CNA Finance Exclusive

Exelixis EXEL Stock News

Exelixis, Inc. (NASDAQ: EXEL)

Exelixis stock is having an incredible day in the market today after the company announced positive top-line results from it’s phase 3 trial of cabozantinib. The trial compared cabozantinib to everolimus in the treatment of 658 patients who suffer from metastatic renal cell carcinoma and who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor. Today, we’ll look at the results of the study and what we can expect to see moving forward.

Phase 3 Trial Results

The trial results reported by EXEL were incredibly positive. By demonstrating a statistically significant increase in progression free survival in the first 375 randomized patients, the trial met its primary endpoint. Ultimately, the trial showed that cabozantinib reduced the patients’ chances of disease progression or death by 42% when compared to everolimus. Following the release of data, Michael M. Morrissey, Ph.D., Exelixis CEO had the following to say.

The positive top-line results from METEOR represent strong progress for the kidney cancer community and for Exelixis, bringing us one step closer to our shared goal of delivering a new and meaningfully differentiated therapeutic option for the many metastatic RCC patients in need… With these data now in hand, Exelixis’ highest corporate priority becomes the submission of U.S. and EU regulatory filings, which we intend to complete in early 2016… Delivering these top-line results for METEOR is one of multiple clinical development and regulatory milestones that we have planned for this year. These milestones collectively have the potential to significantly enhance the opportunities before us and bring value to the multiple stakeholders we serve. We look forward to sharing the detailed results of METEOR with the oncology community at an upcoming medical conference, and we thank all of the patients, families, investigators, and clinical staff who made the trial possible”

What We Can Expect To See Moving Forward

Moving forward, I’m expecting to see more growth from EXEL. The reality is that the Phase 3 study of cabozantinib proved to be a big hit. The results were so positive in fact that EXEL will be looking for FDA approval in the beginning of next year. This is likely to be incredibly profitable down the road.

What Do You Think?

Where do you think EXEL is headed and why? Let us know in the comments below!

Image Credit

MannKind Corporation MNKD Stock News

MannKind Corporation (NASDAQ: MNKD)

MannKind Corporation is a very interesting stock to watch. It is one of the few that can generate big excitement for bulls during downtrends. As a matter of fact, MNKD is currently (11:33) trading at $5.26 per share after a loss of 7.07% so far today. Nonetheless, a quick search on StockTwits yielded the following responses from bulls…

$MNKD Nice try, but u can’t scare us real longs out of our shares. U bring it down, we buy more (Bullish)”… Bo Seeker

$MNKD Added 9500 at 5.24 Total 39500 at 5.7 (Bullish)” … dwcarter654

$MNKD Another 1k @ 5.26. Thanks bears! (Bullish)” … LongStocking

So, what is it about MannKind’s stock that keeps the bulls excited; even through downtrends? Well, there are a few things…

This Is Primarily Caused By Afrezza

Afrezza is an inhaled insulin created by MannKind that is currently in pre-launch stages. While investors aren’t expecting anything major from the inhaled insulin in the short term, long term investors are expecting to see great things. The reality is that Afrezza is an incredible product, and in the long run, it’s likely to be incredibly profitable. Therefore, when bears send the stock tumbling through a short term trend, bulls see it as a great opportunity to scoop up more of the stock at a lower price.

Technosphere Also Plays A Role For MNKD

Tchnosphere is the technology that MannKind developed for the delivery of insulin to the body without an injection. They’ve also openly announced that they are working on developing other medications that will be delivered using this proprietary technology. This is also likely to be incredibly profitable down the road.

Upside Potential Is Enormous In The Long Run

Here’s the bottom line, if you’re looking for major gains from MNKD today, you’re going to be severely disappointment. In fact, real MNKD bulls could care less if they saw gains throughout the rest of the year. The true value in MannKind stock is the value it portrays over the long run…a period of years.

The reality is that Afrezza has had a slow start in the market during pre-launch and is likely to have a slow start when the full launch happens. However, the drug is an incredible feat of medical innovation; and over time, will prove to be an incredibly profitable endeavor for MannKind and its investors. Also, with more indications for technosphere on the horizon, bulls are seeing long term profits on the stock just about everywhere they look.

What Do You Think?

Where do you think MNKD is headed and why? Let us know in the comments below!

