Sarepta Therapeutics: What Now After FDA Delay?

With the recent FDA delay, what's the deal with Sarepta Therapeutics.  Seems like a sure thing but then why would the FDA delay their decision and request more data.

A good look at their clinical trail is in the WSJ this week.  Where's the drug FDA?

The Food and Drug Administration is sitting on a therapy for Duchenne muscular dystrophy, and the agency may have days to waste but the boys don’t. Bureaucratic malpractice on a safe and effective treatment is corroding the agency’s scientific credibility and the public’s trust.

FDA in May delayed a decision on eteplirsen by Boston-based Sarepta Therapeutics. There is no treatment for Duchenne, a fatal disease that claims a boy’s ability to walk before organ failure in his 20s. Eteplirsen jumps over genetic code to produce a missing protein known as dystrophin.

Read more at WSJ(FYI, if you google the link title you can get around their purchase options sometimes)

A look at their stock profile:  $SRPT



I have enjoyed CNBC Meg Terrill's Look at Biopharma lately as well with the upcoming elections and terrible year that Biotech has been having.

Check out more videos of Meg here.  http://www.cnbc.com/meg-tirrell/

Biopharma Investor Further Development - Stock Trading

So it's been a minute.  The principles of the Bio Pharmaceuticals of Stock investments still runs true today. I plan on continuing with the Biopharma process and provide more Data Analytical approach with Financial Data in Biotech and Pharmaceuticals.  I went back to school for computer programming and data analysis and now work for a healthcare company in finance. Can't wait to provide better data analysis and web development on this website.  And thankfully have enough time to work on it now.

Singapore Investing

Protein and DNA technologies

Pfizer's To Present Lung Cancer Data July 3-7

Image via CrunchBase Pfizer Inc. will present early and mid-stage data from its lung cancer portfolio, including PF-00299804 (PF-299) an investigational, oral, pan-HER inhibitor;¹ and crizotinib, an investigational, oral, first-in-class compound that inhibits the anaplastic lymphoma kinase, or ALK,² at the International Association for the Study of Lung Cancer’s (IASLC) 14^th World Conference on Lung Cancer (WCLC), July 3-7 in Amsterdam, The Netherlands.

“While lung cancer remains a difficult-to-treat disease, we’re learning more about how therapies like crizotinib and PF-299 may be able to specifically target ALK or the HER pathway, respectively, and how this may lead to more rationally selected and personalized therapy,” said Maurizio Voi, MD, Thoracic Tumor Strategy Lead, Pfizer Oncology. “Data being presented show survival outcomes for PF-299 and crizotinib, as well as quality-of-life or patient-reported outcomes after treatment for patients with non small cell lung cancer, which represent important considerations in determining the best treatment option for these patients.”

First Presentation of PF-299 Preliminary Overall Survival Data

Continued....

Bristol melanoma drug extends survival in study

By Bill Berkrot

NEW YORK | Mon Mar 21, 2011 6:37pm EDT

(Reuters) - Bristol-Myers Squibb Co's eagerly anticipated experimental drug ipilimumab extended survival of previously untreated patients with advanced melanoma in a late stage study, the company said.

Details of how much longer patients who were suffering from the deadly skin cancer lived after taking the highly promising Bristol drug will be unveiled at a major medical meeting in June.

Bristol-Myers shares were up 4.3 percent at $27.10 in extended trading from their New York Stock Exchange close at $26. They initially jumped 5.7 percent after news of the clinical trial's success was reported.

Extending overall survival -- the primary goal of the study -- is considered the gold standard for cancer drug trials.

U.S. health regulators are expected to approve ipilimumab this week based on results of a different study of patients who had received prior treatment for advanced melanoma.  In that study the Bristol-Myers drug extended survival by an average of four months, which was seen as a major advance for a disease littered with drug failures and for which there are really no effective treatment options.

The Food and Drug Administration in November delayed its approval decision to give it more time to review data on the medicine, setting a new action date of March 26. "Ipilimumab is an exciting drug, especially given the dearth of effective therapies for this bad form of cancer," Sanford Bernstein analyst Tim Anderson said in a research note.Advanced melanoma is one of the deadliest cancers and can quickly spread from the skin to internal organs, such as the brain. Once melanoma spreads to other organs the average survival is typically only six to nine months.

