Biotech

0 516
CEL-SCI Corporation CVM Stock News

CEL-SCI Corporation (NYSEMKT: CVM) is off to an overwhelmingly rough day in the market today, and for good reason. The company informed investors that a clinical hold has been put on a key Phase 3 clinical trial by the FDA. This led to fear among investors, sending the stock sliding down and prompting our partners at Trade Ideas to alert us to the losses. At the moment (8:35), CVM is trading at $0.08 per share after a loss of $0.04 per share (32.19%) thus far today.





CVM Falls On Clinical Hold

As mentioned above, CEL-SCI Corporation is having a rough time in the market this morning after announcing that the FDA has placed a clinical hold on a key Phase 3 clinical trial. The trial is assessing Multikine (Leukocyte Interleukin, Injection) for the treatment of head and neck cancer. As a result of the clinical hold, all dosing of the treatment must stop immediately.




In a statement, the company explained that all participants already enrolled have completed the planned treatment schedule. As a result, the FDA clinical hold will only pertain to new enrollments. Nonetheless, for the time being, CVM will no longer be able to move forward with the study.

Stop wasting your time! Find winning trades in minutes with Trade Ideas!

What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on CVM. In particular, we’re interested in learning more about the clinical hold and watching to see if this hold is lifted any time soon. We’ll continue to follow the story closely and bring the news to you as it breaks!

Never Miss The News Again

Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!

Subscribe Today!

* indicates required









0 1343
Inovio Pharmaceuticals INO Stock News

Inovio Pharmaceuticals Inc (NASDAQ: INO) is off to an incredibly strong day in the market today, and for good reason. The company released results with regard to its HIV Vaccine, showing a nearly 100% immune response rate. Of course, this led to excitement among investors, pushing the stock upward and prompting our partners at Trade Ideas to alert us to the gains. At the moment (8:24), INO is trading at $11.04 per share after a gain of $3.91 per share (54.84%) thus far today.





INO Gains On HIV Vaccine Results

As mentioned above, Inovio Pharmaceuticals is having an incredibly strong day in the market today after announcing that its HIV vaccine, known as PENNVAX®-GP, produced a very strong immune response rate in clinical subjects.

In a press release early this morning, INO said that 71 out of 76 evaluable vaccinated participants showed a CD4+ or CD8+ cellular immune response to at least one of the vaccine antigens. 62 out of 66 of the treated individuals also demonstrated an env specific body response. On the placebo arm, no response was seen on the cellular or antibody level.




According to the release, among the evaluated participants that received PENNVAX-GP and IL-12 via IM vaccination, 100% demonstrated a cellular response and 90% demonstrated an env specific antibody response. In a statement, Dr. J. Joseph Kim, President and CEO at INO, had the following to offer:

These results are among the highest ever responses we’ve seen with an HIV vaccine, and they are remarkably consistent with our recent data reported from our Ebola, Zika and MERS clinical trials in terms of demonstrating nearly 100% vaccine response rates with very favorable safety profile. Furthermore, our newer and more tolerable intradermal vaccine delivery device showed that we can elicity very high immune responses at a much lower dose. We look forward to advancing PENNVAX-GP into later-stage clinical development with our partners and collaborators.”

Stop wasting your time! Find winning trades in minutes with Trade Ideas!

What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on INO. In particular, we’re interested in watching continued work surrounding PENNVAX-GP as the vaccine seems to be overwhelmingly effective. We’ll continue to follow the story closely and bring the news to you as it breaks!

Never Miss The News Again

Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!

Subscribe Today!

* indicates required









0 1437
CytRx Corporation CYTR Stock News

CytRx Corporation (NASDAQ: CYTR) is having a relatively rough start to the trading session today after yesterday’s run toward the top. After a run, we tend to see cold feet among investors, who push the stock down to a more reasonable price. That seems to be what’s happening now, which caused our partners at Trade Ideas to alert us to the losses. At the moment (10:24), CYTR is trading at $0.52 per share after a loss of $0.03 per share (5.60%) thus far today. Nonetheless, it’s probably not a bad idea if you’re considering buying this dip. In fact, there are two catalysts ahead in the short term.





CYTR Catalyst #1: June 2 – 6 Data Release

The first catalyst that’s coming surrounding CytRx Corporation is the release of clinical data. The company said it will soon be offering two abstract presentations at the 2017 American Society of Clinical Oncology Annual Meeting that will be taking place between June 2nd and June 6th. Of course, this could definitely move the stock, as positive clinical data generally does.

The first bit of data to be released comes from a key Phase 3 clinical trial. During the global trial, CYTR evaluated aldoxorubicin in comparison to the investigator’s choice in patients with relapsed and refractory soft tissue sarcomas (STS).




