Biotech

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TherapeuticsMD Inc TXMD Stock News

TherapeuticsMD Inc (NYSEMKT: TXMD) is off to an incredibly rough start in the pre-market hours this morning, and for good reason. The company provided an update with regard to their activity with the United States Food and Drug Administration surrounding TX-004HR. Unfortunately, the update simply wasn’t what investors were expecting. In fact, Adam Feuerstein tweeted that the “update didn’t read well.” As a result, fear struck investors, leading to declines in the value of the stock and prompting our friends at Trade Ideas to alert us to the movement. At the moment (8:50), TXMD is trading at $5.00 per share after a loss of $0.63 per share (11.19%) thus far today.





TXMD Provides Regulatory Update

As mentioned above, TherapeuticsMD issued a PR today, updating investors with regard to conversations it’s having with the FDA surrounding TX-004HR. TX-004HR is the company’s investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse.




In the PR, TXMD said that it participated in a Type A Post-Action Meeting with the Division of Bone, Reproductive, and Urologic Products of the United States Food and Drug Administration on Friday. The purpose of the meeting was to discuss the Complete Response Letter, or simply CRL, that was received surrounding the treatment. Through the meeting, TXMD said that it had presented new information that they believe could address concerns by the FDA in the CRL and possibly help to push TX-004HR to NDA approval.

In the PR, investors learned that TherapeuticsMD has received the minutes of the meeting, and upon the request of the FDA, has formally submitted the new information for consideration. The PR goes on to explain that productive dialogue is continuing with the FDA but there has not been a formal timeline offered with regard to the conclusion of the review. However, the most interesting line in the TXMD PR reads as follows:

The Company looks forward to working with the FDA to address its concerns regarding the NDA for TX-004HR and reserves the right to pursue the FDA’s formal dispute resolution process if a reasonable timeline to address such concerns cannot be established.”

With the line above, Feuerstein may have hit the nail on the head. The PR reads like there may be a hefty debate surrounding the TXMD CRL, one that could be a signal that the treatment isn’t going to be approved, or at least isn’t going to be approved any time soon.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on TXMD. In particular, we’re interested in following the company through the process of working to get TX-004HR to market. While things don’t look so great right now, anything can happen moving forward. We’ll continue to follow the story closely and bring the news to you as it breaks!

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Biocept Inc BIOC Stock News

Biocept Inc (NASDAQ: BIOC) was off to a strong day in the pre-market this morning, and for good reason. The company announced the launch of a new liquid biopsy test. However, at the bell, the stock started finding its way downward, leading it to the red. As is normally the case, our friends at Trade Ideas were the first to alert us to the movement. At the moment (10:28), BIOC is trading at $1.56 per share after a loss of 0.16% thus far today. Below, we’ll talk about the new test, why it could lead to great things ahead, and what we’ll be watching for moving forward.





BIOC Launches New Liquid Biopsy

As mentioned above, Biocept is having a strong day in the market today after announcing the launch of a new liquid biopsy test. This test in particular uses a progesterone receptor or PR, which can be used for the detection and monitoring of a key biomarker in the blood of patients with breast cancer. In a statement, Michael Nall, President and CEO at BIOC, had the following to offer…




We now have 14 commercially available liquid biopsy assays as we execute on our initiative to expand our product menu of non-invasive, cost-effective biomarker tests… Our goal is to offer tests to detect and track all clinically actionable biomarkers listed in the NCCN Guidelines® for solid tumors, which we believe is a compelling value proposition for Biocept in the liquid biopsy market.”

Why This Is Such Big News

At the end of the day, BIOC is a company that’s focused heavily on the liquid biopsy market. Throughout the past several years, the company has been working hard to bring new, non-invasive tests to the market for the screening of cancer, and they have been overwhelmingly successful in the process.

This is great news as a liquid biopsy is a non-invasive test. After all, if your doctor was worried that you may have cancer, would you rather him draw a little blood or go in for an exploratory surgery in an attempt to take a sample from what is believed to be a tumor? The answer is a no-brainer! At the end of the day, the more of these tests BIOC can get into the market, the better their chances of dominating it.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on BIOC. In particular, we’re interested in following the ongoing developments surrounding new biopsy tests the company is launching. We’re also interested in seeing how the new test announced today equates to revenue in the future. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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MannKind Corporation MNKD Stock News

MannKind Corporation (NASDAQ: MNKD) is having a great start in today’s trading session, and for good reason. Yesterday, the company announced that it has brought in a new Chief Commercial Officer, exciting investors and leading to gains. As is almost always the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (10:10), MNKD is trading at $1.39 per share after a gain of $0.07 per share or 5.31% thus far today. Below, we’ll talk about the new addition to the team, why this is such a big deal for the company, and what we’ll be watching with regard to MNKD ahead.





