Biotech

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Idera Pharmaceuticals Inc IDRA Stock News

Idera Pharmaceuticals Inc (NASDAQ: IDRA) is having an overwhelmingly strong day in the market today, and for good reason. The company issued a press release this morning, providing investors with an update with regard to both clinical development and corporate activities. Today, we’ll talk about the update, what we’re seeing from the stock, and what we’ll be watching for with regard to IDRA ahead.





IDRA Provides Key Update

As mentioned above, Idera Pharmaceuticals, Inc. is having an incredibly strong day in the market today after updating investors with regard to clinical development programs as well as providing an outlook for the rest of the year. Of course, the update proved to be overwhelmingly positive, leading to excitement among investors and pushing the stock toward the top. To read the full update, click here. In a statement, Vincent Milano, CEO at IDRA, had the following to offer:




“2018 has the opportunity to be a truly transformative year for Idera in many ways… Our ongoing clinical development programs have advanced well and momentum is building, particularly around IMO-2125, which will now be referred to as the Illuminate Development Program. We continue to make progress in our efforts to advance IMO-2125 into Phase 3 and make IMO-2125 a commercial reality for patients in need of a solution following progression on PD-1 therapy. We’re also looking forward to reporting the results of the Phase 2 trial of IMO-8400 in dermatomyositis, as well as providing a data-driven development decision for IDRA-008 targeting APOC-III.

Outside of the exciting progress we are making clinically with our programs, we continue to be extremely active in business development. We plan to explore partnering opportunities as well as identify assets that fit within our corporate strategy of building a company focused on delivering solutions for patients with rare unmet medical needs.”

What We’re Seeing From The Stock

When we first get started in the market, one of the first things that we learn is that the news moves the market. With such a strong update and outlook for the year 2018, it only makes sense that excited investors are pushing Idera Pharmaceuticals toward the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (11:21), IDRA is trading at $2.34 per share after a gain of $0.11 per share or 4.71% thus far today.

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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 IDRA. In particular, we’re interested in following the progress surrounding IMO-2125 and the rest of the company’s robust clinical pipeline. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Crispr Therapeutics AG CRSP Stock News

Crispr Therapeutics AG (NASDAQ: CRSP) is having an incredibly strong day in the market today after announcing the price of a public offering that it proposed just days ago. Today, we’ll talk about the news, what we’re seeing from the stock, and what we’ll be watching for with regard to CRSP ahead.





CRSP Announces Public Offering Price

As mentioned above, Crispr Therapeutics is having an incredibly strong time in the market today after announcing the price of a public offering that it proposed just days ago. In a press release issued late yesterday, the company announced that it intends on offering 5,000,000 shares of common stock at a public offering price of $22.75 per share before underwriting and discounts. Also, CRSP has granted the underwriters a 30-day option to purchase an additional 750,000 shares. It is expected that the gross proceeds from the offering before deducting underwriter discounts and commissions, as well as other offering expenses, will be around $113.75 million. This figure excludes the underwriter option to purchase additional shares.

In the release, CRSP said that Goldman Sachs & Co. LLC, Piper Jaffray & Co. and Barclays Capital Inc. will act as joint book-running managers for the offering. Also, Guggenheim Securities, LLC will be acting as a co-manager for the offering.




What We’re Seeing From The Stock

As investors, one of the first things that we learn is that the news moves the market. In this particular case, investors are taking the news of the offering to be a positive, leading to massive gains in the value of the stock. Currently (10:58), CRSP is trading at $26.94 per share after a gain of $3.03 per share or 12.68% thus far today.

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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 CRSP. In particular, we’re interested in following the company’s progress surrounding its robust pipeline. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Amarin Corporation plc (ADR) AMRN Stock News

Amarin Corporation plc (ADR) (NASDAQ: AMRN) is having a relatively strong start to the trading session in the pre-market hours this morning, and for good reason. The company released preliminary results for the 2017 year and guidance for the current year, causing excitement among investors. Today, we’ll talk about the news, what we’re seeing from the stock, and what we’ll be watching for with regard to AMRN ahead.





