Biotech

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Flexion Therapeutics Inc FLXN Stock News

Flexion Therapeutics Inc (NASDAQ: FLXN) | Sanofi SA (ADR) (NYSE: SNY)

Flexion Therapeutics is having an overwhelmingly strong start to the trading session today. After FiercePharma made an announcement that the company is nearing a deal with Sanofi, the stock spiked in a big way, prompting our partners at Trade Ideas to alert us to the movement. At the moment (10:30), FLXN is trading at $24.67 per share after a gain of $4.99 per share (25.36%) thus far today.





FLXN Nears $1 Billion Deal With SNY

As mentioned above, Flexion Therapeutics is having an overwhelmingly strong start to the trading session as reports break that the company is close to closing a $1 billion deal with Sanofi. According to a source close to the story, Sanofi is considering purchasing the company and the deal is close.




According to the release, the price on the acquisition, if it happens, will come in the range of the mid-30’s per share. This makes sense, as FLXN has a knee injection product for osteoarthritis that would fit well with SNY’s biosurgery division, which also markets an osteoarthritis injectable. Nonetheless, this report has been unconfirmed. While it looks like there’s definitely validity to this one, it’s important to treat the story as a rumor until confirmation comes.

What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be watching to see if FLXN is acquired by SNY. While we are treating this as a rumor at the moment, there’s a much stronger probability of an acquisition actually happening than we see with most rumors. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

Update 11:02: SNY refuses to comment on FLXN takeover rumor.

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Vascular Biogenics Ltd VBLT Stock News

Vascular Biogenics Ltd (NASDAQ: VBLT)

Vascular Biogenics is having a great start to the trading session today, and for good reason. The company released overwhelmingly positive results from a recent Phase II clinical study. As a result, the stock started to climb dramatically, causing our partners at Trade Ideas to alert us of the gains. Currently (10:13), VBLT is trading at $5.25 per share after a gain of $0.75 per share or 16.67% thus far today.





VBLT Releases Positive Phase II Data

As mentioned above, Vascular Biogenics is having a strong morning in the market today as the result of positive data from a recent Phase II trial. The trial was designed around VB-111, an experimental treatment designed for patients with advanced, differentiated thyroid cancer.




According to the release, the primary endpoint was met. The data showed that 47% of patients in the therapeutic dose cohort achieved PFS-6, compared to 25% in the sub-therapeutic cohort. Both groups in the study met the primary endpoint of 25% PFS response at 6 months or 25% PFS-6.

What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be following VBLT incredibly closely. In particular, we’re interested in following the company’s ongoing work surrounding VB-111 as the treatment seems to be doing well in clinical studies. Nonetheless, we’ll continue to follow the story closely and bring you the news as it breaks!

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Nantkwest Inc NK Stock News

Nantkwest Inc (NASDAQ: NK)

Nantkwest is off to an incredibly strong start in the trading session today, and for good reason. The company just achieved orphan drug designation, leading to excitement among investors. As a result, the stock spiked upward, prompting our partners at Trade Ideas to alert us of the gains. At the moment (10:01), NK is trading at $3.54 per share after a gain of $0.11 per share or 3.15% thus far today.





NK Receives Orphan Drug Designation

As always, as soon as we received the alert, informing us of the gains on Nantkwest, the CNA Finance team went to work to see why the stock was gaining. Ultimately, the gains are the result of the company’s newly realized Orphan Drug Designation from the US FDA. The Orphan Drug Designation has been granted for the experimental treatment known as Ganitumab, which is being tested as a treatment for Ewing Sarcoma.




What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to follow the NK story incredibly closely. In particular, we’re interested in the company’s ongoing work with regard to Ganitumab, especially now considering the orphan drug designation. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Insys Therapeutics Inc INSY tock News

Insys Therapeutics Inc (NASDAQ: INSY)

Insys Therapeutics is having an overwhelmingly strong beginning to the trading session today, starting the day off in the green. As a result, our partners at Trade Ideas sent an alert surrounding the stock, which prompted us to dig and see what was happening. The gains seem to be the result of the company’s new treatment being in the news due to a DEA ruling. At the moment (9:31), INSY is trading at $11.42 per share after a gain of $1.21 per share (11.86%) thus far today.





