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Nektar Therapeutics (NKTR)

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  • On July 21, 2017, Nektar Therapeutics, a Delaware corporation (“Nektar”), was informed by the European Medicines Agency’s Committee for Medicinal Products for Human Use (the “CHMP”) that it has adopted a negative opinion for the conditional marketing authorization application for ONZEALD TM in the European Union (the “MAA”). Nektar intends to appeal the CHMP opinion and immediately seek a re-examination of the opinion by the CHMP. Nektar and Daiichi Sankyo Europe GmbH will continue to collaborate on ONZEALD TM during the re-examination process.
  • From Chemical and Engineering News - July 19, 2017 (July 24, 2017 Issue):
    Nektar advances abuse-proof opioid
    Biotech firm uses PEGylation to stem euphoria effect
    By Michael McCoy

    Nektar Therapeutics is advancing a new drug that uses polymer chemistry to reach an elusive public health goal: relief from chronic pain with little potential for abuse.
    The San Francisco-based biotech firm has released results of a study showing that its developmental opioid, NKTR-181, provides pain release without the high levels of euphoria that can lead to abuse and addiction with standard opioids. Nektar previously reported that the drug significantly reduces pain in patients with chronic lower back pain.
    Pain, particularly back pain, is a big problem for millions of Americans. But abuse of opioid pain relievers is arguably a bigger problem. In 2014, nearly 2 million Americans either abused or were dependent on prescription opioid pain relievers, Nektar says.
    Marketers of oxycodone and other opioids have confronted abuse with formulas intended to make their pills resistant to crushing and snorting. But drug abusers often find ways to thwart the controls and extract the pills’ active ingredients.
    Nektar’s approach is to covalently bond, through an ether linkage, a short-chain polyethylene glycol to a five-ring morphinan, explains Chief Scientific Officer Stephen K. Doberstein. The molecule, whose structure will be published in the coming weeks, crosses the blood-brain barrier slowly, preventing the “rush” that abusers seek. “The speed of onset is super important,” Doberstein says.
    Moreover, the ether linkage is more stable than the morphine ring, according to Doberstein. Thus, a potential abuser can’t use chemistry to break the linkage without denaturing the molecule’s active half.
    NKTR-181 represents only the second example of a PEGylated small-molecule drug, Doberstein says. The first is naloxegol, a derivative of α-naloxol that Nektar licensed to AstraZeneca in 2009. FDA approved it in 2014 for the treatment of opioid-induced constipation.
    Nektar continues to study the long-term safety of NKTR-181 in a Phase III clinical trial. Given its potentially large market, the company will seek a partner with pain drug experience. “We are talking to multiple companies,” Doberstein says.
  • Options players have an $11.00 put on this for earnings
  • from Bloomberg:
    Why Yellen’s Fed cares about America’s opioid epidemic. The deepening crisis has caught the central bank’s attention. If addiction is rendering people unemployable, it could help explain why a historically low portion of the prime-age population is working.
  • There are $12B in opioid sales each year. Nektar's 181 has the product to fully disrupt this market. One-eight-one will be able to be priced higher than the existing opioids since it does not have the addictive side effect. Parents and others will be able to safely store 181 in their house. So -- let's take a look at the value 181 will add to NKTR's stock price. Let's assume conservatively that 181 sells $3B a year even though its ultimate potential is >$12B. With biotechs being conservatively valued at 6 times sales, you'd get a market capitalization of $18B. Let's say about half of that goes to the partner. One-eight-one therefore adds $9B to NKTR's market cap or $58 per share. But NKTR should get let's say $150M upfront -- so that's another $1/share. Then you have 214, which clearly looks efficacious and safe and which would generate a couple more billion in sales. But if it works will 262, you're looking at a $10B combo drug. And I have not even given value to the approved products or to 358 and the others in the pipeline. As you can see, this stock is going to be a $100/share biotech if not a $200 or more per share stock.
  • Any thoughts on when will the 181 partnership will be completed, before the FDA meetings or after. One would think the partner would want to be in the discussions but they may want to see where 181 stands in the eye of the FDA before signing on. HR has a lot of work complete before 2018.
  • What were the CHMP’s main concerns that led to the refusal?

