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Nektar Therapeutics NKTR-181 meets Primary and Secondary Endpoints in Phase 3

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March 20, 2017: Nektar Therapeutics announced positive results from the SUMMIT-07 Phase 3 efficacy study of NKTR-181, a first-in-class opioid analgesic. NKTR-181 is a new chemical entity (NCE) that is the first full mu-opioid agonist molecule designed to provide potent pain relief without the high levels of euphoria that can lead to abuse and addiction with standard opioids. The U.S. Food and Drug Administration (FDA) has granted the investigational medicine NKTR-181 Fast Track designation for the treatment of moderate to severe chronic pain.

The SUMMIT-07 study compared twice-daily dosing of NKTR-181 tablets to placebo in the treatment of over 600 patients with moderate to severe chronic low back pain who were new to opioid therapy (opioid-naïve). The clinical trial met the primary efficacy endpoint of the study in demonstrating significantly improved chronic back pain relief with NKTR-181 compared to placebo (p=0.0019). Key secondary endpoints of the study were also met with high statistical significance.

The Phase 3 SUMMIT-07 study used an enriched-enrollment randomized withdrawal (EERW) trial design in patients with moderate to severe chronic low back pain. The trial included an open-label titration period in which patients were titrated to a tolerated, effective dose of NKTR-181 (100 mg to 400 mg twice-daily). Following this open-label titration period, patients entered a double-blind, placebo-controlled treatment period in which they were randomized 1:1 to either continue to receive the tolerated, effective dose of NKTR-181 or to receive matching placebo (i.e. active drug was withdrawn) for a period of 12 weeks.
During the open-label titration period of the trial in which patients were titrated to a tolerated, effective dose of NKTR-181, average pain scores dropped by 65% (from 6.73 at screening to 2.32 at randomization, n=610).
The primary endpoint of the study was mean change in the weekly average pain score in the double-blind randomized treatment period from baseline (end of open-label titration period) to week 12 (end of double-blind randomized treatment period).

January 8, 2017: BTIG initiates coverage of biotechnology firm Nektar Therapeutics with a Buy rating, and a price target of $22. Nektar Therapeutics stock chart has just done a breakout above $13.50 resistance.

Nektar Therapeutics Stock Chart

Nektar Therapeutics is a clinical-stage biopharmaceutical company with a proven track record of discovering and developing new medicines that treat patients living with debilitating diseases and conditions.

We have granted licenses to medicines which enable third parties to develop, make available and, in some cases, manufacture for which we receive royalties and/or manufacturing revenues.

Such arrangements in the U.S. include the following:

Nektar and AstraZeneca Agreement for Movantik

Under our global agreement with AstraZeneca, AstraZeneca is responsible for all development and commercialization. We receive escalating royalties on net U.S. sales of Movantik starting at 20 percent. We are also eligible to receive additional tiered sales milestone payments based upon global net revenue of Movantik.

Nektar Therapeutics and Baxalta (a division of Shire plc) Agreement for ADYNOVATE

Under our collaboration with Baxalta, a wholly-owned subsidiary of Shire plc (formerly Baxter), we developed ADYNOVATE™, an extended half-life recombinant factor VIII (rFVIII) treatment for Hemophilia A based on ADVATE® [Antihemophilic Factor (Recombinant)]. Baxalta is responsible for development and commercialization and we supply manufacturing materials for a portion of the supply chain to manufacture ADYNOVATE.

We receive escalating royalties of between 4-6 percent on global net revenue of ADYNOVATE up to $1.2 billion in revenue; for revenue above $1.2 billion, we receive a flat 13 percent royalty. Nektar Therapeutics is also eligible to receive additional tiered revenue milestone payments based upon global net revenue of ADYNOVATE.

R&D Pipeline Phase 3

Nektar Therapeutics has a deep and diverse portfolio of investigational medicines in different stages of clinical development. We are focused on using new chemistry approaches to make better medicines to treat cancer, chronic pain and auto-immune disease.

Nektar Therapeutics also has a number of strategic partnerships ranging from joint discovery and co-development to licensing and royalty arrangements with numerous companies.

Below are just the Phase 3 drugs Nektar Therapeutics has in its pipeline. There are many more Phase 1 and 2 drugs not listed below.

