estimate of $12.54 million. The company said that 750 new patients were registered in the quarter.

Clovis Oncology’s Rubraca has shown an impressive growth trend in 2017. The drug received accelerated approval in Dec 2016. Rubraca is a PARP inhibitor, which is approved as a monotherapy for the treatment of advanced ovarian cancer in patients who have been treated with two or more chemotherapies. Rubraca has had an almost 100% growth in sales sequentially in the second quarter of 2017. Rubraca sales were $21.7 million in the first half of 2017. The company had 1100 new patients on therapy in the period.

Two confirmatory studies – ARIEL-3 and ARIEL-4 – are being conducted by Clovis for converting the accelerated approval to continued approval of Rubraca. The company’s shares got a boost when it announced positive top-line results from ARIEL 3 in June 2017. Progression-free survival (PFS) and safety results from the ARIEL-3 study demonstrated that Rubraca had a meaningful impact in delaying disease recurrence in advanced ovarian cancer patients. Clovis is planning to file a supplemental new drug application (sNDA) to the FDA by October this year based on ARIEL-3 data to include second-line or later maintenance indication for advanced ovarian cancer on the label of Rubraca. The company expects the label expansion to increase patient population by at least four times.

Rubraca is under review in the EU for a comparable ovarian cancer indication. An approval is expected from the EU in the first quarter of 2018.

I’m hearing rumors circulating that Clovis Oncology could be a takeover candidate by the end of the year because of Rubraca and the fact that Gilead bought KITE at the end of August.

You can find out more about Clovis Oncology here.

Clovis Oncology Stock Price

Clovis Oncology stock

Clovis Oncology stock usually swings higher at this time of year according to a seasonality study. Clovis Oncology stock is rising nicely off its uptrend line. The Effective Volume study shows large players volume rising. The Twiggs Money Flow is also rising which supports the thesis that large players are accumulating Clovis Oncology stock. I explain a lot of these chart patterns on the Frequently Asked Questions page here.

CLVS does present a good setup opportunity. Prices have been consolidating lately. There is a support zone below the current price at $72.66, a stop order could be placed below this zone.

Top 5 CAR T Stocks To Add To Your Watch List

CAR T stocks are the buzz right now. Even grocery store workers are talking about the FDA approval of the first CAR-T therapy from Novartis last week. Labiotech wrote about the Novartis CAR T approval here.

As swing traders we can’t chase any of these stocks. Back in July I wrote about going long both Cellectis and Novartis.

Back in February 2017 I linked to this YouTube video on how the National Cancer Institute cured leukemia that you may want to review to gain a fuller understanding of what this disruptive technology is about.

Had you bought Cellectis when I wrote about it back in July, you would be up more than 15% right now.

These stocks just can’t be chased higher right now.

My goal is that GuerillaStockTrading become the smartest stock trading website on the internet for amateur traders. Being smart means NEVER chasing a stock higher.

Most of you that watch the weekly Saturday show on YouTube already know that I made a New Year’s resolution to NEVER chase a stock higher in 2017. After making that resolution, my trading profits have improved by over 1000%.

You have to ask yourself, are you a predator or prey for some other predator? You want to be a predator. If you stalk and wait for a pullback to pounce, you’re a predator. If you chase a stock higher, you’re prey. Make sure to review this stock trading lesson on swing trading and the difference between being a predator or being prey.

CAR T Stocks

Be a smart trader. Instead of chasing, create a CAR T watch list and add these stocks to it:

CAR T Stocks Gilead

The next CART-T FDA approval will likely come from Gilead, which just announced the €10Bn acquisition of Kite Pharma that is currently waiting for an FDA decision on its CAR-T candidate KTE-C19.

GILD does not present an entry opportunity at the moment. Prices have been extended to the upside lately. For a good entry it is better to wait for a consolidation.

CAR T Stocks Novartis

Even though the FDA has approved Novartis’ CAR-T therapy Kymriah, officially blessing a new way to attack cancer, the stock has gone pretty much no where. That’s a cautionary yellow flag to traders who think that just because the FDA has approved a CAR-T therapy treatment that this translates into making money in CAR T stocks. Notice how the large players volume continues to downtrend and the Twiggs Money Flow is negative suggesting the stock is still under distribution. I think Novartis is a better setup for a long entry than Gilead. Prices have been consolidating lately and there is a support zone below the current price at $83.76, a stop order could be placed below this zone.

