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Clovis Oncology CLVS Stock News

Clovis Oncology (NASDAQ:CLVS)

On Monday, Clovis Oncology stock closed higher by 9% after it announced that the FDA had approved its drug. The drug in question is known as rucaparib – to be marketed as Rubraca. This was for early approval of rucaparib, which is used to treat patients with advanced ovarian cancer. The stock had a little trouble maintaining all of its gains throughout the day. That’s because it gave back a lot of of what it had gained initially. The stock was initially trading higher by as much as 22%, but gave most of the gains back to only close higher by 9%.

CLVS Big Surprise

The FDA approval of rucaparib came in a lot sooner than what was expected. That’s because the FDA granted approval using a program known as Accelerated Approval. This is where a drug can garner earlier approval if it treats a serious or life-threatening disease. This is based on clinical data that meets typical approval standards and helps those with no other treatment options. First off, the FDA establishes what is known as a surrogate endpoint that is used to determine clinical benefit. In other words, such an endpoint would be used to determine if the drug is efficacious enough to warrant early approval. The FDA wasn’t supposed to decide on approval for rucaparib until February. That’s why this early approval came as such a huge surprise.

Clinical Trial

The phase 3 trial showed some substantial efficacy, which is why the drug has been approved early. In addition, the drug targets a patient population with a huge unmet medical need. There were two single-arm trials done to prove efficacy of rucaparib. The two trials recruited up to a total of 160 patients with advanced ovarian cancer. The ovarian cancer patients recruited into the trial had to meet another requirement. That requirement is that they had to have the BRCA mutation in order to enroll into the clinical trial. That wasn’t the only requirement though, because patients also had to have been treated with two prior chemotherapy treatments. The final result of the trial was that 54% of patients experienced complete or partial shrinking of their tumor over a median of 9.2 months.

Looking Forward

This FDA accelerated approval for rucaparib is good because now CLVS can go after additional indications. Other indications being targeted include prostate cancer, breast cancer, and gastroesophageal cancer. This early approval for ovarian cancer bodes well for the company and its stock. The stock has been beaten down pretty badly in the past for pipeline setbacks, but now it seems like things are finally starting to shape up for it. Ovarian cancer is a large unmet medical need because not many treatment options exist for it. At least 22,000 women are diagnosed with ovarian cancer each year. Out of all the patient population, at least 15% to 20% have the BRCA mutation needed to take the drug rucaparib. The fact that its a rare form of cancer means that the whole market of the BRCA  mutation will belong to CLVS. That means that the future is very bright indeed for the company.

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Nivalis Therapeutics NVLS Stock News

Nivalis Therapeutics (NASDAQ:NVLS)

On Monday Nivalis Therapeutics stock fell by more than 52% after the company announced that it had failed its phase 2 trial in patients with Cystic Fibrosis — CF. As soon as the results were released the stock tumbled as investors sold their shares to the open market. The phase 2 trial used the company’s drug known as cavosonstat to treat these patients with CF that had the F508del-CFTR mutation. The trial tested the safety and efficacy of two doses of cavosonstat of 200 mg and 400 mg. One thing to note is that these patients that were given the NVLS drug had already been taking treatment with Orkambi.

Trial Bust

Patients were already on Orkambi, because that is what is being used as the current therapy for these patients. Orkambi was approved by the FDA back in July of 2015. It was developed by a pharmaceutical company by the name of Vertex Pharmaceuticals. The hope was that the NVLS drug cavosonstat would be able to achieve the primary endpoint of the study in order to improve clinical outcome. The problem is that the trial failed on the primary endpoint of the study. The primary endpoint was to determine if the drug could change the FEV1 measurement from baseline compared to the placebo compound. Not even the secondary endpoint of reducing sweath chloride at week 12 was successful. Unfortunately, the trial didn’t achieve any endpoint. The CEO of the company Jon Congleton had this to say about the results:

“While we are disappointed in the outcome of this trial, we plan to continue to investigate the therapeutic potential of cavosonstat and our S-nitrosoglutathione reductase (GSNOR) inhibitor portfolio to  determine  next steps”

