Exelixis Gets FDA Priority Review for Cabomteyx

The FDA has granted priority review for Exelixis Cabomteyx. The sNDA seeks approval of Cabometyx for patients with previously untreated advanced renal cell carcinoma (RCC). The FDA determined the sNDA to be sufficiently complete. This means an FDA approval decision will be made by Feb. 15, 2018.
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Mannkind Corporation Stock 38.2 Percent Retracement On Analyst Buy

Mannkind Corporation stock has done a 38.2 percent Fibonacci Retracement on a new Buy rating on the stock. HC Wainwright picked up coverage of the stock and issued a Buy rating on Tuesday, October 10, 2017.

Mannkind stock also has insider buying. Director Kent Kresa purchased 166,600 shares of the firm’s stock in a transaction on Friday, October 13th. The stock was bought at an average cost of $6.00 per share, with a total value of $999,600.00.
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Flexion Therapeutics Offering To Raise $122.4 Million

Flexion Therapeutics announced a proposed public offering of 4 million shares to raise $122.4 million to market osteoarthritis knee pain treatment Zilretta. The company recently received FDA approval for Zilretta.

Flexion Therapeutics is a specialty pharmaceutical company focused on the development and commercialization of local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis (OA), a type of degenerative arthritis.
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Flexion Therapeutics Stock Higher on FDA Approval of Zilretta

Flexion Therapeutics stock has rocketed higher on FDA approval of Zilretta. Zilretta is the first and only extended-release, intra-articular injection for osteoarthritis knee pain.

Michael Clayman, M.D., President and Chief Executive Officer of Flexion said, “The approval of Zilretta marks a major advancement in the treatment landscape for managing OA knee pain. It comes at a time when our society is in urgent need of non-addictive therapies to help the millions of Americans who suffer from this condition. We believe that Zilretta has the potential to be a transformative medicine for the more than five million patients who receive an intra-articular injection for OA knee pain each year.”

Zilretta’s peak potential sales could hit $750 million but that could be a conservative estimate. With additional revenues from label expansion and potential new indications such as osteoarthritis of the hip and shoulder (for which clinical trials are anticipated to initiate by the end of this year), Zilretta’s sales could easily top $1 billion and that doesn’t include international sales.
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Cryoport Stock Gets Janney Montgomery Scott Price Target of $12

Cryoport stock received a price target hike from Janney Montgomery Scott to $12 which is 42% upside from the previous close of $8.45.

Cryoport provides cryogenic logistics solutions to the life sciences industry through its packaging, information technology, and cold chain logistics expertise. The Company provides logistics solutions for biologic materials, such as immunotherapies, stem cells, chimeric antigen receptors (CAR)-T cells, and reproductive cells for clients.

If someone wants to ship something cryogenically using UPS, FedEx, or DHL, they are directed to Cryoport by these shipping companies.

A whopping 70% of Cryoport’s business comes from biopharma companies. About 15% comes from human reproduction needs and another 15% comes from animal health needs.
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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.