AMRN Releases Preliminary Results

As mentioned above, Amarin Corporation is having a strong start to the trading session after releasing preliminary results for 2017 and guidance for 2018. Here’s what we saw from the release:




  • 2017 Revenue – When it comes to revenue, AMRN showed some positive results. In fact, revenue for 2017 are estimated to have reached between $177 and $180 million, a record year! In the fourth quarter, it is expected that revenue came in between $51 million and $54 million. Once again, breaking another record.
  • 2018 Guidance – For the year 2018, AMRN is expecting that record-breaking growth will continue. In fact, it is expecting that revenue from Vascepa will grow by around $50 million to close the 2018 year off at $230 million. The company also estimates that net product revenue for the first quarter will come in the range between $45 and $48 million, showing strong year over year growth.
  • REDUCE-IT – Finally, Amarin Corporation provided an update with regard to the landmark cardiovascular outcomes study, known as REDUCE-IT. In the PR, the company said that the study has accumulated more than 30,000 patient years of study. Also, the first patient’s last visit will be in March of 2018, leading to the report of top-line results by the end of the third quarter and publication and presentation of these results before the end of the fourth quarter.

In a statement, John F. Thero, President and CEO at AMRN, had the following to offer:

“2017 was another year of tremendous accomplishment for Amarin as we achieved record product revenues, advanced our landmark outcomes study towards completion and otherwise made broad operational progress to support anticipated growth in 2018 and beyond… We enter 2018 with a strong, experienced and dedicated team of Amarin employees and collaborators and a terrific product in Vascepa. We also enter 2018 with expectations that our outcomes study will be successful and confidence that with such success we will be well positioned to improve preventative cardiovascular care for at-risk patients while accelerating Amarin’s growth. It should be an exciting and positive year.”

What We’re Seeing From The Stock

As investors one of the first things that we learn is that the news moves the market. Any time positive news is released with regard to a publicly traded company, we can expect to see gains in the value of the stock that’s representative of that company. So, it’s no surprise that with such positive news, we’re seeing strong gains out of Amarin Corporation today. Currently (8:55), AMRN is trading at $4.41 per share after a gain of $0.22 per share or 5.25% thus far today.

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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 AMRN. In particular, we’re interested in following the story surrounding the REDUCE-IT trial, growth in Vascepa sales, as well as overall company growth. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Audentes Therapeutics Inc BOLD Stock News

Audentes Therapeutics Inc (NASDAQ: BOLD) is having an incredibly strong day in the market today, and for good reason. The company announced positive interim data from a key clinical trial. Today, we’ll talk about the data that was released, what we’re seeing from the stock, and what we’ll be watching for with regard to BOLD ahead.

BOLD Releases Positive Clinical Data





As mentioned above Audentes Therapeutics is having an incredibly strong day in the market today after issuing a press release early this morning. In the press release, investors learned about positive interim data from the first dose cohort of a clinical trial known as ASPIRO. ASPIRO is a Phase I/II clinical trial of AT132 in patients with X-Linked Myotubular Myopathy. The data released proved to be positive, leading to excitement among investors. In a statement, Dr. Suyash Prasad, Senior Vice President and Chief Medical Officer at BOLD, had the following to offer:




“The early AT132 efficacy data observed in our first dose cohort of patients have exceeded our expectations… At the 12-week timepoint, Patient 1 has improved from a severely compromised baseline to achieve a CHOP-INTEND score and maximal inspiratory pressure that are approaching ranges normally seen in healthy children. Importantly, Patient 1 has also attained several age-appropriate development milestones within this time period, including head-control, rolling over and sitting unassisted. While still early in the trial, we view these initial efficacy data as a promising indicator of the potential for AT132 to bring meaningful benefit to patients and families living with this devastating disease.”

What We’re Seeing From The Stock

As investors, one of the first things that we learn is that the news moves the market. In the biotechnology sector, there are few bits of news that have the ability to cause movement quite like positive clinical data. Considering the positive data released by Audentes Therapeutics, it only makes sense that excited investors are sending the stock toward the top today. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (12:06), BOLD is trading at $40.24 per share after a gain of $4.71 per share (13.26%) thus far today.

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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 BOLD. In particular, we’re interested in following the continued development of AT132, as the treatment seems to be incredibly promising. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Skyline Medical Inc SKLN Stock News

Skyline Medical Inc (NASDAQ: SKLN) is having an overwhelmingly strong day in the market today after issuing a press release early this morning. In the release, the company provided investors with a key sales update. Today, we’ll talk about the update, what we’re seeing from SKLN as a result, and what we’ll be watching for ahead





SKLN Gains Big On Sales Update

As mentioned above, Skyline Medical is having an incredibly strong trading session today after providing investors with an update regarding sales. In a press release issued early this morning, the company provided an update on commercial activities surrounding its STREAMWAY® System for automated, direct-to-drain medical fluid disposal.

