Cyclacel Pharmaceuticals Inc(NASDAQ:CYCC)’s shares plunged 70.32% to $0.82. The company on Dec. 16 announced enrollment of 486 patients, continuation to final analysis and recommendations of the independent Data and Safety Monitoring Board (DSMB) of the Company’s Phase 3 SEAMLESS study of oral sapacitabine capsules in acute myeloid leukemia (AML). All patients will continue to be followed up until mature data become available for final analysis. The DSMB conducted its planned interim analysis for futility after 247 events and the final safety review of 470 randomized patients. The DSMB found no safety concerns. However, the planned futility boundary has been crossed and the DSMB determined that based on available interim data, it would be unlikely for the study to reach statistically significant improvement in survival.
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Amgen Inc. (NASDAQ:AMGN)’s shares gained 0.31% to $160.10. Amgen and AstraZeneca (AZN) on Dec. 11 announced that additional results from AMAGINE-1TM, a pivotal, multi-arm Phase 3 trial evaluating two doses of brodalumab in patients with moderate-to-severe plaque psoriasis will be presented at the Psoriasis: From Gene to Clinic International Congress in London on Saturday, Dec. 13, 2014, at 11:20 a.m. GMT (Abstract FC30). Brodalumab is the only investigational treatment in development that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 cytokines (A, F and A/F) to the receptor. The IL-17 receptor and cytokine family play a central role in the development and clinical manifestations of plaque psoriasis.
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bluebird bio, Inc. (NASDAQ:BLUE)’s stock declined 1.29% to $85.11. The company on Dec. 15 announced the pricing of an underwritten public offering of 2,650,000 shares of its common stock at a public offering price of $85.00 per share, before underwriting discounts. In addition, bluebird bio has granted the underwriters a 30-day option to purchase from it up to an additional 397,500 shares of common stock. BofA Merrill Lynch and Cowen and Company are acting as joint book-running managers of the proposed offering. SunTrust Robinson Humphrey, Wedbush PacGrow Life Sciences and Roth Capital Partners are acting as co-managers. The offering is expected to close on or about December 19, 2014, subject to customary closing conditions.
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Amgen Inc. (NASDAQ:AMGN)’s shares gained 0.73% to $117.71. The company on July 1 announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to investigational bispecific T cell engager (BiTE®) antibody blinatumomab, for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow. The Breakthrough Therapy Designation was based on the results of a Phase 2 trial of 189 adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab.
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Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN)’s shares dropped 3.52% to $6.85. The company on July 1 announced that it has been added to the Russell 2000 and Russell Microcap Indexes. Each June, Russell realigns its family of global equity indexes to reflect market changes in the past year.
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Additionally, the company on June 10 announced the Company has begun dosing ACH-3422, a uridine-analog nucleotide polymerase inhibitor, for seven days in patients with genotype 1 chronic hepatitis C viral infection (HCV) in its ongoing Phase 1 clinical trial. Proof-of-concept results from this trial are expected to be reported during the fall of 2014.
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Novavax, Inc. (NASDAQ:NVAX)’s shares dropped 5.12% to $4.26. The company on June 23 announce that it has been recognized as one of The Washington Post Top Workplaces. The Washington Post Top Workplaces are determined based solely on employee feedback. The employee survey was conducted by WorkplaceDynamics, LLP, a leading research firm on organizational health and employee engagement. Over the past year, more than 5,000 organizations in the U.S. have turned to WorkplaceDynamics to better understand what’s on the minds of their employees. Through its workplace improvement offerings, WorkplaceDynamics provides solutions, training and tools to help clients improve their workplace.
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Idera Pharmaceuticals Inc (NASDAQ:IDRA)’s shares decreased 7.64% to $2.66. The company was scheduled to be added to the Russell 3000 and Russell 2000 Indexes when Russell Investments reconstitutes its comprehensive set of U.S. and global equity indexes on June 27, 2014, according to a preliminary list of additions posted on June 13, 2014 on www.russell.com/indexes. The company is a clinical-stage biotechnology company engaged in the discovery and development of novel synthetic deoxyribonucleic acid (DNA) – and ribonucleic acid (RNA) – based drug candidates.
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Novavax, Inc. (NASDAQ:NVAX)’s shares droped 1.75% to $4.49. The company on June 23 announce that it has been recognized as one of The Washington Post Top Workplaces. The Washington Post Top Workplaces are determined based solely on employee feedback. The employee survey was conducted by WorkplaceDynamics, LLP, a leading research firm on organizational health and employee engagement. Over the past year, more than 5,000 organizations in the U.S. have turned to WorkplaceDynamics to better understand what’s on the minds of their employees. Through its workplace improvement offerings, WorkplaceDynamics provides solutions, training and tools to help clients improve their workplace.