Mannkind Is Having Increased Momentum and Volatiliy in January----This was the title before the stock was rejected by the FDA and the stock has declined considerably

Biotech and Pharmaceutical news:  Mannkind (MNKD)

Google Finance:  MNKD
Mannkind Corp.  Website
Mannkind Pipeline

I am cautious about Mannkind's approval chances with the FDA in the next coming weeks (FDA delayed Dec 29th decision 4 weeks) but I am optimistic about its chances of an increase in stock price while the FDA reviews Mannkind's approval for Afrezza for Diabetes.  Here are some news that has occurred for Mannkind in the past few weeks.  Continued

Spectrum Pharmaceuticals is Making Headlines in Early 2011

Spectrum Pharmaceuticals Submits Supplemental New Drug Application (sNDA) For Ready-to-Use Formulation Of FUSILEV(R) In Colorectal Cancer

Main Category: Colorectal Cancer
Also Included In: Cancer / Oncology

Article Date: 06 Jan 2011 - 1:00 PST
Spectrum Pharmaceuticals (Nasdaq: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced it submitted a supplemental New Drug Application with the U.S. Food and Drug Administration (FDA) for a Ready-to-Use formulation of FUSILEV (levoleucovorin) for Injection. This submission is in support of FUSILEV's use in colorectal cancer, which is currently under review by the FDA with a Prescription Drug User Fee Act (PDUFA) action date of April 29 2011. FDA has up to 60 days to formally accept the submission.

"If approved, we believe a RTU formulation of FUSILEV, as the name implies, will be more convenient for the staff and easy to use. RTU formulation requires no reconstitution, and since it will also be of a higher strength than the currently available lyophilized formulation, the healthcare provider's time to administer FUSILEV to colorectal cancer patients will be considerably reduced," said Rajesh C. Shrotriya, MD, Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals.   Continued

Aastrom Announces Phase II Clinical Results, Shares Sink

Good and Bad news for Aastrom Biosciences today.  Shares dropped heavily after Reuters reports that Aastrom's potential stem cell therapy did not meet a secondary endpoint for it's Phase II clinical trial for the treatment of Critical Limb Ischemia which can cause amputation in those who suffer from the disease.  I have seen this a few times lately, where a stock receives generally positive news, only to come crumbling down.  Aastrom simply rose too fast, too soon.

Yahoo Finance:  Aastrom Biosciences--(ASTM)

Aastrom Ischemia Therapy Data Disappoint; Shares Tank

*  Says study meets main safety and efficacy goal

*  Did not show significant amputation free survival
*  Shares fall 36 pct

Nov 18 (Reuters) - Aastrom Biosciences Inc (ASTM.O) reported its experimental ischemia treatment met its main goals, but the company's shares, which had soared in anticipation of the data, crashed as the secondary goal of the trial was not met.

The study met the primary goals of safety and efficacy in patients with critical limb ischemia (CLI), a cardiovascular condition that often leads to amputation of the limbs.

CLI is a painful condition caused by obstructions in the arteries that decreases blood flow to the limbs with no medical therapy available at present.

Inhibitex Has Two Upcoming Catalyst Events

Image via Wikipedia

Today we will examine Inhibitex.  Here is Inhibitex's website and Yahoo Finance's Profile:  INHX.

Inhibitex has 2 upcoming catalysts and is recommended by Zacks Research.  Extensive Recommendations by Zacks can be found in the two articles below.  Find out more Research Tools from Zacks at their website Zacks.com.

Inhibitex Pipeline Moves Forward
Buy Inhibitex Ahead of Big Catalysts

A Call for a Stock Double (INHX)

Searching for the Next Dendreon, Biovest's Emerging Cancer Vaccine



Image via Wikipedia

Non-Hodgkins Lymphoma Cell

I am always on the hunt for the next Dendreon.  Previously, I have mentioned Arqule in my article,  Is Arqule the next Dendreon?  Now possibly the future Cancer Vaccine maker, Biovest (BVTI).  Here is a news article that discusses the next possible cancer vaccine to follow Dendreon's Provenge.  Biovest is in clinical trials for Non-Hodgkins Lymphoma with BiovaxID.  Yahoo Finance  BVTI

Biovest currently is emerging from bankruptcy, so this could be a very risky trade. Read more in this Florida newspaper article titled, Accentia, Biovest prepares to leave bankruptcy.  So it will remain on my radar until things get a little better financially.

What Comes After Dendreon’s Provenge?