According to the press release, SKLN sold ten of these systems in the year 2017. Five of the systems were sold in the fourth quarter. Also, the company said that an additional six STREAMWAY units have been booked for sale this month.




The SKLN STREAMWAY System is the first direct-to-drain fluid disposal system specifically designed for medical applications. The system has various uses in the field, including, but not limited to, radiology, endoscopy, arthroscopy, urology and cystoscopy procedures. Skyline Medical designed STREAMWAY to connect directly to the facility’s plumbing system to automate collection, measurement, and disposal of waste fluids. In a statement, Dr. Carl Schwartz, CEO at SKLN, offered the following:

“We have entered 2018 with great momentum, having already secured six STREAMWAY unit sales in January. This follows a ramp in commercial activity throughout 2017, which drove ten unit sales throughout the year, five of which took place in the last three months of 2017. Most of the recent demand was generated from Interventional Radiology and Cystoscopy rooms across the U.S. We are very pleased with this progress and will continue to invest in sales and marketing of the STREAMWAY throughout 2018, supported by our recent partnerships with international distributors in five different countries, and by our growing network of potential customers.”

What We’re Seeing From The Stock As A Result

One of the first things that we learn when we start to dabble in the market is that the news causes movement. With positive sales momentum surrounding Skyline Medical and its STREAMWAY system, it’s no surprise to see strong gains in the value of the stock today. Currently (11:40), SKLN is trading at $1.07 per share after a gain of $0.10 per share (9.74%) thus far today.

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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 SKLN. In particular, we’re interested in following the sales growth surrounding the company’s STREAMWAY system and are excited to see the results as sales and marketing advertisements continue to pay off. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Cellect Biotechnology Ltd APOP Stock News

Cellect Biotechnology Ltd. (NASDAQ: APOP) is having an overwhelmingly strong start to the trading session this morning after announcing breakthrough results surrounding stem cell technology. Of course, this led to excitement among investors, sending the stock toward the top. Below, we’ll talk about the breakthrough, what we’re seeing from the stock as a result, and what we’ll be watching for ahead.





APOP Gains On Stem Cell Breakthrough

As mentioned above, Cellect Biotechnology is having an overwhelmingly strong day in the market today after announcing a stem cell-related breakthrough. The company announced that it has successfully completed transplantation of the first group of three patients with the use of their ApoGraftTM technology.




The transplants were completed in the company’s Phase I/II clinical trial. In the release, APOP said that, after one month, all three patients that completed the transplants have demonstrated complete acceptance with no adverse events related to the study treatment. Also the company said that there were no adverse events or suspected unexpected serious adverse reactions.

APOP said that it believes that the interim results surrounding ApoGraft present the first signs of a breakthrough in stem cell transplantation. According to the release, the product is transplantable within less than 12 hours from donation. In a statement, Dr. Shai Yarkoni, CEO at APOP, had the following to offer:

“Our ApoGraft technology shows consistently successful results in the use of stem cell transplants for treating patients suffering from life-threatening conditions. We see our position strengthened with each patient treated. We aim for stem cell based regenerative medicine to become a safe and affordable treatment for most of mankind’s diseases.”

What We’re Seeing From the Stock

As investors, one of the first things that we learn is that the news moves the market. In the biotechnology space, there are few bits of news that can cause movement quite like medical breakthroughs. So, with the overwhelmingly positive news surrounding Cellect Biotechnology, it only makes sense that we’re seeing strong gains in the value of the stock today. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (10:58), APOP is trading at $10.42 per share after a gain of $3.32 per share (46.62%) thus far today.

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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 APOP. In particular, we’re interested in following the ongoing development of ApoGraft and excited to see this breakthrough therapy progressing at a positive rate. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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AmpliPhi Bio APHB Stock News

Ampliphi Biosciences Corp (NYSEAMERICAN: APHB) is having an incredibly strong start to the trading session this morning, and for good reason. The company announced topline results for the first seven patients in a key clinical trial. Of course, this led to excitement among investors. Today, we’ll talk about the results, what we’re seeing from the stock, and what we’ll be watching for with regard to APHB ahead.