DEA Issues Ruling On INSY Syndros(TM)

As mentioned above, Insys Therapeutics is having an overwhelmingly strong start to the trading session today after its treatment came up in a DEA ruling. In an announcement, the US Drug Enforcement Agency announced that it issued an interim final rule on Syndros(TM). The DEA has scheduled the treatment as a Schedule II controlled substance under the Controlled Substances Act. This is great news, as the marijuana-derived treatment has been scheduled as a safer drug than marijuana itself. In a statement, Dr. Santosh Vetticaden, Ph.D., M.D., Interim CEO and CMO at INSY, had the following to offer:




Insys is looking forward to bringing this new drug product to chemotherapy patients to help alleviate their nausea and vomiting and AIDS patients with anorexia associated weight loss, respectively. We look forward to interacting with the FDA to finalize labeling and subsequent launch of Syndros in the second half of 2017.”

What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on INSY. In particular, we’ll be following the ongoing work surrounding Syndros, and we are excited for the launch of the treatment later this year. We’ll continue to follow the story closely and bring you the news as it breaks!

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Sunshine Heart Rg SSH Stock News

Sunshine Heart Rg (NASDAQ: SSH)

Sunshine Heart is having an overwhelmingly good time in the pre-market hours today after providing a key business update. As a result, our partners at Trade Ideas quickly alerted us to the upward movement, prompting some research to see what’s happening. At the moment (8:27), SSH is trading at $2.66 per share after a gain of $0.49 per share (22.58%) thus far today. Here’s what’s happening…





SSH Provides Business Update

As mentioned above, the gains on Sunshine Heart are the result of a business update the company offered this morning. The company said that its progress in successfully executing its Aquadex growth strategy is going well. After acquiring Aquadex from Baxter International, a revenue growth strategy commenced at the company. By the end of the year 2016, the company had successfully re-engaged 95 hospital accounts that are currently purchasing disposable blood sets on a regular basis.




Along with the business update, the company provided four steps in which it is focused on, and it believes they are the key to growth. The steps SSH will be following include:

  1. Provide better diagnostic tools that will enable healthcare professionals to improve patient selection.
  2. Generate meaningful economic evidence to support reimbursement and drive utilization.
  3. Expand utilization of Aquadex in other areas of the hospital.
  4. Expand the use of Aquadex in an outpatient setting.

In a statement, John Erb, Chairman and CEO at SSH, had the following to offer:

Our momentum is increasing as we reach more hospital accounts that have been quiet over the past few years..”

What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on SSH. In particular, we’ll continue to follow the company through this growth process and are expecting to see more positive news in the near future. We’ll continue to watch the story closely and bring you any updates as they break!

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HTG Molecular Diagnostics Inc HTGM Stock News

HTG Molecular Diagnostics Inc (NASDAQ: HTGM)

HTG Molecular Diagnostics is having a wonderful start to the day in the pre-market hours. In fact, the gains are so big that it was the first alert our partners at Trade Ideas sent this morning. Currently (8:07), HTGM is trading at $2.14 per share after a gain of $1.43 per share (66.82%) thus far today.





Why HTGM Is Gaining

As is always the case, as soon as we received the alert that HTG Molecular Diagnostics was making a run for the top, the CNA Finance team started working to see what was causing the movement. It didn’t take long to dig up the story. The gains are ultimately the result of the company’s announcement that it has obtained CE marking in the EU for its HTG EdgeSeq ALKPlus Assay EU. This is an in vitro diagnostic assay that’s designed to measure and analyze mRNA ALK gene rearrangements in formalin-fixed, paraffin-embedded lung tumor specimens. In a statement, TJ Johnson, President and CEO at HTGM, had the following to offer:




We are pleased to add the HTG EdgeSeq AlkPlus Assay EU to our diagnostic assay menu in Europe… Lung cancer is a significant global health problem and an important focus area for HTG. We plan to offer this assay to selected European early adopters as we seek additional regulatory approvals elsewhere.”

What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be watching HTGM incredibly closely. In particular, we’re interested in following the company as it turns this approval into a profit. We’ll continue to follow the story and bring you any updates to the news as they break!

Update: 12:44: HTGM continues to have an incredible day in the market, however, it looks like this run may have reached its peak after nearly doubling in value. At the moment, the stock is trading at $4.23 per share after a gain of $2.09 per share (97.44%) thus far today.

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Synergy Pharmaceuticals Inc SGYP Stock News

Synergy Pharmaceuticals Inc (NASDAQ: SGYP)

Synergy Pharmaceuticals is having a rough time in the market as of late. In fact, the stock’s price has been falling on a nearly daily basis. However, one of Warren Buffet’s biggest lessons is to buy when fear is high, and there’s a strong argument at the moment that while SGYP is weak, it represents some serious horsepower in terms of opportunity.





The SGYP Opportunity Lies In Trulance

When Synergy Pharmaceuticals received FDA approval for Trulance, the stock went wild. However, since then, excitement has died down a bit, and so too has the stock price. This is normal when it comes to first time FDA approvals in these small biotech companies, and historically, it actually represents a strong opportunity.