Patricia F. Dimond, Ph.D.
Analysis & insight: Oct 18, 2010 
 

KEYWORDS:  Cancer, Geron, Lymphoma,  Vaccines , Dendreon, Biovest, Immunotherapies, Provenge, Ovarian Cancer, AML, BiovaxID, GRNVAC1, Prima Biomed, CVac

 

Avanir and Exact Sciences Crash in Afterhours Trading

Exact Sciences (EXAS)  has crashed steadily since yesterday's close of 8.57.  It has slumped to the 6.90 range after yesterday announcing Positive Study News.  Unfortunately, this is just a study which will lead into a lengthy clinical trial that will cost money.  I think investors have been misled by this news and now they don't know what to do and are panicking.  Hey Stop Panicking.

Exact's stock is rated a buy and will soon return to the 9-10 range in a few months and could skyrocket to 13 with Positive Clinical Trial News.  There really is no quick buck when it comes to stock investing.  It happens, and it can happen, but more times than not, these things take time. 

On other news Avanir's Stock (AVNR) has declined sharply in afterhours saying they have not heard from the FDA and is anticipating news concerning their approval for psuedobulbar affect.  I am expecting a CRL from the FDA and no approval and this would be devastating to Avanir Shareholders.  But it could get approved.  It does have a fighting chance. 

In other news Vivus receives a CRL for Qnexa and the share price has gone up.  That one I really don't get but investors sometimes don't know what they are getting themselves into.  Sure if approved it would be monumental, but I don't see that happening anytime soon.  Vivus' shares are up 26.43% at 7.75.  Today it gained 1.62 points.  I don't see this ride ending well for investors but what do I know.  I am baffled at the stock market right now.

Wikinvest--Exact Sciences (EXAS)
Wikinvest--Avanir (AVNR)
Wikinvest--Vivus (VVUS)

Put Calls Anyone?

Image via Wikipedia Arena Pharmaceuticals is in a tough spot as the FDA rejects their weight loss drug lorcaserin, apparently one of the safer of the 3 up for approval.

Here is the link to investors. 

This decision was expected and predicted in my past articles on the Obesity Drug Market.  We all saw it coming.  I'm sorry if you didn't.  But expect loses for Orexigen, and Vivus with their upcoming FDA decisions.   I can only see gains made with shorting the stocks.  Those that had are sitting pretty right now.  It's a gamble but sometimes these gambles pay off.  I expect more loses to mount for these companies in the near future.  Arena Pharmaceuticals, Vivus Inc., and Orexigen Therapeutics.

What they chose to do next is anyones guess.  The technology could be sold off for further research.  And the company enters bankruptcy court.  Nonetheless just passing on the news.  I'm not always right but some are easier to pick than others.  Last weeks news of Amylin, Alkermes, and Eli Lilly and Company for their diabetes medicine was a heartbreaker for those who thought it would go the other way.  But there are always more to look at.  Keep looking forward and use it as a lesson.

Arena Pharmaceuticals Enters FDA Purgatory

Welcome to FDA purgatory, Arena Pharmaceuticals. It could be a long wait.

Peregrine Pharmaceuticals Announces Positive Phase II Clinical Trials For Brain Cancer

Image via Wikipedia Wikinvest--Peregrine Pharmaceuticals  PPHM

Google Finance--Peregrine  PPHM
 
Peregrine Pharmaceutical Pipeline

Press Release From November 9, 2004--Peregrine's commitment to treat Brain Cancer Patients:

Peregrine Pharmaceuticals and New Approaches to Brain Tumor Therapy (NABTT) Consortium Enter Collaboration to Treat Brain Cancer Patients

Today's news seems positive.  More Clinical Trials are necessary but this could be pushed through due to their orphan drug status.  Here is a news article designating Peregrine as receiving Orphan Drug Designation for Cotara in 2002.  That is a long time but this is highly special needs cancer therapy that could be helpful if it gains FDA approval after Phase III clinical trials.  It will possibly take another year or two but these will be pushed through accordingly.  They use targeted Monoclonal Antibodies to kill the cancer tumors from the inside of the tumor without hurting surrounding cells.  That is the theory.  Hopefully it works and is approved for those at risk with Brain Tumors. 
 
