On Monday, Celladon Corp (NASDAQ:CLDN)’s shares declined -80.70% to $2.64.
Celladon Corp (CLDN) declared that its Phase 2b CUPID2 trial did not meet its primary and secondary endpoints. CUPID2 is a randomized, double-blind, placebo-controlled, multinational trial evaluating a single, one-time, intracoronary infusion of the cardiovascular gene therapy agent MYDICAR(R) (AAV1/SERCA2a) as compared to placebo added to a maximal, optimized heart failure drug and device regimen.
In the study, the primary endpoint comparison of MYDICAR to placebo resulted in a hazard ratio of 0.93 (0.53, 1.65 95%CI) (p=0.81), defined as heart failure-related hospitalizations or ambulatory treatment for worsening heart failure. The secondary endpoint comparison of MYDICAR to placebo, defined as all-cause death, need for a mechanical circulatory support device, or heart transplant, likewise failed to show a noteworthytreatment effect. The efficacy endpoint analyses were performed on the (n=243) modified intent to treat population (mITT), which excludes clinical events that occurred in patients who did not receive MYDICAR or placebo, or which occurred preceding to dosing. All other exploratory efficacy endpoints (improvement in New York Heart Association classification, 6 Minute Walk Test, and Quality of Life) were also incompriseent with a treatment effect. No safety issues were noted.
Celladon Corporation, a clinical-stage biotechnology company, focuses on developing cardiovascular gene therapy and calcium dysregulation. The companys lead product candidate comprises MYDICAR that uses genetic enzyme replacement therapy to correct the Sarco/endoplasmic reticulum Ca 2+ -ATPase 2a enzyme deficiency in heart failure patients that result in inadequate pumping of the heart.
Penn Virginia Corporation (NYSE:PVA)’s shares dropped -5.55% to $6.30.
Penn Virginia Corporation (PVA) declared that it will release its first quarter 2015 results after the market closes on Monday, May 11, 2015, and hold a conference call / webcast on Tuesday, May 12, 2015, at 10:00 a.m. ET.
The full text of the first quarter earnings release and a link to the webcast will be accessible at PVA’s website and through other electronic business news services. You can take part in the conference call by phone or via the Internet.
Penn Virginia Corporation, an independent oil and gas company, explores, develops, and produces crude oil, natural gas liquids, and natural gas in various onshore regions of the United States.
At the end of Monday’s trade, Amedica Corporation (NASDAQ:AMDA)‘s shares dipped - -12.93% to $0.235.
Amedica Corporation (AMDA) declared that it will release financial results for its first quarter 2015 on Thursday, May 7, 2015, after the market closes.
Following the release, that same day the Company will host a conference call and simultaneous audio webcast with Dr. Sonny Bal, Chairman and CEO of Amedica Corporation, in addition to key members of the administration team to review its first quarter 2015 financial results.
Amedica Corporation, a commercial-stage biomaterial company, develops, manufactures, and sells a range of medical devices based on its silicon nitride technology platform in the United States, Europe, and South America. It offers Valeo silicon nitride interbody spinal fusion devices for use in the cervical and thoracolumbar areas of the spine; and a line of non-silicon nitride spinal fusion products.
Celldex Therapeutics, Inc. (NASDAQ:CLDX), ended its Monday’s trading session with -15.85% loss, and closed at $25.33.
Celldex Therapeutics, Inc. (CLDX) declared preclinical results that further support varlilumab’s expansion into combination studies with PD-1 inhibitors. The data were presented in a poster session entitled “Synergistic anti-tumor activity of PD-1 signaling blockade and CD27 costimulation correlates with improved ratio of effector to regulatory T cells at the tumor site” at the 2015 American Association for Cancer Research Annual Meeting.
Varlilumab is a fully human immunoglobulin (Ig)G1 agonist antibody that binds to and activates CD27, a critical T-cell co-stimulatory molecule in the immune-activation cascade. Specific and controlled activation of CD27 in the presence of T-cell receptor (TCR) signaling by varlilumab results in improved immune responses with a favorable safety profile. Varlilumab is in clinical development for a range of cancers in combination with other therapies that target potentially synergistic points of immune-regulation, counting with Opdivo(R), BMS’s PD-1 blocking antibody and with MPDL3280A, Roche’s anti-PDL1 investigational cancer immunotherapy
Celldex Therapeutics, Inc., a biopharmaceutical company, develops, manufactures, and commercializes novel therapeutics for human health care in the United States. The company’s lead drug candidates comprise rindopepimut (CDX-110), a targeted immunotherapeutic in a pivotal Phase III study for the treatment of front-line glioblastoma, in addition to in Phase II study for the treatment of recurrent glioblastoma; and Glembatumumab vedotin (CDX-011), a targeted antibody-drug conjugate in a randomized Phase IIb study for the treatment of triple negative breast cancer, in addition to in Phase II study for the treatment of metastatic melanoma.
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