Amikacin Inhale (BAY41-6551) Phase 3

Amikacin Inhale is a drug-device combination product, comprised of a specially formulated Amikacin Inhalation Solution with Nektar’s Pulmonary Drug Delivery System (PDDS). It is being developed in partnership with Bayer HealthCare as an adjunctive treatment for intubated and mechanically ventilated patients with Gram-negative pneumonia. The unique areosolization system, PDDS, was designed to achieve optimal lung penetration of the specially formulated Amikacin Inhale Solution, delivering antimicrobial agent directly to the site of infection in the lungs.

Ciprofloxacin Dry Powder for Inhalation (DPI) Phase 3

Under development by Bayer Healthcare, Ciprofloxacin Dry Powder for Inhalation (DPI) is an innovative drug-device combination being investigated in non-CF bronchiectasis (NCFB). The investigational product candidate is currently in Phase 3 clinical trials in patients with NCFB and features a small, hand-held inhaler for ease-of-use. Nektar is entitled to royalties on sales of Ciprofloxacin DPI upon commercialization.

The first of the Phase 3 efficacy studies, RESPIRE 1 assessed the safety and efficacy of Cipro DPI in NCFB patients and met both primary endpoints. Cipro DPI 14 day on/off regimen significantly prolonged time to first exacerbation vs pooled placebo (p=0.0005) and significantly reduced frequency of exacerbation vs matched placebo (0.0061). The frequency of treatment emergent adverse events was similar across groups.

Fovista® (pegpleranib) Phase 3

Fovista® (pegpleranib) is an anti-platelet-derived growth factor (anti-PDGF) agent. Ophthotech is investigating Fovista® administered in combination with anti-vascular endothelial growth factor (anti-VEGF) therapy for the treatment of neovascular age-related macular degeneration (wet AMD). A Phase 3 clinical trial evaluating the safety and efficacy of Fovista® in combination with Avastin® or Eylea® for the treatment of wet AMD is ongoing.

As part of the agreement, Nektar is entitled to development and commercial milestones and royalties on product sales of Fovista.

NKTR-181 Phase 3

NKTR-181 is a first-in-class, mu-opioid analgesic investigational drug candidate with a novel molecular structure designed to provide potent pain relief with a slow rate of entry into the brain. This slow rate of entry is designed to reduce the euphoria that can lead to the abuse of current opioid analgesics.

PEGPH20 Phase 3

PEGPH20 is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase under development for the systemic treatment of tumors that accumulate hyaluronan (HA). Emerging data show that most pancreatic cancers surround themselves with a protective hyaluronan-rich matrix, which makes the disease difficult to treat and is an indicator of poor prognosis. PEGPH20 has been shown to deplete this matrix component from the tumor that rapidly changes the tumor microenvironment and metabolism, which may render the tumor more vulnerable to therapy as well as inhibit tumor growth. PEGPH20 is being evaluated in a Phase 3 HALO 301 study as a first-line therapy for patients with metastatic pancreatic cancer. The trial will be conducted at approximately 200 sites with two co-primary endpoints of progression free survival and overall survival in patients receiving investigational new drug PEGPH20 in combination with gemcitabine and ABRAXANE (nab-paclitaxel) compared to gemcitabine and nab-paclitaxel alone. Additional clinical studies for PEGPH20 include a Phase 1b clinical study evaluating PEGPH20 in combination with KEYTRUDA® (pembrolizumab) in relapsed lung and gastric cancer patients; and a Phase 1b/2 clinical collaboration with Eisai evaluating eribulin in combination with PEGPH20 in women with advanced or metastatic, HER2-negative, HA-high breast cancer.

Nektar has an exclusive worldwide license agreement with Halozyme for PEGPH20. As part of the agreement, Nektar is entitled to development and commercial milestones and royalties on product sales of PEGPH20.

ONZEALD™ (etirinotecan pegol) Phase 3

ONZEALD (etirinotecan pegol) is the first long-acting topoisomerase I-inhibitor (Topo I). ONZEALD is a new type of chemotherapeutic designed to enhance the anti-cancer effects of topo I-inhibition while minimizing its toxicities.

Nektar Therapeutics invented ONZEALD using our unique chemistry platform and is developing it for the treatment of advanced breast cancer patients with a history of brain metastases.

In preclinical models, ONZEALD achieved a 300-fold increase in tumor concentration as compared to a first-generation topo I-inhibitor.3 Because ONZEALD is a large molecule, it is believed to penetrate the leaky vasculature within the tumor environment more readily than normal vasculature, concentrating and trapping ONZEALD in the tumor tissue. ONZEALD has been evaluated in breast, ovarian, colorectal, brain and lung cancer.

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