Biotech stocks for your portfolio: Galena Biopharm
Post# of 22755
Posted On: 04/08/2016 4:12:52 PM
Biotech stocks for your portfolio: Galena Biopharma, Inc. (GALE), Celldex Therapeutics, Inc (CLDX)
The American Red Cross
Galena Biopharma, Inc. (GALE) ended last trading session with a change of -3.97 percent. It trades at an average volume of 2.34M shares versus 2.37M shares recorded at the end of last trading session. The share price of $1.45 is at a distance of 145.76 percent from its 52-week low and down -39.33 percent versus its peak. The company has a market cap of $240.57M and currently has 165.91M shares outstanding. The share price is currently 28.72 percent versus its SMA20, 56.86 percent versus its SMA50, and 4.23 percent versus its SMA200. The stock has a weekly performance of 6.62 percent and is -1.36 percent year-to-date as of the recent close.
Galena Biopharma, Inc. (GALE) on March 29, 2016 announced that the 70th qualifying disease free survival (DFS) event has been achieved in the NeuVax™ (nelipepimut-S) Phase 3, PRESENT (Prevention of Recurrence in Early-Stage, Node Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial. NeuVax is a peptide immunotherapy vaccine currently being evaluated for the prevention of cancer recurrence and is Galena’s lead development agent in multiple ongoing and planned clinical trials.
Based on clinical and radiological data, seventy qualifying DFS events have been confirmed by the trial’s independent Endpoint Adjudication Committee (EAC), comprised of two oncologists and one radiologist with expertise in the conduct of clinical trials in breast cancer. In the ensuing months, Galena will compile and submit the clinical data to the trial’s Independent Data Monitoring Committee (IDMC) to perform the Interim Analysis. The Interim Analysis is a pre-specified futility and overall safety analysis to evaluate the likelihood of the study to achieve its primary objectives. Upon completion of this prospective analysis, the IDMC will provide a recommendation to the Company regarding further continuation of the trial.
PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) is an international, Phase 3 study to evaluate NeuVax plus granulocyte macrophage-colony stimulating factor (GM-CSF) versus placebo plus GM-CSF to prevent cancer recurrence. The trial is being run under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA). PRESENT is targeting patients who are node positive, HER2 IHC 1+/2+, and HLA A2+ and/or A3+. The study is double blind, randomized 1:1, and is stratified by stage, type of surgery, hormone receptor status, and menopausal status. Galena enrolled a total of 758 patients who constitute the Intention to Treat (ITT) population, and the primary endpoint for the trial is disease free survival (DFS) upon reaching 141 events with 3 years minimum follow-up.
Celldex Therapeutics, Inc. (CLDX) recently recorded -3.68 percent change and currently at $4.71 is 59.12 percent away from its 52-week low and down -84.45 percent versus its peak. It has a past 5-day performance of 24.6 percent and trades at an average volume of 4.18M shares. The stock has a 1-month performance of 27.99 percent and is -69.96 percent year-to-date as of the recent close. There were about 98.65M shares outstanding which made its market cap $464.64M. The share price is currently 27.59 percent versus its SMA20, -19.56 percent versus its SMA50, and -66.25 percent versus its SMA200.
Celldex Therapeutics, Inc. (CLDX) on March 7, 2016 announced that the independent Data Safety and Monitoring Board (DSMB) has determined, based on a preplanned interim analysis, that continuation of the Phase 3 ACT IV study of RINTEGA® (rindopepimut) in patients with newly diagnosed EGFRvIII-positive glioblastoma will not reach statistical significance for overall survival in patients with minimal residual disease, the primary endpoint of the study, as both the RINTEGA arm and the control arm are performing on par with each other. In the ACT IV study, RINTEGA has performed consistently with prior Phase 2 studies but the control arm has significantly outperformed expectations (Hazard ratio = 0.99; median OS: RINTEGA 20.4 months vs. control 21.1 months). Based on this recommendation, Celldex is discontinuing the study and does not anticipate incurring substantial additional costs related to RINTEGA at this time. All patients on the RINTEGA arm of the ACT IV study, prior Phase 2 studies and existing compassionate use recipients will be offered ongoing access to RINTEGA on a compassionate use basis. Celldex first received the data after market close on Friday, March 4th and is in the process of reviewing the results.
Celldex currently has seven company-led clinical trials across five product candidates ongoing. The Company expects to report data from a number of these studies over the next three to 18 months, including a registration study in triple negative breast cancer and a number of Phase 1 and 2 cancer immunotherapy combination trials.
