since Maui has taken to truth manipulation, let me also let you know something I found out. When that Piper analyst came out with the Sgen downgrade due to 80 some odd deaths due to Adcetris I did a FOI request to the FDA requesting all Adcetris reported adverse events. Although I only requested the last 2 years, the response stated they supplied the last five years, even though technically it was still 35 five years ago.
There were 66 reported cases were death was the outcome although the report made it clear that death as an outcome was not the same as death being related to the drug. Death as an adverse event was only reported 10 times. That still does not implicate Adcetris as the cause of death. The number one reported AE was of all things Hodgkin's disease which as you all know is the indication for many taking the drug. Even the reported death outcomes, while containing duplication of patients due to multiple sources reporting the same info, to me, seems like a small number due to the fact most of the patients getting the drug have failed multiple treatments. For 60 bucks I could get the individual case reports, I just obtained the summary of reported events. By the way, acute pancreatitis which caused such an uproar a few months ago, has only been reported as an AE 3 times. There were well over hundred different AE listed on the report, most of which are more related to the patients debilitated condition as opposed to Adcetris.
I'm not sure we're that analyst got his numbers although he claimed the FDA. They were not what I received .
It's been so much fun ... suspense, intrigue, lying, malfeasance. We always wondered whether this would be the day when SGen would take off. Should I buy more now or wait for the inevitable dip? Many of us have been driving 18 year old cars, accumulating cash for the next dip. Some of us sold a few shares after each new high.
But the institutions have ruined it. SGen will never again suffer another dip. SGen has started a gradual ascent. Why get up in the morning? This is like UCLA's runup from 1964 to 1973. No suspense. Boring!
SGen shares are too expensive for us gamblers ... and always will be.
It's been fun reading Red, Maui, Ricky et al. Most of the abrasive braggarts and Short salesmen were run off. The drivel of the past few days is obnoxious, not worth reading.
It's time to find another hobby ... and drive my new Lexus.
SGEN closed at $23.11 on Dec. 31, 2012. After a significant intra-day rally, it closed today at $39.89. That's a 72 percent year-over-year gain. I would say that SGEN longs had a rather fine year.
Congratulations to all, with best wishes for a healthy and prosperous 2014.
Here are some highlights of SGEN CEO Clay Siegall’s verbal presentation during today's J.P. Morgan Healthcare Conference in San Francisco:
- The headline clearly is the accelerated unblinding and release of the key "Athera" maintenance-type double-blind study of post-auto high risk HL patients. In laymen’s terms, with the approval of the FDA and European regulators, the results will be released early because the outcomes apparently are so promising.
“It’s really exciting,” Siegall told the group. “We’re getting close to completing this. Now, instead of an event endpoint, it’s more of a time-point-driven analysis.
"The events [deaths due to the illness] were moving along much slower than we had initially anticipated could happen," he said. "You can’t predict [how] the drug will work, but we’re very excited that the events are slower than we thought they would be. Perhaps, we are making a big difference. Waiting many more years [to unblind the trial] would not be appropriate. I think this is a very good outcome.”
- Adcetris is now a global brand. “We’re now approved in 38 countries,” Siegall said. “And we have a very broad development program…. Our research is strong and our pipeline is deep.” Market share for the two approved indications (HL and sALCL) is greater than 70 percent.
- More than 30 clinical trials are underway for expanding use of Adcetris -- frontline, maintenance, new lines of indications.
- He’s “very excited” about early tests for SGN-CD33A and CD19A. He says they’re seeing results and patterns very similar to the early results and patterns for Adcetris. In the past, when Siegall has used the term "very excited," good things always have happened.
- SGEN will release its 4Q/full year 2013 financial results and 2014 guidance on Feb. 11.
Overall, his presentation was completely upbeat. No issues or problems were detected. In its scope and magnitude, it felt like a briefing from a very major pharmaceutical company.
Listened to replay on Roche's IR website. In Q&A two analysts asked questions on moving aCD79b ADC into late stage development (which was only touched on briefly in the main presentation as evidence of the strength of their late stage pipeline). Q&A at ~1h04min30sec and at the end ~1:42:30. aCD79b and aCD22 are in a head to head phase 2 in combo with Rituxan in ~120 relapsed/refractory patients. Enrollment completed in Jan, have some data in house and expect final readout in 2014. aCD79b has been moved into late stage development while strategy for acd22 will be determined over the course of the year with additional data reading out from the phase 2. aCD79b was moved into late stage development "in a fairly aggressive, early way". Paraphrasing further based on my notes: They want to get quickly into label enabling trials but at the same time pII trial is continuing and final readout expected in 2014. data will be presented in 2014. Team is looking at variety of combinations. Want to explore fast to market strategy along with additional "de-risking" strategies in phII studies with various combinations. 2014 for this compound will be a year of planning and trying to decide exactly how to move forward, and then being prepared to move with speed in future years.
my take: they are encouraged by the early activity of aCD79b (perhaps on the fence for acd22, at least relative to aCD79b) and wanted to bolster # of projects on their late stage pipeline slide, but were clearly not ready to divulge any details around possible timing/strategy of label enabling trials (seems genuine that this has not yet been fully determined internally).
