Well said, atpl. The amazing thing is this: Ricky/Maui/fsout/smelky consistently thinks he's smarter than the rest of us and has us fooled. He also seems to think that he somehow moves markets, though he obviously never bought and sold a share of this or any other stock. And he spends so much time and energy trolling actual investors on so many boards. Something very bad happened to that fellow somewhere along the way.
Yep. Never a sure thing, but seemingly as close to a sure thing as one might hope.
BOTHELL, Wash.--(BUSINESS WIRE)--Apr. 20, 2015-- Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (BLA) for ADCETRIS (brentuximab vedotin) in the AETHERA setting for the post-transplant consolidation treatment of Hodgkin lymphoma (HL) patients at high risk of relapse or progression. The FDA granted Priority Review for the application and the Prescription Drug User Fee Act (PDUFA) target action date is August 18, 2015. The submission of the supplemental BLA is based on positive results from a phase 3 clinical trial called AETHERA that was designed to determine if 16 cycles of ADCETRIS as consolidation therapy immediately following an autologous stem cell transplant (ASCT) could extend progression-free survival (PFS) in HL patients at high risk of relapse or progression. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in classical HL and systemic anaplastic large cell lymphoma (sALCL), as well as other lymphoma subtypes. ADCETRIS is approved in relapsed HL and sALCL but is currently not approved for consolidation therapy in HL patients immediately after ASCT.
It does - Glembatumumab vedotin (Anti-GPNMB ADC), for melanoma, with Celldex. It also has collaborations looking into various efficacies against pancreatic, breast, prostate, ovarian and other "hard cell" malignancies. I suspect that it is these that are of the most interest - and are offering the most promise to - the Bakers and other big, smart SGEN investors.
You still are an idiot. You're never right about anything. You do no research. You know nothing. The Bakers cannot sell without filing SEC documents, which they have not done. Stocks go up and they go down. Biotech stocks have wider ranges than most. And never forget, ricky/maui/fsout/smelky/etc.: "10-is10," right?
You got it, Ricky/Maui/fstout/smelky, though I reserve the right to take you off ignore from time to time to see why others are laughing at you. That said, I'm a little worried about you. Do try to stay on the meds. They'll help you keep track of which lies you posted on which message board on which day under which alias.
The jackass says he's going to buy at $34, then forgets he said that and announces that he bought at $35.95 and day traded. Ricky/Maui/fstout/smelky really is quite a dope.
Listen, for the last time: As board members/insiders and as large holders, the Bakers have to file SEC forms every time they buy or sell SGEN shares. They have filed numerous forms reflecting their buys; they have filed no forms reflecting a sale. They have not sold any shares. Is that so hard to understand?
SGEN and Takeda already collaborate worldwide on Adcetris and are in Phase 2 of a trial focused on advanced gastrointestinal malignancies.
One way is to keep an eye on the Twitter feeds of frequent biotech buyers and traders, and to periodically search Twitter for references to Baker brothers, Felix Baker and Julian Baker. That's how I found out fairly quickly some time ago that they opened a position in Mast Therapeutics (MSTX) and later added to it. Based solely on that, I also opened a position in MSTX. Full disclosure - this is essentially a penny stock (now trading at 49 cents a share) and it is an extremely risky investment. But I figure if they're taking a chance on it, I will, too.
The phase 3 trial of brentuximab vedotin included 329 patients, aged 18 and older, who were at high risk of cancer relapse or progression after undergoing stem cell transplant, in which healthy stem cells from the patient are used to replace those lost to cancer or chemotherapy.
The patients were randomly assigned to receive 16 cycles of brentuximab vedotin infusions once every three weeks, or an inactive placebo.
After two years, there was no cancer progression in 65 percent of the patients who received the drug, compared with 45 percent of those in the placebo group, the researchers found. Progression-free survival was 43 months for those who received the drug, compared with 24 months for those in the placebo group.
"Nearly all of these patients who are progression-free at two years are likely to be cured since relapse two years after a transplant is unlikely," Moskowitz said in a journal news release. "No medication available today has had such dramatic results in patients with hard-to-treat Hodgkin lymphoma," he said.
O'Connor agreed. He said the new findings "represent a significant advance for patients with high-risk Hodgkin lymphoma who relapse or were [unresponsive] following initial therapy."
Common side effects associated with the drug were numbness or pain in the extremities due to nerve damage, and low white blood cell count.
As the researchers explained, brentuximab is an antibody that's attached to a chemotherapy drug that seeks out a protein on Hodgkin lymphoma cells. The drug then "sticks" to the protein and delivers targeted chemotherapy directly into the cancer cells, killing them.
Dr. Jonathan Kolitz is associate chief of hematologic oncology at North Shore-LIJ Cancer Institute in Lake Success, N.Y. He called brentuximab "a welcome addition to strategies aimed at improving outcomes in patients with Hodgkin lymphoma."
Brentuximab has been approved in 50 countries to treat patients with relapsed or treatment-resistant Hodgkin lymphoma, and received U.S Food and Drug Administration approval in 2011.
A four-day-old alias, with an obsession about the Baker brothers and their alleged shorting, which they are not doing. Obviously, another alias of Rickarooski/Maui/Fsout/Smelky, etc. A very ill puppy.
Bull has it right - the Bakers bought another 300,000 or so shares on Monday, March 9, and Tuesday, March 10. One really must wonder what they are up to - why so many huge buys and so consistently. You also really have to wonder why any short is still shorting SGEN. The Bakers are sending every possible signal that there is no future in this for a short - and that the hammer could fall on them at any moment.
Here are a few highlights of CEO Clay Siegall's presentation this morning during the Barclays Healthcare Conference in Miami:
- Takeaway quote: "We think this year can be a fantastic year for Seattle Genetics. We've been building up to this year.."
- The company expects to hear from the FDA in April regarding SGEN's supplemental BLA related to the AETHERA trial, and "we hope to have an additional label for Adcetris before the end of the year."
- He spent a good deal of time on SGN-CD33A and the phase 1 trial in acute myeloid leukemia, a major unmet need for the last 30 years. Clearly, the company is seeing something special here. He said SGEN is looking to accelerate that program by gaining permission to move from Phase 1 directly to a pivotal study.
- In quickly running through the long list of collaborations, he mentioned three companies specifically: Genentech, Abbvie and Genmab. Let the speculation begin.
- Importantly, a revenue slide added clarity to the financial projections that the company somewhat botched during the most recent conference call. It is now crystal clear that collaboration revenue DOES NOT include royalty revenue. For 2014, the slide breaks out Adcetris net sales at $178.2 million, collaboration revenue at $68.6 million and royalty revenue (all from Takeda) at $40 million. For 2015, the slide breaks out expected Adcetris sales of $200-210 million (a significant gain over last year), and collaboration revenue at $60-70 million (about the same as in 2014). There is no projection for royalty revenue, as that only can be predictive of another company's sales, and SGEN is not in the position to do that. Of royalty revenue, however, Siegall said: "We expect that to grow."
That's all I have.
As always, you are encouraged to listen to the replay.
Unlikely. They never break news at an investor conference. But if they do have news to release, it will come in the form of a press release issued at some point before the 8:30 a.m. EDT conference.