Biotech

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CEL-SCI Corporation CVM Stock News

CEL-SCI Corporation (NYSEMKT:CVM) is having an overwhelmingly strong day in the market today and for good reason. It looks like the company is going to get its hands on a patent it was after. As a result, investor excitement ensued, leading to gains in the stock and prompting our partners at Trade Ideas to send the alert. At the moment (11:17), CVM is trading at $0.14 per share after a gain of $0.04 per share or 36.36% thus far today.





CVM Will Be Getting A New Patent

As mentioned above, CEL-SCI is having a strong day in the market today after announcing that it will be receiving a new European patent on Multikine* (injections of Leukocyte Interleukin). Multikine* is an investigational cancer immunotherapy. The patent that the company will soon receive is titled A METHOD FOR MODULATING HLA CLASS II TUMOR CELL SURFACE EXPRESSION WITH CYTOKINE MIXTURE. In a statement, Geert Kersten, CEO at CVM had the following to offer…




Our patent portfolio for Multikine consists of multiple patents issued in the United States, Europe, China and Japan. In addition to these patents that offer certain protections for Multikine, the method of manufacture for Multikine held by CEL-SCI as trade secret offers additional protections.”

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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 following the company through the ongoing development of Multikine*, as the treatment seems to be promising in early stages. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Novartis AG (ADR) NVS Stock News

Novartis AG (ADR) (NYSE:NVS) is having a relatively rough day in the market today, spending most of the morning in the red. However, that could change due to news that was just released. The FDA has approved Rydapt. At the moment (10:32), NVS is trading at $76.72 per share after a loss of $0.34 per share (0.44%) thus far today.





FDA Approves NVS Rydapt

As mentioned above, the FDA has approved Rydapt by Novartis. The approval is for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3, in combination with chemotherapy. In a statement, Richard Pazdur, M.D., Acting Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and Director of the FDA’s Oncology Center of Excellence, had the following to offer about the newly approved NVS treatment:




Rydapt is the first targeted therapy to treat patients with AML, in combination with chemotherapy… The ability to detect the gene mutation with a diagnostic test means doctors can identify specific patients who may benefit from this treatment.”

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be watching NVS incredibly closely. In particular, we’re interested in the next step, the commercialization of Rydapt, and how the company will go about it. We’ll continue to follow the story closely and bring the news to you as it breaks!

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Radius Health Inc RDUS Stock News

Radius Health Inc (NASDAQ:RDUS) wasn’t off to the best of days early on the in the market. In fact, for the first half hour or so, the stock found itself in the red. However, an FDA approval came down the line minutes ago, exciting investors and sending the stock into the green and beyond. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (10:08), RDUS is trading at $40.60 per share after a gain of $1.88 per share (4.87%) thus far today.





FDA Approves RDUS TYMLOS

As mentioned above, Radius health wasn’t off to the best of days in the market today. That is, until minutes ago when an FDA approval came down the line. Minutes ago, it was announced that the United States Food and Drug Administration has made the decision to approve TYMLOS.




TYMLOS is a human parathyroid hormone related peptide [PTHrP(1-34)] analog. The treatment is indicated for postmenopausal women that are dealing with osteoporosis and are at high risk for fracture. To view the full approved label, click here.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on RDUS. In particular, now that TYMLOS is approved, we’re interested in how the company is going to go about the commercialization process. Of course, there are several companies that would likely love to partner in this venture. We’ll continue to follow the story closely and bring the news to you as it breaks!

Update (10:50): RDUS will be hosting a conference call on Monday to discuss the approval as well as 2017 EPS expectations.

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Neurotrope Inc NTRP Stock News

Neurotrope Inc (NASDAQ: NTRP) is having a pretty good start to the trading session today, and for good reason. The company said that it would be providing the results from key Phase 2 clinical trial incredibly soon. Of course, this led to excitement among investors, causing gains in the stock and prompting our partners at Trade Ideas to send the alert. At the moment (9:53), NTRP is trading at $15.89 per share after a gain of $0.75 per share or 4.94% thus far today.




NTRP To Announce Results Of Alzheimer’s Disease Trial

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As mentioned above, Neurotrope is having a pretty strong start to the trading session this morning after releasing a PR stating that it would be announcing the results from a key Phase 2 clinical trial. The trial is a Phase 2 trial assessing Bryostatin-1 as a treatment for moderate to severe Alzheimer’s disease. Through the trial, the treatment was assessed in 148 patients. The trial results will be released via press release on May 1st at 8:30 am.