Image Credit

Healthcare Stock News

Celgene Corporation Climbs After Acquisition

Celgene Corporation (NASDAQ: CELG)

Celgene Corporation stock is up in a big way today after the company announced after hours Tuesday that it had acquired Receptos (RCPT). The deal was valued at roughly $7.2 billion or $232 per share in cash. The goal of the acquisition of for CELG to enhance its inflammation and immunology portfolio with implications for inflammatory bowel disease and multiple sclerosis treatments. In a statement, here’s what Bob Hugin, CELG CEO had to say about the acquisition…

This acquisition enhances our inflammation and immunology portfolio and allows us to leverage the investments made in our global organization to accelerate our growth in the medium and long-term…”

Currently (11:42), CELG is trading at $134.66 per share after a gain of 9.61% so far today. Considering the reason for the climb in value, I’m not expecting a long term reversal anytime soon. So, now is the time to look for dips that may prove to be incredibly profitable buying opportunities.

ACADIA Pharmaceuticals Stock Is Back In Bullish Mode

ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD)

ACADIA Pharmaceuticals stock climbed in a big way earlier this week after the company announced data from it’s most recent Phase 3 study looking into an experimental treatment for mid to mild atopic dermatitis. The company’s results proved to be incredibly positive, sending the stock up in a big way. However, we saw declines yesterday. Nonetheless, I explained that the declines were nothing to worry about as they were the result of normal market movement; and the stock proved me right today. ACAD is climbing back up today; currently (11:45) trading at $51.80 per share after a gain of 6.39% so far today. As I’ve mentioned in previous pots, given the reason for the uptrend, I don’t see a reversal in the near future for ACAD. So, if you’re not already in, you may want to consider looking for pull backs as entrance opportunities.

Gilead Sciences May Not Be Undervalued For Much Longer

Gilead Sciences, Inc. (NASDAQ: GILD)

Gilead Sciences has been one of my favorite stocks to follow for quite some time now. I’ve found it intriguing that here we have a company that maintains control over the HCV and HIV treatment markets. However, due to competition, investors are afraid to push the value up. So, the current PE on the stock is around 10; which means it is incredibly undervalued. However, GILD will be releasing its earnings report on the 22nd of this month. That’s when I’m expecting to see a major change in the valuation. Once investors realize that with or without AbbVie in the picture, Gilead is likely to profit, this one is going to rally. So, it may be a good idea to get this one in your profile before earnings as they are likely to prove to be a major catalyst.

MannKind Corporation Stock Upgraded…Finally

MannKind Corporation (NASDAQ: MNKD)

MannKind is another stock that I tend to watch closely. Although I’m not expecting to see major gains in the short run, the long run is quite a bit different. The reality is that the company will be starting the Direct-to-Consumer campaign for Afrezza; picking up sales and exciting investors relatively soon. Nonetheless, investors have kept this one at a low price. However, analysts like Vetr are starting to see the incredible upside potential in the stock. As a matter of fact, yesterday Vetr upgraded the stock from a “buy” rating to a “strong buy” rating with a target price of $6.59. With all of that being said, keep your eyes on this one as it is likely to produce big gains throughout the next several months.

Zogenix Stock Climbs On KOL Meeting

Zogenix, Inc. (NASDAQ: ZGNX)

Finally, Zogenix is up after the company hosted a KOL meeting yesterday that was well received among investors and analysts alike. As a result of the meeting Brean Capital analyst Difei Yang maintained a buy rating on the stock and raised the target price by $8. Here’s what Yang wrote…

The meeting was divided into three sections: 1) Dr. Joseph Sullivan who is a Director at UCSF Pediatric Epilepsy Center and Associate Professor of Neurology & Pediatrics University of California, San Francisco, gave an overview of the disease state, disease incident and prevalence, symptoms, diagnosis, current treatment options and limitations; 2) Lieven Lagae from Pediatric Neurology University Hospitals KULeuven Belgium gave an in-depth overview of the clinical study he has conducted over many years in treating Dravet patients with low dose fenfluramine; and 3) there was a presentation from management which included an update from recent positive FDA interactions. Management guided for filing an IND by the end of August and re-affirmed earlier guidance to initiate two Phase III trials during Q4, 2015…

We revisited the assumptions we used to derive TP for ZGNX shares and thought some of the assumptions were too conservative, e.g., operating income margin for an orphan disease company like ZGNX. We had used the assumption of 35% which is in line with most of other specialty pharma companies, but lower than that for orphan drug companies, which typically is in the 50% range. In addition, we believe because of strong long-term clinical data on ZX008 as well as the fact that orphan drugs appear to have better R&D successes due to their highly targeted patient population, there is a lower efficacy bar due to lack of an alternative therapy. We revised our success rate for the pending pivotal trials from 70% to 80%.”

