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FDA, Clinical Trial Updates: MAPP, CYTK, and HEB Post Big Gains

Wed, 27 May 2009 12:26:35 GMT

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, s (...)[More...]

Cytokinetics Announces Addition to Board of Directors

Fri, 06 Nov 2009 11:46:00 GMT

Cytokinetics, Incorporated (NASDAQ: CYTK) announced today that Pat Gage has been appointed to the company's Board of Directors.
From 1998 to 2002, Dr. Gage was President of Wyeth Research and subsequently also Senior Vice President, Science and Technology.
"We are pleased to welcome Pat to our Board of Directors at this important next stage of Cytokinetics' evolution," stated Robert I. Blum, Cytokinetics' President and Chief Executive Officer.

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Cytokinetics to Present Phase IIa Clinical Trials Data on Omecamtiv Mecarbil at the European Society of Cardiology Congress 2009

Mon, 24 Aug 2009 19:55:00 GMT

SOUTH SAN FRANCISCO, CA -- -- 08/24/09 -- Cytokinetics, Incorporated announced today that data relating to two Phase IIa clinical trials evaluating omecamtiv mecarbil , one in stable heart failure patients and one in patients with ischemic cardiomyopathy and angina, are scheduled to be presented in two poster presentations at the European Society of Cardiology Congress 2009, to be held August 29 - September 2, 2009 at the Fira Gran Via Plaza Europa in Barcelona, Spain.[More...]

Cytokinetics, Incorporated Reports Second Quarter 2009 Financial Results

Wed, 29 Jul 2009 20:51:00 GMT

Of this revenue, $50.0 million was related to Amgen's payment for the exercise of its option to an exclusive worldwide license (excluding Japan) to the company's cardiac contractility program, including omecamtiv mecarbil (formerly CK-1827452), and $21.4 million was related to the recognition of the remaining deferred revenue associated with Amgen's December 2006 non-exclusive license and technology access fee under the parties' collaboration and option agreement.
"Cytokinetics executed effectively on key activities in the second quarter, which we believe positions the company well both financially and operationally, to advance our pipeline with emphasis to our drug candidates that leverage our muscle contractility expertise," stated Robert I. Blum, Cytokinetics' President and Chief Executive Officer.
Examples of such statements include, but are not limited to, statements relating to Cytokinetics' financial guidance, including expected cash operating expenditures, revenues and R&D and G&A expenses for 2009 and the ability of its cash reserves to suffice for over 24 months; Cytokinetics' and its partners' research and development activities, including the initiation, conduct, focus, scope and completion of development activities (including of clinical trials) for omecamtiv mecarbil (formerly CK-1827452) and Cytokinetics' other drug candidates and potential drug candidates, the significance of clinical trial results for omecamtiv mecarbil, the planned presentation of clinical trial results, the progression of IND-enabling studies, the advancement of Cytokinetics' pipeline, and the activities to be conducted by Cytokinetics under its collaboration with Amgen; the potential receipt of funds under Cytokinetics' collaboration with Amgen; the submission of the omecamtiv mecarbil name for publication; and the properties and potential benefits of Cytokinetics' compounds.

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Cytokinetics to Announce Second Quarter Results on July 29, 2009

Wed, 22 Jul 2009 19:55:00 GMT

SOUTH SAN FRANCISCO, CA -- -- 07/22/09 -- Cytokinetics, Incorporated announced today that it is scheduled to report second quarter results on Wednesday, July 29, 2009 at 4:00 p.m. Eastern Time. Following the announcement, Cytokinetics' senior management will host a conference call at 4:30 p.m. Eastern Time to discuss operational and financial results and the company's outlook for the future.[More...]

Cytokinetics Announces the Initiation of a First-Time-in-Humans, Phase I Clinical Trial of CK-2017357

Thu, 18 Jun 2009 11:25:00 GMT

SOUTH SAN FRANCISCO, CA -- -- 06/18/09 -- Cytokinetics, Incorporated announced today that the company has initiated a first-time-in-humans, Phase I clinical trial of CK-2017357 in healthy male volunteers. CK-2017357 is a fast skeletal muscle troponin activator and is the lead drug candidate that has emerged from the company's skeletal sarcomere activator program. CK-2017357 selectively activates the troponin complex and increases its sensitivity to calcium, subsequently leading to an increase in skeletal muscle force. This mechanism of action has demonstrated encouraging pharmacological activity in preclinical models that may relate to the potential treatment of diseases associated with aging, muscle wasting, and neuromuscular dysfunction.[More...]