Peregrine Pharmaceuticals (Symbol:  PPHM)  Reports Promising Interim Survival Data From Phase II Cotara(R) Brain Cancer Study

October 18, 2010
Single Medical Center Reports Interim Median Overall Survival of 86 Weeks in Patients With Glioblastoma Multiforme (GBM) Treated at First Relapse; Data Presented at 2010 Congress of Neurological Surgeons Annual Meeting

TUSTIN, CA and SAN FRANCISCO, CA,

Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today reported interim data from an ongoing Phase II clinical trial of its novel brain cancer therapy Cotara(R). Interim median overall survival was 86 weeks for a cohort of 14 patients with glioblastoma multiforme (GBM) treated at first relapse with a single infusion of Cotara. Cotara is a targeted monoclonal antibody linked to a radioisotope that is administered directly into the tumor, destroying the tumor from the inside out, with minimal exposure to healthy tissue.

Exact Sciences Anticipating Oct. 29th Results

Image by Christiana Care via Flickr Exact Sciences has been on fire lately.  I do think that the stock will dilute in the next few weeks but I could be wrong.  They will need to recoup some of their capital from their clinical trials debt that they have accrued.  Exact Sciences is a very explosive stock that could really go higher than expected.  Who Knows?  I really like the options for Exact Sciences growth in 2011 and beyond.  In 3 Months Exact has gone from  3.46 to 8.88, a gain of 158.89%.    I expect it to drop down a bit and would suggest any future purchase of shares to come down a bit with a Limit Order.  Buy Exact at  some form discount at these very hyped up increased levels.  But they might not come down and you should buy some at the current Market Price. 

Wikinvest---Exact Sciences (EXAS)

Google Finance--Exact Sciences (EXAS)


Biotech Stock Mailbag: Exact Sciences

BOSTON (TheStreet) -- Did you catch Jim Cramer's excellent Mad Money segment Wednesday on Exact Sciences(EXAS_)?

If not, a question from Paul P. on the colon cancer diagnostic stock kicks off this week's Biotech Stock Mailbag: "Have you followed and/or have any thoughts on Exact Sciences? I've been following it and am hearing that it may be overhyped. Your thoughts would be appreciated."

Disappointing Day For Alexza Pharmaceuticals

Image via CrunchBaseI quietly predicted today's FDA outcome on Alexza and Jazz Pharma's CRL, last week in my FDA Calendar prediction.  Here were My Predictions which stated that investor's should be shorting Alexza last week.  That would have netted a huge profit on Alexza's demise.  I think that shorting stocks or place put call options on FDA catalyst events can be profitable if done properly.  Although Jazz did not go down today, I do not see good things for their future

You really have to know what you are doing though when you make projections like this as is the drugs are approved then you will not be too happy with the results.  It's really a difficult line to cross but I see the value of Shorting Stocks under the Obama FDA panel.  The panel has rejected 4 drugs so far in October. 

That doesn't mean that you should have shorted Hospira or Human Genome Sciences (HGSI) because these are large and mid cap stocks that are affected less by these FDA decisions.  Human Genome has an upcoming drug approval in December for their Lupus therapy and I actually like the stock right now and consider it a buy.  Alexza and Jazz just had too many red flags for me for approvals.  You have to do your homework and look through the clinical trial data available.  Or just follow BioPharma Investor and let me give you helpful advice on these decision. 

Wikinvest--Alexza Pharmaceuticals (ALXA)  Closed:  1.35 Down 1.65 for a 54.46% Loss

Wikinvest--Jazz Pharmaceuticals (JAZZ)  Jazz will probably will be going down with today's CRL.

Jazz Pharmaceuticals Receives FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia


FDA O-Fer October Drug Approvals

BOSTON (TheStreet) -- U.S. regulators have to approve at least one new drug in October, right?


The U.S. Food and Drug Administration has a perfect 0-4 record so far this month -- four drug approval decisions, four drug rejections. Monday, Alexza Pharmaceuticals(ALXA) and Jazz Pharmaceuticals(JAZZ) received the bad news. Last week, it was FDA rejections for Human Genome Sciences(HGSI) and Hospira(HSP).

Perhaps the best shot for more positive news will come Tuesday when Alkermes(ALKS) is expecting FDA to rule on its drug for opioid addiction.

Roche Promotes Lung Cancer Therapies, ArQule

Roche drugs point to personalized lung cancer care

(Reuters) - Roche's experimental drug MetMab and its established product Tarceva showed impressive results in lung cancer trials on Saturday, highlighting how treating the disease is becoming much more focused.


Cancer experts meeting Milan said personalized treatment, first seen in breast cancer, was now emerging as a major theme in lung cancer. The shift could reduce the use of less targeted drugs, including Roche's own top-selling Avastin.