Do You Know Of Any Others?

Do you know of any other stocks in biotech that are well worth watching? If so, let us know in the comments below!

Image Credit

Healthcare Stocks To Watch ANAC GILD JNJ

Today is another great day in US Markets as it seems as though the Greek and Chinese fueled correction is over. I was digging through healthcare earlier today and I was able to dig up a few opportunities that I figured I would share. Here’s what I found

Anacor Pharmaceuticals Is Down, But Not For Long

Anacor Pharmaceuticals Inc (NASDAQ: ANAC)

Yesterday, Anacor Pharmaceuticals stock had an awesome day in the market; gaining over 50% in the trading session. The gains were caused by the release of data from two Phase 3 studies into Crisoborole Topical Ointment for the treatment of mild-to-moderate atopic dermatitis. As you would imagine from the growth we saw in the stock, the results of the study were overwhelmingly positive. However, today’s movement isn’t quite what we saw yesterday. As a matter of fact, ANAC is currently (12:25) trading at $128.43 per share after a loss of 2.65% so far today. However, I have to say that I’m not concerned at all about today’s declines.

The first thing that we have to remember in scenarios like this is the fact that price movements in the market happen through a series of overreactions. So, when the positive news came out yesterday, it’s no surprise that investors overreacted; pushing Anacor’s value higher than it should have gone. As a result, we’re seeing a bit of a slight correction today. Nonetheless, the positive news that came out yesterday is great news that is likely to prove to be profitable. So, it may be a good idea to buy today’s pullback as this one is likely to grow long term.

Johnson & Johnson Beat Earnings Expectations

Johnson & Johnson (NYSE: JNJ)

Johnson & Johnson released their second quarter earnings report as expected. While analysts expected the company to produce $1.67 per share in earnings, the company came in with earnings at $1.71 per share; beating expectations by $0.04. They also beat expectations with regard to revenue; coming in at $17.8 billion for the quarter compared to the expected $17.76 billion. Here’s what Alex Gorsky, CEO of JNJ had to say about the earnings…

Our solid sales and earnings results in the quarter reflect the strong underlying growth we’re seeing across the enterprise…Our diverse portfolio and scale are enabling this performance, and we’ve continued to invest in building a robust enterprise pipeline that will drive our growth over the long term. Our passion to deliver transformational new medicines and products reflects the ongoing commitment of our dedicated employees to improve health and well-being.”

Surprisingly however, investors haven’t given a positive response to the report. Unfortunately, JNJ is currently (12:36) down 0.8%; trading at just $99.47 per share. Nonetheless, I always have faith in companies that prove their ability to produce earnings. So, I’m expecting to see growth from JNJ relatively soon.

Gilead Sciences Earnings Are Coming Soon | This Will Prove To Be A Catalyst

Gilead Sciences, Inc. (NASDAQ: GILD)

Finally we have Gilead Sciences; a stock that I’ve talked about quite a bit recently. The reality is that thanks to AbbVie’s (ABBV) entrance in the HCV market, investors have been afraid to push the value of this stock up. Nonetheless, the intrinsic value of the company continues to grow; causing its PE ratio to remain relatively low…around 10. This means that Gilead Sciences is an incredibly discounted stock. Nonetheless, I think that’s going to change on July 22nd. You see, investors have been awaiting another earnings report to see how much ABBV has affected GILD; and I don’t think that affect is going to prove to be very big. With that said, Gilead Sciences is likely to produce an overwhelmingly positive earnings report; causing the bulls to come out to play. So, if you’re looking to get in on the fray, you may want to do it before the release of the company’s earnings!

Do You Know Of Any Others?

Do you know of any other healthcare stocks that are presenting strong opportunities? If so, let us know in the comments below!

Image Credit

Biotech Stock News

Oncolytics Biotech (NASDAQ:ONCY)

On July 6, 2015 shares of Oncolytics went up approximately 17% after the company reported positive phase 2 results in patients with pancreatic cancer. The study known as REO 017 recruited up to 34 patients to determine if the company’s drug REOLYSIN would be able to improve upon the clinical benefit rate — CBR — and the progression-free survival — PFS — rate in patients with pancreatic cancer.

Although one thing to note was that the company wasn’t comparing the arm of the study to a placebo compound. Instead Oncolytics gave patients their drug REOLYSIN in combination with gemcitabine — a typical chemotherapy drug given to patients with pancreatic cancer as standard of care. These patients in the study were known what is called “chemotherapy naive”, meaning that these patients have previously not been treated with standard of care chemotherapy prior to being treated with drug in this trial.

