Key Developments: Peregrine Pharmaceuticals Inc (PPHM.O)

PPHM.O on Consolidated Issue listed on NASDAQ Capital Market

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Latest Key Developments (Source: Significant Developments)

Peregrine Pharmaceuticals Inc presents data on bavituximab at AACR
Wednesday, 9 Apr 2014 11:00am EDT 

Peregrine Pharmaceuticals Inc:Presents data from studies validating immune-stimulatory mechanism of action of bavituximab.Demonstrating that combination of preclinical phosphatidylserine (PS)-targeting antibody with immune checkpoint inhibitors anti-CTLA-4 or anti-PD-1 antibodies yielded superior anti-tumor immune responses in animal models of melanoma.Says colon cancer compared to anti-CTLA-4 and PD-1 antibodies alone.Bavituximab is investigational immunotherapy being evaluated in second-line, non-small cell lung cancer (NSCLC) as part of SUNRISE pivotal Phase III clinical trial.Data from these combination studies are compelling as they provide further evidence that support immune-stimulatory effects of bavituximab in reducing prevalence of key immunosuppressive checkpoints in tumor environment.Reducing tumor-suppressive factors, reducing immune suppressor cells and providing increased tumor-specific immunity.These data also show that when combined with downstream immune checkpoint inhibitors such as anti-CTLA-4 and anti-PD-1, PS targeting mediates improved protective tumor-specific immunity following tumor rechallenge.  Full Article

Peregrine Pharmaceuticals Inc updates progress in investigator-sponsored phase i/ii Trial of Peregrine's Bavituximab in Combination With Sorafenib in Liver Cancer
Friday, 14 Mar 2014 08:00am EDT 

Peregrine Pharmaceuticals Inc:Presentation of update to ongoing Investigator-Sponsored Trial (IST) of immunotherapy bavituximab in combination with the chemotherapy sorafenib (Nexavar) in patients with advanced hepatocellular carcinoma (HCC) or liver cancer.Phase II portion of this trial is ongoing with 34 of 38 intended patients enrolled, 10 of which are on treatment with longest one on treatment for 18 months.This open-labeled trial is almost complete and while the results are preliminary, they are promising.Phase II portion of this trial is a single-center, single-arm, non-randomized, open-label trial with the primary endpoint of radiologic time to progression with imaging occurring at 6 week intervals.Secondary endpoints of trial include overall survival (OS), progression free survival (PFS), safety and response rates.Trial is scheduled to enroll 38 patients with advanced liver cancer.In order to leverage recent understandings surrounding the immune-stimulatory mechanism of action of bavituximab, several additional components have been installed into this portion of the trial.These include plasma and serum collection and tissue biopsies for evaluating changes in immune response following bavituximab treatment.Specifically, to assess whether combination therapy reactivates tumor immunity by changing the tumor microenvironment from immunosuppressive to immunoreactive, changing the tumor infiltrating cell composition or inducing T cell response to tumor antigens.  Full Article

Peregrine Pharmaceuticals Inc declares quarterly dividend on its series E convertible preferred stock
Tuesday, 11 Mar 2014 04:10pm EDT 

Peregrine Pharmaceuticals Inc:Declares a quarterly cash dividend on the company's 10.50 pct Series E Convertible Preferred Stock.Payable on Apr. 1 to holders of record at the close of business on Mar. 21.  Full Article

Peregrine Pharmaceuticals Inc reaffirms FY 2014 revenue outlook
Friday, 7 Mar 2014 08:00am EST 

Peregrine Pharmaceuticals Inc:Says it on track to be on the higher end of previously stated guidance for FY 2014 revenue of $18 and $22 mln.FY 2014 revenue of $22 mln - Thomson Reuters I/B/E/S.  Full Article

Peregrine Pharmaceuticals Inc announces closing of preferred stock offering
Wednesday, 19 Feb 2014 10:17am EST 

Peregrine Pharmaceuticals Inc:Closes previously announced underwritten public offering of 700,000 shares of its 10.50% Series E Convertible Preferred Stock at a public offering price of $25.00 per share.Says it has filed an application to list the shares of Series E Preferred Stock on the NASDAQ Capital Market under the symbol PPHMP.Holders of Series E Preferred Stock may convert their shares, in whole or in part, into shares of the company's common stock at a conversion price of $3.00 per share.Gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses payable by Peregrine, were about $17.5 million.MLV & Co. LLC book-runner.  Full Article

Peregrine Pharmaceuticals Inc announces public offering of series E preferred stock
Wednesday, 5 Feb 2014 04:01pm EST 

Peregrine Pharmaceuticals Inc:Says it intends to offer and sell shares of its newly-designated 10.50 pct Series E Convertible Preferred Stock in an underwritten public offering.Says in connection with the offering, the company intends to grant the underwriters a 30-day option to purchase up to an additional 15 pct of shares of the Series E Preferred Stock.Says the company intends to use the net proceeds from the offering for general corporate purposes.  Full Article

