Yes, I bought on a short term trade at $10.74. There is no rumor premium. I see only normal market risk if it doesn't pan out, but big reward if it does. I'll play those odds. ARIA is another possibility, but that stock jumped at the news. $2B would be about right for either company.
I'll see what is going to happen. $2B would be about a 35% premium.
Baxalta in talks to buy U.S. hematology-oncology specialist - Bloomberg
16 minutes ago
Aug 28 (Reuters) - Drugmaker Baxalta Inc is working with bankers to buy a U.S.-based hematology and oncology specialist valued at about $2 billion, Bloomberg reported, citing people familiar with the matter.
The target could not immediately be identified, Bloomberg reported on Friday.
Baxalta is also being pursued by drugmaker Shire Plc , which has made a $30 billion bid for the company.
Baxalta, spun off from Baxter International Inc in July, was not immediately available for comment.
The discussions continue and there is no certainty that a deal will be reached, Bloomberg reported.
3% RECIST (one response in thirty seven patients) isn't very good. And that one patient was still in stage 1 (localized). I don't think NSCLC is the big app for NKTR-102.
A woman and her best friend Opie. Is that too funny, or what?
Although Movantik is approved for only for patients who are taking opioids for a long period of time, that aspect is way downplayed in the commercial. Neatly played for attracting the attention of off-label patients on short course treatment.
I was barking up the wrong tree at the open yesterday. Coulda had VZ in the 30's and GILD in the 80's, both of which I follow. Instead was looking at energy. Oh well.
I'm about 25% cash now, another 10% in preferred stocks. If this plays out like the past, there are going to be some good short term trades in energy. If it turns into a multi-week rout, got my eye on semis, including KLIC.
Good luck, all.
Rintega may be the best analog of what to expect from the FDA for possible AA for NKTR-102. Rintega is for GBM patients with EGFRvlll positive tumor status. Its phase 2 was a controlled study, Rintega+Avastin vs. Avastin alone. Avastin is the last chance drug for these patients. The results from the Rintega phase 2 were virtually identical to NKTR-102 against brain mets. Rintega is in the midst of a full blown phase 3 for GBM. The FDA recently rejected AA for Rintega.
Search for "Celldex and the limits of ‘overall survival benefit’ in cancer trials".
ReACT is a randomized, controlled Phase 2 exploratory study designed to determine if adding RINTEGA to standard of care bevacizumab (BV; Avastin®) improves outcomes for patients with EGFRvIII-positive, recurrent glioblastoma across multiple measures. Patients [n=73 intent to treat (ITT); n=67 per protocol (PP)] were bevacizumab-naïve at study entry.
RINTEGA+BV demonstrated a statistically significant, clinically meaningful overall survival benefit compared to BV alone. Consistent with previous studies of RINTEGA and the published data observed for immune-mediated therapeutics, this survival benefit includes an emerging "tail" on the RINTEGA survival curve with multiple patients exceeding what is customary survival for EGFRvIII-positive glioblastoma. Nine patients (ITT) on the RINTEGA arm continue to be followed for survival, including six without disease progression receiving ongoing treatment. Six patients on the control arm continue to be followed for survival, including two without disease progression receiving ongoing treatment. At 12 months, 45% of RINTEGA patients (ITT) were alive versus 31% of control patients. While these data are early and continue to mature, at 18 months, 30% of RINTEGA patients (ITT) were alive versus 15% of control patients.
Hazard Ratio (HR)
Intent to treat: HR = 0.57 (0.33, 0.98); p=0.0386
Per protocol: HR = 0.53 (0.30, 0.93); p=0.0244
There are other sodium channel blockers for analgesia under development that are ahead of NKTR-171. Biogen's CNV1014802 has successfully completed phase 2. Teva's TV-45070 is a topical drug that recently failed a study for OA of the knee, but its major application of post-herpetic neuralgia (PHN) is still in phase 2. I have posted about both before.
There are other similar drugs in development. PFE's PF-05089771 has completed phase II clinical trials for wisdom tooth removal and primary erythromelalgia. Dainippon Sumitomo has DSP-2230 in phase 1.
The field is crowded with major players.
I've learned to take everything the company says about a drug candidate with a grain of salt. The one thing about NKTR-214 that I accept as true is that it has a unique method of action compared to other drugs under development. Look at the history.
NKTR-102 - How many years and how many wasted studies before we finally discover that its niche is brain cancer? Now the company is approaching a cash crunch and has stated they won't sink any more money into development.
NKTR-105 - Cured cancer in mice, and disappeared without a trace following its Phase 1. Meanwhile, another modern taxane developed at the same time, Abraxane, is approaching blockbuster status.
NKTR-181 - Failed Phase 2. Tons of hype, and all sorts of rationalizations about why it failed. The simplest and most likely explanation is that the drug isn't very effective. Even if NKTR-181 passes this new Phase 3, it will have to separate itself in efficacy from the NSAID's. The failed study design would have demonstrated that, I'm not sure the new one does. Will it be considered an opioid without side effects, or an NSAID-like drug that paralyzes the digestive system?
NKTR-192 - Tons more hype, but failed Phase 1 safety. Yikes! Did the company even hint that might happen?
NKTR-171 - At least two years behind the competition, never mentioned by the company.
Bayer partnered candidates - An in-depth analysis of the current competition is needed.
Ten bagger in market cap, or ten bagger in stock price? HR has increased market cap, but diluted away stock price.
I've seen this movie before. SNFCA mortgage operations use a boom-bust model, the pending litigation/reserves are a screaming sign. We're in the boom phase, and SNFCA is making money hand over fist. Watch how quickly It busts if the housing market turns. I continue to own, even added last quarter, but I'm not married to the company.
This shouldn't happen with loans originated in the past five years. Supposedly there is 20% or more down, and home owners shouldn't be defaulting right away. SNFCA provides default information on the loans it holds but not on the loans it sold off, so the calculation of the reserve number is a mystery. We do know it's four times larger than Q1.
One thing we learned from the housing bust is that reserve estimations can be way off. Prior to 2008, even with no money down and liar loans, housing prices appreciated so rapidly that banks could sell off defaulted houses and come out even. After the bust, banks could lose big on foreclosed houses that had 30% or more equity in them. So what are the assumptions that go into the reserve estimations? The best way to avoid this predicament is to lend only to very well qualified buyers.
Right now, things are good. SNFCA is going to make big money on their marginal clientele as long as housing is booming, but it can turn on a dime.
Looks like it is on the way. Lots more detail about problems with mortgages sold to "third party investors". Money for loan loss reserves increased to $2.2M from $500K in Q2.
Another point is that there must be a single agent baseline before the combo study can begin. The investigators must know that the combination is acting synergistically. As opposed to one drug being effective, and the other one just tagging along.