CAR T Stocks Cellectis

Cellectis is a death-trap stock. This is like the stock you tell your father-in-law to check out because it looks so good (wink, wink). Cellectis stock does NOT present a decent entry opportunity at the moment. Prices have been extended to the upside lately. For a good entry it is better to wait for a consolidation.

CAR T Stocks Juno Therapeutics

JUNO is a little better than CLLS but not by much. JUNO does not present a good swing long entry opportunity at the moment. Price movement has been a little bit too volatile to find a nice entry and exit point. It is probably a good idea to wait for more of a consolidation first.

CAR T Stocks Celyad

Large players have been selling CYAD into the upward move. We see reduced volatility while prices have been consolidating in the most recent period. There is a very little resistance above the current price. I don’t really like trading ADRs when I can find a similar opportunity in a non-ADR stock. The Twiggs Money Flow is weak and the falling large players volume means the stock is not a good setup right now unless both improve. I did this stock trading lesson on large players volume that you should review.

Make sure to leave your comments on CART T stocks and this exciting new medical technology below.

Cellectis CAR T Treatment Will Be Better Than Novartis

The Cellectis CAR T treatment will be better than Novartis on price point. The Novartis therapy called tisagenlecleucel will be very expensive and this is a big problem as insurance companies will simply not cover it. This is why Cellectis stock got a sympathy bump on Friday after Novartis got an FDA Advisory Panel positive recommendation which should result in the first FDA approval of a CAR T treatment.

With Novartis’ method, each patient will require his or her own special batch of genetically engineered cells to be made. The process takes about 22 days and costs around $500,000.

Cellectis CAR T Treatment Can Be Mass Produced

Cellectis just submitted an Investigational New Drug application to the FDA for an off-the-shelf CAR-T candidate. If approved, the company will soon start Phase I trials with UCART123 in patients with acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm.

Cellectis is working on a technology it calls universal CAR-T therapy or UCART. Cellectis has edited genes in these cells to make them like universal donor cells. They can work in the vast majority of patients. UCART can be manufactured in large scale using cells from a healthy donor instead of treatments relying on the patient’s own cells. This means that Cellectis can mass-produce a CAR-T therapy, making it cheaper to produce.

Cellectis CAR T Treatment Deals With Cytokine-release Syndrome

Cytokine-release syndrome (CRS) is a big problem for all CAR T treatments. A whopping 79% of trial patients experienced CRS, of which 21% was grade 3 and 27% was grade 4. CRS occurred within 3 days of treatment (range, 1-22) and lasted for a median of 8 days (range, 1-36). Fifty-nine percent of patients with CRS were admitted to the intensive care unit for a median of 8 days (range, 1-34).

Cellectis is working on preventing CRS by controlling the activity of these genetically modified cells. It’s designed an architecture where CAR T cells can be given the equivalent of an on-off switch. The switch can be a small-molecule drug that’s given to the patient to control the activity of the cells. The possibility of controlling CAR T activity is very desirable to mitigate potential unwanted risks such as CRS. To date, few strategies are available and mostly rely on suicide mechanisms that ultimately lead to a complete eradication of the engineered T-cells, thus resulting in a premature end of the treatment.

Cellectis CAR T treatment should not only be cheaper than Novartis’ $500,000 price tag, it should also be safer with the ability to control the immune system response.

Cellectis Fundamentals

CLLS reported negative earnings for the last year, which makes the Price/Earnings Ratio negative. CLLS has a Quick Ratio of 5.68. This indicates that CLLS is financially healthy and has no problem in meeting its short term obligations. CLLS has an Altman-Z score of 10.37. This indicates that CLLS is financially healthy and little risk of bankruptcy at the moment.

Like most clinical-stage biopharmaceutical companies, the fundamental data is poor on Cellectis.

Cellectis Stock Chart

Cellectis stock had a big Novartis sympathy move on Friday, July 14, 2017. This is a stock you do not want to chase. The chart looks like a horrible setup right now IMO. Price has spiked to the upside. It is better to buy on a consolidation rather than a spike.

While this stock is not a good buy right now, it’s worth putting on our watch list to stalk for the next consolidation.

