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/
Showing posts with label Pharmaceuticals. Show all posts
Showing posts with label Pharmaceuticals. Show all posts
10/14/10
Blockbuster FDA Decisions In The Next Few Months--FDA Calendar Predictions
FDA's Upcoming Blockbuster Drug Decisions for Q4 2010
October 11, 2010
Again I am predicting the upcoming FDA Calendar for the next upcoming months for the Fourth Quarter. This is just an initial walkthrough of all the upcoming decisions. Lets see how well I do. I am doing pretty well from October's FDA calendar.
The FDA has some of its biggest decisions of the year looming in the next few months. The first new lupus drug in half a century, a blood-thinner with mega-blockbuster potential, controversial weight drugs and more are all up for regulatory decisions that can move markets and either throw a bucket of cold water or high octane gasoline on stock prices.
In every case, BioPharma Investor has been following the deals and data every step of the way--from early-stage development right through to the NDA and deal-making phases. Now everyone faces the moment of truth, or at least a complete response letter.
The FDA's final decision may be signaled by an expert panel vote, but this is one area where there really is no sure thing. The agency has appeared to be taking a tough stance on safety, which has bedeviled some late-stage therapies. And its complete response letters are always opened with a mix of dread and hope. We've seen plenty of surprising decisions so far this year, and there will likely be more in the months ahead.
I have to do some more research on my Approval Decisions---Here is an preliminary list of FDA Approvals coming in the 4th Quarter of 2010. This is just an estimated guess off the top of my head. Some are toss-ups. The FDA is leaning more on the Complete Response Letter side which isn't necesarily a death sentence as why the drug was not approved and how it might be possible to get approval. Usually, it requires more Clinical Trials when a company receives a CRL from the FDA.
If you would like more Subscribe To BioPharma Investor for everyday stock news and up to date FDA decisions. Biopharma Investor
FDA Calendar Predictions
October 11, 2010
Again I am predicting the upcoming FDA Calendar for the next upcoming months for the Fourth Quarter. This is just an initial walkthrough of all the upcoming decisions. Lets see how well I do. I am doing pretty well from October's FDA calendar.
The FDA has some of its biggest decisions of the year looming in the next few months. The first new lupus drug in half a century, a blood-thinner with mega-blockbuster potential, controversial weight drugs and more are all up for regulatory decisions that can move markets and either throw a bucket of cold water or high octane gasoline on stock prices.
In every case, BioPharma Investor has been following the deals and data every step of the way--from early-stage development right through to the NDA and deal-making phases. Now everyone faces the moment of truth, or at least a complete response letter.
The FDA's final decision may be signaled by an expert panel vote, but this is one area where there really is no sure thing. The agency has appeared to be taking a tough stance on safety, which has bedeviled some late-stage therapies. And its complete response letters are always opened with a mix of dread and hope. We've seen plenty of surprising decisions so far this year, and there will likely be more in the months ahead.
I have to do some more research on my Approval Decisions---Here is an preliminary list of FDA Approvals coming in the 4th Quarter of 2010. This is just an estimated guess off the top of my head. Some are toss-ups. The FDA is leaning more on the Complete Response Letter side which isn't necesarily a death sentence as why the drug was not approved and how it might be possible to get approval. Usually, it requires more Clinical Trials when a company receives a CRL from the FDA.
If you would like more Subscribe To BioPharma Investor for everyday stock news and up to date FDA decisions. Biopharma Investor
FDA Calendar Predictions
9/7/10
Help Keep This Site Up and Running
Help keep this site bring everyone up to date BioPharma News for Free. Any donations made help keep this site free. It only takes a second. Thanks For Your Continued Support. Again thank you as I am entering my Second Year of providing BioPharma Stock updates and advice.
8/27/10
Friday's Top Performing Healthcare Stocks
Image via Wikipedia Here are today's top performing Biotech, Pharmaceutical and Medical Stocks. The stock market did well today but these stocks took off today. Most have been beaten up pretty bad with the economic downturn this past year and lack of credit lending for biotech businesses by the big banks. Top Performing Medical Stocks
8/17/10
Biotech and Pharmaceuticals Top Performers Tuesday's Edition
Big Day today in the market as Wal-Mart, Kraft and Home Depot pushed earnings up today. Both the DOW and NASDAQ were up 1% today, but this does little to mend the broken market returns of last week just yet.
My big surprise is the Biotech and Pharmaceuticals that don't rise much before big FDA decisions anymore. They seem to crash with the market and get oversold quickly before the big decisions. Jazz Pharma has been down heavily the past two sessions and others as of late have been slightly mixed before big FDA Decisions are looming.
Nonetheless here are today's Top Performers. Beat The Street on these stocks today. I like a lot of these upswing trades made today for Long-Term Growth.
Top Biotech Performers Tuesday
My big surprise is the Biotech and Pharmaceuticals that don't rise much before big FDA decisions anymore. They seem to crash with the market and get oversold quickly before the big decisions. Jazz Pharma has been down heavily the past two sessions and others as of late have been slightly mixed before big FDA Decisions are looming.
Nonetheless here are today's Top Performers. Beat The Street on these stocks today. I like a lot of these upswing trades made today for Long-Term Growth.
Top Biotech Performers Tuesday
8/12/10
Top BioPharma Performers Thursday August 12th
7/7/09
Jazz Pharmaceutical pays back loans and interest owed. Stock up big for today. JAZZ
Jazz Pharmaceuticals Pays Accrued Interest Under Senior Secured Notes
PALO ALTO, Calif., July 7, 2009 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced that it has paid to the holders of its senior secured notes the interest payments that were due, but not paid, on December 31, 2008, March 31, 2009 and June 30, 2009, for a total payment of approximately $14.6 million. The $119.5 million principal amount of the notes is due in June 2011. Jazz Pharmaceuticals also announced today that it has delivered to the holders of the notes financial statements for the quarter ended June 30, 2009, which indicate that Jazz Pharmaceuticals had achieved as of June 30, 2009 net product sales at the level required to suspend its prior obligation to maintain a minimum cash balance in an account that is pledged to the collateral agent for the notes. The requirement to maintain the account was triggered in May 2009, and Jazz Pharmaceuticals did not, at that time, establish the required account.
Jazz Pharmaceuticals believes that it has cured all material defaults under the agreement governing the notes, and that it will be able to comply with the agreement on an ongoing basis, including payment of future interest payments when due and repayment of the principal amount of the notes when due in June 2011.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments for important, underserved markets in neurology and psychiatry. For further information, please see www.jazzpharmaceuticals.com.
The co also announced the signing and closing of a private placement of an aggregate of 1,895,734 units, comprised of an aggregate of 1,895,734 shares of common stock and warrants to purchase up to 947,867 additional shares of common stock for aggregate gross proceeds of approx $7 mln. The per unit purchase price for a share of common stock and a warrant to purchase 0.50 of a share of common stock was $3.6925. The warrants have an exercise price of $4.00 per share and are exercisable for seven years.
Jazz Quote FROM NASDAQ:
7/7/2009 12:56:39 PM Market Open
NASDAQ Last Sale
4.3001 0.67 18.46% UP
Volume
3,141,201
Previous Close
$ 3.63
Today's High
$ 4.98
Today's Low
$ 3.61
52 Wk High
$ 8.85 52 Wk Low
$ .515
NASDAQ Official Price
Open Price/Date
$ 3.86
Jul 07, 2009 Close Price/Date
$ 3.63
Jul 06, 2009
1y Target Est
$ 4.50
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