The second bit of data that the company plans to release surrounds a Phase 1 / 2 clinical trial. During this clinical trial, the company is combining aldoxorubicin with infosfamide/mesa (I-M). The treatment is designed as a first-line and second-line treatment for STS. In a statement with regard to the CYTR data release, Daniel Levitt, M.D., Ph.D., CEO and CMO at CytRx Corporation, had the following to offer:

The data from both of these important clinical trials evaluating aldoxorubicin in sarcomas, along with our several other completed clinical and preclinical studies, will form the basis of our planned New Drug Application submission to the U.S. Food and Drug Administration, and we are pleased to share these more mature and detailed results in this peer-reviewed forum with the medical and scientific communities.”

Stop wasting your time! Find winning trades in minutes with Trade Ideas!

Catalyst 1 | Catalyst 2 | Next Page

Never Miss The News Again

Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!

Subscribe Today!
* indicates required









0 337
EnteroMedics Inc ETRM Stock News

EnteroMedics Inc (NASDAQ: ETRM) is having an overwhelmingly strong start to the trading session this morning, and for good reason. The company has announced that it has acquired BarioSurg. This led to excitement among investors, causing gains and prompting our partners at Trade Ideas to alert us to the movement. At the moment (9:24), ETRM is trading at $6.07 per share after a gain of $1.48 per share or 32.24% thus far today.





ETRM Acquires BarioSurg

As mentioned above, EnteroMedics is having a strong day in the market today after announcing that it has acquired BarioSurg, Inc. BarioSurg is the investor of Gastric Vest, an investigational, minimally-invasive, laparoscopically implanted medical device. Lining up with the ETRM vBloc, Gastric Vest is designed to help treat morbid obesity.




The Gastric Vest device is wrapped around the stomach. Once there, it emulates the effect of conventional weight loss surgery. However, the treatment doesn’t permanently change the patient’s anatomy.

Gastric Vest is also proving to be effective. In fact, in a pilot study that was conducted out of the United States, patients that were treated with Gastric Vest demonstrated a mean percent excess weight loss of 85% after 12 months. This came with an average drop in HbA1c of 2.1 points as well as an average waist circumference reduction of 38 centimeters or approximately 15 inches.

Stop wasting your time! Find winning trades in minutes with Trade Ideas!

1 | 2 | Next Page

Never Miss The News Again

Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!

Subscribe Today!

* indicates required









0 918
CytRx Corporation CYTR Stock News

CytRx Corporation (NASDAQ: CYTR) is off to a relatively strong day in the market today after announcing a coming annual meeting. This led to excitement among investors, pushing the value of the stock upward and prompting our partners at Trade Ideas to send the alert. At the moment (2:56), CYTR is trading at $0.54 per share after a gain of $0.02 per share or 4.14% thus far today.





CYTR Announces Coming Annual Meeting




As mentioned above, CytRx is having an incredibly strong day in the market today after releasing an SEC filing informing investors of a coming annual meeting. The company has invited investors to the 2017 Annual Meeting of Stockholders of CytRx Corporation. The meeting will be held on Wednesday, July 12, 2017 at 10:00 A.M. At the Hotel Bel Air in Los Angeles California. For complete details, see the filing here.

Stop wasting your time! Find winning trades in minutes with Trade Ideas!

What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on CYTR. In particular, we’re interested in seeing the result of this annual meeting. We’re also interested in the coming data presentation that will take place between June 2nd and June 6th. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

Never Miss The News Again

Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!

Subscribe Today!

* indicates required









0 2100
MannKind Corporation MNKD Stock News

MannKind Corporation (NASDAQ: MNKD) is having an incredibly strong day in the market today, and for good reason. One Drop | Plus has been launched. Of course, we’ll get into why that’s a big deal in a minute. Nonetheless, this launch led to excitement among investors who pushed the stock upward. As is almost always the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (12:17), MNKD is trading at $1.32 per share after a gain of $0.19 per share (17.12%) thus far today.





MNKD Gains On Global One Drop Launch

One Drop is becoming a leader in diabetes management, and it’s happening quickly, ultimately benefiting not only the company, but MannKind as well. So far, the digital diabetes management platform has 200,000 users worldwide, and that number is expanding quickly.

Today, MNKD investors were excited to learn of the launch of One Drop | Plus. This is helping One Drop expand its offering in order to better meet the individual needs of people that struggle with pre-, type 1 and type 2 diabetes. The new product is now available in the United States and Europe.




This is overwhelmingly positive news for MNKD, as the company announced a planned collaboration with One Drop earlier this month. This collaboration will provide cost savings and customized coaching content and will lead to innovation with regard to packaging and exploration of a reusable Afrezza inhaler with integrated Bluetooth technology. So, the launch of yet another likely popular One Drop product means that Afrezza will be seen by more and more consumers. With regard to the launch, Jeff Dachis, CEO and Founder of One Drop, had the following to offer:

At One Drop, we are bringing evidence-based diabetes care into the 21st century with seamlessly integrated devices, a fully featured diabetes management app, data-driven insights, and ongoing one-on-one support from dedicated diabetes experts (likely including MNKD experts) – all right on your mobile phone… No one wants more ‘business as usual’ with yet another clunky device in a vinyl zippered case, expensive supplies, or impersonal, reactive, remote diabetes monitoring from a call center. People deserve much better.”