Novartis FDA Car T Approval – Most Exciting New Medicine Of Our Lifetimes

Big news: Novartis FDA Car T approval is likely coming soon after a Food and Drug Administration advisory panel unanimously recommended approval for Novartis’s leukemia drug tisagenlecleucel. The FDA usually follows its panels’ recommendations.

The big thing though will be price point. Car T is very expensive because it involves personalized treatment. If it’s too expensive, insurance companies won’t cover it.

Novartis FDA Car T

Novartis said that in patients with recurrent leukemia, 75% were still cancer free after CAR-T treatment.

Wells Fargo’s David Maris told clients that this ground-breaking approval is “the most exciting thing I’ve seen in my lifetime.”

CAR-T medicine is a new, personalized treatment which requires taking a patient’s own cells, removing them from the body, reengineering them for immunotherapy, and placing them back in the body.

The official Novartis FDA Car T approval is expected in October 2017.

Novartis Stock Chart

NVS has an ok setup pattern but I’m not really thrilled about it. I feel like we need more of a consolidation and a candle over candle reversal too so we know other buyers are stepping in at this level. There is a very little resistance above the current price. There is a support zone below the current price at 82.96, a stop order could be placed below this zone.

Add Merck To Your Watch List As It Pulls Back For Swing Long Setup

Add the stock of Merck to your watch list as it pulls back and becomes a compelling swing long set up.

Merck’s Keytruda got an amazing FDA approval. Keytruda produced data so incredible that the FDA approved it immediately for a specific genetic mutation, regardless of cancer location. The FDA has never given a drug a blanket approval like this. The Fool published an excellent report on this crazy FDA approval here.

Merck Stock Chart

I think we have to be cautious because there is no Pocket Pivot signal and the Twiggs Money Flow just went negative. Nevertheless, the chart does show a decent setup pattern after the most recent pullback. There is a resistance zone just above the current price starting at 64.13. Right above this resistance zone may be a good entry point. There is a support zone below the current price at 64.02, a stop order could be placed below this zone.

GO HERE TO CHART LARGE PLAYERS AND THE TWIGGS MONEY FLOW LIKE THE CHART ABOVE… EXCELLENT TIMING TOOL FOR SWING TRADERS

Ocular Therapeutix Dextenza Play On Hammer Flush

Ocular Therapeutix Dextenza decision by the FDA is expected by July 19, 2017. The chart formed a Bullish Hammer pattern on Friday, June 23, 2017, which flushed out a lot of the weaker long positions.

Ocular Therapeutix Dextenza

The company presented awesome Phase 3 data on Dextenza back at the end of May. Dextenza met its primary endpoints of the absence of anterior chamber (AC) cells, which is a sign of inflammation, on day 14 and the absence of pain on day 8. More than 52% of patients that got Dextenza after cataract surgery had no AC cells on day 14 compared to 31.1% patients that got placebo. The pain reading was also superior, with 79% of patients who took Dextenza reporting no pain on day 8 compared to 61.3% of patients that took placebo.

Ocular Therapeutix Stock Chart

That’s an ugly chart with large players selling the stock on Friday, June 23, 2017, and the Twiggs Money Flow threatening to go negative. The stock has formed a momentum squeeze.

A pullback is taking place, which may present an opportunity for an entry on a candle over candle reversal. There is very little resistance above the current price. There is a support zone below the current price at 10.14, a stop order could be placed below this zone.

GO HERE TO CHART LARGE PLAYERS AND THE TWIGGS MONEY FLOW LIKE THE CHART ABOVE… AWESOME TOOL

Adamis Pharmaceuticals Gets FDA Approval, Stock Explodes Higher!

Trader alert: Adamis Pharmaceuticals explodes higher on FDA approval of Epinephrine injection. Adamis Pharma announces FDA approval of its EPINEPHRINE INJECTION for the emergency treatment of allergic reactions (Type I) including anaphylaxis; anticipates launching in the back half of the year.

This will be a low cost alternative to Mylan’s EpiPen. The epinephrine-products market generated about $1.2 billion in sales last year so this is big news folks. This little pharmaceutical company could explode higher over the coming year.

Adamis Pharmaceuticals said, “With an anticipated lower cost, small size and user-friendly design, we believe Symjepi could be an attractive option for a significant portion of both the retail (patient) and non-retail (professional) sectors of the epinephrine market. We are currently in the process of exploring all of our commercialization options and in discussions with potential partners in order to facilitate broad patient access to this new epinephrine treatment option and to maximize the value of our important asset. In the interim, we expect to build inventory levels in preparation for an anticipated launch in the second half of this year.”