Cytokinetics to Present at the Eighth Annual Needham Life Sciences Conference

Thu, 04 Jun 2009 19:55:00 GMT

SOUTH SAN FRANCISCO, CA -- -- 06/04/09 -- Cytokinetics, Incorporated announced today that Sharon Barbari, Senior Vice President, Finance and Chief Financial Officer, is scheduled to present a corporate update at the 8th Annual Needham Life Sciences Conference on Thursday, June 11, 2009 at 10:30 a.m. Eastern Time in the Fahnestock Room at The Palace Hotel in New York, New York.[More...]

Cytokinetics Presents Clinical Data Relating to Ispinesib in Patients With Metastatic Breast Cancer at the 2009 Annual Meeting of the American Society of Clinical Oncology

Tue, 02 Jun 2009 11:25:00 GMT

SOUTH SAN FRANCISCO, CA -- -- 06/02/09 -- Cytokinetics, Incorporated announced today that a poster presentation summarizing interim data from the Phase I portion of a Phase I/II clinical trial evaluating ispinesib, a novel inhibitor of kinesin spindle protein , in patients with locally advanced or metastatic breast cancer was presented at the 2009 Annual Meeting of the American Society of Clinical Oncology held from May 29 - June 2, 2009 in Orlando, FL. This poster highlights the safety and tolerability of ispinesib and tumor-reductions of 30 percent in 3 patients in this ongoing Phase I/II clinical trial of ispinesib dosed on days 1 and 15 of a 28-day cycle. In this trial, ispinesib appears to demonstrate anti-cancer activity with a similar toxicity profile when compared with prior clinical trials conducted with a once every 21 days dosing schedule.[More...]

Cytokinetics Announces Non-Clinical Data Relating to GSK-923295 Presented at the 2009 Annual Meeting of the American Society of Clinical Oncology

Mon, 01 Jun 2009 19:55:00 GMT

SOUTH SAN FRANCISCO, CA -- -- 06/01/09 -- Cytokinetics, Incorporated announced today that a poster presentation summarizing non-clinical data for GSK-923295, a novel inhibitor of centromere-associated protein E , was presented at the 2009 Annual Meeting of the American Society of Clinical Oncology held from May 29 - June 2, 2009 in Orlando, FL. The poster summarizes an evaluation of GSK-923295 in pediatric preclinical cancer xenograft models and highlights possible opportunities for exploration of this novel mechanism in pediatric cancers.[More...]

Cytokinetics Announces Presentations of Data From Phase IIa Clinical Trials of CK-1827452 at the 2009 Heart Failure Congress of the European Society of Cardiology

Mon, 01 Jun 2009 11:25:00 GMT

SOUTH SAN FRANCISCO, CA -- -- 06/01/09 -- Cytokinetics, Incorporated announced today that data from two Phase IIa clinical trials evaluating CK-1827452 were presented in the Late Breaking Trials Session and in two poster presentations at the 2009 Heart Failure Congress of the European Society of Cardiology, held May 30-June 2, 2009 in Nice, France. The company believes these results support further clinical development of CK-1827452. Amgen Inc. has exercised its option and has obtained an exclusive, world-wide license to CK-1827452, subject to specified development and commercialization participation rights retained by Cytokinetics.[More...]

Cytokinetics Presents Clinical Data Relating to SB-743921 in Patients With Non-Hodgkin or Hodgkin Lymphoma at the 2009 Annual Meeting of the American Society of Clinical Oncology

Sat, 30 May 2009 11:55:00 GMT

SOUTH SAN FRANCISCO, CA -- -- 05/30/09 -- Cytokinetics, Incorporated announced today that a poster presentation summarizing interim data from the Phase I portion of a Phase I/II clinical trial data evaluating SB-743921, a novel inhibitor of kinesin spindle protein , in patients with non-Hodgkin and Hodgkin lymphoma was presented at the 2009 Annual Meeting of the American Society of Clinical Oncology held from May 29 - June 2, 2009 in Orlando, FL. The poster highlighted that greater dose-density has been achieved with a dosing schedule of days 1 and 15 of a 28-day cycle in this clinical trial, as compared to a previous Phase I trial evaluating SB-743921. In addition, a potential amplified efficacy signal was observed without any significant increase in side effects.[More...]