Key Developments For ARCA biopharma, Inc.
ARCA biopharma, Inc. (ABIO.O) (Consolidated Issue listed on NASDAQ Global Market)
ARCA biopharma, Inc. Receives FDA Fast Track Designation for Gencaro
ARCA biopharma, Inc. announced that the United States Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Gencaro, the Company`s investigational, pharmacologically beta-blocker and mild vasodilator, for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population. The Company intends to submit a study protocol for review under the FDA`s Special Protocol Assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy of Gencaro in approximately 3,000 patients with chronic heart failure who have the genotype that appears to respond most favorably to Gencaro.
ARCA biopharma, Inc. Announces Management Changes
ARCA biopharma, Inc. announced changes to its management team to reflect the Company`s recent change in commercial strategy to seek alternatives for the potential commercialization of Gencaro. Richard B. Brewer will assume the role of Chairman of the Board of Directors and resign as Chief Executive Officer. Michael R. Bristow, will become President and Chief Executive Officer, a position he previously held with ARCA prior to Mr. Brewer joining the Company. Dr. Bristow will resign as Chairman but will remain a member of the Board of Directors. These changes will be effective on July 10, 2009.
ARCA biopharma, Inc. Receives Complete Response Letter From FDA On GencaroTM NDA
ARCA biopharma, Inc. announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) seeking approval for GencaroTM (bucindolol hydrochloride) for the treatment of patients with chronic heart failure. In its Complete Response letter, the FDA states that it cannot approve the NDA in its current form and specifies additional actions and information required by the Agency for approval of the Gencaro NDA.
Nuvelo, Inc. Appoints Kathryn Falberg as Chief Financial Officer and Chief Operating Officer
Nuvelo, Inc. announced that Kathryn E. Falberg, formerly Chief Financial Officer (CFO) of Amgen, Inc., has been appointed CFO and Chief Operating Officer (COO), effective February 24, 2009.
Lee Bendekgey Announces Resignation As General Counsel Of Nuvelo, Inc. But To Continue As Chief Financial Officer Form 8-K
Nuvelo, Inc. announced in its Form 8-K that Lee Bendekgey resigned from his position as the Company’s general counsel, but will remain with the Company as its Chief Financial Officer and Treasurer on a transitional basis. On January 27, 2009, Mr. Bendekgey provided written notice to the Company that he will continue as the Company’s Chief Financial Officer and treasurer through March 31, 2009.