Patrick McCauley Joins The MNKD Team

As mentioned above, MannKind Corporation is having a strong day in the market today after announcing that Patrick McCauley, J.D., M.B.A., has become the new Chief Commercial Officer at the company. Ultimately, his responsibilities surrounding leading commercial operations at MNKD on a global level.




At the end of the day, this is a great thing for MNKD and its investors. After all, McCauley brings with him more than 25 years of industry experience. Over the past 12 years, he worked with Astellas Pharma in a series of senior sales and compliance leadership roles, each with more responsibilities than the last. He’s also played a role at Yamanouchi Pharma, DuPont Pharmaceuticals, and Bristol-Myers Squibb. In a statement, Dr. Castagna, CEO at MNKD, had the following to offer…

Pat is an exceptional addition to our executive leadership team and he will be a huge asset for us as we transform MannKind into a world class company… I expect Pat will help us to accelerate the growth of Afrezza and pipeline products to come, and position our company to deliver strong results in the years ahead.”

Mr. McCauley followed up with a statement of his own, saying…

MannKind’s future is undoubtedly bright and I am thrilled to be part of the company. Afrezza is an innovative product with the attributes that I believe can provide benefits to patients battling diabetes in this unfortunately large area of unmet medical need.”

Why This Is So Important For The Company

At the end of the day, Mr. McCauley joining MNKD is incredibly big news. The reason for this surrounds afrezza. You see, MNKD received approval for afrezza quite a while ago. When they did, they contracted out commercialization, which didn’t work too well. From there, they went on to work on their own commercialization efforts, which have yielded relatively little in the grand scheme of things.

However, when you get knocked down, you have to get back up, and that seems to be exactly what MannKind is doing by bringing Mr. McCauley on the team. Ultimately, MNKD has decided to bring in a key player, one with great industry experience and the talent to get the job done. At the end of the day, this is great news for the company.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on MNKD. In particular, we’re interested in following Mr. McCauley and excited to see how he revamps the company’s commercialization efforts surrounding afrezza. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Pernix Therapeutics Holdings Inc PTX Stock News

Pernix Therapeutics Holdings Inc (NASDAQ: PTX) is off to an incredibly strong start in the trading session this morning, and for good reason. On Thursday, news of a crackdown on those involved in the opioid epidemic in the United States broke, leading to excitement surrounding the stock, and sending it upward. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (9:32), PTX is trading at $5.13 per share after a gain of $0.37 per share or 7.77% thus far today. Below, we’ll talk about what’s going on with the opioid epidemic, why this is good for PTX, and what we’ll be watching for ahead.





PTX Benefits From Opioid Crackdown

As mentioned above, Pernix Therapeutics is having a strong start to the trading session this morning as more news breaks with regard to the opioid epidemic in the United States. This time, the Justice Department announced a massive crackdown in which more than 400 people found themselves in some serious trouble for medical fraud.




Ultimately, the crackdown focused on doctors who prescribed what authorities believe to be unnecessary opioid related medications. The crackdown also focused on medical facilities that authorities believe preyed on addicts in order to make money, but in the process, worsening their conditions.

Why This Is Great News For Pernix

At first glance, it may seem as though this news has nothing to do with PTX. However, that notion couldn’t be further from reality. The fact of the matter is that Pernix Therapeutics has Zohydro ER. For those of you who haven’t been following Zohydro ER is a treatment designed to help manage pain. However, it is not an opioid-based treatment. Instead, PTX focused on creating a treatment that would combat pain without creating an addiction, and that’s exactly what they’ve done.

Ultimately, as the opioid epidemic continues to grow in the United States, we’re likely to see more and more doctors doing their best to give patients treatments that will not create addiction issues. Because Zohydro ER is one of those treatments, it only makes sense that while the authorities focus on the epidemic, PTX will start to see stronger sales.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on PTX. In particular, we’re interested in following the story surrounding the opioid epidemic crackdown and seeing how this news relates to stronger Zohydro ER sales. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Delcath Systems, Inc. DCTH Stock News

Delcath Systems, Inc. (NASDAQ: DCTH) is having a bit of a rough time in the market today. The blame for the losses can partly be placed on an article that was published on Seeking Alpha by White Diamond Research. In response to the article, I, Joshua Rodriguez, have decided to personally do a write up, as the idiots behind the cloak by the name of “White Diamond Research” decided to defame my business in their most recent article.