Founded in 2006 and headquartered in San Diego, Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company that provides high quality, low-cost solutions for patients, physicians, and healthcare organizations in the multi-billion dollar therapeutic areas of respiratory disease and allergies. Adamis Pharmaceuticals lead pipeline product is an epinephrine injection pre-filled syringe product for potential use in the emergency treatment of anaphylaxis. Adamis is also currently developing other specialty pharmaceutical product candidates including APC-1000, an HFA inhaled nasal steroid product for the potential treatment of asthma; APC-2000, albuterol with a dry powder inhaler (DPI) propellant for the potential treatment of bronchospasms, and APC-4000, fluticasone with a DPI propellant for the potential treatment of asthma. With the rising costs of healthcare in recent years, Adamis has been focusing on creating low-cost therapeutic alternatives in large markets in order to grow its business and to make treatments more affordable for more people. Adamis will pursue the 505(b)(2) regulatory approval filings with the FDA whenever possible in order to minimize costs and shorten the time to market. With its lead pipeline product and specialty pharmaceutical pipeline, ADMP is poised to become a leader in the specialty biopharmaceutical industry.

Adamis Pharmaceuticals Stock Chart

ADMP presents a decent setup pattern. Prices have been consolidating lately. There is a very little resistance above the current price. We notice that large players showed an interest for ADMP in the last couple of days, which is a good sign.

GO HERE TO CHART LARGE PLAYERS AND THE TWIGGS MONEY FLOW LIKE THE CHART ABOVE… AWESOME TOOL

Sell Cancer Genetics For an Awesome 133% Win!

April 16, 2017: Sell Cancer Genetics for an incredible 133% win in 85 days and congratulations if you made money on the trade.

December 9, 2016: H.C. Wainwright/ Rodman & Renshaw reiterates a Buy rating on Cancer Genetics, and sets a price target of $6.

December 7, 2016: Cancer Genetics announced a collaboration with BeiGene, a global, clinical-stage, research-based biopharmaceutical company developing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer. The two companies will work together on BeiGenes immune marker and genomics initiatives to accelerate studies of tumor microenvironment in cancer patients, which will aid in drug target identification and biomarker discovery.

BeiGenes clinical-stage drug candidates inhibit four major oncology targets, including Brutons tyrosine kinase (BGB-3111), the immune checkpoint receptor PD-1 (BGB-A317), the PARP family of proteins (BGB-290), and the RAF dimer protein complex (BGB-283). Each of BeiGenes drug candidates has demonstrated promising early anti-tumor activity and a favorable safety profile and has the potential to be a best-in-class or first-in-class product. These drug candidates are being evaluated as monotherapies and in combination regimens for the treatment of a variety of cancers, including solid tumors and hematological malignancies. CGI will provide biomarker and central laboratory for multiple clinical trials for BeiGenes BGB-3111, BGB-A317, and BGB-290 programs to promote accelerated market entrance and identify subsets of patient populations.

December 5, 2016: Cancer Genetics announces it is on Merck’s list of national reference laboratories offering the PD-L1 22C3 pharmDx immunohistochemistry (IHC) assay, the first U.S. Food and Drug Administration (FDA)-approved companion diagnostic test for pembrolizumab, KEYTRUDA, for PD-L1 testing in non-small cell lung cancer (NSCLC). The company first started offering the DAKO PD-L1 IHC 22C3 pharmDx test in early 2016 and was recently listed as a national reference laboratory.

Cancer Genetics now offers all the available FDA approved companion diagnostics for PD-L1 testing across several cancer indications and is providing these tests for both patient management in the clinical setting as well as for immuno-oncology trials sponsored by leading pharmaceutical companies. Cancer Genetics is now supporting over 100 clinical studies and trials, and over 30 with a component for immuno-oncology testing and monitoring.

Cancer Genetics, Inc. offerers diagnostic products and services that enable precision medicine in the field of oncology. Products and services being developed at CGI are poised to transform cancer patient management, increase treatment efficacy, and reduce healthcare costs. CGI’s cutting-edge proprietary tests and state-of-the-art reference laboratory provide critical genomic information where patients and their physicians need it most – to diagnose, monitor and inform cancer treatment.

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.