It is looking like the EMA didn’t like the way NKTR publicized the Onzeald/EU details. NKTR stated they would get accelerated review (7 months instead of 10), but they ended up with over 10 months. And NKTR said they are including Onzeald revenue in 4Q17. Now it is looking like the EMA won’t let that happen either. I’m guessing Onzeald will get a positive CHMP opinion in October with conditional approval later this year, but it won’t occur soon enough for NKTR to get revenue this year.
All true. I wish HR was replaced tomorrow
Why ??? People are dying! Can anyone please explain to me why the FDA cannot meet with Nektar regarding a path to marketing 181 prior to "sometime in the 4tg quarter"? What is of greater priority then this epidemic of death and destruction? Perhaps a major reason that our company needs a partner is tohave more influence with the appropriate authorities. As to compensation, I still think the product is worth $500 M up front, plus 30% of sales and additional stipents as volume targets are hit. I know many think I am high on these numbers, but this is a unique and badly meeded drug, and the initial phase 3 came in extremely positively/ Anyway, the timing seems ubsurd to me. People, don't you understand - people are hurting. This should be the priority. We should be speaking now and looking for a way to move this product to those who so desperately need it. Sometime in the 4th quarter is just not reasonable,
Nektar feeling good about the data and what they are seeing ..
Nektar Therapeutics Announces Seven Abstracts Accepted for Presentation at SITC
Anyone know why NKTR move up only 0.05 on almost twice the average volume. A few minutes before closing, volume was only about 900K. Increased to over 2 mil after close.
Clinical data from the PIVOT program evaluating NKTR-214 in combination with the checkpoint inhibitor nivolumab were accepted for an oral presentation in the Clinical Trials: Novel Combinations Session on November 11, 2017. The PIVOT trial is comprised of two stages, the dose-escalation stage (PIVOT-02, n=38)
…..NKTR 214 Patient updated June 2017 ASCO data. These 38 patients at ASCO had SD Sable Disease with tumor reductions. June, July, Aug, Sept, Oct. – 5 full months or 16 weeks. As a min. 7 doses. Either these patients are cured or not. This is a big deal. PIVOT-02: Preliminary safety, efficacy and biomarker results from the Phase 1/2 study of CD-122-biased agonist NKTR-214 plus nivolumab in patients with locally advanced/metastatic solid tumors
Data presentation for the clinical trial of single-agent NKTR-214 in patients with advanced solid tumors: "The novel IL-2 cytokine immune agonist NKTR-214 harnesses the adaptive and innate immune system for the treatment of solid cancers." "NKTR-214 enhances anti-tumor T cell immune responses induced by checkpoint blockade or vaccination." "Harnessing the innate and adaptive immune system to eradicate treated and distant untreated solid tumors." The other 3 abstracts are not important.
Physicians Get Too Much Blame for Opioid Crisis, Some Say
A plethora of new cancer treatments is under development
There will be more cures, and they will be expensive
I finished my last and final buy trade. let it all ride. min 300pps in the near term.Looking at moving new #$%$ into something else from here.
JP Morgan HR said he is working with Washington DC on NKTR 181. Until the second indication is completed, Oxy can not be pulled off the shelves. NKTR is most likely right now building up nktr 181 inventory per the FDA. IMO
Board of Directors get their options priced today or tomorrow. I am so happy for them !
Like the action. Holding above 21.31 for the last 3 days. High volume on Fri.
HR and JZ basically said NKTR 214 works great and data will show it in NOV.
Just picked up some more at 21.38 for the IRA. Time to breakout of this range. Chart looks great.
Nov 12 NKTR binary event. up or down
NKTR 214 patient update
Wonder how that short trade has worked out for Martin Shkreli? So much for his bail bond:
Martin Shkreli has been sent to jail for offering $5,000 for a strand of Hillary Clinton's hair on Facebook. "That is a solicitation to assault in exchange for money," said Judge Kiyo A. Matsumoto.
Here we go again. The CHMP 11-14 Sept meeting highlights are out and no mention of Onzeald. No new NKTR SEC filing either. FYI - Fanaptum is not mentioned either.
NKTR-214 only needs to mark a 10% improvement in these combo studies (10%=more living) over their mono therapies
We are going to see some wins and some Meh ...
$21 will be ... "I got in"
Pivot 1-2 poster shows phase one complete, but didn't show response rates. Comments?