On Tuesday, Shares of Exelixis, Inc. (NASDAQ:EXEL), gained 3.04% to $5.63.
Exelixis declared that it has accomplished the submission of its rolling New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy. Exelixis has requested Priority Review as part of the NDA filing.
In August 2015, the FDA granted Breakthrough Therapy designation to cabozantinib for this potential advanced RCC indication. Breakthrough Therapy designation can expedite the development and review of drugs that are intended to treat serious or life-threatening diseases, and for which preliminary clinical evidence indicates the drug may demonstrate substantial improvement over existing therapies on one or more clinically noteworthyendpoints. Drugs that receive Breakthrough Therapy designation may benefit from the involvement of FDA senior leadership in the review process, rolling submission, and other benefits. Before receiving Breakthrough Therapy designation, cabozantinib received Fast Track designation for its potential advanced RCC indication in April 2015.
The NDA submission is based on results of METEOR, a phase 3 pivotal trial comparing cabozantinib to everolimus in patients with advanced RCC who practiced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor. In July 2015, Exelixis declared top-line results from METEOR demonstrating that the trial had met its primary endpoint of improving progression-free survival; contrast with everolimus, cabozantinib was associated with a 42% reduction in the rate of disease progression or death. These data were later presented at the European Cancer Congress in September 2015 and conpresently published in The New England Journal of Medicine.
Shares of Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM), declined -2.87% to $1.19, during its current trading session.
Peregrine Pharmaceuticals declared financial results for the second quarter of fiscal year (FY) 2016 ended October 31, 2015, and offered an update on its advancing clinical pipeline and other corporate developments.
Clinical Development Highlights
As of today, more than 90% of the planned number of patients have been enrolled in the Phase III SUNRISE trial, representing a sufficient number of patients required to trigger the two pre-planned interim analyses in addition to the final analysis for trial unblinding. The company anticipates to reach the trial’s estimated enrollment of 582 patients in the coming weeks.
Peregrine and AstraZeneca expanded their cancer immunotherapy clinical trial partnership to evaluate bavituximab in combination with AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736). The companies are presently planning a global Phase II study in patients with formerly treated squamous or non-squamous NSCLC, in addition to a Phase I/Ib trial that will evaluate the safety and efficacy of bavituximab in combination with durvalumab and chemotherapy in multiple solid tumors. The company anticipates the Phase II study to be initiated in early 2016 with the Phase I/Ib study starting later in 2016.
Peregrine continues to finalize plans for its Phase II/III trial to evaluate bavituximab with chemotherapy combinations in HER2-negative metastatic breast cancer. This trial is on track to be initiated by the end of calendar year 2015.
Peregrine Pharmaceuticals, Inc., a biopharmaceutical company, researches and develops monoclonal antibodies for the treatment and diagnosis of cancer in the United States and internationally. The company’s lead immunotherapy candidate, bavituximab, which is in Phase III development stage for the treatment of formerly-treated non-small cell lung cancer together with various investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. It is also involved in the development of molecular imaging agent, 124I-PGN650, which is in exploratory clinical trial for the imaging of various solid tumor types.
Finally, Shares of CTI BioPharma Corp. (NASDAQ:CTIC) are trading with -1.94% loss.
Shares of CTI BioPharma Corp (NASDAQ:CTIC) have received an average rating of “Hold” from the six ratings firms that are presently covering the firm, AnalystRatings.NET reports. One equities research analyst has rated the stock with a sell recommendation, two have issued a hold recommendation and three have assigned a buy recommendation to the company. The average 1-year price target among brokers that have issued a report on the stock in the last year is $3.01.
CTI BioPharma Corp., a biopharmaceutical company, engages in the acquisition, development, and commercialization of novel targeted therapies for blood-related cancers in the United States and internationally. It primarily focuses on the commercialization of PIXUVRI, an aza-anthracenedione derivative for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma in the European Union.
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