Different stages in breast cancer treatment. Neratinib is for newly diagnosed patients prior to surgery. NKTR-102 is third line for MBC patients who cannot benefit from surgery. The drugs do not compete.
I think that's just one of the patents for the peripheral tricyclic antidepressants they are one set of compounds NKTR was looking at in neuropathic pain. I haven't pulled anything just looking at the bit of the title there and searching with Nektar in the search that'a what comes up. The most advanced neuropathic pain candidate 171 is not part of this class that one is a Na channel blocker.
As promised--soon is now! New Seeking Alpha article linked here on Yahoo news for NKTR.
Sentiment: Strong Buy
Honestly one could argue the time to add was when we were well below 10 post 181 PII announcement and pre quarterly call. Day to day swings of 5% or so, while nothing to sneeze at, aren't so unusual here. While I believe in the big picture this will be a price you can be fine with (even thrilled about) over time. I have to believe if past is prelude we have another few events of being thrust in alternate directions more substantially with or without news.
Bull or bear, there is agreement IMO that the 2 monster issues in front of NKTR are the Naloxegol ad comm(more correctly the peripheral opiod advisory meeting) , and nearer term financing. EITHER could/will have a monster impact in one direction or the other at least in the relatively short term.
If the tone of the meetings are largely positive E.G. the FDA has been overly cautious in a way that is not at all supported by the data generated to date for Relistor, Naloxegol, and others we might not visit the current price range ever again. The same applies to financing if there is a sense that any of the non-dilutive (partnership) options are in the works: revisiting 102, ex US rights for 181, or something else.. the positive impact would be very substantial IMO.
On the flip side selling 20M or so shares in this range, or a negative ad comm tone would likely offer what I would consider another buying opportunity for those with a longer time horizon, but it would surely #$%$ off anybody backing up the truck at the current price- at least in the shorter term. JMO
For me it's hard to get excited about 12 when I was debating adding more sub 9 not long ago at all.
Dow down .48%
nasdaq down .36%
btk down .07%
nbi up ,34%
however, nktr is down 4.30 % (low volume) with no negative news or downgrade. It simply does not make any sense. Tomoprrow i will add to my position if i can buy at these prices!!
On the other hand, Regado seeks to run a 13,200 patient PIII trial in ACS, which I believe is a very competitve area at this time (but I could be wrong). As of 11/4, CT.gov. shows one center that is actively recrutiing. A 2014 interim readout seems to be a pipe dream at this point, especially givein its funding difficulties (from a Fiercebiotech story):
A month after limping onto the biotech IPO scene with a slashed-price $47 million raise, Regado Biosciences ($RGDO) is trimming about 15% of its staff, saving cash it'll need for a costly Phase III study.
Regado has let loose 5 of its 32 full-time employees, mostly in R&D, a move that will make for annual savings of $625,000 by the second quarter of next year, Regado said.
The company is staring down a roughly $150 million bill to take its lead candidate, REG1, through a 13,000-patient Phase III trial and into an interim analysis. The drug is a two-component anticoagulant, combining pegnivacogin and anivamersen to control bleeding during coronary interventions and open-heart surgeries, ideally making for faster, safer procedures.
But convincing Wall Street of the drug's value has proven difficult. After eyeing an IPO worth $14 to $16 per share, Regado made its debut at just $4, having to more than double the number of shares offered to scrape together that $47 million. Added to the company's recent $51 million venture round, that haul will make a dent in the cost of studying REG1, but Regado will have to either partner up or go back to the well when it needs more cash.
And that's just fine, CEO Dave Mazzo told FierceBiotech last week. Some big investors balked at Regado's gameplan and shied away from supporting a company undertaking such an expensive trial, Mazzo said, but the biotech now has its work cut out for it. The plan is to execute on Phase III, educate investors and, eventually, resurface with strong data and an eye for partnerships, Mazzo said.
The Ophthotech drug Fovista has potential. More importantly, it has raised enough cash to fund its 3 PIII trials, all of which are scheduled to complete in July 2013. From a Medscape "ARVO 2013 Wrap--up":
There is a new drug that doesn't reduce the number of injections; in fact, it doubles the number of injections -- which of course seems backward, but it gives better results. It is Fovista® (formerly E10030), which inhibits platelet-derived growth factor (PDGF) and is given in combination with ranibizumab. There was a large phase 2 trial with 449 patients (much larger than a typical phase 2 trial), and those data were presented last year. The results were re-presented at ARVO by David Boyer, because of the large audience there, and they showed significant advantage to using those 2 drugs in combination.
We are seeing the first signs of combination therapy being effective for the treatment of wet AMD. That will be exciting going forward. They are going to start gearing up for phase 3 trials. It turns out that higher doses, or more frequent injections, of monotherapy anti-VEGF doesn't help. You need to go to a combination.
Fovista strips the parasites from the immature blood vessels from angiogenesis and allows the VEGF to be more effective. Ironically, the anti-VEGF therapy tends to mature those vessels as they are being treated, so they become harder to treat. Fovista makes the new blood vessels more susceptible to the treatment with anti-VEGF. That combination was shown to be significantly more beneficial.
We are going backward initially in terms of frequency or number of injections, but what we are looking for increased efficacy. This will set the bar higher if these results are borne out in the phase 3 trial.
I was going to comment on your post until you did the food run down... Hope the keyboard is drool proof mmmm pie.....
It is very hard to look at OS at that time point, and to generate statistically significant data re OS? its just too early. The interim data would be mostly clinical response data and progression data, therefore even with a great drug FDA putting everybody on study drug (essentially giving the drug an immediate nod of approval) is a pretty high bar.
Mind you if more complete responses or near complete responses crop up (especially if the previous 4 or 6 we heard about in PII did well) that might just tip things. While tumor response data doesn't always translate to survival there is a lot of Irinotecan SN-38 data that says in this case it does. Yes 102 has to be treated like a NCE to some extent, but the large body of history and understanding of the parent absolutely needs to be considered.
I often visit the NKTR website to see if new data has been updated. I happened to be looking today and saw something I must have been overlooking, as I don’t ever remember seeing the two companies that are mentioned under—“Other Royalty Bearing License Partnerships”. Listed is a Phase III program with Ophthtech for an (AMD) eye treatment. Appears that this is expected to have final data in 2016—so this is way out into the future. The other company mentioned is Regado Bioscience with their Phase III drug (Reg-1) for acute coronary syndrome, and interim data for this Phase III is expected in early 2014. There is a huge market for a new (ACS) drug. So in total NKTR has six (6) drugs in Phase III, plus the pending two drugs waiting FDA decisions. Baxter-855, two drugs with Bayer, and NKTR-102. NKTR has a lot on the plate—with many of them coming in the near term.
Happy T-Day to those who love turkey, cranberry sauce, pecan pie---and other stuffings!
Sentiment: Strong Buy