The American Red Cross
Galena Biopharma, Inc. (GALE) ended last trading session with a change of -3.97 percent. It trades at an average volume of 2.34M shares versus 2.37M shares recorded at the end of last trading session. The share price of $1.45 is at a distance of 145.76 percent from its 52-week low and down -39.33 percent versus its peak. The company has a market cap of $240.57M and currently has 165.91M shares outstanding. The share price is currently 28.72 percent versus its SMA20, 56.86 percent versus its SMA50, and 4.23 percent versus its SMA200. The stock has a weekly performance of 6.62 percent and is -1.36 percent year-to-date as of the recent close.
Galena Biopharma, Inc. (GALE) on March 29, 2016 announced that the 70th qualifying disease free survival (DFS) event has been achieved in the NeuVax™ (nelipepimut-S) Phase 3, PRESENT (Prevention of Recurrence in Early-Stage, Node Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial. NeuVax is a peptide immunotherapy vaccine currently being evaluated for the prevention of cancer recurrence and is Galena’s lead development agent in multiple ongoing and planned clinical trials.
Based on clinical and radiological data, seventy qualifying DFS events have been confirmed by the trial’s independent Endpoint Adjudication Committee (EAC), comprised of two oncologists and one radiologist with expertise in the conduct of clinical trials in breast cancer. In the ensuing months, Galena will compile and submit the clinical data to the trial’s Independent Data Monitoring Committee (IDMC) to perform the Interim Analysis. The Interim Analysis is a pre-specified futility and overall safety analysis to evaluate the likelihood of the study to achieve its primary objectives. Upon completion of this prospective analysis, the IDMC will provide a recommendation to the Company regarding further continuation of the trial.
PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) is an international, Phase 3 study to evaluate NeuVax plus granulocyte macrophage-colony stimulating factor (GM-CSF) versus placebo plus GM-CSF to prevent cancer recurrence. The trial is being run under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA). PRESENT is targeting patients who are node positive, HER2 IHC 1+/2+, and HLA A2+ and/or A3+. The study is double blind, randomized 1:1, and is stratified by stage, type of surgery, hormone receptor status, and menopausal status. Galena enrolled a total of 758 patients who constitute the Intention to Treat (ITT) population, and the primary endpoint for the trial is disease free survival (DFS) upon reaching 141 events with 3 years minimum follow-up.
Celldex Therapeutics, Inc. (CLDX) recently recorded -3.68 percent change and currently at $4.71 is 59.12 percent away from its 52-week low and down -84.45 percent versus its peak. It has a past 5-day performance of 24.6 percent and trades at an average volume of 4.18M shares. The stock has a 1-month performance of 27.99 percent and is -69.96 percent year-to-date as of the recent close. There were about 98.65M shares outstanding which made its market cap $464.64M. The share price is currently 27.59 percent versus its SMA20, -19.56 percent versus its SMA50, and -66.25 percent versus its SMA200.
Celldex Therapeutics, Inc. (CLDX) on March 7, 2016 announced that the independent Data Safety and Monitoring Board (DSMB) has determined, based on a preplanned interim analysis, that continuation of the Phase 3 ACT IV study of RINTEGA® (rindopepimut) in patients with newly diagnosed EGFRvIII-positive glioblastoma will not reach statistical significance for overall survival in patients with minimal residual disease, the primary endpoint of the study, as both the RINTEGA arm and the control arm are performing on par with each other. In the ACT IV study, RINTEGA has performed consistently with prior Phase 2 studies but the control arm has significantly outperformed expectations (Hazard ratio = 0.99; median OS: RINTEGA 20.4 months vs. control 21.1 months). Based on this recommendation, Celldex is discontinuing the study and does not anticipate incurring substantial additional costs related to RINTEGA at this time. All patients on the RINTEGA arm of the ACT IV study, prior Phase 2 studies and existing compassionate use recipients will be offered ongoing access to RINTEGA on a compassionate use basis. Celldex first received the data after market close on Friday, March 4th and is in the process of reviewing the results.
Celldex currently has seven company-led clinical trials across five product candidates ongoing. The Company expects to report data from a number of these studies over the next three to 18 months, including a registration study in triple negative breast cancer and a number of Phase 1 and 2 cancer immunotherapy combination trials.
(0)
(0)
I'm in it to win it!
NASDAQ DIP and RIP
Here is the best word that describes what i do here.
Intuitive;
means having the ability to understand or know something without any direct evidence or reasoning process.
I was born with it, I'm truly blessed!
Alway's searching for winners'
NASDAQ DIP and RIP
Here is the best word that describes what i do here.
Intuitive;
means having the ability to understand or know something without any direct evidence or reasoning process.
I was born with it, I'm truly blessed!
Alway's searching for winners'
Scroll down for more posts ▼