Competition Wins

There is no denying that the phase 2 trial was being watched closely by NVLS management and investors. There was, however, another key player that was really watching to see how the trial went. That key player being Vertex Pharmaceuticals, which is the one that produced Orkambi as standard of care treatment for CF patients. The reason why Vertex was looking at this trial was to see if cavosonstat would steal its thunder. In other words, if cavosonstat was positive and made it to market it could compete toe to toe with Orkambi. That’s not the case anymore and now Vertex Pharmaceuticals can breathe a sigh of relief. This means that Vertex still maintains its position as the leader in the Cystic Fibrosis space. Although, this means that NVLS will not be a direct competitor. If NVLS can’t find a way to come back from this, then the company doesn’t have that much of a bright future in its path.

Looking Forward

It’s tragic that the trial did not do much compared to placebo in helping these patients with CF. The truth is that the drug cavosonstat targeting CF was the lead candidate of the pipeline. This is a bad blow for the company which was heavily relying on a positive clinical outcome in this phase 2 study. The NVLS stock will continue to suffer because of this setback. It is not clear whether or not the company will continue to develop the cavosonstat drug in the CF indication. The company says it wants to evaluate the next steps for this program but the truth is that it doesn’t have that much of a future left after missing the primary endpoint. The good news is that there is another drug candidate in the pipeline that is being developed to treat asthma. The bad news is that it is still in earlier stage clinical trials. It will take many years before it makes to a phase 2 trial. That means investors will be cautious of investing in this stock as it doesn’t have much of a pipeline left.

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Dynavax Technologies DVAX Stock News

Dynavax Technologies (NASDAQ:DVAX)

On Monday, Dynavax Technologies stock closed the day lower by 64.55% after the company announced that the FDA has rejected Hepislav-B, its lead vaccine product. This product is being used to treat patients with the Hepatitis B virus. Not many treatment options are available to those with the Hepatitis B virus, therefore a vaccine of this caliber is more severely wanted. The problem is that DVAX has had many problems in the past in bringing this vaccine to market. This has led many investors to doubt that the company is even capable of bringing this product to market on its own. This is evidenced by the fact that this is the second time in three years that the FDA has flat out rejected the vaccine with a Complete Response Letter — CRL.

Rejection Continues

As soon as DVAX announced the rejection by the FDA, the stock traded lower for the day by as much as 72%, falling to $3.20 per share. This is the lowest trading level the stock has seen since 2008. The good news, if it can be construed as good news, is that the stock was able to close lower by 65.55% instead. That’s still a steep drop, but for good reason. DVAX had the same issue back in 2013 when the FDA cited that Hepislav-B couldn’t be approved in its current form because of safety issues. The same items have been indicated in this CRL – such issues as clarification with adverse events observed in clinical trials, cardiac events, and other safety issues. DVAX CEO Eddie Gray has given investors a positive outlook citing that approval of Hepislav-B is still doable. Unfortunately, that doesn’t bring a whole lot of confidence to those investors who have been waiting for the approval of this vaccine for many years now. The problem is that the drug has proven to be effective, but the safety of patients taking the vaccine has always been a concern for the FDA. Yet again, safety played an important role in the FDA deciding to reject the vaccine again.

Safety Issues

The FDA has cited that, while Hepislav-B is very efficacious, it can’t approve the vaccine without addressing a lot of the safety issues that it has. Adverse events are something that DVAX must address before going back to the FDA to seek approval for its product. The CEO claims that the safety issues can easily be addressed and that the vaccine can easily approved by the FDA pending certain clarification issues. There is just one major hurdle in the way, and that is that the company is not at all confident in bringing this product to market. The CEO stated in the press release that it will have to meet with the FDA to figure out how to better address the safety issues. In addition, the CEO stated that it will not be able to go the FDA route alone. This means that it will have to now bring a financial or pharmaceutical partner on board to help carry the Hepislav-B vaccine to the finish line. The problem with this is that there can be no assurance that such a partner will be able to achieve this goal.