APHB Gains Big On Clinical Results

As mentioned above, Ampliphi Biosciences is having an incredibly strong start to the trading session today after announcing topline results from a portion of patients treated in a key clinical trial. In a press release issued early this morning, APHB announced the topline results for the first 7 patients treated under an ongoing single-patient expanded access program.

According to the release, 6 out of the 7 patients treated achieved treatment success. Success was defined as complete resolution or significant improvement of baseline signs and symptoms. At the time treatment was administered, all patients were severely sick and unresponsive to antibiotic treatment. In a statement, Paul C. Grint, M.D., CEO at APHB, had the following to offer:

“I am very encouraged by these initial results for treatment with AB-SA01 or AB-PA01 in severely ill patients who were not responding to antibiotics… We look forward to treating up to an additional 20 patients during the first half of 2018 and discussing our findings with the FDA to determine a development path forward to registration. Our ongoing dialogue with infectious disease thought leaders continues to indicate growing support for our program.”




The above statement was followed up by Dr. Jonathan Iredell, Director of Infectious Diseases at the Westmead Hospital in Sydney and Professor of Medicine and Microbiology at the University of Sydney and Westmead Institute of Medical Research. Here’s what he had to offer with regard to the Ampliphi Biosciences results:

“Bacteriophage therapeutics have the potential to be a safe and potential modality for treating serious bacterial infections, and also provide an option for those with antibiotic resistant or relapsing infection. Encouraging initial results make it important to proceed to full clinical evaluation and further development of this therapeutic approach.”

What We’re Seeing From The Stock

As investors, one of the first things that we learn is that the news causes the moves in the market. With such positive news surrounding Ampliphi Biosciences, it only makes sense that the value of the stock is screaming for the top today. At the moment (10:02), APHB is trading at $1.37 per share after a gain of $0.25 per share (22.32%) thus far today.

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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 APHB. In particular, we’re interested in following the ongoing clinical development of AB-SA01 and AB-PA01, as this new approach to the treatment of antibiotic-resistant bacterial infections seems to be yielding incredible results. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Celsion Corporation CLSN Stock News

+Celsion Corporation (NASDAQ: CLSN) is having an overwhelmingly strong start to the trading session in the pre-market hours this morning, and for good reason. The company announced FDA news that proved to be a source of excitement among investors. Today, we’ll talk about the news, what we’re seeing from the stock, and what we’ll be watching for with regard to CLSN ahead.





CLSN Announces FDA News

As mentioned above, Celsion Corporation is having an overwhelmingly strong start to the trading session in the pre-market hours this morning after releasing news it received from the FDA. According to an early-morning press release, the United States Food and Drug Administration has accepted the company’s submission with regard to a key clinical study. As a result, the FDA has provided clearance for CLSN to move forward with the OVATION II Study, a planned Phase I/II clinical trial of GEN-1, DNA-based immunotherapy for the localized treatment of ovarian cancer.




In the press release, CLSN said that the next Phase I/II clinical study is designed with a single dose escalation phase to 100 mg/m2 to identify a safe and tolerable dose while maximizing immune response. This will be followed up by a continuation at the selected dose in Phase II as part of an open label, 1:1 randomized design with up to 90 patients that are dealing with stage III/IV ovarian cancer in the United States.

The ultimate goal of the clinical trial, or primary endpoint if you will, is a 33% improvement in progression-free survival when comparing GEN-1 with neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone. In a statement, Dr. Nicholas Borys, Senior Vice President and Chief Medical Officer at CLSN, had the following to offer with regard to the news:

“In previous clinical studies performed to date, GEN-1 has demonstrated excellent safety and impressive clinical activity supported with dose dependent, pro-immune improvement in the tumor micro environment. A one time dose escalation may prove to be even more impressive… As we continue to follow patients, the latest PFS analysis from the OVATION Study is showing a median of at least 15.4 months in the as-treated group which compares favorably to a historical control of 12 months. OUr highest dose cohort has not demonstrated any progressions at our current 14 month follow up. This same cohort also had a 100% R0 surgical resection rate. One of our patients in the OVATION Study even had a complete pathological response.”