Even though the trial enrolled 34 patients the results that were presented only showed 29 of the patients that were available for efficacy analysis. The trial met the primary endpoint of the CBR because the rate achieved was a CBR of 83%. More specifically:

  • Partial response — 1 patient
  • stable disease — 23 patients
  • progressive disease 5 patients

Pancreatic cancer is rough because it is typically detected only at later stages since the patient doesn’t show any symptoms until the end of tumor progression. The fact that 23 patients saw stable disease means that the cancer hadn’t grown or spread further into the body.

This brings us to the secondary endpoint of median progression-free survival — PFS. In terms of PFS, it is a measure of how long a patient lives without progressing to a later stage with their cancer prognosis. Patients who take gemcitabine alone– historical control — always see a PFS of about 3.3 months to live, but patients who took REYOLYSIN in combination with gemcitabine saw a PFS of 4 months. This secondary endpoint is not a huge difference but allowing the patient to live even one month longer with pancreatic cancer is greatly needed.

Horizon Pharma (NASDAQ:HZNP) & Depomed (NASDAQ:DEPO)

On July 7, 2015 Horizon Pharma made a proposal to buy Depomed for $29.25 per share, which is a 42% premium over the July 6, 2015 closing share price. If this deal was to go through it would be valued at a $3 billion dollar acquisition deal. In addition this deal proposed by Horizon Pharma would be an all stock type deal — no cash given. At this time this deal needed approval by the board of directors at Depomed in order to be completed.

This wasn’t the first time that Horizon Pharma attempted to buy Depomed, because its previous attempt in May of 2015 proved to be unsuccessful. With the possible successful acquisition of Depomed, Horizon would see an increase of 2015 net sales for the year. In addition Horizon would have a combined total of 13 regulatory approved drugs in its pipeline making the company that much more valuable than ever before.

Although on July 13, 2015 Depomed enacted new rules for its “shareholder rights plan” changing the bylaws so that it is not shareholder friendly. The reason the board of directors of Depomed did this was to avoid being taken over by Horizon. For instance if Horizon attempts to buy any amount of shares over 10% of Depomed it would automatically enact a “poison-pill” that would immediately dump more shares in the market. This would make it a lot harder for Horizon to attempt to takeout Depomed common shares in the open market.

Depomed has stated that this takeover offer severely undervalues the company and that it will not want to accept the offer. Can you blame the board of directors of Depomed in doing this? After all this current offer was the same offer made back in May of 2015 that never went through. Horizon has responded back on July 13, 2015 as well stating that the board of directors of Depomed should listen to its shareholders who are happy with the takeover offer. Depomed for now continues its stance of fending off Horizon Pharma’s offer as it believes it should be valued much higher than the $29.25 per share offer made by Horizon.

Epizyme (NASDAQ:EPZM) & Celgene (NASDAQ:CELG)

On July 9, 2015 Epizyme had announced that it had extended a previous agreement that it made with Celgene to collaborate on several rare cancer therapies. With this new extension now the collaboration program will be extended for an additional three years. Celgene will have the option to license three pre-determined HRT inhibitors as they pass through the clinic.

Epizyme’s platform is known as “Epigenetics” and the technology is quite adaptive. That’s because the Epigenetics platform adjusts to each rare cancer by being able to modify a different approach of treatment for each. This technology platform itself doesn’t change any of the genes of the disease, instead is controls the way these genes are expressed in the body.

Epizyme with this new agreement will now have appropriate cash levels to run the company all the way up to the 2nd quarter of 2017.

The revised terms of the Epizyme and Celgene deal can be seen by the original  press release shown here and below: Epizyme Announces Extension Of Celgene Research Collaboration

Under the terms of the revised agreement:

  • Epizyme will receive a $10 million extension fee from Celgene in return for an option to individually license global rights for two of the targets and ex-US rights for the third target.
  • Celgene may exercise its option with respect to each of the targets at the time of the IND filing for an additional pre-specified license payment.
  • Epizyme will be responsible for leading and funding development for each target candidate through phase 1 clinical trials.
  • Following the completion of phase 1, if Celgene chooses to continue its license for a specific target, it may do so by making an additional pre-specified payment.
  • Epizyme may earn total potential milestones of up to $610 million on the three targets, including up to $75 million in development milestones and license fees, $365 million in regulatory milestones, and $170 million in sales milestones
  • Epizyme also may earn a royalty of up to a low double-digit percentage on worldwide net sales for two of the product candidates, and on ex-US net sales for the third product candidate.
  • Epizyme will retain global rights to the remainder of its pipeline, as Celgene’s option to license ex-US rights for any other preclinical programs will terminate.”