Looking Forward

Things were not shaping up from September for DVAX anyway, because that is when the FDA cancelled a schedule advisory panel meeting. This was where the advisory committee was to review Hepislav-B for both efficacy and safety. Unfortunately, that never happened, since the FDA has completely cancelled the meeting. The ironic thing is that most believed that the cancelling of the meeting was highly bullish. In other words, the FDA would approve the vaccine. As can be seen, that’s not how things played out, and now DVAX has about $109.9 million in cash left as of the end of the third-quarter. That gives DVAX enough cash for at least three more quarters, but, obviously, it will have to seek other options before then. It will have to either partner with a pharmaceutical company or find a new form of financing to continue operations. Considering that DVAX has yet to find a partner after so many years, this doesn’t bring a lot of confidence to investors. All is now dependent upon management’s actions over the course of this year. If there are positive signs that the company can turn things around, it will be great for investors; if not, then DVAX will fall into an bottomless pit with no end in sight.

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Allergan AGN Stock News

Allergan (NYSE:AGN)

On Monday, Allergan started of the month of October and the 4th quarter with yet another deal. The big pharmaceutical company has been busy the last few months either scooping up small-cap biotechnology companies or forming partnership deals. The deal announced on Monday was between Allergan and AstraZeneca. This deal is expected to use AstraZeneca’s drug MEDI2070 to target gastrointestinal and inflammtory diseases.

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Allergan Deal

Under the terms of the agreement Allergan will have to pony up and pay AstraZeneca an upfront milestone payment of $250 million. The reason for this payment was because Allergan will gain a full exclusive license agreement to develop and commercialize MEDI2070. That seems like a very large deal, and while it is a pretty big sum amount of money it is not the final amount AstraZeneca is set to receive. Pending successful results in clinical trials and other development milestones Allergan will pay AstraZeneca up to $1.27 billion. Now that is a lot of money, but AstraZeneca is set to gain additional funds. These additional funds will come in tiered royalty for when the products are approved and sold on the market. MEDI2070 is currently in a phase 2b clinical trial treating patients with moderate to severe Crohn’s Disease, a type of inflammation in the intestines. The good news is that the drug is also ready to target the next gastrointestinal disease of Ulcerative Colitis. Both of these diseases are large markets, and is probably a big reason why Amgen wanted to make the deal.

Key Points 

This deal is good for Allergan, but for AstraZeneca there is one problem. That problem is that AstraZeneca had already made a deal with Amgen back in 2012 for the MEDI2070 drug. That means that AstraZeneca will have to give up some rights it received when it formed the deal back then. AstraZeneca will have to give Amgen 1/3 of all the payments it is receiving from Allergan. In addition, Amgen will also gain single digit royalty on sales of MEDI2070. I guess one could say that this scenario is a win for all companies, so long as the drug is successful through all of its clinical trials. Both the companies and patients will benefit with new treatment options in these disease areas.

Multiple Deals

The deal Allergan started off with in October with AstraZeneca is just one of the many deals that it has embarked on. Allergan is looking to expand into many different areas, so don’t be surprised to see another possible deal this month. Before this deal in the gastrointestinal arena, Allergan bought two liver disease drug companies in the same day. This was a few weeks ago on September 20. It paid $1.7 billion to buy Tobira Therapeutics, and $50 million to purchase Akarna Therapeutics. The reason for these deals is that Allergan gains access to the next hottest thing in biotech which is NASH, which stands for non-alcoholic steatohepatitis. In other words it’s a fatty liver disease. It is a liver disease due to excess fatty foods, and has nothing to do with abundant alcohol drinking. Allergan along with every other big pharmaceutical company wants to get in on this disease, because the estimated market for the NASH indication is $35 to $40 billion by 2025. That means that any pharmaceutical company that is successful in bringing such a drug to market would be expected to make billions of dollars in revenue.

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Moving Forward

Allergan has been performing all the right deals to set itself up for future growth. That is a good thing because some big pharmaceutical companies are neither spending heavily in R&D nor are they aggressive in acquiring growth. This is where Allergan shines greatly. It has been spending its money like crazy, but has been buying pharmaceutical companies going after large markets, and that makes a lot of sense. Allergan is still below its 52-week high of $322.68 but there is plenty of room for it to trade higher. A lot of the growth will depend upon how successful the clinical trials are over the next few years.

