73 Decision Dates on Updated FDA Calendar

The accompanying table (click to enlarge) includes an updated calendar of 75 expected FDA decision dates as part of the ETF Innovators (ETFI) New Drug Regulatory Catalyst Index, which includes a full slate of expected action before year-end outlined in my previous article. The last few days have been busy for antibiotics at the agency, resulting in sharply lower stock prices for Targanta Therapeutics (TARG) and Theravance (THRX).

An FDA panel voted against Targanta's oritavancin, which has an upcoming decision in early December and sent shares crashing from 8 bucks before the decision to around $1.30 in trading on Friday. Despite the panel endorsement for telavancin, shares of Theravance lost about 25% Friday and the company is still waiting for the FDA to issue a formal PDUFA date.

Vanda Pharma (VNDA) received word yesterday from the FDA that its resubmission for iloperidone was accepted with a decision date expected by 5/6/09. Some other recent filings include Ista Pharma's (ISTA) NDA for eye drop Bepreve and two new filings by Johnson & Johnson (JNJ) for Comfyde and trabectedin.

On a positive note, GlaxoSmithKline (GSK) and Ligand Pharma (LGND) received approval late on Thursday for Promacta to treat a rare condition known as chronic immune thrombocytopenic purpura in which a patient's immune system attacks platelets, resulting in easy bruising and bleeding episodes. The drug will compete with Amgen's (AMGN) Nplate, which was approved for the same condition back in August but required injections as compared to Promacta which is taken by mouth.

An additional approval was won by JNJ earlier today for an adult pain medication called tapentadol, which is pending classification by the DEA as a controlled substance before it can be marketed.

Comments

[BlueOkie:]

Nice to know information but not sure how it relates to investment decisions. Unless a new drug will cause a big move in stock price, it has only small value.

2008 Nov 23 09:59 AM

[NOWHEREMAN:]

If its a small market cap company with large short interest exposure, 50% plus would not be uncommon.

Thanks for the info, will look at names I'm not familiar with.

2008 Nov 23 01:47 PM

[Mike Havrilla:]

How about 50% gain or LGND, 103% gain for AMAG, 80% decline for TARG witihin the last few weeks based on either approval decisions or panel recommendations


On Nov 23 09:59 AM BlueOkie wrote:

> Nice to know information but not sure how it relates to investment
> decisions. Unless a new drug will cause a big move in stock price,
> it has only small value.

2008 Nov 24 05:23 AM

[Mike Havrilla:]

But since those examples are history --> Look for major upcoming decisions for small/mid-caps CYPB, PTIE, KG, ALO to name a few that will have major stock price impact


On Nov 24 05:23 AM mikehav wrote:

> How about 50% gain or LGND, 103% gain for AMAG, 80% decline for TARG
> witihin the last few weeks based on either approval decisions or
> panel recommendations

2008 Nov 24 05:31 AM