You see, at the moment, investors are in the wait-and-see mode that they were in shortly after Gilead Sciences got their first FDA approval. Of course, we all know where the company is today! The truth is that if SGYP does what it needs to do with Trulance, it will put itself on a beeline toward major success, and that will send the price skyrocketing.




Analysts Are Betting On Opportunity

Just yesterday, an analyst weighed in on SGYP, betting that the current weakness represents a strong opportunity. That analyst was Timothy Chiang of BTIG. In his note, he reiterated a Buy rating with an $11 price target, pointing to Trulance as the primary reason for his bullish opinion. Here’s what he had to say:

With the US launch of Trulance (3mg plecanatide, for the treatment of chronic constipation) now officially underway, investor focus now turns to the ramp for trulance in the US market. We continue to believe management is up to the task of successfully launching Trulance via its hybrid sales model (utilizing an experienced contract sales force of ~150 – 200 reps), which is expected to target ~27,000 high-prescribing physicians. While we believe formulary access for Trulance could take up to 6 months, we think most insurance plans will put Trulance on a Tier 3 co-pay, with the Co. offering its “savings to go” program as an offset. Our channel checks with several local pharmacies in NYC this morning suggest that this program will enable patients to get access to Trulance at a much lower cost (no more than $25 per Rx). Management also recently highlighted at an investor conference earlier today that a nationwide sampling program is underway. In sum, we expect the launch of Trulance to lead to more patients switching from OTC laxatives to Rx treatments, with Trulance leading to an expansion of the overall Rx market.”

The Bottom Line

The bottom line here is that chances are that SGYP has something big with Trulance. Considering their planned marketing of the treatment, chances are that it will quickly fly off of the shelves. With the stock currently trading far lower than it should (in my opinion), now may be the perfect time to consider adding the stock to your portfolio.

What Do You Think?

Where do you think SGYP is headed moving forward? Join the discussion in the comments below!

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Idera Pharmaceuticals Inc IDRA Stock News

Idera Pharmaceuticals Inc (NASDAQ: IDRA)

Idera Pharmaceuticals is having an incredible day in the market today. The movement in the stock is driven by news that JPM securities has initiated coverage on the stock, and they have a positive view overall. As a result of the news, the stock spiked, causing our partners at Trade Ideas to send the alert. At the moment (10:01), IDRA is trading at $2.28 per share after a gain of $0.19 per share or 8.85% thus far today.





JPM Securities Initiates IDRA Coverage

As mentioned above, the gains that we saw in after-hours and the pre-market are the result of JPM securities making the decision to initiate coverage on the biopharmaceutical company. In a note, JPM Securities Analyst, Michael King said that IDRA is “Capable of generating a host of promising drug candidates,” He went on to explain that he is impressed with the company’s work thus far in the space of immunology, stating that they have shown “impressive clinical activity in combination with checkpoint inhibition in the setting of anti-PD-1 refractory metastatic melanomoa.”




As a result of his strong opinion on the stock, King initiated coverage on Idera Pharmaceuticals with a rating of market outperform as well as a price target of $8.

What We’ll Be Watching For

Moving forward, the CNA Fiannce team will be watching IDRA incredibly closely. In particular, we’ll be watching the company’s continued work in the field of oncology and we are excited to see the progress the company continues to make. Nonetheless, we’ll be watching closely and bringing you the news as it breaks!

What Do You Think?

Where do you think IDRA is headed moving forward? Join the discussion in the comments below!

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Pernix Therapeutics Inc PTX Stock News

Pernix Therapeutics Holdings Inc (NASDAQ: PTX)

Let’s keep it real. I am long Pernix stock and, while I may have gotten to the point of where I play hide and seek with the daily share price fluctuations, I am far from throwing in the towel on this company. I’m not stubborn to the point of becoming poor, nor do I enjoy frequent episodes of pain. Rather, I tend to have the ability to cut through the minutia and get to the nitty gritty of the issue at hand, and, as for the issue at PTX, I still see significant upside value in PTX.





Don’t call me crazy, and please don’t call me “surely,” but when I take a good, long look at PTX, I see far more potential and intrinsic value in the shares than is currently being represented by the stock price.

From There To Here

For many shareholders, the lingering pain of the 1:10 reverse split still causes some sleepless nights, but, from a strategic standpoint, the r/s provided some much-needed ammunition in times of need, leaving a considerably low share count that can raise significant capital at current or even discounted prices. Far removed from the threat of being delisted, PTX now trades at roughly $3.90 a share, battling back feverishly from the previous month trading lows of $2.74. Additionally, with approximately 9.5 million shares outstanding, PTX has a plethora of options available to them to keep the momentum going, inclusive of favorable court decisions, a stout IP portfolio and a pipeline of franchise quality drugs that can return considerable value shortly. For the number hawks, PTX is scheduled to announce Q4 earnings next Tuesday, so expect that a lot of trading eyes will be focused toward PTX on that day, with perhaps more funneled interest in management’s comments than they have in results from months past.