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Durrect Corp DRRX Stock News

Durect Corp. (NASDAQ:DRRX)

On Monday, Durect Corp stock fell by 32% after Pain Therapeutics (PTIE) received a Complete Response Letter — CRL — from the Food and Drug Administration — FDA. The drug that received the CRL is known as Remoxy ER, and was Pain’s drug obtained through a license from Durect Corp. The FDA noted that it could not approve the drug in the current form. The reason for the rejection was cited as the FDA not being comfortable enough with the labeling of the drug, and its abuse deterrent properties.

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Investors were greatly shocked with respect to this CRL, and sent Durect’s stock trading lower by 32%. Pain Therapeutics took more of a hit with a 52% drop in its stock price. Pain Therapeutics received the CRL from the FDA, and states that it will evaluate the letter. Most importantly mentioned by the company is that it will have to run trials that satisfies the FDA’s conditions. Running such another trial will take at least one year to complete. If that was the only issue it wouldn’t be so bad, but there is another problem. That trial will cost at least $5 million to run which will greatly affect Pain Therapeutics as it attempt to bring Remoxy ER back to the FDA.

If Remoxy ER is a drug that Pain Therapeutics licensed from Durect Corp., then why did DRRX stock tank so badly? There are two reasons why this happened. Before getting into that it would be wise to explore the original license deal both companies made.  About a decade ago, Pain Therapeutics decided that it wanted to license Durect Corp’s drug Remoxy ER. The agreement made was that Pain Therapeutics would gain the right to develop and commercialize the drug. In addition, it was responsible for all clinical costs associated with the drug. Durect was set to receive development and regulatory milestone payments.

This is where Durect Corp’s stock tanking comes in. Durect was set to receive a royalty up to 11.5% of net sales of Remoxy ER. That means that this revenue Durect would have made is now being delayed by at least a year. Even then, there is no guarantee that the FDA will approve on the next go around. There is another reason why Durect fell as well. The Remoxy ER drug was originally owned by Durect, and the fact that the FDA felt that the application wasn’t enough to warrant approval spooks investors. This is because it puts Durect’s pipeline into question, and maybe brings about more risk.

This is why investors decided to dump the stock even though Durect wasn’t responsible for the clinical trials. Even with this problem of a CRL, there may be some good news after all. The good news is that the FDA doesn’t have a big issue with the safety or efficacy of the drug. Instead, it just needs to see more clinical date to persuade it for approval. This is good news for both Durect and Pain investors.

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That means that the application issue can be fixed, and may be refiled by next year. While investors may have lost a lot in Durect stock there is a chance for recovery with a new NDA filing by Pain Therapeutics. There is an additional way the stock can recover, and that is dependent upon clinical trial data from the company. Durect is expected to release some clinical trial data for its drug candidate DUR-928. This drug candidate is treating patients with Chronic liver disease and acute organ injury. If the results come out positive, then there is a chance for stock appreciation from this as well.

[Image Courtesy of Wikimedia]

Sarepta Therapeutics In SRPT Stock News

Sarepta Therapeutics (NASDAQ:SRPT)

On Monday, Sarepta’s stock closed the day up 73.85% after the company announced that the FDA had given its drug Eteplirsen FDA approval. More specifically, the company filed for accelerated approval. In other words, drugs can be approved after only completing a phase 2 study if the results show that a surrogate endpoint is met. If that happens then they company can gain approval for an unmet medical need without having to go through a phase 3 trial.

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Duchenne Muscular Dystrophy — DMD — is a rare muscle wasting disorder where patients are unable to produce their own dystrophin for muscular movement. A lot of patients are in wheelchairs by the time they are in their teens and live as long as up to 30 to 40 years of age. Although, with recent treatments patients of this rare disorder have been living somewhat longer. Still, Eteplirsen has been showing to help patients restore some dystrophin levels in the body.

The approval picture was quite mixed. There were a majority of analysts who believed that the FDA would reject the drug, and a few analysts that thought the FDA would be more lenient because the drug treats a rare condition. As was seen on Monday, the FDA was more lenient with the drug approval process. Considering that the stock had gained 20% for the year, before FDA approval, there seems to have been a highly bullish bet.

