Microsoft (MSFT) Turns Positive Ahead of FQ3 Report Apr 24, 2014 03:10PM

Microsoft (Nasdaq: MSFT) shares are modestly positive heading into the company's FQ314 report, which is expected out after markets close on Thursday.

The Street is currently looking for Microsoft to post Q3 EPS of $.63 with revenue of $20.4 billion, from EPS of $.72 and revs of $20.5 billion reportd in the same period last year.

Money flow is positive $28.9 million in afternoon trading, suggesting more buying pressure on the stock. The uptick-to-downtick ratio is at 1.3 times.

Speaking on today's webcast will be Satya Nadella, CEO and Amy Hood, CFO.

Microsoft Corp. will publish fiscal year 2014 third-quarter financial results after the close of the market on Thursday, Apr. 24, 2014 on the Microsoft Investor Relations website at http://www.microsoft.com/investor. A live webcast of the earnings conference call will be made available at 2:30 p.m. Pacific Time on the Microsoft Investor Relations Web site at http://www.microsoft.com/investor.


Prothena Corp (PRTA) to Present Update on NEOD001 Phase 1 Interim Data at XIV ISA Apr 23, 2014 11:46AM

Prothena Corporation plc (Nasdaq: PRTA) announced that an abstract was published by the XIV International Symposium on Amyloidosis (ISA) and described interim data from an ongoing Phase 1 study of NEOD001, a monoclonal antibody in clinical development for the treatment of patients with AL amyloidosis and persistent organ dysfunction, as of the abstract submission date. Updated data will be presented for the first time at ISA in Indianapolis, Indiana.

"AL amyloidosis is a hematological disorder caused by plasma cells that produce misfolded AL protein. The abnormal AL protein forms deposits, known as amyloid, in the tissues and organs of individuals suffering from this disease," said Michaela Liedtke, MD, Assistant Professor of Medicine at Stanford University. "Autologous stem cell therapy and off-label use of chemotherapy is often used in an effort to reduce or eliminate the plasma cells producing the misfolded protein, but even after treatment, residual organ dysfunction remains the primary cause of morbidity and mortality for patients suffering from AL. It is exciting to observe that some patients are potentially responding to NEOD001 as we look to confirm these interim results in a larger Phase 2/3, controlled clinical trial. A therapy that works effectively for AL would be welcomed by the amyloidosis community."

"NEOD001 is the first potential treatment that directly targets the toxic forms of the AL protein and offers hope for this unmet medical need," said Dale Schenk, PhD, President and Chief Executive Officer of Prothena. "The encouraging signals observed in this ongoing Phase 1 study, both in safety and tolerability and in the cardiac biomarker responses, suggest that a Phase 2/3 study is warranted to further evaluate the safety and efficacy of NEOD001."

The Phase 1 study is evaluating the safety, tolerability, pharmacokinetics and immunogenicity of NEOD001 in patients with AL amyloidosis and persistent organ dysfunction. It is also designed to define a maximally tolerated dose and/or recommended dose(s) for a Phase 2/3 study and to evaluate exploratory biomarkers of cardiac, renal and hepatic function.

At the date of the abstract submission, 15 patients, with a median age of 60 years and a median of two organs involved, had been treated with NEOD001, administered intravenously once per month at five dose levels ranging from 0.5 to 8.0 mg/kg for a period of one to nine months. At the time of enrollment into the study, all patients completed one or more prior anti-plasma cell therapies, did not require additional chemotherapy, and had persistent organ dysfunction.

Key data from the published abstract include:

Safety and Tolerability

The interim data demonstrate that NEOD001 was generally safe and well-tolerated at the doses studied. In addition, NEOD001 demonstrated acceptable pharmacokinetic properties and immunogenicity was not observed in any patient. The most frequently reported adverse events were musculoskeletal (N=4), infection (N=4), and fatigue (N=3). All adverse events were mild to moderate and no dose limiting toxicities have been observed. A total of three patients had discontinued the trial at the time of abstract submission: one due to hematological progression, one due to organ progression and one due to withdrawal of consent.

Evidence of Cardiac Biomarker Activity

Of the 15 patients enrolled in the study at the time of abstract submission, 9 patients (56%) had pre-specified baseline levels of the N-terminal prohormone of brain natriuretic peptide (NT-proBNP) that were ≥ 650 pg/mL (required baseline level for evaluation) and at least one post-baseline NT-proBNP determination. Of those 9 patients, one patient met the progression criteria based on an increase of NT-proBNP, and the remaining 8 patients either met the response criteria based on a decrease in NT-proBNP or were considered stable. Specifically, 5 of 9 (56%) patients had NT-proBNP levels that decreased to a level that met pre-defined response criteria, 3 of 9 (33%) patients had stable NT-proBNP levels, and 1 of 9 (11%) patients showed an increase in NT-proBNP levels in a manner that met pre-defined progression criteria.

Presentation of NEOD001 Poster at ISA

Presentation of the NEOD001 poster at ISA will include updated safety, tolerability, pharmacokinetic and NT-proBNP data from the ongoing Phase 1 study as of March 11. The full poster will be made available at www.prothena.com on April 29 at 8:00 a.m. EDT (concurrent with when it will be made available for viewing at ISA).