Stop wasting your time! Find winning trades in minutes with Trade Ideas!

What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on MNKD. In particular, we’re interested in following the coming collaboration with One Drop and how this collaboration turns into a profitable opportunity for the company. We’ll continue to follow the story closely and bring the news to you as it breaks!

Never Miss The News Again

Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!

Subscribe Today!

* indicates required









0 538
Amyris Inc AMRS Stock News

Amyris Inc (NASDAQ: AMRS) is having a strong start in the trading session today, and for good reason. The company announced that it has exceeded its debt reduction goal in a big way. As a result, investor excitement ensued, leading to gains in the value of the stock. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (10:23), AMRS is trading at $0.30 per share after a gain of $0.01 per share (4.22%) thus far today.





AMRS Gains On Debt Reduction

As mentioned above, Amyris is off to a relatively strong day in the market today after announcing that it has exceeded its debt reduction goal. On May 8th, the company announced that it intended to reduce debt by around $75 million. Well, here we are, couple of weeks later, and the company has already exceeded that goal. In fact, AMRS said it has already retired $86 million in debt. In a statement, John Melo, CEO and President at AMRS, had the following to offer:




We are pleased to have already exceeded our previously stated goal of reducing our debt by approximately $75 million and to have done so in such a short time… We continue to lead the industry in revenue growth and product sales and are very pleased with the continued expansion of collaborations that provide us with a strong and sustainable product pipeline and commercial execution that we expect will continue delivering very strong product revenue. Our continued operational performance combined with strong cash position and much improved balance sheet enable us to deliver on our growth plan.”

Stop wasting your time! Find winning trades in minutes with Trade Ideas!

What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on AMRS. In particular, we’re interested in following the company’s continued debt reduction work as well as work on collaborations that we believe will lead to more profitable products ahead. We’ll continue to follow the story closely and bring the news to you as it breaks!

Never Miss The News Again

Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!

Subscribe Today!

* indicates required









0 749
Puma Biotechnology Inc PBYI Stock News

Puma Biotechnology Inc (NASDAQ: PBYI) is having an overwhelmingly strong start to the trading session this morning. So strong, in fact, that the stock has already seen 2 volatility halts. The gains are ultimately the result of the FDA review of neratinib, which seems to support the potential approval of the treatment. As a result, investors became excited, sending the stock skyward and prompting our partners at Trade Ideas to alert us to the gains. At the moment (9:58), PBYI is trading at $55.00 per share after a gain of $17.20 per share (45.50%) thus far today.





PBYI Gains On FDA Review

As mentioned above, the FDA recently reviewed Puma Biotechnology’s neratinib. Today, the results of that review were released, which proved to be overwhelmingly positive. In the review, the FDA waged no serious concerns, nor dropped any major landmines.

In fact, in the review, the FDA pretty much concluded that the efficacy of the treatment supported the its potential approval. In a key paragraph from the review text, the FDA had the following to offer with regard to PBYI neratinib:




The applicant conducted a multicenter, randomized, double-blind, placebo-controlled study of neratinib versus placebo in women with early-stage HER2-overexpressed/amplified breast cancer after adjuvant treatment with trastuzumab. There were several major unplanned amendments made to the trial impacting enrollment, the number of iDFS events observed, and the period of patient follow up. The primary analysis showed an improvement with neratinib with an absolute difference in iDFS of 2.8% after a 2-year follow-up [stratified HR: 0.66 (0.49, 0.90); p value: 0.008 ]. Despite the unplanned amendments and potential uncertainty introduced with respect to the magnitude of neratinib effect, based on the sensitivity analyses conducted, the results appear to be generally similar to the primary analysis results, supporting an effect of neratinib. The tolerability of neratinib in this patient population is a concern given the frequent dose interruptions, reductions, and discontinuations observed, mostly due to diarrhea. In Study 3004, nearly all patients experienced any Grade diarrhea and 40% of patients experienced Grade 3 diarrhea. Results from the ongoing Phase 2 Study 6201 suggest that antidiarrheal prophylaxis decreases the incidence and severity of diarrhea.”

Stop wasting your time! Find winning trades in minutes with Trade Ideas!

What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on PBYI. In particular, we’re interested in the ongoing application surrounding bringing neratinib to the market, one which seems as though it’s going overwhelmingly well. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

Never Miss The News Again

Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!

Subscribe Today!