It was an uphill battle for Sarepta to obtain this FDA approval for Eteplirsen. That’s because an FDA advisory committee voted against approval for the drug. Of course, that panel wasn’t the final decision but typically the FDA listens to its advisory panel. In this case, it doesn’t seem like the FDA took the panel’s recommendation to heart. Even the FDA’s own reviewers on that panel expressed multiple concerns. Such concerns were the fact that the trial was done without a placebo drug in place.

Normally, every other pharmaceutical company in the business must run a final placebo controlled trial to test the efficacy of the drug in question. Without a placebo the FDA does not give out a marketing approval. Which is why many were shocked that Sarepta received approval for its drug. One of the lead FDA reviewer on the panel, Dr. Ronald Farkas, contested against the efficacy of the drug. He believed there was not enough evidence to prove that Eteplirsen was providing adequate dystrophin levels for these patients. He wanted to see a placebo controlled trial that would prove that the drug was far superior.

It seems highly odd that Dr. Ronald Farkas resigned from the FDA one week before this decision was announced. Nobody knows the reason, but it is highly possible he was not happy with the FDA’s decision on the matter. It seems that the FDA caved in to lobbyists who have been calling for Eteplirsen approval for many months now. The agency’s chief Scientists and other internal members opposed approval, but ultimately it was up to head of pharmaceuticals Janet Woodcock. Considering the huge involvement from patients and lobbyists it seems that Janet was swayed to approve the drug despite lack of efficacy.

Many analysts were perplexed with this decision. This is because pharmaceutical companies are supposed to be held to higher standards. The FDA can’t just approve drugs based on lobbyists and patient advocates. Of course the FDA is compromised of human beings, but they must make the decision based on science and merit. In this case, it seems the decision to approve was based on emotion. Analyst Simos Simeonidis of RBC capital markets had this to say:

He stated that the approval was “one of the most perplexing regulatory decisions in recent history

This statement above by Simos states what every other analyst is thinking. The FDA wasn’t looking at efficacy or data for approval. It approved Eteplirsen based on pressure from lobbyists, patient advocates, and patients themselves. Sarepta will sell the drug on the market as ” Exondys 51″, and the drug is estimated to make up to $2 billion in peak annual sales. Sarepta also received a voucher for its rare pediatric disease.

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The company can use this to either gain approval of its drug within a 6 month time frame instead of 10 months, or it can choose to sell it to another biotech for $350 million. Even though Sarepta made it out with an accelerated approval it doesn’t mean its time to bring out the party hats quite yet. The stipulation for accelerated approval of the drug is that Sarepta must run a confirmatory trial. This new confirmatory trial will be one that runs Exondys 51 against a placebo compound. That means if the confirmatory trial fails to show Exondys 51 superior over placebo, then the FDA has the authority to yank the drug off the market.

[Image Courtesy of Pixabay]

Biotech Stock News

About a week ago Aurinia Pharmaceuticals cratered by 55.75% to close at $1.81 per share. The ironic thing is that the company had announced positive phase 2 results in patients with Lupus Nephritis. If the company posted positive phase 2b results in this patient population then why did the share price tank by so much? The reason for the drop is because there were 13 patients that died in the trial. Even with good efficacy it doesn’t matter when patient deaths are involved. Let’s get one thing right here, as of yet there is no evidence to prove that Aurinia’s drug Voclosporin caused these deaths.

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It’s just that in the world of biotech, when patient deaths are involved, investors sell first and ask questions later. That’s because there is no way of knowing until the issue is resolved. So investors lock in profits, and thus the stock falls. Which is the main reason why the stock tanked by 55.75% despite announcing positive phase 2b results in patients with Lupus Nephritis. In addition, about 10 of the 13 deaths had occurred in patients that took the low dose are in the study. This led investors to believe that a low dose of the drug may have been responsible for the patient deaths. Again, this is all speculative for the moment. Nobody knows exactly if the drug arm caused the deaths.

The good news is that many analysts are siding with the management team at Aurinia. They are all claiming that these deaths were part of the patients’ illness, and not because of the dosing received by Voclosporin. Up to date, the company’s drug has been safe and tolerable to take. Therefore, the drug causing these patient deaths is not a logical conclusion.  The company is set to meet up with the FDA in the fourth quarter of 2016, where it will discuss a potential path of approval for Voclosporin.