Yes, I want to hear about growth and continued traction in the currently marketed drugs, but, indeed, investors are looking to understand considerably more about the hardball being played with creditors. Investors want guidance as to the impact of the recent court decisions and the strategic options that are now in play based on the company prevailing in the Zohydro ER ANDA litigation.

For those that were not paying attention, in late February, PTX announced that they had received a favorable opinion in its litigation with Actavis Laboratories FL, Inc. regarding a proposed generic version of Zohydro ER. In a release by PTX, the company stated, “Judge Gregory M. Sleet of the United States District Court for the District of Delaware concluded that Actavis’ proposed generic versions of Zohydro ER infringe U.S. Patent Nos. 9,132,096 (which expires on September 12, 2034) and 6,902,742 (which expires on November 1, 2019) following a trial that took place in October 2016. The Judge has entered an order enjoining Actavis from engaging in the commercial manufacture, use, offer to sell, or sale in the United States, or importation into the United States of Actavis’ Abbreviated New Drug Application (ANDA) product prior to expiration of the two patents. Actavis did not assert invalidity or unenforceability of the patents at trial.”

Not only was the decision a potential windfall for PTX, but it also served to validate the strength and longevity of the Zohydro ER patent portfolio. It further allows PTX to advance the Zohydro franchise well into the future, without the continued overhang of litigation and uncertain legal opinions. For investors, the decision acted as a pressure valve release, and the stock has been on an ascent ever since. The patents are strong, and the litigation appears to be ending. Both patents are listed in the FDA’s “Orange Book” for Zohydro ER and are licensed to Pernix by Recro Gainesville LLC. Recro and another generic pharmaceutical manufacturer, Alvogen Malta Operations Ltd., filed a stipulation of dismissal last year ending a patent infringement lawsuit Recro filed against Alvogen concerning its proposed generic version of Zohydro ER. Thus, for the time being, we, the shareholders and PTX, are free at last.

Some Good, Some…Not So Good

Those that have kids know that way too often after a child has one of these strong belly laugh attacks, it is quite frequently followed with a voracious cry. I’m not sure why we were created in that fashion, but perhaps it’s because our maker wanted to make sure we knew that there was balance in life.

Such was the case at PTX when investors were told that the company had lost its arbitration case. On February 3, 2016, PTX announced that “On January 31, 2017, the arbitration tribunal issued opinions in favor of GSK, awarding it damages and fees in the amount of approximately $35 million, plus interest (estimated to be approximately $2 to $5 million). The tribunal also denied Pernix’s claim that GSK breached its obligations under the supply agreement. Pernix has already paid to GSK, or into an escrow account, an aggregate of $16.5 million, which will offset the total award. Pernix is reviewing the opinions, including the amount of interest, and intends to work with GSK to conclude the matter.

As of February 1, 2017, Pernix’s unaudited cash balance was approximately $26 million, after making the scheduled payment of interest and principal in respect of its Treximet secured notes on such date.”

On that day, the sun was definitely not shining on my face. But, balance reared its beautiful face and by the time February ended, the sun was not only shining back on my face but the company’s primary cash cow, Zyhodro ER was fully back in play.

Such is life; you win some, you lose some. But, by the time February came to a close, PTX, at least in my opinion, is in a better place than at the start of the year. Removed are the storm clouds of legal uncertainty. And, with a clear path for Zyhodro ER, PTX can cut a deal on the remaining $18.5 million owed and concentrate on rebuilding the PTX brand and continue to deliver product traction and better financial results.

Where To Now

PTX is not alone in the quest to be reincarnated as a beautiful stock. There are more than a handful of other drug stocks that have a similar story, Valeant Pharmaceuticals (VRX), Infinity Pharmaceuticals (INFI), and Portola Pharmaceuticals (PTLA), just to name a few. And, like PTX, both Infinity and Portola have rallied back hard since the beginning of 2017. As for Valeant, the market, and Congress, still needs a poster child, and they seem to have monopolized that position, for now, sliding over 50% lower since the beginning of the year. Seeing that there can still be some good in the bad, though, gives me hope. And, if there were a way to siphon and share some of that good karma away from Infinity and Portola, I would.