* indicates required









0 254
Biocept Inc BIOC Stock News

Biocept Inc (NASDAQ: BIOC) is having an incredibly strong time in the pre-market trading hours this morning, and for good reason. The company has been awarded a new patent. Of course, this caused excitement among investors who pushed the stock upward. As is almost always the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (9:04), BIOC is trading at $1.73 per share after a gain of $0.30 per share or 20.98% thus far today.




BIOC Receives New Patent

As mentioned above, Biocept is having a strong time in the pre-market hours this morning after announcing that it has been awarded yet another patent. The patent, number 9671407 surrounds the broad use of antibodies for the capture of any target of interest on any solid surface from a sample type. The title of the patent is DEVICES AND METHODS OF CELL CAPTURE AND ANALYSIS. In particular, the targets of interest are primarily circulating tumor cells, sub-cellular vesicles, and exosomes shed by solid tumors that are found in the blood stream.




This is incredible news as this new patent expands intellectual property protection by BIOC in a big way. In fact, as a result of the issuance of the new patent, the company now has 20 patents in the United States and key international territories. In a statement, Michael Nail, President and CEO at BIOC, had the following to offer…

Obtaining new intellectual property distinguishes our platform’s unique and novel features and, in this case, we believe it offers the potential to drive additional value given the broad implications of this patent. We continue to execute on our business plan, as we leverage our proprietary liquid biopsy technology to help physicians obtain actionable biomarker information to improve treatment pathways and patient outcomes.”

Stop wasting your time! Find winning trades in minutes with Trade Ideas!

What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be watching BIOC incredibly closely. In particular, we’re interested in learning the company’s plans surrounding this particular patent. With the broad coverage offered under this patent, the company could use this property as a licensing tool, which could get very interesting. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks.

Never Miss The News Again

Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!

Subscribe Today!

* indicates required









0 1403
Pernix Therapeutics Holdings Inc PTX Stock News

Pernix Therapeutics Holdings Inc (NASDAQ: PTX) has long been a victim of what many publicly traded companies fear… the short attack. The reality is that shorts often distort the true value of a company, and in this particular, case, that’s exactly why the stock is trading at far below the value it should be. Unfortunately, PTX has been the victim of several shorts that hope the stock will fall. However, if you’re on the short side of the coin, you may want to think again. You’re likely playing a very dangerous game.





A Reminder To PTX Shorts

As you know, shorting any stock can be incredibly dangerous. After all, if the stock finds a way to start climbing, well, your losses can be massive. However, Pernix Therapeutics Holdings takes this danger to the next level. The reality is that we’re not talking about whether or not PTX will climb, it’s more of a conversation of when! There’s one big reason that I say that…




John Sedor Is No Spring Chicken!

Quite a while ago, John Sedor took over as the CEO of PTX, a company that at that time was in some serious trouble. The financial picture wasn’t a good one, the sales process lacked direction, and well, Pernix Therapeutics was seemingly falling apart. However, Sedor would soon change all of that, and that’s no surprise. Sedor is a well known expert in the biotech industry that has a history of turning companies around, pushing to gains, and ultimately, selling the company. Well, that’s what we’re seeing…

  • The Turn Around – About a year ago, John Sedor released his plans for company restructuring. He noticed several redundancies in the sales process, which allowed him to restructure this process, leading to higher efficiency for PTX. Of course, higher efficiency means lower cost.
  • Work Continues On Restructuring Debt – When Donald Trump made it to the White House, he continuously reminded the world that he inherited a mess. Well, Sedor found himself in the same shoes. From a financial standpoint, Sedor was handed a hoarder’s house and asked to clean it, which he has done a great job of so far.
  • The Sale – Finally, John Sedor ultimately plans to sell PTX, and these plans are likely to turn into a reality. After all, his track record shows that he has been overwhelmingly successful with regard to walking into crippled companies, preparing them for sale, and ultimately, demanding a strong premium! There’s no reason he can’t do that with Pernix Therapeutics Holdings. There’s also no doubt that this is his plan. In fact, in an outline about future capital requirements, Sedor made it clear that these requirements are dependent on “the extent to which we are able to sell all or a portion of the Company and the prices at which we are able to effect any such sales.”

Stop wasting your time! Find winning trades in minutes with Trade Ideas!

The Bottom Line

The bottom line here is that it’s usually not a good idea to second guess yourself. However, if you’re shorting PTX, this is one of those rare times when it is. If you’re into shorting stocks, you know the danger involved. Well, with PTX, that danger is exacerbated by the fact that a sale is lingering. In order to lose massive amounts of money as a short, all you need to do is short a stock that is destined for gains. In other words, all you need to do is short PTX!

Never Miss The News Again

Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!

Subscribe Today!

* indicates required









Thought Leader Discussions

Gevo, Inc. GEVO Stock News

0 5141
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...