(Abstract #PB-48) Preliminary cardiac biomarker responses demonstrated in an ongoing phase 1 study of NEOD001 in patients with AL amyloidosis and persistent organ dysfunction

  • Presenter: Dr. Michaela Liedtke, Stanford Cancer Institute, Stanford, California
  • Presentation Date and Time: Tuesday, April 29, 4:30-6:00 p.m. EDT


UPDATE: General Dynamics (GD) Boosts FY14 EPS Outlook to $7.05 - $7.10; Says Funded Backlog Strongest 'in Years' Apr 23, 2014 09:15AM

(Updated - April 23, 2014 9:15 AM EDT)

General Dynamics Corp. (NYSE: GD) sees FY14 EPS of $7.05 - $7.10 versus $7.21 expected. The company had sees FY14 EPS of $6.80 to $6.85.

On the company's quarterly conference call, it said that the Aerospace group is off to a good start and that it has the strongest funded backlog in years.


UPDATE: General Dynamics (GD) Boosts FY14 EPS Outlook to $7.05 - $7.10; Says Funded Backlog Strongest 'in Years' Apr 23, 2014 09:15AM

(Updated - April 23, 2014 9:15 AM EDT)

General Dynamics Corp. (NYSE: GD) sees FY14 EPS of $7.05 - $7.10 versus $7.21 expected. The company had sees FY14 EPS of $6.80 to $6.85.

On the company's quarterly conference call, it said that the Aerospace group is off to a good start and that it has the strongest funded backlog in years.


Cytokinetics, Inc. (CYTK) to Present BENEFIT-ALS Results at 66th AAN Apr 22, 2014 07:49AM

Cytokinetics, Incorporated (Nasdaq: CYTK) announced that results from BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS) will be presented during a Platform Session scheduled at the 66th Annual Meeting of the American Academy of Neurology (AAN) to be held April 26 - May 3, 2014 at the Pennsylvania Convention Center in Philadelphia, PA. Cytokinetics also announced that additional poster presentations related to tirasemtiv and ALS will be presented at AAN.

Platform Session Presentation at the 66th Annual Meeting of the American Academy of Neurology

Title: The Effect of Tirasemtiv on Functional Status in Patients with ALS
Presenter: Jeremy M. Shefner, M.D., Ph.D
Date: Tuesday, April 29, 2014
Presentation Time: 4:15 PM (Eastern Time)
Session: S16.005 - 5LB.001 - Platform Session: Neuromuscular and Clinical Neurophysiology

About Tirasemtiv and BENEFIT-ALS

Tirasemtiv, a novel skeletal muscle activator, is the lead drug candidate from Cytokinetics' skeletal muscle contractility program. Tirasemtiv selectively activates the fast skeletal muscle troponin complex by increasing its sensitivity to calcium and, in preclinical studies, demonstrated increases in skeletal muscle force in response to neuronal input and delays in the onset and reductions in the degree of muscle fatigue. In previously conducted Phase IIa clinical trials in patients with amyotrophic lateral sclerosis (ALS), tirasemtiv appeared generally well-tolerated, and demonstrated encouraging trends to improvement in patients' functional abilities and increases in measures of respiratory and skeletal muscle strength and endurance.

BENEFIT-ALS is an international, double-blind, randomized, placebo-controlled, Phase IIb clinical trial which was designed to evaluate the safety, tolerability and potential efficacy of tirasemtiv in patients with ALS. Patients enrolled in BENEFIT-ALS began treatment with open-label dosing of tirasemtiv at 125 mg twice daily. Patients who tolerated open-label treatment for one week were randomized to receive 12 weeks of double-blind treatment with twice-daily oral ascending doses of tirasemtiv or placebo, beginning at 125 mg twice daily and increasing weekly up to 250 mg twice daily (or a dummy dose titration with placebo). Clinical assessments occurred monthly during double-blind treatment; patients also returned for follow-up evaluations at one and four weeks after their final dose of double-blind study medication. The primary efficacy analysis of BENEFIT-ALS compares the mean change from baseline in the ALS Functional Rating Scale in its revised form (ALSFRS-R) on tirasemtiv versus placebo. Secondary endpoints include Maximum Voluntary Ventilation (MVV) and other measures of respiratory and skeletal muscle function and fatigability.

Additional Poster Presentations at the 66th Annual Meeting of the American Academy of Neurology

Title: Fast Skeletal Muscle Troponin Activator Tirasemtiv Increases Muscle Function and Performance in the B6SJL SOD1G93A ALS Mouse Model
Presenter: Fady I. Malik, M.D., Ph.D., F.A.C.C.
Date: Monday, April 28, 2014
Presentation Time: 3:00 PM (Eastern Time)
Session: P1.081 - Poster Session I: Anterior Horn Cell Disease: Pathogenesis and Pathology
Poster on Display: 3:00 PM - 6:30 PM (Eastern Time)

Title: Tirasemtiv Amplifies Skeletal Muscle Response to Nerve Activation in Humans
Presenter: Fady I. Malik, M.D., Ph.D., F.A.C.C.
Date: Wednesday, April 30, 2014
Presentation Time: 7:30 AM (Eastern Time)
Session: P4.077 - Poster Session IV: ALS: Trials and Biomarkers
Poster on Display: 7:30 AM - 11:00 AM (Eastern Time)

Title: Profile of Medical Care Costs in Patients with Amyotrophic Lateral Sclerosis in Medicare Program and Under Commercial Insurance
Presenter: Lisa Meng, Ph.D.
Date: Thursday, May 1, 2014
Presentation Time: 3:00 PM (Eastern Time)
Session: P7.102 - Poster Session VII: Neuromuscular Health Services/Outcomes Research
Poster on Display: 3:00 PM - 6:30 PM (Eastern Time)


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