Roche and Immunogen Develop Highly Targeted Specific Cancer Drugs

Image via Wikipedia

Articles Today about Roche's partnership with ImmunoGen on TDM-1.  TDM-1 is a highly targeted cancer drug for Breast Cancer.

ImmunoGen-(IMGN)

Roche Holdings (RHHBY)

Drugs

ImmunoGen's TDM-1 Looks Strong at ESMO

BOSTON (TheStreet) -- The "armed antibody" drug TDM-1 under development by Roche and ImmunoGen(IMGN) posted a higher response rate and lower toxicity than the blockbuster breast cancer drug Herceptin, according to results from the first head-to-head study of the two drugs to be presented at a European cancer meeting Monday.


The data from the TDM-1 phase II study in front-line breast cancer patients are early and very preliminary, but also encouraging because they suggest TDM-1 may be the next-generation successor to Herceptin that Roche has been looking for.

ImmunoGen, as Roche's partner on TDM-1, stands to profit as well if the drug is approved and successful.

BSD Medical's Stock is Rising Fast: BSDM

BSD Medical is going up like hotcakes these days. I still think there is plenty of room for future growth. Today's trading is BSDM 3.16 +0.19 (6.40%) They recently had FDA approval for cancer treatment medical device. I don't think it's too late to get on board with this stock and see it as a real Long Term Growth Potential. They are selling their newly acquired 510K approved products at a rapid pace to Cancer Treatment centers across the country.

Wikinvest is a great Market Tool: BSD Medical




Texas Oncology Acquires Hyperthermia System from BSD Medical

Chelsea Therapeutics Rockets Upward on Clinical Trial Data

Image via Wikipedia So yesterday I was cautiously optimistic on Chelsea Therapeutics' 2nd go around with their Phase III Clinical Trial and I will eat crow on that story. I am simply a cautious investor. There is nothing wrong with that. I just want the facts before I jump into an investment.

But if the story had gone the other way, people would have lost a lot of money today upon negative results. I just wasn't so sure it would work this time around. I see now that it will be a good run-up candidate pending FDA approval. The stockcould go down a little after all the hoopla today and when it hits a bottoming price I see it as a buy. I'm not so sure I would be buying it just yet as there will be some selloff after today's news but putting a limit price target on the stock could be a good idea.

Most of the trading was done by Wall Street Investors in Pre-Market hours, so if you bought it this morning you might have lost a small chunk of change. Wall St. has a funny way of controling things before and after trading hits the floor for the everyday investor. They like to control the floor and let the little guy suffer sometimes. I won't go too much into that but you have to be careful when playing with the big boys in this game. Today is a good example if you look at todays stock chart.

Google Finance: CHTP

Here is the news today.

Chelsea Therapeutics 2nd Clinical Trial Pending Results

Image via CrunchBase

From Wikinvest: Chelsea Therapeutics (CHTP) traded higher Friday closing at 5.06 +0.94 for a 22% gain. I am showing some caution for Chelsea Therapeutics as this Clinical Trial was previously rejected last September. News from that rejection from Sept. 2009: Chelsea Therapeutics (CHTP) Dives After Trial Did Not Demonstrate Statistically Significant Improvement Versus Placebo. For more information on the 2009 Clinical Trial you can read more about it here: Chelsea Therapeutics Reports Preliminary Phase III Data of Droxidopa for Treatment of Symptomatic Neurogenic Orthostatic Hypotension

The catalyst that pushed Chelsea higher this past Friday was based on an Upgrade of Chelsea pending a 2nd Phase III clinical trial results.

Savient Soars On Gout Treatment Approval While Arena Slumps On Weight Loss

Image via Wikipedia

Market Pulse
Sept. 15, 2010, 1:14 p.m. EDTSavient shares soar on FDA gout treatment approval

SAN FRANCISCO (MarketWatch) -- Shares of Savient Pharmaceuticals Inc. (SVNT 20.23, +0.25, +1.24%) jumped Wednesday after the biotech company said the Food and Drug Administration approved its gout treatment. Savient shares rose 29% to $19.09 in recent trading. The FDA approved Savient's Krystexxa for the treatment of hard-to-treat gout in adults. Gout is a type of arthritis where uric acid crystallizes in the joints causing inflammation and pain. Savient expects Krystexxa to be available on the U.S. market later in the year, and said the drug is protected by patents out to 2026

Biotech Stocks

Sept. 14, 2010, 1:11 p.m. EDT

Arena plunges on FDA news; drug indexes climb