Dexcom Tumbles on Abbott, Big Foot Deal

Bigfoot stomps on Dexcom shares with Abbott partnership

Dexcom tumbles on Bigfoot news. See Stockwinners.com Market Radar

Shares of Dexcom (DXCM) are slipping after Bigfoot Biomedical selected Abbott’s (ABT) #FreeStyle Libre as the continuous glucose monitor for its diabetes management system.

Jefferies analyst Raj #Denhoy says the decision to choose Abbott over Dexcom and others was a surprise move, and is an endorsement of “simplicity over point accuracy.”

BIGFOOT SELECTS ABBOTT

In a statement today, Abbott and Bigfoot Biomedical announced that they have entered into an agreement to develop and commercialize diabetes management systems, integrating the former’s FreeStyle Libre glucose sensing technology with the latter’s insulin delivery solutions in the U.S.

Abbott will provide Bigfoot with the next generation of its FreeStyle Libre #glucose sensing technology, which will be utilized in the development of personalized systems intended to optimize #insulin delivery without the need for fingerstick calibration of a glucose sensor.

#Bigfoot said it anticipates initiating a pivotal trial incorporating FreeStyle Libre technology in 2018 at clinical research sites across the U.S. The FreeStyle Libre system is currently pending approval by the Food and Drug Administration in the U.S.

SURPRISING DECISION

Commenting on the news, #Jefferies’ Denhoy told investors that the selection of Abbott’s #Libre over Dexcom and others comes as “a surprise” and is an endorsement of “simplicity over point accuracy” in the future of glucose monitoring and diabetes management.

Bigfoot will use the second-generation Libre, which will include real-time communication, in its pivotal trial starting in 2018, with approval expected in late 2019/early 2020, the analyst pointed out.

Additionally, Denhoy noted that Bigfoot has granted Abbott a period of exclusivity as its Continuous Glucose Monitoring, or #CGM, sensor partner, though Abbott can partner with other systems.

The analyst reiterates a Buy rating and $58 price target on Abbott’s shares.

PRICE ACTION

In Thursday’s trading, shares of Dexcom dropped almost 4% to $69.11, while Abbott’s stock has gained about 1% to $47.99.

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Gilead Receives EMA Approval

The European Medicines Agency validated Gilead’s #bictegravir, a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide for the treatment of HIV-1 infection in adults

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Gilead Sciences’ Marketing Authorization Application for an investigational, once-daily single tablet regimen containing bictegravir, a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide for the treatment of HIV-1 infection in adults has been fully validated and is now under evaluation by the European Medicines Agency.

BIC/FTC/TAF has demonstrated high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in Phase 3 clinical trials among treatment-naive adult patients and among virologically suppressed adult patients who switched regimens.

The MAA for BIC/FTC/TAF is supported by data from four Phase 3 studies in which the regimen met its primary objective of non-inferiority at 48 weeks.

Noninferiority trials are intended to show that the effect of a new treatment is not worse than that of an active control by more than a specified margin.

The BIC/FTC/TAF filing will be reviewed by the #EMA under the centralized licensing procedure for all 28 member states of the European Union.

Gilead (GILD) submitted a New Drug Application for BIC/FTC/TAF in the U.S. on June 12.

#Bictegravir in combination with FTC/TAF as a single tablet regimen is an investigational treatment that has not been determined to be safe or efficacious and is not approved anywhere globally.

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Cara Therapeutics Reports Positive Results for Chronic Kidney Disease

Cara Therapeutics announces summary data from Oral CR845 Phase 1 trial

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Cara Therapeutics (CARA) announced summary results from its Phase 1 safety and pharmacokinetic trial of Oral CR845 in chronic kidney disease, or #CKD , patients undergoing hemodialysis.

The Phase 1 results showed that all four tablet strengths of Oral #CR845 were generally well-tolerated when administered either daily or after dialysis three times per week.

Top-line pharmacokinetic analysis indicated that plasma levels of CR845 attained after oral administration of doses up to 2.5 mg were comparable to or exceeded those attained with clinically efficacious intravenous doses of CR845 for the treatment of moderate-to-severe CKD-associated pruritus, or CKD-aP, in hemodialysis patients.

The plasma levels of CR845 attained after oral administration of the 1.0 mg tablet strength approximated those attained with the 1.0 mcg/kg I.V. CR845 dose, which demonstrated significant clinical benefit in the recently reported Phase 2/3 trial in hemodialysis patients with CKD-aP.

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Arena Pharmaceuticals Reports Positive Ralinepag Results, Shares Rise!

Arena reports successful primary efficacy analysis in Phase 2 trial of ralinepag

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Arena Pharmaceuticals (ARNA) announced Phase 2 results for ralinepag, an investigational, long-acting, orally administered prostacyclin receptor agonist under development for the treatment of pulmonary arterial hypertension, or #PAH.

In this 61-patient study, the primary efficacy analysis demonstrated a statistically significant absolute change from baseline in pulmonary vascular resistance compared to placebo.

#Ralinepag also demonstrated numerical improvement in 6-minute walk distance.

