Geron (GERN) Stock Soars as FDA Lifts Hold

Shares of Geron Corporation (GERN) were up +0.86 or +33.07 percent to $3.46 per share in pre-market trading on Thursday, after the company announced early this morning that the FDA had notified Dr. Ayalew Tefferi of the Mayo Clinic the partial hold on clinical trials for Geronâ s treatment of myelofibrosis, imetelstat, had been lifted. Geron stock closed up +0.25 or +10.64 percent to $2.60 per share in Wednesdayâ s regular trading session.

Founded in 1990, Menlo Park, California based Geron Corporation is a biotechnology and biopharmaceutical company that specializes in the development and marketing of therapeutic products for cancer treatment. The company is also heavily involved in developing cell based therapies for a variety of chronic diseases from human embryonic stem cells. Geron is currently developing a first in class telomerase inhibitor known as imetelstat. Telomerase is the enzyme which enables cancer cells to maintain telomere length, providing them with the capacity for limitless replication. Imetelstat inhibits telomerase and is also being developed to treat hematologic myeloid malignancies such as acute myelogenous leukemia (AML), myelofibrosis (MF) and myelodysplastic syndromes (MDS). Geron announced early this morning that the U.S. Food and Drug Administration (FDA) had removed a partial clinical hold on trials of imetelstat in myelofibrosis. The hold for trials was placed in March of this year due to indications of hepatotoxicity identified in clinical trials of imetelstat. For the partial hold to be lifted, Dr. Ayalew Tefferi of Mayo Clinic, Rochester, Minnesota, was obligated to provide a follow up on the reversibility of the drugs hepatotoxicity for all trial patients having received imetelstat for the treatment of Myelofibrosis IST. A letter dated yesterday was sent by the FDA informing the investigator that it had completed reviewing the complete response submission, finally concluding that trials for Myelofibrosis IST could proceed. Geron stopped enrolling new patients for the Myelofibrosis IST trials when the hepatotoxicity issue first arose, nevertheless, the Mayo Clinic did not specify any safety concerns as the basis for the decision. Patients already undergoing treatment and reacting favorably, continue to receive imetelstat in the trials. While the partial hold for imetelstat for Myelofibrosis IST has been lifted by the FDA, the companyâ s Investigational New Drug or IND application for imetelstat continues to be on full clinical hold, affecting clinical trials for thrombocythemia or polycythemia and in multiple myeloma. Geron needs the FDA to lift the full clinical hold on imetelstat in order to initiate new clinical trials in the United States. Geron stock has been under considerable pressure since the hold on their IND for imetelstat was imposed last March, taking the stock down to $2.00 per share from $5.00. With yesterdayâ s ten percent gain and the 35 percent increase the stock will have on todayâ s opening, bring the two day total to over 45 percent and the stock price back over $3.50 per share. Once the FDA removes the complete hold on imetelstat, and allows full clinical trials to continue, Geron stock could easily trade back over $5.00 per share. Other News About Geron Pomerantz Law Firm Announces the Filing of a Class Action Against Geron Corporation Investors who bought stock between June of 2013 and March of 2014 may join class-action suit. Form 8-K for GERON CORP Change in Directors or Principal Officers Company files SEC form to submit matters to a vote of security. Other Stocks in the News Amazon adds lower movie prices to battle over books Amazon goes after movie sales. Intel loses court challenge against $1.4 billion EU fine Intel loses challenge on 2009 decision.

Published on Jun 12, 2014
By Jay Hawk
Jay Hawk
Jay Hawk enjoyed a 12-year professional financial markets career incorporating extensive first hand futures and options experience obtained by trading in the stock, commodity and forex markets on U.S. exchanges. Since retiring as a full-time financial market professional, he has been actively trading stock, commodities, forex and options for his own account and managing funds for others, as well as writing financial market commentary and educational articles.

Copyrighted 2016. Content published with author's permission.

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