White Diamond Research Simply Can’t Be Trusted

In a post that was published on Seeking Alpha yesterday, White Diamond Research laid out a bearish argument for Delcath Systems. While I will admit that some of their points were valid, and if things would have gone differently I would have loved to debate with them until I was blue in the face, I have to say their research simply can’t be trusted.




In their explanation of why DCTH went from $0.02 to $0.20 per share over the past couple of months, White Diamond Research said that this was the result of paid stock promotion (something that is completely illegal without proper disclaimers). In particular, they said that CNA Finance was being paid to promote DCTH. Here’s a quote from their article…

Part of the reason why DCTH went from $0.02 to $0.20 within a couple months, before falling to $0.14, is from promotional stock websites. CNAFinance.com is one of the promoters. See its DCTH articles here.”

The article went on to quote our disclaimer, which can be viewed on the right sidebar of every page of our website, using it as evidence that we were paid by DCTH. While I will admit that we are sometimes approached and indeed paid to provide public research with regard to a stock, that is not the case here. In fact, we haven’t been paid a dime by DCTH. If we were, you would have seen an additional disclaimer at the end of the articles written about the company that explained that we were indeed paid, the amount of the payment, and who the payment came from… you know… general, ethical business practice!

Interestingly enough, as a business we keep record of who paid us, when, and for what. Had White Diamond Research pulled their figurative head out of their figurative A$$ and gave us a call, we would have provided them with detailed information on every company that has paid us and for what over the past year. However, they didn’t do that, and for that they should be ashamed.

Why I’m Excited About Delcath Systems

As mentioned above, the articles we have written surrounding DCTH have nothing to do with payment. My team and I have not received a single penny, share, or any other form of reimbursement for the articles we have written surrounding the company. So, why is it that I’m so excited about Delcath? Here’s why…

In a previous article on the company, I explained that I am excited about the fight us mere humans have waged against cancer. I lost my aunt, uncle, and stepfather to the illness, and I’m sure most reading this have lost someone they loved to it as well. During the battle, I had the opportunity to see how this disease tears down the body, mind, and soul. I witnessed agonizing pain, much of which was caused by the medication that was used to fight the illness.

Then, I was researching the latest and greatest in oncology a few months ago, and I came across DCTH. I dug in and was intrigued to say the least. You see, if you happen to have cancer and head for chemotherapy right now, you will receive treatment that invades your entire body. However, DCTH has found a way to target specific organs through catheter systems, which, in my opinion, is not only likely to improve efficacy of what we know as chemotherapy today, but also safety of the treatment.

Does Delcath have some work to do on the financial side of the coin?  Sure they do. Have they made all the right moves in the history of their company? Absolutely not!  I don’t know of any company that has. But are they worth your time? Absolutely! Here we have a company that has an approved treatment that is saving lives in Europe. They are working on 2 Phase 3 studies in the United States as we speak, and while some information may not be so positive surrounding the company, there’s no such thing as perfection – we’re all human!

The Bottom Line

The bottom line here is that I would love to be paid to get behind a great company like DCTH. However, I, nor anyone else on the CNA Finance team, has been paid a penny by the company, it’s IR firm, or anyone associated with the company. So, why do I get behind them? Because they’re a great company!

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Valeant Pharmaceuticals Intl Inc VRX Stock News

Valeant Pharmaceuticals Intl Inc (NYSE: VRX) is having a great start to the trading session this morning, and for good reason. The company announced the redemption of Senior Notes. Of course, this led to excitement among investors, causing gains in the value of the stock and prompting our friends at Trade Ideas to alert us to the movement. At the moment (9:43), VRX is trading at $17.59 per share after a gain of $0.60 per share (3.53%) thus far today.





VRX Announces Redemption Of Senior Notes

As mentioned above, Valeant Pharmaceuticals is having an incredibly strong start to the trading session this morning after announcing that it will be redeeming Senior Notes. In fact, the company said it would be redeeming the remaining approximately $500 million aggregate principal amount of its outstanding $6.75 Senior Notes that are due in 2018. In order to do so, the company will use cash on hand and will issue an irrevocable notice of redemption today.