What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on NTRP. In particular, we’re interested in the company’s ongoing work with regard to Bryostatin-1. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Ignyta Inc RXDX Stock News

Ignyta Inc (NASDAQ: RXDX) is having an incredibly strong start to the trading session this morning, and for good reason. The company announced a key program update with regard to entrectinib, a clinical stage candidate that’s nearing the NDA submission process. As a result, investor excitement ensued, leading to gains and prompting our partners at Trade Ideas to send the alert. At the moment (9:32), RXDX is trading at $9.35 per share after a gain of $0.60 per share or 6.86% thus far today.





RXDX Gains On Entrectinib Update

As mentioned above, Ignyta is having an incredibly strong start to the trading session today after announcing a comprehensive program update on entrectinib. The treatment is in the midst of a Phase 2 clinical trial known as STARTK-2. In the trial, entrectinib is being investigated as a treatment for tumors that harbor TRK, ROS1 or ALK fusions. Here are the key points that were provided through the update…




  • According to the release by RXDX, enrollment is more than 85% complete for the primary efficacy analysis to support a TRK tissue agnostic NDA submission.
  • The company also stated that more than 50 patients with ROS1 fusion-positive NSCLC have been enrolled. Interim data sampled from 32 of these patients demonstrate that 24 of them or 75% confirmed RECISTORR and 17.2 months DOR.
  • Confirmed RECIST ORR of 64%, or 7 out of 11 patients, in the ROS1 NSCLC with CNS metastases arm.
  • If clinical data continues to be positive, the company is expecting a dual NDA submission in TRK and ROS1 in 2018 with a commercial launch anticipated in 2019.

In a statement, Jonathan Lim, M.D., Chairman and CEO at RXDX had the following to offer…

Today’s update is the result of our team’s diligent efforts to advance entrectinib through the clinic for the benefit of patients with TRK and ROS1 fusion-positive cancers… We are proud to announce substantial progress towards dual entrectinib NDA submissions for both TRK and ROS1, and are excited by the opportunity to serve two distinct groups of patients with cancer.”

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on RXDX. In particular, we’re interested in following the ongoing work with regard to entrectinib as the treatment seems to be one that will yield strong gains in the future. Nonetheless, we’ll continue to follow the story and bring the news to you as it breaks!

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Sarepta Therapeutics Inc SRPT Stock News

Sarepta Therapeutics Inc (NASDAQ: SRPT) is off to an incredible start in the pre-market hours this morning, and for good reason. The company reported earnings, missing on earnings per share, but beating on revenue. Also, the company informed investors that the CEO would be stepping down. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (8:56), SRPT is trading at $36.70 per share after a gain of $1.98 per share (5.70%) thus far today.





SRPT Announces Earnings | CEO Stepping Down

As mentioned above, Sarepta Therapeutics is having an incredibly strong start to the day in the market today after reporting earnings and announcing that the CEO of the company would be stepping down. In terms of earnings, here’s what we saw:




  • Earnings Per Share – In terms of earnings per share, SRPT didn’t do all that well. During the quarter, analysts expected that the company would generate a loss of $0.36 per share. However, the loss generated was far wider, coming in at $0.60 per share.
  • Revenue – While the company did miss earnings estimates, revenue proved to be positive. During the quarter, analysts expected that SRPT would generate revenue in the amount of $13.86 million. However, the company actually generated revenue in the amount of $16.3 million.
  • Guidance – Finally, Sarepta Therapeutics said that it expects to generate $95 million throughout the year 2017, coming in right in line with analyst expectations.

On top of the earnings news, we found out that SRPT CEO Ed Kaye will be stepping down. In the filing, we learned that the plans for the CEO to step down were already in place. While Kaye will still be a director of the company, they are now in search of a new CEO.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on SRPT. In particular, we’re interested in following the CEO search and ongoing work with regard to Exondys 51. Also, many speculate that the departure of the CEO opens the door to a takeover, potentially by Sanofi (SNY). Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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CytRx Corporation CYTR Stock News

CytRx Corporation (NASDAQ:CYTR) is having an overwhelmingly rough morning in the pre-market hours, and for good reason. The company priced a public offering of common stock, low balling investors and leading to fear. As a result, the stock took a dive, prompting our partners at Trade Ideas to alert us to the losses. At the moment (8:36), CYTR is trading at $0.56 per share after a loss of $0.12 per share (18.21%) thus far today.





CYTR Announces Price Of Offering

As mentioned above, CytRx is having a rough start in the market today after announcing the price of a public offering. The company is planning on offering a total of approximately 30 million shares of common stock. The price per share under this offering is $0.50 and the offering is expected to close on May 2, 2017. Of course, the closing is subject to customary closing conditions.