The phase 2b trial recruited patients with Lupus Nephritis. There were a total of 265 patients recruited into the clinical trial, to test Voclosporin against a placebo. More specifically, Voclosporin was added together with Roche’s Cellcept, and then tested against a placebo compound. It is a good idea that the company chose to test its drug in combination with Roche’s drug Cellcept. The Cellcept drug helps patients with lupus, especially those who have signs of kidney disease.

The final result was that the low dose drug arm of the study saw 32.6% of patients achieve complete remission, while the high dose arm saw 27.3% with complete remission. Considering that the placebo arm only saw 19.3% of patients achieve complete remission, both drug arms performed far better. Lupus Nephritis is inflammation of the kidney in the body. This inflammation is caused by systemic lupus. It is a huge unmet medical need, one in which a treatment is needed for. At least 60% of lupus patients will get Lupus Nephritis.

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The problem with these patients getting Lupus Nephritis is when the kidney can no longer perform its function of handling proteins. If such a dilemma is not contained then it can lead to kidney failure. The Lupus market is a big market. It is estimated to be a $4 billion market, therefore even taking into account only 60% of the population has Lupus Nephritis, then that means any company that develops a drug stands to make billions of dollars. As long as Aurinia can put the death issue behind itself, then it definitely has a path forward for FDA approval.

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Biotech Stock News
Raptor Pharmaceuticals (NASDAQ:RPTP)

On Monday September 14, 2015 shares of Raptor Pharmaceuticals ended the day down 38% after the company announced that it had failed a phase 2b liver study in children with NASH — non-alcoholic steatohepatitis. The phase 2b trial enrolled up to 169 children with NASH between the ages of eight and seventeen. The company randomized these patients into many different types of dosing groups.

Patients were randomized to either take 600 mg, 750 mg, 900 mg of Raptor’s drug RP-103 or a placebo compound instead. The compound RP-103 was created to target the underlying factors of metabolic diseases such as NASH. The phase 2b trial treating these patients with NASH is known as the “Cynch” Trial. Another name for NASH is NAFLD — which stands for non-alcoholic Fatty liver disease. The primary endpoint of the trial was to determine if RP-103 could produce a two point decrease in the NAFLD score — score used to monitor NASH — and no worsening of the fibrosis of the patients livers’ during the trial.

As noted above the stock crashed after the news because the company did not see a two point decrease in the NAFLD score and the drug wasn’t able to inhibit worsening of the fibrosis of these patients’ livers. With these results on hand Raptor Pharmaceuticals has chosen to completely discontinue this program entirely, which means it will definitely not be seeing a comeback any time in the future. The company has stated that a further detailed analysis of these results will be displayed at the upcoming American Association for the Study of Liver Diseases — AASLD — meeting. This meeting is being held November 13th through the 17th. The only positive thing about RP-103 is that it is being studied for other indications, which may or may not yield successful future clinical results.

Aerie Pharmaceuticals (NASDAQ:AERI) 

On Wednesday September 16, 2015 shares of Aeri Pharmaceuticals were up 75% in after-hours trade after the company announced positive phase 3 results for its Rhopressa trial. Rhopressa is a once daily triple action eye drop drug intended to relieve intraocular pressure in patients with either glaucoma or ocular hypertension. One thing to note is that there are a total of three different Rhopressa trials that are running in tangent with one another.

The results displayed on September 16th come from the phase 3 trial known as the “Rocket 2” Study. The Rhopressa drug was dosed as both a once daily and twice daily type of drug. The good news was that the drug was able to meet on the primary endpoint in both the once daily and twice daily dosing regimen. The primary endpoint was for Rhopressa to demonstrate non-inferiority compared to timilol — a placebo drug for these patients — twice daily regimen.

It would have been enough for the drug to achieve its primary endpoint but it also was able to show intraocular pressure lowering through the entire 90-day efficacy period. There was one adverse event seen in the trial of eye redness but that was only seen in the once daily dosing arm of the study. In addition this adverse event is not a serious one therefore it doesn’t take away from the efficacy of the drug to help treat these patients with glaucoma.

