Sales, Clinical Hold Removal, Trial Initiations, and Committee Recommendations - Analyst Notes on Geron, Zalicus, Northwest Biotherapeutics, Progenics and TG Therapeutics
Editor Note: For more information about this release, please scroll to bottom.
NEW YORK, June 17, 2014 /PRNewswire/ --
Today, Analysts Review released its analysts' notes regarding Geron Corporation (NASDAQ: GERN), Zalicus Inc. (NASDAQ: ZLCS), Northwest Biotherapeutics, Inc. (NASDAQ: NWBO), Progenics Pharmaceuticals Inc. (NASDAQ: PGNX) and TG Therapeutics, Inc. (NASDAQ: TGTX). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/3775-100free.
Geron Corporation Analyst Notes
On June 12, 2014, Geron Corporation (Geron) announced the removal of the partial clinical hold on the investigator-sponsored clinical trial of imetelstat in myelofibrosis (Myelofibrosis IST) by the U.S. Food and Drug Administration's (FDA). According to the Company, in March 2014, the partial clinical hold was placed due to a safety signal of hepatotoxicity that was identified in clinical trials of imetelstat. Additionally, the Company stated that its Investigational New Drug (IND) application for imetelstat remains on full clinical hold affecting Geron's clinical trials in essential thrombocythemia or polycythemia vera and in multiple myeloma. The full analyst notes on Geron are available to download free of charge at:
http://www.analystsreview.com/Jun-17-2014/GERN/report.pdf
Zalicus Inc. Analyst Notes
On June 2, 2014, Zalicus Inc. (Zalicus) announced that the Company has closed the sale of its combination High Throughput Screening (cHTS) platform and related assets to Horizon Discovery Group. According to the Company, the sale was closed for $8 million plus certain additional amounts relating to the working capital of these assets. Additionally, the Company stated that as a result of the cHTS sales proceeds, it expects net cash in excess of $9 million at the closing of the merger with Epirus Biopharmaceutical. Mark H.N. Corrigan, M.D., Zalicus President and CEO, stated, "I am pleased that the cHTS platform will continue to be leveraged to its fullest potential under the stewardship of Horizon. In addition, the sale of cHTS has increased our cash balance by approximately $8 million ensuring Zalicus shareholders with at least a 17% ownership position in our previously-announced merger with Epirus Biopharmaceuticals." The full analyst notes on Zalicus are available to download free of charge at:
http://www.analystsreview.com/Jun-17-2014/ZLCS/report.pdf
Northwest Biotherapeutics, Inc. Analyst Notes
On June 10, 2014, Northwest Biotherapeutics, Inc. (Northwest Biotherapeutics) announced the initiation of the Phase III trial of DCVax-L in Germany. According to the Company, it has now scheduled full-day site initiations for three sites in June and four sites in July. The Company's first German site, which was initiated in late May, is starting its patient screening for purposes of enrollment, and the additional German sites will begin doing so following their scheduled initiations. Commenting on the trial initiation, CEO Linda Powers, stated, "We are excited to have the Phase III DCVax-L trial open for enrollment in Germany. It has taken a major team effort to accomplish the steps required for these sites. However, we are now ready to initiate a substantial set of clinical trial sites throughout Germany, and we have built a strong foundation for our clinical programs in Germany." The full analyst notes on Northwest Biotherapeutics are available to download free of charge at:
http://www.analystsreview.com/Jun-17-2014/NWBO/report.pdf
Progenics Pharmaceuticals Inc. Analyst Notes
On June 12, 2014, Progenics Pharmaceuticals Inc. (Progenics), along with Salix Pharmaceuticals, Ltd., reported that the Anesthetic and Analgesic Drug Products Advisory Committee of the Food and Drug Administration (FDA) has provided an assessment on potential cardiovascular risk associated with products in the class of peripherally-active opioid receptor antagonists (PAMORAS) and recommendations regarding the necessity, timing, design and size of cardiovascular outcomes trials to support approval of products in this class for the proposed indication of opioid-induced constipation (OIC) in patients taking opioids for chronic pain. According to the Company, 12 Advisory Committee members voted to not require cardiovascular outcomes trials (CVOTs) for PAMORAS, seven members voted to require CVOTs for all PAMORAS, and five members voted to require CVOTs, but only for specific PAMORAS. Progenics added that the Committee recommended that observational studies be conducted on a post-marketing basis. The full analyst notes on Progenics are available to download free of charge at:
http://www.analystsreview.com/Jun-17-2014/PGNX/report.pdf
TG Therapeutics, Inc. Analyst Notes
On June 12, 2014, TG Therapeutics, Inc.'s (TG Therapeutics) stock went up by 20.82%, to close at $8.82. For the past one month trading period, Company stock reflected a significant increase of 83.37% compared to the Nasdaq Composite which increased by 3.71% during the same trading period. The full analyst notes on TG Therapeutics are available to download free of charge at:
http://www.analystsreview.com/Jun-17-2014/TGTX/report.pdf
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