Analyst, Chad Messer, said, "The pivotal SYNGERY trial is on track to complete patient enrollment in 4Q:12 with data late next year. We forecast extremely strong Custersin sales in metastatic castrate-resistant prostate cancer (mCRPC) in the U.S. alone, with OncoGenex receiving significant royalties up to the mid-20’s. OncoGenex is also developing wholly-owned OGX-427 in randomized Phase II studies in CRPC and bladder cancer. The CRPC study will report full top line data in 4Q:12 as will a Phase I study in superficial bladder cancer. We view shares of OGXI as significantly undervalued with accelerating news flow and pivotal data in a blockbuster indication less than 6 quarters away."
Where is Dr. Kuvasz? Among other things, he might be able to provide more detail on Needham's recommendation.
Needham reiterated its Buy rating and price target of 30 today:
Analyst, Chad Messer, said, "Enrollment remains on track to complete this year for the 1,000 patient SYNERGY trial. We look for data in 4Q:13. OncoGenex recently announced the design of the Phase III ENSPIRIT trial in 2nd line NSCLC to begin this year. The trial will randomize 1,100 patients to docetaxel plus Custersin or placebo. The trial is powered to achieve a 0.8 hazard ratio in favor of the combination arm versus a 9 months assumed overall survival in the docetaxel alone at 90% power. The trial has 2 scheduled interim analyses, although neither has a stopping rule for efficacy. We also await the near term initiation of the 630-patient pivotal AFFINITY study of Custersin in combination with Jevtana in 2nd line CRPC."
I expect that the closure of enrolment in 011 will give the boost to move this stock up. It isn't going to be 427 - no going into phase III or partnership expected there for time being.
The question is how much accretion will there be in pps before approval date? how will we know exact time of announcing 011 approval?
Questions to start thinking about. I will hold pending approval. Either I get my pension or ….oh well, work isn't that bad. I am sure at 75 I will be happy to be putting on a suit and shaving every day.
re "I'm just not sure OGXI can get close to $30 before the SYNERGY results are announced."
Considering $30 would mean a 120% gain from here it should take that or something else really good to get there.
I think that if the 011 SYNERGY trial succeeds the pps should exceed $30, maybe by quite a bit. Success in SYNERGY will add substantially to their cash position thanks to milestones and royalties from Teva, which will put them in a solid position to further develop 427. They will have a second P3 for 011 in prostate and presumably a third P3 in lung underway, funded by Teva. And by then, the P2 trials for 427 in bladder and in combination with Zytiga in prostate should be pretty far along.
I'm just not sure OGXI can get close to $30 before the SYNERGY results are announced.
Sorry I have been invisible. My internet wasn't working at home. now I got a satellite system on my farm. I am now able to more actively participate again.
The report states positive news:
1. pivotal SYNGERY trial is on track to complete enrolment in 4Q/12
2. forecast extremely strong Custersin sales custerin sales in US alone with OGXI receiving royalties up to the mid 20s
3. OGXI owns 427 with phase II trials in CRPC and bladder and phase I into superficial bladder
OGXI shares significantly undervalued with accelerating news flow and pivotal data in blockbuster indication less than 6 quarters away
buy with 30 target.
Welcome back! Based on all your previous posts I was reasonably confident you hadn't sold, but that left open the possibility of something worse such as your coming out on the losing end of a battle with a vengeful fish. Glad you're still with us in every sense of the term.
The Needham report was nice and seems to be having more effect than analyst reports usually do. Maybe it's helping to address one of OGXI's main problems, which is that no one seems to know it exists.
I realize that I ♥ this stock
but!!!!, if 427 is stat sig in p2 prostate trials and shows positive P1 data in bladder and given HSP27 is prevelant in other oncology indications like ovarian cancer we have a blockbuster poroduct and $30 is VERY VERY CHEAP.