Peregrine Pharmaceuticals Inc receives FDA fast track designation for its immunotherapy bavituximab
Monday, 6 Jan 2014 07:30am EST 

Peregrine Pharmaceuticals Inc:Says has received fast track designation by the U.S. Food and Drug Administration (FDA) for its investigational immunotherapy bavituximab for the potential treatment of second-line non-small cell lung cancer (NSCLC).Says the company initiated SUNRISE, a pivotal Phase III clinical trial comparing bavituximab plus the chemotherapy docetaxel against placebo plus docetaxel in this indication.Says SUNRISE is a Phase III, global, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability and efficacy of bavituximab plus docetaxel in patients with second-line non-small cell lung cancer.Says trial is evaluating bavituximab plus docetaxel versus docetaxel plus placebo in about 600 patients at more than 100 clinical sites worldwide.Says patients with Stage IIIb/IV non-squamous, NSCLC who have progressed after standard front-line treatment are eligible for enrollment.Says patients will be randomized into 1 of 2 treatment arms.  Full Article

Peregrine Pharmaceuticals Inc Announces Encouraging Results In Breast And Pancreatic Cancers For Patients Treated With Peregrine's Immunotherapy Bavituximab
Monday, 3 Jun 2013 08:25am EDT 

Peregrine Pharmaceuticals Inc announced clinical candidate bavituximab. In the first study presented, interim data from a Phase I trial evaluating bavituximab plus paclitaxel therapy in patients with HER2-negative metastatic breast cancer (MBC) showed that 85% of patients achieved an objective tumor response, including 15% of patients achieving a complete response (CR) measured in accordance with RECIST criteria. clinical candidate bavituximab. In the first study presented, interim data from a Phase I trial evaluating bavituximab plus paclitaxel therapy in patients with HER2-negative metastatic breast cancer (MBC) showed that 85% of patients achieved an objective tumor response, including 15% of patients achieving a complete response (CR) measured in accordance with RECIST criteria. In this open-label trial, 14 patients with HER2-negative MBC were treated with paclitaxel (80 mg/m2) weekly for three weeks of each four-week cycle and bavituximab (3 mg/kg) was administered weekly beginning on day 15 after two weekly doses of paclitaxel. Interim results from 13 evaluable patients showed that 11 patients (85%) achieved an objective response, including 2 patients (15%) that achieved a complete response (CR). In addition, the combination of bavituximab and paclitaxel was safe and well-tolerated.  Full Article

Peregrine Pharmaceuticals Inc's Cancer Drug Moves to Late-Stage Trial-DJ
Monday, 20 May 2013 10:49am EDT 

Dow Jones reported that Peregrine Pharmaceuticals Inc announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Phase III registration trial design of the Company's lead clinical immunotherapeutic candidate bavituximab in second-line non-small cell lung cancer (NSCLC). The trial design was supported by promising data from a Phase IIb trial in patients treated with bavituximab plus docetaxel. Final data from the study will be presented at the upcoming ASCO Annual Meeting on June 1, 2013. The Phase III clinical trial will be a randomized, double-blind, placebo-controlled trial evaluating bavituximab plus docetaxel versus docetaxel alone enrolling approximately 600 patients at sites worldwide. The trial will enroll Stage IIIB/IV non-squamous, NSCLC patients who have progressed after standard front-line treatment. The primary endpoint of the trial will be overall survival (OS). Bavituximab is a investigational immunotherapy that activates the maturation of dendritic cells and cancer-fighting (M1) macrophages to the development of cytotoxic T-cells that fight solid tumors. Bavituximab has been studied in 17 clinical trials including lung, breast, pancreatic, liver and rectal cancers. Data from three of these clinical trials will be presented at the ASCO Annual Meeting beginning June 1, 2013.  Full Article

Faruqi & Faruqi, LLP Is Investigating Peregrine Pharmaceuticals Inc On Behalf Of Its Shareholders
Tuesday, 9 Apr 2013 08:00am EDT 

Faruqi & Faruqi, LLP announced that it is investigating potential wrongdoing at Peregrine Inc. (Peregrine or the Company). The investigation focuses on whether certain executive officers and directors of Peregrine breached their fiduciary duties by failing to disclose that: there were major discrepancies between various patient sample test results and patient treatment code assignments; the clinical data from the Company's randomized, double-blind placebo-controlled Phase II trial of bavituximab in second-line non-small cell lung cancer was misleading; and as a result of the foregoing, the Company's positive statements about Peregrine's business, operations, and prospects, including those statements relating to the clinical data from the Company's randomized, double-blind placebo-controlled Phase II trial of bavituximab in second-line non-small cell lung cancer lacked sufficient support. On September 24, 2012 Peregrine disclosed that during the course of preparing for an end-of-phase II meeting with regulatory authorities and following recent data announcements from its randomized, double-blind placebo-controlled Phase II trial of bavituximab in second-line non-small cell lung cancer, the Company discovered major conflicts between patient sample test results and patient treatment code assignments.  Full Article

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