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

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