Once the notes are redeemed, VRX will have cut a big chunk out of its outstanding debt, reducing it by more than $4.8 billion since the end of the first quarter of 2016. Once the notes are redeemed, the company will have no significant debt maturities as well as no mandatory amortization requirements through the year 2019. In a statement, Joseph C. Papa, Chairman and CEO at VRX, had the following to offer:

By redeeming these Notes, we will be close to achieving our expectation of paying down $5 billion of debt from divestitures and free cash flow within 18 months of August 2016… We are confident we will not only meet, but also exceed our debt reduction commitment early.”

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on VRX. In particular, we’ll continue to follow the company’s efforts in paying down $5 billion debt on a deadline – something they are doing well with so far. We’ll continue to follow the story closely and bring the news to you as it breaks!

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Delcath Systems, Inc. DCTH Stock News

Delcath Systems, Inc. (NASDAQ: DCTH) isn’t having the best of days in the market today. In fact, the stock is down, causing Trade Ideas to alert us to the losses. So, what’s the deal? Well, it all has to do with news, or lack thereof. We’ll get into that in a minute. At the moment (11:57), DCTH is trading at $0.17 per share after a loss of $0.01 per share (3.50%) thus far today.





DCTH Hasn’t Released News Recently

Delcath Systems is one of those companies that generally releases news quite regularly. In fact, it’s overwhelmingly rare to go more than a few weeks with silence. However, in recent weeks, we have heard nothing by way of updates from DCTH. So, it’s no surprise that as I strolled StockTwits, Twitter, and various message boards, I’ve seen various posts talking about the lack of news, and the idea that this lack of news was concerning.




Well my friends, I beg to differ. While it is nice to have management consistently putting news out about their company, there are going to be quiet periods, no matter how proactive the company is. At the end of the day, before big news comes out, there’s generally a quiet period where investors don’t hear a peep out of the company.  That’s OK, that’s all part of the investing game, my friends.

Could There Be Big News Around The Corner?

The truth is that DCTH hasn’t been completely quiet. In fact, the company released an amended 8K today, but that was nothing new. The amendment was in a disclosure and the news surrounding the 8K was already known. So, could there be big news coming soon? In my opinion, you can bet your bottom dollar on it!

At the moment, Delcath Systems is working on 2 Phase 3 clinical trials. The first of these trials surrounds their Melphalan/HDS treatment and the second surrounds the percutaneous hepatic perfusion option of treatment for patients with intraheptic cholangiocarcinoma. Considering the fact that both of these trials surround treatments with overwhelmingly positive early-stage results, it only makes sense that the results from these trials will likely be overwhelmingly positive as well.

Think About It From The Company’s Perspective

The truth is we all know that DCTH is all about getting their news out there. In fact, it actually seems as though they enjoy communicating with investors… shouldn’t all companies? So, when we put ourselves in their shoes with regard to lack of news releases, it’s clear that something is happening. Why would they go quiet? Well, it’s likely because there is some big clinical news that will soon be released! Chances are that this quiet period is as painful to the company’s management as it is to their investors.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on DCTH. After all, we are impressed with the CHEMOSAT product that’s already been approved in Europe and excited to see the results from the trials that are already ongoing. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Ocular Therapeutics Inc OCUL Stock News

Ocular Therapeutics Inc (NASDAQ: OCUL) is having a rough day in the market today, there’s no doubt about that. However, the declines actually all happened last night when the company received a Complete Response Letter (CRL) from the FDA surrounding Dextenza. Today, the stock has actually been finding its way upward from the bottom. This begs a big question, “Is this a buying opportunity?”





FDA Offers CRL Surrounding Dextenza

As mentioned above, Ocular Therapeutics isn’t off to the best of starts in the market today, following massive after-hours declines in the stock yesterday. The declines were ultimately the result of a CRL released by the FDA surrounding Dextenza. Dextenza is an ocular steroid that is designed to give the patient a full course of steroids after an operation.




In the letter, the FDA informed OCUL that they were unable to approve the treatment as of yet, offering up key points that need to be addressed before an approval can happen. In response to the CRL, Amar Sawhney, Ph.D., CEO, President, and Chairman at OCUL, had the following to offer:

We are evaluating the FDA’s response and plan to work closely with the agency in an effort to satisfy the requirements related to the NDA… Importantly, there were no clinical issues identified in the CRL pertaining to efficacy or safety related to the post-surgical pain indication. We believe that DEXTENZA can be approved once these open manufacturing items are resolved.”