    The CHMP considered that the benefit of Onzeald in the treatment of breast cancer that had spread to the brain had not been sufficiently demonstrated.
    The claim of effectiveness relied on data from a subgroup of patients from a main study which, overall, failed to convincingly show the effectiveness of Onzeald. The Committee considered that the data from this subgroup, which were not supported by additional studies, were not sufficient to prove the effectiveness of Onzeald in patients whose breast cancer had spread to the brain, even when analysed by different methods.
    Therefore, the CHMP was of the opinion that the study did not provide enough evidence on the benefits of Onzeald and recommended that the marketing authorisation be refused.

    Assume NKTR will meet with CHMP and tell them it was EMA that instructed NKTR, 3-years ago, to run the additional Ph 3, so more data would be available. This is for conditional approval. The left hand not talking to the right hand, dah.
  • Conference call highlights:

    1. "They are talking to a number of companies right now [on partnering 181]".
    2. They believe that they have "done all we need to do from the standpoint of these types of studies."
    3. They worked closely with the FDA in the HALs study design.
    4. They "don't envision doing a larger study".
    5. They believe physicians will use 181 as an initial drug.
    6. Time v. reward and amount to take are critical in drug abuse situations. NKTR's 181 has a substantially delayed liking effect (2.5 hours) and requires much more 40 mg v 1200 mg.
    7. "We have created ... the holy grail of pain medicine."
    8. They are in constant discussions with FDA. By Q4, they expect to have all answers with respect to a NDA.
    9. "Years of hard work have now come to fruition."
  • While early it appears once again NKTR is forming at pennant pattern. The pattern is a flagpole (from the 181 announcement) followed by a consolidation (Looks like a triangle with higher lows and tighter highs).
  • Once again the chart looks terrific. Beautiful pennant formation. Looks like a triangle following the spike up or flag pole.
  • Not good, the CHMP on 20Jul17 adopted a negative opinion on Onzeald. NKTR has 15 days to request a re-examination. I searched CHMP EMA then etirinotecan pegol.
  • Taking 20 pills 60mg strength and it's safe and effective. Now that's a superior drug.
  • Obamacare REPEALED coming
  • This from the Nov. 06, 2015, 10-Q: We are currently exploring various future regulatory paths forward for NKTR-102 with the EU and U.S. regulatory authorities. In Europe, we have met with the European Union National Authorities in Sweden (MPA) and the United Kingdom (MHRA) to discuss the BEACON data. Based on the outcome of these meetings, we believe that there is a path forward to file a marketing approval application (MAA) for conditional approval of NKTR-102 for patients with metastatic breast cancer with brain metastases. If we decide to file the MAA, we would be required to start a confirmatory trial in conjunction with the MAA review. In the United States, we met with the FDA and the Oncology Division said that we would not be able use the BEACON data to support an accelerated approval for a new drug application (NDA). However, the FDA staff also indicated that positive results from the potential completed confirmatory trial for the MAA could also support a NDA filing. We are currently evaluating next steps and potential designs and costs for a confirmatory trial. At this time, we do not plan to advance development of NKTR-102 without a collaboration partner.
  • Tomorrow, we open at 50.00
  • NKTR-181 is a new chemical entity (NCE), designed to treat pain without inducing euphoria associated with opioids that can lead to abuse and addiction. Notably, the FDA had granted a Fast Track designation to the NKTR-181 development program, back in May 2012. So far, the drug has not been approved by the FDA or any other regulatory agencies.
  • Provisional Schedule

    Committee meeting: 08 August 2017
    Etirinotecan pegol
  • John McCain could benefit from NKTR 102. The only cancer drug for brain cancer.
    Extends life 2X.
  • CHMP gave negative opinion NKTR102, Nektar to appeal.
  • Looks like Dr. G just got a half a mil from his stock options. Well deserved Dr. G, keep up the good work!