Alert..bought TLON at $1.00 Some DD attached. PDUFA date for Marqibo is August 12th
http://yhoo.it/K5YgiJ. 190,000 shares have traded thus far with 5 hrs 30 min left in the trading day. I think that the stock has strong upside into their August PDUFA date and think the decision will be made on Friday Aug 10th. I like the risk/reward here at this price level. TLON PDUFA date of Aug 12th falls on a Sunday.
Now TLON is exactly 30 trading days away from their PDUFA date as it will most likely be decided on Friday Aug 10th. This PDUFA date is the one traders will be trading from now into August. The other is GILD and it is over $50 share and their date is Aug 27th which is closer to September. I don’t think investors will see a major pullback here as it is too close to the PDUFA date and volume has been over 100K for the past 4 days with 750K on 6/27. That is the most volume since May 7th extension announcement where it traded 1.54m shares. Talon received a 3 month extension & not a CRL after a positive AD-COM panel of 7 for/4 against/2 abstain in favor of the benefit vs risk profile of Marqibo. Marqibo dosed the first patient from their HALLMARQ study which was key before their PDUFA date
http://yhoo.it/K1ZK8B .
The company has
NO cash currently as the January financing was only suppose to last until May. Craig Carlson, CFO, touched upon this during the May 15th 1st Qrtr Financial Results Call. He stated:
”TLON is likely to require a small capital raise to provide sufficient cash to the end of Aug 2012 as the new PDUFA is Aug 12th.” at 7:50 mark of the conf call.
-They won’t require the 11m amount that they needed in January. This should have a minimal effect on share price.
Warburg Pincus is heavily invested in Talon & they are not going to let them fail prior to their PDUFA. The expectation is that Talon was going to have to tap Warburg Pincus again once the PDUFA date was extended from May 12th to Aug 12th. They had warned investors in their 10Q that they only had enough funding to last thru their original PDUFA date of May 12th. This capital raise (via preferred shares) is not a
New revelation to investors but one that was expected to get them thru their Aug 12th PDUFA. A July financing would be small as the company is gearing up for an approval in August.
TLON Presentation..
http://bit.ly/OwOt7f Jonathan Leff is the managing director for Healthcare at Warburg Pincus
http://bit.ly/xkOh0d . More importantly is he is a
board member with Talon so he wants the company to succeed & has a financial stake in the company http://bit.ly/KETq7K. Jonathan Leff is a big & key player in the biotech industry who also knows Janet Woodcock very well, Head of CDER, of the FDA.
http://on.wusa9.com/w4kX2O Jonathan Leff Bio:
http://bit.ly/yoCA4W Partnering for Cures Video:
http://bit.ly/zsFDYA July: PDUFA’s July 26th HZNP ($6.36) & AMRN ($14.32)
July 27th ONXX ($66.39), LGND ($15.62), PGNX ($9.18), SLXP ($52.61)
August: PDUFA’s Aug 12th TLON ($1.00) Aug 27th GILD ($50.37)
Sheff’s Take on Financing in July 2012. I discussed that they could possibly go back to Warburg if they used the money thru the May PDUFA. Because of the delay, they need a little more to carry them through August.
http://bit.ly/MYhBSM Regarding Financing thx to Brick1981.
http://bit.ly/NRgTaO Warburg has an option for more preferred shares pending approval which is outlined in Talons quarterly filings. Warburg gave Talon 11 Million in financing back in January to get Talon financed to the approval date. That financing gave Warburg the option to invest another 60 million at .35 cents a share which Warburg would receive preferred shares in return. As Warburg has done in the past their strategy is to get companies to FDA approval and they sell/partner off to Big Pharma. This seems to be the strategy here and Talon has mentioned partnerships in their recent Conference calls. They have also hired Thomas DeZao who worked with Howie Pien at Chiron Corporation which was eventually bought out by Novartis. In their PR for the hiring Talon's CEO states, "With Marqibo(R)'s PDUFA date of August 12, 2012, active partnership discussions, and ongoing Phase 3 trials in adult acute lymphoblastic leukemia (ALL) and adult non-Hodgkin's lymphoma (NHL), Talon will greatly benefit from the addition of Tom's commercial, business development, and strategy experience." BTW Howie Pien was recently appointed to Talons Board of Directors. http://www.globenewswire.com/newsroom/news.html?d=242286 http://ir.talontx.com/releasedetail.cfm?ReleaseID=675654 Schedule SC 13G/A- Orbimed Advisors on 2/14/12 (4% ownership)
http://bit.ly/L35XIo Talon Therapeutics Receives Notification of Three Month PDUFA Date Extension for Marqibo(R)
http://yhoo.it/K5YgiJ http://ir.talontx.com/releasedetail.cfm?ReleaseID=670848 
Trading from late May into June Volume is picking up steadily. TLON has not traded below $.80 since June 4th. At that point they were two months plus away from their PDUFA date of Aug 12th. Now they are exactly 30 days away from approval date as it will most likely be approved on Aug 10th which is a Friday. May 25th-June 27th volume was a total of 2.73M shares.
Disclosure: This is not a recommendation to buy or sell this security. Do your own DD before investing.