Maybe I am just an eternal optimist, but I no longer obsess about past PTX transgression and focus even less on waiting for new skeletons to materialize from PTX attic. Heck, PTX is its own concern, not a subsidiary of the Bates Motel. Investors, myself included, may finally be able to take a breath of fresh air and give PTX management the time necessary to fully right this ship and create shareholder value.

If they want to spook the creditors, I’m all for it, sell a couple of million shares when needed, shore up the balance sheet and let the predators understand that the value in PTX is there for the taking, but at prices far more than the current value. The Gordon Gecko, Blue Star Airline approach to conquer and divide is so totally 1980’s. Scrapping the pieces of a viable company is old school mentality. Investors today understand that while in extreme cases of distress, perhaps breaking up small pieces and salvaging them at pennies on the dollar makes sense. But, there can’t be an argument made that doing the same at PTX makes sense.




PTX has a franchise drug in place, a well fortified IP portfolio, and a decent cash balance that can carry the company forward during the next round of investor “fake news” and general market turmoil. PTX management are not new kids on the block, and they will ultimately deliver back shareholder value, and rightfully so since that’s what they get paid to do. While high double-digit share prices may very well be a thing of the past, once management clearly proves that the company is indeed tracking in the right direction and churning all the pistons, then it is not unimaginable to believe that share prices won’t be printed at considerably higher prices than where they are today.

I can take criticism, and I can take a loss. But, just because I can handle it does not mean that I deserve it. I’m not the only believer in a PTX turnaround, and by the way the share price has been acting during the past month, many investors are also alive and well in the PTX long camp. When stocks tick higher, retail investors are typically the last to know why, it’s for that reason that investors should keep a close eye on volatility and understand that erratic stock behavior isn’t necessarily a bad sign, rather it’s often a sign of significant news to come.

Admitting the problem is the first step in any recovery process. PTX management has admitted to having a problem long ago. Since then, they have been working on a solution and from an investor’s point of view, appear to be making significant progress. For me, I can’t abandon a work in progress, and as long as I believe that PTX is working diligently on a favorable solution and has a long-term vision for the company, hanging tight may be worth my while.

In the meantime, I’ll stay long and stay patient, and if the stock continues to get beaten around, all I can say at that point is, “please sir, may I have another.”

Disclosure: This article was written by Kenny Soulstring, and it reflects my own opinions and unique articulation. This article is not intended to offer investing advice, guarantee 100% accurate predictions or to be interpreted as providing a personal recommendation. What I can guarantee, though, is accurate research, thoughtful analysis and an enthusiasm about any stock that I cover.

I wrote this article myself and it includes my own research and expresses my own opinions. I am not receiving compensation for it (other than from CNA Finance). I have no business relationship with any company whose stock is mentioned in this article.

Additional Disclosure: I am long PTX and may purchase additional shares within the next 72 hours.

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Achillion Pharmaceuticals, Inc. ACHN Stock News

Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN)

Achillion Pharmaceuticals is having a strong start in the pre-market hours today, and for good reason. The commpany has been issued a patent. As a result, the stock is soaring, and as soon as the gains started, our partners at Trade Ideas alerted us of the movement. At the moment (8:34), ACHN is trading at $4.00 per share after a gain of $0.16 per share or 4.17% thus far today.





ACHN Awarded Patent

As mentioned above, Achillion Pharmaceuticals is having a strong time in the market after being awarded a patent. The patent surrounds compositions of matter for compounds that inhibit complement factor D activity. This is a key mediator in the complement alternative pathway, also known as AP. In a statement, Millind Deshpande, Ph.D., President and CEO at ACHN had the following to offer with regard to the patent…

Achillion’s aim is to establish a broad patent portfolio for its complement program. With the granted of this first patent we are pleased that the USPTO has confirmed that Achillion possesses a multitude of patentable complement factor D inhibitors… As a leader in AP biology, we are proud to have been the first to clinically demonstrate, in healthy volunteers, the ability to suppress AP activity following oral dosing of our complement factor D inhibitor, ACH-4471. The receipt of this patent, along with the number of additional patent applications under review by the USPTO, strengthens our position as a leader in factor D inhibitors for the potential treatment of AP-mediated diseases, such as C3G, PNH and geographic atrophy.”




What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be watching ACHN incredibly closely. In particular, we’re interested in following the company’s ongoing work with regard to ACH-4471. Nonetheless, we’ll continue to follow the story closely and bring you the updates as they break.

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Where do you think ACHN is headed moving forward?

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Thought Leader Discussions

Gevo, Inc. GEVO Stock News

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Gevo, Inc. (NASDAQ: GEVO) Before we get into this interview, I'd like to extend a special thanks to my friend Joey who both set up the...