On Wednesday, Shares of Aeterna Zentaris Inc. (NASDAQ:AEZS), lost -5.41% to $0.07.
Aeterna Zentaris Inc., declared that the independent Data and Safety Monitoring Board has recommended that the pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer, continue as planned. The DSMB’s decision follows completion of its pre‑specified second interim analysis on efficacy and safety for the ZoptEC Phase 3 trial at about 192 events. In April 2015 , the DSMB made the same recommendation following its first pre-specified analysis on safety and futility at about 124 events. A final analysis of the data is predictable at about 384 events.
David Dodd , Chairman and CEO of Aeterna Zentaris, commented, “This positive second recommendation from the DSMB is an important milestone since it supports our continuation of the ZoptEC Phase 3 trial in endometrial cancer until its completion. The DSMB recommendation was based upon a comprehensive review of the data on efficacy and safety. We believe that zoptarelin doxorubicin has the potential to become the first FDA approved medical therapy for advanced, recurrent endometrial cancer. This could result in its rapid adoption as a novel core therapy for patient treatment and administration, and therefore, would represent a noteworthy market opportunity for the Company. Moving forward, we are ongoing to develop our commercialization plans regarding zoptarelin doxorubicin in this indication, counting establishing additional partnerships in territories that won’t be pursued by Aeterna Zentaris. In addition, contingent on the success of the ZoptEC program, we have additional areas of interest for further therapeutic development, counting ovarian, prostate and triple negative breast cancer.”
Aeterna Zentaris Inc., a specialty biopharmaceutical company, engages in developing and commercializing novel treatments in oncology, endocrinology, and women’s health. The company’s product pipeline comprises MACRILEN, which accomplished the Phase 2 trial for use in the diagnosis of adult growth hormone deficiency; and zoptarelin doxorubicin, which is in Phase 3 clinical study zoptarelin doxorubicin in endometrial cancer (ZoptEC) of the compound in women with advanced, recurrent, or metastatic endometrial cancer.
Shares of Celgene Corporation (NASDAQ:CELG), declined -0.04% to $113.73, during its last trading session.
Celgene International Sàrl, a wholly owned partner of Celgene Corporation (CELG), recently declared that results from its ongoing phase III LIBERATE™ trial evaluating Otezla® (apremilast), the Company’s oral, selective inhibitor of phosphodiesterase 4 (PDE4), in patients with moderate to severe plaque psoriasis were presented as a late-breaker at the 24th European Academy of Dermatology and Venereology (EADV) Congress in Copenhagen, Denmark, October 7-11, 2015.
“Many patients with moderate to severe plaque psoriasis need treatment options that can assist in managing multiple facets of the disease, counting itching and impact on disease-related quality of life,” said Kristian Reich, M.D., SCIderm Research Institute and Dermatologikum Hamburg, Germany. “The encouraging findings presented at EADV add to the growing body of data which suggest that treatment benefits observed with OTEZLA at week 16 are maintained through week 52 of treatment.”
The LIBERATE study evaluated the clinical efficacy and safety of either oral OTEZLA 30 mg twice daily or weekly subcutaneous (SC) etanercept 50 mg contrast with placebo at week 16 in 250 patients who had no prior exposure to a biological therapy. It also examined the relative safety of a switch from etanercept to OTEZLA after week 16 during an open label extension phase. Primary findings were formerly presented at the 73rd Annual Meeting of the American Academy of Dermatology (AAD) in San Francisco, California. LIBERATE was not designed or powered to directly compare OTEZLA to etanercept.
Celgene Corporation, a biopharmaceutical company, discovers, develops, and commercializes therapies to treat cancer and inflammatory diseases in the United States and Internationally. It markets REVLIMID, an oral immunomodulatory drug for multiple myeloma, myelodysplastic syndromes (MDS), and mantle cell lymphoma; ABRAXANE, a solvent-free chemotherapy product to treat breast, non-small cell lung, pancreatic, and gastric cancers; POMALYST/IMNOVID to treat multiple myeloma; and VIDAZA, a pyrimidine nucleoside analog to treat intermediate-2 and high-risk MDS, and chronic myelomonocytic leukemia, in addition to acute myeloid leukemia (AML).
Finally, bluebird bio, Inc. (NASDAQ:BLUE), ended its last trade with -0.15% loss, and closed at $80.96.
bluebird bio, has market capitalization of $2.94 billion. Its shares were below its 50 days simple moving average with -33.61%. The company offered earning per share of $-3.60 while its 36.26 million shares were outstanding. YTD performance of the company was -12.76%. Stock volatility for the week was 7.35% while for the month it was shown at 9.80%.
bluebird bio, Inc., a clinical-stage biotechnology company, focuses on developing transformative gene therapies for severe genetic and rare diseases. Its advanced product candidate is Lenti-D, which is in phase II/III clinical studies for the treatment of childhood cerebral adrenoleukodystrophy, a rare, hereditary neurological disorder affecting young boys; and LentiGlobin that is in phase I/II clinical studies for the treatment of beta-thalassemia major and severe sickle cell disease (SCD) in France, in addition to a phase I study in the United States for the treatment of severe SCD.
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