It is great to see that investors received a much needed redemption after the previous results which ended in a huge disaster for the share price of Aeri and its shareholders. That is because back in April 23, 2015 shares of Aeri Pharmaceuticals tumbled as much as 64% in one day after announcing that Rhopressa had not met the primary endpoint compared to the placebo timilol. Investors now should keep an eye on the 12-month safety data for Rhopressa which is set to be released in late 2015 or early 2016.

Now that Aeri Pharmaceuticals has these positive results from the Rocket 2 study, and the previous positive Rocket 1 Study results the company expects to file an NDA for Rhopressa in the glaucoma indication by mid 2016.

Can-Fite Biopharma (NASDAQ:CANF) 

On Thursday September 17, 2015 shares of Can-Fite Biopharma soared 92% after the company reported that it was given the FDA Fast Track Status for its liver cancer drug. The company’s liver cancer drug is known as CF-102 and is currently in a phase 2 clinical trial targeting Child Pugh Class B Cirrhosis. This CF-102 drug is being tested against a placebo to determine if it can achieve greater efficacy.

The patients in this trial are very ill, because these patients had already failed with a previous treatment that uses standard of care known as Nexavar. The current phase 2 trial uses 25 mg of CF-102 compared to a placebo compound. The reason why Can-Fite chose the 25 mg dosing of this drug is because in a previous phase 1/2 trial it was established to be the most efficacious dose.

Fast-Track Status is given to biotechnology companies to be able to bring drugs that treat unmet medial needs to market at a quicker pace. When a biotechnology company receives this indication there are many benefits that help move the drug along quicker through the approval process. For instance a biotechnology company gets additional communication from the FDA which is a huge advantage. Not only that but it gives the company the ability to file the New Drug Application — NDA — on a rolling basis.

What that means that the company can submit the NDA early and then update the results as they come in. This avoids having to wait until all clinical results are in and then having to wait a year before the FDA can review the drug. As you can see this provides quicker access for any biotechnology company that receives this FDA Fast Track Status.

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Biotech Stock News

Nymox Pharmaceutical (NASDAQ:NYMX)

On July 27, 2015 Nymox surged as high as 100% after the company reported positive phase 3 results for its BPH study. BPH stands for benign prostatic hyperplasia, and is characterized by an enlarged prostate gland. This enlarged prostate gland causes problems such as problems of urinating or the need to urinate often.

Both phase 3 trials used Nymox’s drug known as NX-1207 — also known as fexapotide triflutate. Both of these phase 3 trials are extension studies and both were able to produce positive efficacy results for these patients. Both studies met the primary endpoint of being statistically significant over the placebo compound in each trial.

The NX-1207 drug and placebo compound were compared using a measurement score known as the AUA BPH symptom score. About 64% of the patients achieved a statistically significant higher score than those of the placebo patients. What makes these results even more impressive is that these patients only received one injection in a two year period and were able to achieve efficacious results.

With these results on hand Nymox can now talk with both the FDA and EMA — two regulatory authorities — and seek approval from each respective territory. Why on earth did the share price for Nyxom surge 100% in one day? Not only did NX-1207 achieve high efficacy but it did so with limited treatment necessary as compared to standard of care. Current treatments for BPH require a patient to have to take a pill everyday for the rest of their lives.

On the other hand NX-1207 only requires one injection that can last for a few years. Think about what option a patient would like to choose for their treatment? Pay for pills every month from a local pharmacy or go once to a doctors office for single injection. Most likely than not most patients would choose to receive a single injection that would work in the body for several years. There are about 3 million people in the U.S. diagnosed with BPH each year. Therefore the market is huge and Nymox has the ability to capitalize on a pretty big market for this indication.

Galena Biopharma (NASDAQ:GALE)

On July 29, 2015 Galena ended the day up around 5% after it had announced the launch of its new anti-nausea drug known as Zuplenz. Zuplenz is an oral soluble film that helps reduce nausea and vomiting in patients that receive toxic chemotherapy cancer treatment. Although this drug product helps with other toxic cancer treatments as well. As we all know current chemotherapy drugs may or may not clear the cancer but they definitely kill every white blood cell in the body.