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Idera Pharmaceuticals Inc (NASDAQ:IDRA)’s shares increased 1.05% to $2.88. The company was scheduled to be added to the Russell 3000 and Russell 2000 Indexes when Russell Investments reconstitutes its comprehensive set of U.S. and global equity indexes on June 27, 2014, according to a preliminary list of additions posted on June 13, 2014 on www.russell.com/indexes. The company is a clinical-stage biotechnology company engaged in the discovery and development of novel synthetic deoxyribonucleic acid (DNA) – and ribonucleic acid (RNA) – based drug candidates.
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Peregrine Pharmaceuticals (NASDAQ:PPHM)’s shares jumped 2.26% to $1.81. The company announced that it will report financial results for the fourth quarter and fiscal year (FY) 2014 ended April 30, 2014 on July 14, 2014 after market and will host a conference call and webcast at 1:30 PM Pacific Daylight Time (4:30 PM Eastern Daylight Time). Peregrine’s senior management will discuss financial results for the fourth quarter ended April 30, 2014 of FY 2014 and will review recent progress of its clinical development programs.
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Novavax, Inc. (NASDAQ:NVAX)’s shares droped 1.31% to $4.51. The company on June 23 announce that it has been recognized as one of The Washington Post Top Workplaces. The Washington Post Top Workplaces are determined based solely on employee feedback. The employee survey was conducted by WorkplaceDynamics, LLP, a leading research firm on organizational health and employee engagement. Over the past year, more than 5,000 organizations in the U.S. have turned to WorkplaceDynamics to better understand what’s on the minds of their employees. Through its workplace improvement offerings, WorkplaceDynamics provides solutions, training and tools to help clients improve their workplace.
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Geron Corporation (NASDAQ:GERN)’s shares jumped 3.09% and closed at $3. The company on June 12 announced that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on the investigator-sponsored clinical trial of imetelstat in myelofibrosis (Myelofibrosis IST). The partial clinical hold was placed in March 2014 due to a safety signal of hepatotoxicity that was identified in clinical trials of imetelstat. In order to resolve the partial clinical hold, the investigator, Dr. Ayalew Tefferi of Mayo Clinic, Rochester, Minnesota, was required to provide follow-up information regarding reversibility of hepatotoxicity for all patients who received imetelstat in the Myelofibrosis IST. In its letter dated June 11, 2014, the FDA informed the investigator that it had completed the review of his complete response submission and concluded that the Myelofibrosis IST may proceed.
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PDL BioPharma, Inc. (NASDAQ:PDLI)’s shares jumped 0.42% to $9.62. The company on June 12 announced that it has paid the June 12, 2014, regular quarterly dividend payment of $0.15 per share to all stockholders owning shares of PDL as of June 5, 2014, the record date.
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Additionally, the company on June 10 announced revenue guidance for the second quarter ending June 30, 2014, of approximately $140 million, as compared with actual revenue of $143.6 million for the second quarter of 2013, an approximate 3 percent decrease.
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Additionally, the company on June 10 announced the Company has begun dosing ACH-3422, a uridine-analog nucleotide polymerase inhibitor, for seven days in patients with genotype 1 chronic hepatitis C viral infection (HCV) in its ongoing Phase 1 clinical trial. Proof-of-concept results from this trial are expected to be reported during the fall of 2014.
Amgen Inc. (NASDAQ:AMGN)’s shares fell 0.52% and closed at $118.95. The company on July 1 announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to investigational bispecific T cell engager (BiTE®) antibody blinatumomab, for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow. The Breakthrough Therapy Designation was based on the results of a Phase 2 trial of 189 adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab.
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Celldex Therapeutics, Inc. (NASDAQ:CLDX)’s shares decreased 1.33% to $14.12. The company on June 2 reported data from its ongoing Phase 1 study of the fully human monoclonal antibody varlilumab (CDX-1127) in cancer. Varlilumab is an immunotherapy designed to enhance the body’s natural immune response by directly activating T cells that can specifically recognize and kill cancer cells. Preclinical data support the broad study of varlilumab in combination with a number of other anti-cancer agents including but not limited to checkpoint inhibitors, chemotherapies, targeted therapies and vaccines. Varlilumab will enter at least four combination studies in the second half of 2014.
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