What We’re Seeing From The Stock

As investors, one of the first things that we learn is that the news moves the market. When it comes to biotechnology companies, there are few bits of news that can lead to movement like FDA news. So, with the overwhelmingly positive news, it only makes sense that we’re seeing strong gains in the value of the stock. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:14), CLSN is trading at $3.16 per share after a gain of $0.44 per share (16.18%) thus far today.

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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 CLSN. In particular, we’re interested in following the coming clinical trial as well as the ongoing PFS results from the OVATION trial. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Valeant Pharmaceuticals Intl Inc VRX Stock News

Valeant Pharmaceuticals Intl Inc (NYSE: VRX) is having an incredibly strong day in the market today, and for good reason. The company announced that it has paid down a massive amount of debt. Of course, this led to excitement among investors, sending the stock running for the top. Today, we’ll talk about the news, what we’re seeing from the stock, and what we’ll be watching for with regard to VRX ahead.





VRX Announces The Repayment Of Debt

Valeant Pharmaceuticals is a company that struggled for some time following the Philidor scandal. Unfortunately, this scandal left the company in a position where it had a massive amount of debt, and revenue just wasn’t what anyone thought it was. However, since Joseph C. Papa took over the company as the CEO, he made it clear that the repayment of debt would be his top priority, and he’s done a great job of keeping that promise thus far.

Today, VRX released even more news with regard to the repayment of debt. In fact, in a press release issued early this morning, the company said that it has paid back an additional $300 million in senior secured term loans. The payment was made using cash on hand.




This is incredible news. After all, with this additional $300 million on the books, the company has reduced its outstanding debt by $6.5 billion since the end of the first quarter of the year 2016. As of December 31st, the new total debt owed by the company is approximately $25.7 billion, a number that is shrinking far faster than most expected it to. In a statement, Joseph C. Papa, Chairman and CEO at VRX, had the following to offer:

“We have reduced our debt by an additional $300 million due to ongoing strong cash flow from operations… In 2018, we will continue to invest in the core business that will drive the future growth of the Company, including durable product franchises and our innovative pipeline.”

How The Stock Is Reacting To The News

As investors, one of the first things that we learn is that the news moves the market. So, with the news of more debt being repaid, yet again at a faster rate than expected, it’s no surprise that Valeant Pharmaceuticals is making a run for the top. Currently (1:10), VRX is trading at $23.17 per share after a gain of $1.38 per share (6.33%) thus far today.

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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 VRX. In particular, we’re interested in following the story surrounding the company’s plans to continue its reduction of debt as well as plans to expand upon its robust pipeline and franchising business. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Trevena Inc TRVN Stock News

Trevena Inc (NASDAQ: TRVN) is having an overwhelmingly strong day in the market today, and for good reason. The company issued a press release recently announcing key FDA news that led to excitement among investors, sending the value of the stock toward the top. Today, we’ll talk about the news, what we’re seeing from the stock, and what we’ll be watching for with regard to TRVN ahead.




TRVN Announces FDA News

As mentioned above, Trevena is having an incredibly strong day in the market today after issuing a press release informing investors of FDA news. According to the release, the United States Food and Drug Administration has accepted the company’s New Drug Application (NDA) for the treatment known as OLINVOTM (oliceridine). OLINVO is an injection designed to treat and manage moderate-to-severe acute pain and is the first G protein biased ligand of the mu receptor designed to provide IV opioid pain relief with fewer adverse events. It is expected that the PDUFA date for the New Drug Application will be in the fourth quarter of 2018. In a statement, Maxine Gowen, Ph.D., CEO at TRVN, had the following to offer:




“The NDA file acceptance represents another major step in our progress towards delivering OLINVO to patients and healthcare providers in need of new options for managing moderate to severe acute pain in the hospital setting… We look forward to working with the FDA as they evaluate the OLINVO application.”

What We’re Seeing From The Stock

As investors, one of the first things that we learn is that it’s important to keep a close eye on the news. After all, the news moves the market, and there are few bits of news that have the ability to cause movement quite like FDA news. With such positive news surrounding Trevena, it’s no surprise that the stock is making a run for the top in the market today. Currently (11:34), TRVN is trading at $1.98 per share after a gain of $0.18 per share (10.00%) thus far today.

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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 TRVN. In particular, we’re interested in following the story surrounding the NDA for OLINVO and excited to learn the FDA’s response. 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...