This killing of good and bad white blood cells leads to nausea, vomiting, and other complications. More specifically Zuplenz helps with three types of toxic treatments: Chemotherapy-induced nausea and vomiting, Radiotherapy-induced nausea and vomiting, and post-operative nausea and vomiting.

Zuplenz is a type of formulation that is similar to a current anti-nausea drug known as ondanestron. Galena states that it will make available two different doses in which patients can take. The company will be able to supply 4 mg and 8 mg of Zuplenz to patients.

What makes this Zuplenz product superior to current therapies? Well for starters Zuplenz is taken as a film that a patient puts in their mouth and then dissolves in 10 seconds or less. No more having to swallow pills for that Nausea. In addition Zuplenz has some additional advantages over other medications as well such as:

  1. No drowsiness seen after taking it
  2. Is created with a fresh peppermint flavor to avoid nasty sour taste
  3. Drug can be taken without the need for water
  4. No nasty aftertaste like other drugs have

It is too early to see how patients and doctors respond to this type of treatment but with the clear advantages Zuplenz provides over current therapy ondanestron it will take a huge chunk of the market. Galena has this marketed drug along with other therapeutic pipeline drug candidates like its breast cancer vaccine Neuvax currently in a phase 3 clinical trial.

Synergy Pharmaceuticals (NASDAQ:SGYP)

On July 30, 2015 Synergy shares closed the day up 5% after the company announced positive results for its phase 3 trial in patients with Chronic Idiopathic Constipation — CIC. This was the second phase 3 study the company had initiated to provide efficacy of its drug compound Plecantide against a placebo. This phase 3 trial recruited 1,337 patients with CIC and were split into different dosing groups.

One group of CIC patients were provided with a lower dose of 3 mg of Plecantide, and the other group of patients were given a higher dose of 6 mg of Plecantide. What made the results of Plecantide so great? Well for starters both the 3 mg and 6 mg of Plecantide were superior to the placebo compound. Matter in fact patients on the drug obtained a 20% durable response rate compared to placebo patients who only obtained an 8% durable response rate.

The only serious adverse event observed in the Synergy drug Plecantide was diarrhea, which was slightly higher than placebo. Despite Plecantide having a slightly higher rate of diarrhea over placebo patients shouldn’t be a huge burden for the company. Synergy’s drug managed to achieve a higher efficacy over its placebo counterpart and a higher rate of diarrhea is not a huge cause for concern from the FDA. Now Synergy will have to meet with the FDA to determine an NDA filing date to attempt to gain regulatory approval for Plecantide in the CIC indication.

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Wells Fargo Stock News

Wells Fargo (WFC) is expected to report earnings on Tuesday, July 14th. The whisper number is $1.05, two cents ahead of the analysts’ estimate and showing confidence from the WhisperNumber community. Whispers range from a low of $1.00 to a high of $1.10. Wells Fargo has a 39% positive surprise history (having topped the whisper in 17 of the 43 earnings reports for which we have data).

Earnings history:

– Beat whisper: 17 qtrs
– Met whisper: 1 qtrs
– Missed whisper: 25 qtrs

Our primary focus is on post earnings price movement. Knowing how likely a stock’s price will move following an earnings report can help you determine the best action to take (long or short). In other words, we analyze what happens when the company beats or misses the whisper number expectation.

The table below indicates the average post earnings price movement within a one and thirty trading day timeframe:


The strongest price movement of +7.6% comes within ten trading days when the company reports earnings that beat the whisper number, and +2.5% within five trading days when the company reports earnings that miss the whisper number. The overall average post earnings price move through ten trading days is ‘positive’ (beat the whisper number and see strength, miss and see strength) when the company reports earnings.

The table below indicates the most recent earnings reports and short-term price reaction:


The company has reported earnings ahead of the whisper number in one of the past four quarters with a whisper number. In the comparable quarter last year the company reported earnings three cents short of the whisper number. Following that report the stock realized a 0.7% gain in one trading day. Last quarter the company reported earnings four cents ahead of the whisper number. Following that report the stock realized a 1.4% gain in ten trading days. Overall historical data indicates the company to be (on average) a ‘positive’ price reactor (through ten trading days) when the company reports earnings.

To start receiving earnings trade alerts based on fifteen years of proprietary whisper number data analysis, click here.

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