New Restless Leg Syndrome Review for XenoPort (XNPT, GSK)

February 6, 2010 · Filed Under fda 

XenoPort, Inc. (NASDAQ: XNPT) has a big day coming for its GSK1838262/XP13512 (gabapentin enacarbil) next week.  The company has a date of February 9 for an FDA Prescription Drug User Fee Act (PDUFA) decision on its Horizant. This is the dated  goal for the company’s New Drug Application for Horizant for the treatment of moderate-to-severe primary restless legs syndrome. Horizant is licensed to GlaxoSmithKline (NYSE: GSK) in the United States and several other countries.

There is one concern here… The company’s release last week noted that the GaxoSmithKline partnership may be in doubt because Glaxo has noted that it may end research on depression and pain treatments.  GSK and XenoPort are discussing the next steps in the development plan for XP13512 in the neuropathic pain area and will disclose this development plan at a future date.

XenoPort shares closed up 3.4% at $19.01 Friday on 422,000 shares. Average volume is 337,000 shares, but the stock trading has been elevated over the last week.

Date  Volume  Close
5-Feb 422,100 $19.01
4-Feb 504,800 $18.38
3-Feb 373,200 $19.90
2-Feb 420,200 $19.99
1-Feb 216,400 $18.50

There is also a binary options event factored in here, although on far fewer options contracts than what you normally see.  Here is the CALL and PUT volume for Feb-2010 expiration that expire on February 19, with data on the Friday volume and the open interest:

CALL    Volume    OpInt
17.50    44    1,006
20.00    167    1,995
22.50    170    1,938
PUT$    Volume    OpInt
12.50    209    1,062
15.00    95    1,467
17.50    114    2,055
20.00    170    2,812

The stock did manage to close up for the week, which might be impressive considering the weak stock ticker tape action we saw this last week.  It looks like the company still has $150 million or so in liquidity with revenues from partnership income looking very spotty and also looking like they are in the rear-view mirror.  Analysts expect losses in 2010 and revenues of only about $63 million per Thomson Reuters consensus data.

XenoPort will be able to survive without GSK if push comes to shove.  But the restless leg syndrome is not an area without controversy.  Ask someone with it if they think it is real or not.  Then ask one of their younger family members if they think it largely from inactivity or what the RLS patient consumes daily.

This PDUFA date may not seal the fate of XenoPort, but a very positive review will be of help.  The stock has a 52-week trading range of $13.36 to $28.33 and a market cap of about $576 million.

JON C. OGG

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