From clinical trials gov website I do see a new aCD79b trial that started in Q4 2013 (search for DCDS4501A). Trial is a 90pt phase 1 looking at dose escalation in combination with Rituxan and chemo. The expansion phase will move into previously untreated patients with DLBCL.
Wow. Tough crowd to please. High volume, low volume, whatever. Stock is up 42 percent since Jan. 6. I'll settle for that at this point.
Also noted from Roche slide deck (slide 141) that anti-NaPi2b ADC is set to start a phase II study in platinum-resistant ovarian cancer this quarter (single agent vs Pegylated liposomal
doxorubicin)... In Q4 2013 they also started a phase 1 in platinum-sensitive ovarian cancer (Dose escalation of anti-NaPi2b ADC in combination with carboplatin, with or without Avastin). Nice to see progress in a solid tumor indication; including start of pII...!
Should be a pleasant wait, with good news flow and milestones for the next few years as all of this and other SGEN pipeline and partner pipeline progress continues to unfold... looking forward to the post transplant and frontline indications for Adcetris too! Just sharing some of my DD homework, not investment/valuation advice, everyone’s risk tolerance and timeframes are different!
These things take time. Looking at every dip and blip will drive you crazy. Look at the long term chart and believe in the thesis. If not go find a co you like and put your $$ there. Unless something changes, I'll stick around. If every stock I own had done as well as SGEN ......
Positive Adcetris News From Great Britain re patient who had just weeks to live is now CLEAR of TUMOURS and in REMISSION. Patient, per article, is the first person outside U.S. to try drug...http://www.dailymail.co.uk/health/article-2567455/Cancer-patients-lethal-70-tumours-disappear-just-two-WEEKS-thanks-pioneering-treatment.html
Sentiment: Strong Buy
Schedule 13G reports today that Baillie Gifford has added to its SGEN holding. Now 13,315,804 up from 9,811,312. Along with BB's increase, seems like a pretty good vote of confidence.
And when you buy back in with your 100 shares I'm sure you'll be paraphrasing some goofy analyst with a strong buy. So predictable which side of the trade your on.
A Schedule 13G reports today that Blackrock increased it's holdings in SGEN from 2,520,254 (reported in September 30, 2013) to 7,371,957. There's some big-time accumulation occurring recently with Baker, Blackrock and Baillie Gifford all reporting upping their stakes in this company. One might think there's something to all of this concentrated interest.
the antagonist is back for his feeding. And some of the usually good contributors to this board are feeding him. That's why he returns, he needs to be feed. Then this board gets mucked up till the feeding stops.
scr2002, as an SGEN investor since around 2007, I certainly understand your impatience insofar as I've also fallen victim to it from time to time. But, at the same time, I know this: Every thing that Siegall and his team have promised would happen over the years has, indeed, happened. Consequently, my considerable holding of SGEN shares has increased in value by more than 500 percent.
You might want to keep in mind that, in many ways, this is a company still deep within the research and development phase. Thus, research costs and losses may widen for a bit longer. But, if Siegall says he intends to grow this into a company with a market cap two, three or even four times its current size, I'm willing, based on his success thus far, to give him the benefit of the doubt.
Also, note that the Baker brothers remain firm holders and now the Vanguards of the world are taking positions in SGEN not at the prices that you and I did, but at these current, much higher prices. I don't know about you, but I'm pretty sure that the Bakers and the other big institutions are smarter than I am about these things. So, if they're happy and hopeful, I am, too.
They are discussing this stock like they are holding shares raising questions planting doubt in us longs investment even if you bought in the forties ignore these fools!!!!
I didn’t hear any news, but also never was heard a discouraging word.
The prime takeaway: Many catalysts are coming during the rest of this year in the form of trial results involving Adcetris and other ADCs produced by SGEN and its partners. Look for these results during ASCO and ASH and at other, less predictable times.
“It’s going to be a very strong year for Seattle Genetics,” Siegel told the investors, repeatedly using the terms “exciting results” and “we’re very excited.”
The replay is available now through the link on SGEN's investor page.