Ralinepag improved median PVR by 163.9 dyn.s.cm-5 from baseline compared to a 0.7 dyn.s.cm-5 worsening from baseline in the placebo arm. Patients treated with ralinepag had a 29.8% improvement in PVR compared to the placebo arm and a 20.1% improvement in PVR compared to baseline.

Additionally, adverse events observed in the study were consistent with other prostacyclin treatments for the management of PAH, with headache, nausea, diarrhea, jaw pain and flushing being the most commonly reported adverse events.

“The positive outcome of this Phase 2 trial in a contemporary PAH patient population is an important milestone in the development of ralinepag for the treatment of patients suffering from this grievous illness. It is exciting to see the positive nonclinical pharmacological profile translating into potentially the first oral prostacyclin therapy that may approach consistent therapeutic levels without the complexity of parenteral therapy. These data give us confidence to move expeditiously toward a Phase 3 clinical program,” said Preston Klassen, Chief Medical Officer of Arena.

ARNA closed at $18.39 on Monday, shares last traded at $25.50.

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Nektar Therapeutics Announces Positive Results

Nektar presents new ‘positive’ preclinical results for NKTR-358

 

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Nektar Therapeutics (NKTR) announced positive preclinical results for NKTR-358, a first-in-class resolution therapeutic for autoimmune disease.

The new preclinical data demonstrate that treatment with NKTR-358 induces profound regulatory T cell effects and suppresses inflammation in multiple preclinical models.

The data were highlighted in an oral presentation at the 13th Annual World Congress on Inflammation on July 9, 2017.

“These studies show that NKTR-358 increases the suppressive capacity and prolongs activation and proliferation of regulatory T cells with limited effects on conventional T cells in order to address the imbalance found in many autoimmune diseases,” said Jonathan Zalevsky, PhD, Senior Vice President, Biology and Preclinical Development at Nektar Therapeutics. “NKTR-358 also demonstrated suppression of antigen-driven inflammation in multiple preclinical models including systemic lupus erythematosus.

We are very excited about NKTR-358’s potential as a resolution therapy in autoimmune disease.”

Autoimmune diseases cause the immune system to mistakenly attack healthy cells in a person’s body.iv A failure of the body’s self-tolerance mechanisms enables the formation of the pathogenic auto-reactive T lymphocytes that conduct this attack. NKTR-358 works by optimally targeting the interleukin-2 (IL-2) receptor complex in order to stimulate proliferation and activation of regulatory T cells. By increasing the number of regulatory T cells, the pathogenic auto-reactive T cells can be controlled and the proper balance of effector and regulatory T cells can be achieved to restore the body’s self-tolerance mechanisms.

In preclinical studies, #NKTR-358 demonstrates attenuated and optimized affinity for human IL-2 receptors to promote biological activity favoring activation of regulatory T cells over conventional T cells. This preferential activity combined with prolonged exposure in vivo led to significant Treg mobilization in blood and spleen following a single subcutaneous administration in rodents.

Increases in regulatory T cells were sustained for 7 to 10 days, and were concomitant with increases in cytometric markers of activation and increased suppressive capacity.

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MetLife to Buy Fortress Investment’s Logan for $250 Million

MetLife to acquire Logan Circle Partners for roughly $250M in cash

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MetLife (MET) and Fortress Investment Group (FIG) announced a definitive agreement for MetLife to acquire Logan Circle Partners, L.P., Fortress’ traditional fixed income asset management business, for approximately $250M in cash.

Following the anticipated separation of Brighthouse Financial next month and assuming the closing of the Logan Circle Partners acquisition, MetLife’s Investment Management business would have more than $560B in total assets under management, of which more than $140B would be managed on behalf of third parties.

Under the terms of the agreement, MetLife will acquire 100% of Fortress’ ownership stake in Logan Circle Partners.

This transaction will not impact MetLife’s existing $3B repurchase authorization, which is expected to be completed by year-end 2017. The transaction is subject to customary closing conditions and regulatory approvals, and is expected to close in the third quarter of 2017.

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Advisory Board Could Be Sold for $1.5 Billion

UnitedHealth, Vista nearing deal to buy, split Advisory Board

Stocks to Buy, Take over targets

UnitedHealth (UNH) and Vista Equity Partners are close to a deal to buy and split up Advisory Board (ABCO), a health and education consultant, Bloomberg reports, citing people familiar with the matter.

According to the report, UnitedHealth would acquire Advisory Board’s health-care unit and Vista would acquire its education business, which may sell for as much as $1.5B.

Vista has focused on high-growth software companies in recent years. First-quarter education revenue at Advisory Board, while comprising only 33 percent of the company’s overall sales, grew 15 percent from a year earlier. Health-care sales declined 6.6 percent, excluding exited programs.

UnitedHealth’s consulting unit focuses on aiding leaders of hospitals and insurers, implementing new technologies and advising health plans on how to design products and set rates.

Advisory Board’s consulting and research projects include collecting bills after care, improving patient care and helping hospitals and doctors with strategy and planning.

An announcement could be up to a month away given the complicated structure of the deal, the people noted.

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