The company said that after deducting placement agent’s fees and other expenses associated with the offering, it is expecting to generate $13.8 million. The goal is to use this money for general corporate purposes, clinical and regulatory activities, and drug discovery activities, as well as potential strategic transactions.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on CYTR. In particular, we’re interested in the company’s ongoing work with regard to aldoxorubicin and how the funds gained through this offering help the company push the treatment to commercialization. We’ll continue to follow the story closely and bring the news to you as it breaks!

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BioMarin Pharmaceutical Inc. BMRN Stock News

BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) is having an incredible time in the market at the moment. In fact, minutes ago, the stock started spiking. The gains are ultimately the result of an FDA approval. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (1:19), BMRN is trading at $98.31 per share after a gain of $2.24 per share or 2.33% thus far today.





FDA Approves BMRN Treatment

As mentioned above, minutes ago, BioMarin Pharmaceutical started gaining after news broke that the United States Food and Drug Administration approved the company’s new drug application. The application surrounded the now FDA approved treatment Brineura. The treatment is designed for patients dealing with Batten disease.




What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on BMRN. In particular, we’re interested in following the company’s next steps following the news of FDA approval. With this, the company is now free to move toward commercialization. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Synergy Pharmaceuticals Inc SGYP Stock News

Synergy Pharmaceuticals Inc (NASDAQ: SGYP) is having yet another strong day in the market today. Ultimately, the gains seem to be the result of takeover rumors that we reported on earlier in the week. Of course, if a takeover were to happen, it would likely happen at a strong premium, leading to investor excitement. As is almost always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (10:48), SGYP is trading at $4.34 per share after a gain of $0.07 per share (1.64%) thus far today.





Are The SGYP Takeover Rumors Realistic?

As mentioned above, takeover rumors seem to be the reason for recent gains in Synergy Pharmaceuticals. However, are the rumors realistic? First off, let’s talk about what the rumors say. If you believe the hype, Allergan and Takeda are both interested in taking the company over. The rumor offers no price prediction, and there has been no confirmation, though the rumor first broke a couple days ago.




Nonetheless, I will say that both Allergan and Takeda definitely have something to gain through an acquisition of SGYP. Not only would the acquisition include an already approved product (Trulance), but it would also include a relatively impressive gastrointestinal pipeline. So, is there reasoning? Yes! Both companies could stand to gain from an acquisition.

Would SGYP Sell?

This is a hard question to answer. Of course Synergy Pharmaceuticals would sell if it was a good deal that they thought was in the best interest of their shareholders. However, what would that deal have to look like? Considering the strong pipeline, I would imagine that if they sold the company, it wouldn’t be for anything less than a premium around 15% to 20%.

Can The Prospective Buyers Afford The Acquisition?

Now we have to wonder whether or not the buyers could afford the potential acquisition, as it would be a big chunk of money. Nonetheless, a quick look into both Allergan and Takeda will show you that both of these companies have the money bags to put up. The only question is, will they want to?

Final Thoughts

At the end of the day, no one can tell you if an acquisition is going to happen. Sure, both of the companies mentioned in the rumor have a bit to gain from an SGYP acquisition, and they can clearly afford it. The question is, whether or not they want to. Nonetheless, with no confirmation from either side, investors are left scratching their heads and wondering if there is any validity to the concept. We’ll continue to follow the story closely and bring the news to you as it breaks!

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[Image Courtesy of Flickr]

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EXACT Sciences Corporation EXAS Stock News

EXACT Sciences Corporation (NASDAQ: EXAS) is off to an incredibly strong start to the trading session today, and for good reason. The company reported earnings for the first quarter, beating expectations and exciting investors. As a result, the stock went on a path toward the sky, prompting our partners at Trade Ideas to alert us to the gains. At the moment (10:27), EXAS is trading at $29.04 per share after a gain of $5.25 per share (22.04%) thus far today.





EXAS Reports Strong Earnings

As mentioned above, EXACT Sciences is off to an incredibly strong day in the market today after reporting its earnings results for the first quarter. Here’s what we saw from the report:




  • Earnings Per Share – In terms of earnings per share, EXAS did overwhelmingly well. During the first quarter, analysts expected that the company would generate a loss of $0.41 per share. However, the company reported a loss of $0.32 per share – $0.09 better than expectations.
  • Revenue – Revenue also proved to be overwhelmingly positive for EXAS. During the quarter, analysts expected that the company would generate revenue in the amount of $37.29 million. However, the company actually generated revenue in the amount of $48.4 million.
  • Guidance – Finally, to top everything off, EXACT Sciences has strong expectations for the 2017 year. During the year, the company is expecting revenue to come in between $195 and $205 million. That’s great news, considering that analysts are only expecting to see $178 million.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on EXAS. In particular, we’ll be following their performance throughout the year and we are excited to see the results, especially considering the high bar the company has set for itself. 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...