Is This Really A Buying Opportunity?

In my opinion, the declines that we saw last night do indeed present a strong buying opportunity. The reason is relatively simple. The FDA didn’t reject the treatment because of anything that had to do with safety or efficacy. In fact, the treatment proved to be effective and relatively safe. The issue the FDA had with the treatment surrounded manufacturing. At the end of the day, these are very easy issues to resolve in the grand scheme of things. Ultimately, there’s nothing wrong with Dextenza, and OCUL knows it – the problem is in manufacturing.

As a result, I would go out on a line and say that chances are that Dextenza will eventually find its way to approval. As a result, we find ourselves in the midst of a waiting game. However, while we wait, we might as well earn, right? With OCUL trading on incredible lows and fear being high, now is the time to strike if you have the stomach for it!

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to follow OCUL incredibly closely. In particular, we’re interested in following the company’s continued work to bring Dextenza to the market. We’ll continue to follow the story closely and bring the news to you as it breaks!

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Cara Therapeutics Inc CARA Stock News

Cara Therapeutics Inc (NASDAQ: CARA) is off to an overwhelmingly strong day in the market today, and for good reason. The company released results from a Phase 1 clinical trial, and those results proved to be overwhelmingly promising. As a result, investor excitement ensued, leading to gains in the stock and prompting our partners at Trade Ideas to alert us to the movement. At the moment (9:31), CARA is trading at $14.19 per share after a gain of $1.63 per share (12.98%) thus far today.





CARA Gains On Clinical Data

As mentioned above, Cara Therapeutics is having an overwhelmingly strong day in the market today after releasing Phase 1 clinical data. The data surrounded the Phase 1 safety and pharmacokinetic trial of Oral CR845, a treatment designed for patients with chronic kidney disease that are undergoing hemodialysis.




According to the release by the company, the Phase 1 clinical results show that all four tablet strengths were generally well-tolerated when administered either daily or after dialysis three times per week. It was also announced that on the pharmacokinetic side, top-line data analysis indicated that plasma levels of CR845 attained after oral administration in all doses were comparable to or exceeded those reached with clinically efficacious intravenous doses of CR845. In a statement, Frederique Menzaghi, Ph.D., Vice President of Research and Development at CARA, had the following to offer:

We are pleased to establish that plasma levels of CR845 attained with oral tablets equaled or exceeded plasma levels previously associated with clinically efficacious I.V. CR845 doses in hemodialysis patients with moderate-to-severe CKD-associated pruritus…. These data will inform the design of our planned Oral CR845 pruritus clinical program in the non-dialysis CKD-ap population, which we aim to initiate later this year.”

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on CARA. In particular, we’re interested in following the ongoing work the company is doing with regard to CR845 and excited to see the results of future clinical trials. We’ll continue to follow the story closely and bring the news to you as it breaks!

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Ocular Therapeutics Inc OCUL Stock News

Ocular Therapeutics Inc (NASDAQ: OCUL) is likely going to have a rough time in the market after-hours today and throughout the day tomorrow. That’s because a CRL was just released by the FDA announcing a rejections. At 4:35, OCUL was halted ahead of the news, trading at $7.55 per share. Shortly after the CRL was released, the stock resumed and fell dramatically. Currently (5:31), OCUL is trading at $5.26 per share after a loss of $2.34 per share or 30.79% thus far today.





OCUL Rejected

As mentioned above, the FDA recently released a Complete Response Letter or CRL, announcing that it has rejected a recent New Drug Application filed by Ocular Therapeutics. Dextenza was a treatment that was designed to deliver a complete course of steroids to the eye following an ocular procedure.




Recently, OCUL asked the FDA for an extended review surrounding the treatment. However, they obviously did not get what they wanted. Just minutes ago, the FDA released a complete response letter, informing the company and its investors that they have made the decision to reject the treatment. In a statement, OCUL President, CEO and Chairman, Amar Sawhney, Ph.D, had the following to offer…

We are evaluating the FDA’s response and plan to work closely with the agency in an effort to satisfy the requirements related to the NDA… Importantly, there were no clinical issues identified in the CRL pertaining to efficacy or safety related to the post-surgical pain indication. We believe that DEXTENZA can be approved once these open manufacturing items are resolved.”

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on OCUL. In particular, we’re interested in how the company reacts to the rejection by the FDA. In particular, the company says that it does believe that it can get the treatment approved, but how long will this take and what steps will be taken to make this happen? Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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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...