Image Credit

Healthcare Stock News

The US market is off to a great start this week; showing green pretty much across the board. The biotech space is no different. However, there are some gems in biotech that you may want to watch incredibly closely. Here’s what I was able to dig up.

Anacor Pharmaceuticals Stock Climbs On Data Release

Anacor Pharmaceuticals Inc (NASDAQ: ANAC)

Anacor Pharmaceuticals is up in a big way today after announcing preliminary top line results from two Phase 3 studies of Crisoborole Topical Ointment. The ointment is a novel non-steroid anti-inflammatory phosphodiesterase-4 inhibitor. It is an experimental treatment designed to treat mid to moderate atopic dermatitis in both children and andults. The data released shows that the studies have both achieved statistically significant results in all endpoints; both primary and secondary. The study also demonstrated a safety profile that is consistent with previous studies. As a result, ANAC is soaring in the market today; currently (12:07) trading at $46.74 per share after a massive gain of 55.24%. In a statement, Paul L. Berns, CEO of Anacor Pharmaceuticals had the following to say…

We are extremely pleased by the top-line results from our Phase 3 pivotal studies of crisaborole. We believe there is a significant unmet medical need for a novel non-steroid topical anti-inflammatory treatment option for the patients who are affected by mild-to-moderate atopic dermatitis….We also want to extend a special thanks to the clinical investigators who conducted the studies and the patients and their families who volunteered to participate in our studies. We currently plan to file a New Drug Application for crisoborole in the first half of 2016 and, if approved, we believe crisaborole could offer an important treatment option for patients with mid-to-moderate atopic dermatitis.”

Given the reason for the climb today, I don’t see any long term downtrends in the near future for ANAC. While we are likely to see a correction after massive gains, I think the overall trend is going to be relatively bullish. So, watch for pull backs as your opportunity to get in on the gains!

MannKind Corporation Is Up As investors Anticipate D2C Phase

MannKind Corporation (NASDAQ: MNKD)

MannKind Corporation is having a strong day in the market today as investors anticipate the Direct-to-Consumer phase for Afrezza. We know that this is just around the corner. However, an exact date hasn’t been provided quite yet. However, insider buying shows that it may be closer than we think. It was recently disclosed that the COO of MNKD purchased 20,000 shares in the company at a value of $91,400. Insider buys insinuate confidence from insiders that the stock will grow; and with the Direct-to-Consumer phase coming soon, there’s no reason to think any different. So, keep a close eye on this one as we’re likely to see big movement very soon.

Gilead Sciences Continues To Climb On Rights To Sell In Japan

Gilead Sciences, Inc. (NASDAQ: GILD)

If you’ve followed CNA Finance or my writing just about anywhere else, you know that I’m a big fan of Gilead Sciences. The reality is that thanks to uncertainty revolving around competition in the HCV market, the company’s stock has been kept at a relatively low price; even when earnings justified growth. However, it seems like GILD is going to see the growth it deserves moving forward. Last week, the company announced that it had received regulatory approval for the sale of Harvoni in Japan; a massive HCV market. As a result, investors have reacted in an overwhelmingly positive way; pushing the stock up. Considering the low valuation on the stock and massive upside potential, I don’t see any major downtrends in Gilead’s near future. So, keep your eye out for dips as they will likely prove to be incredibly profitable times to buy!

Synergy Pharmaceuticals Is Likely To See Big Gains Soon

Synergy Pharmaceuticals Inc (NASDAQ: SGYP)

Synergy Pharmaceuticals has been one of my favorite stocks in biotech to watch recently. The reason revolves around the company’s experimental drug known as plecanatide. Last week, the company brought a new member to the board for the commercialization of the drug; showing that a New Drug Application with the FDA isn’t far off. Generally, when NDAs are submitted, they prove to be catalysts for the stock; and I’m not expecting anything different in this case. So, this is another one to watch closely as its likely to present a strong opportunity for gains.

Do You Know Of Any Others?

Do you know of any other stocks in biotech that are presenting strong opportunities? If so, let us know in the comments below!

Image Credit

Thought Leader Discussions

Gevo, Inc. GEVO Stock News

0 7813
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...