Geron Shares Surge 25% After The Removal Of A Clinical Hold By The FDA

Shares of Geron (GERN) surged as much as 25% after the company announced that the FDA has removed the full clinical hold on one of its key drugs, known as Imetelstat. Back in March of 2014 the FDA  placed a full clinical hold on Imetelstat due to concerns that the drug caused liver toxicity in patients. Shares of Geron tumbled down as much as 67% trading down to $1.42 per share at that time. After yesterday's 25% surge on the news of the removal of the FDA clinical hold for Imetelstat, Geron now trades at around $2.80 per share.

This removal of the FDA clinical hold was key for the company as Imetelstat was due to start a phase 2 trial in patients with myelofibrosis. Myelofibrosis is a rare type of blood cancer where the bone marrow in the body becomes damaged by scarring and it disrupts the patient's ability to produce blood cells at a normal production rate. The FDA placing a clinical hold on this drug was a huge blow not only to Geron but also to the patients being treated with Imetelstat. This is because Imetelstat showed the ability to actually reverse the affects of myelofibrosis, again allowing the body to produce blood cells in the bone marrow at a normal production rate.

Geron intended to start a phase 2 trial at the beginning of 2014 but the FDA placed that full clinical hold on Imetelstat, stating that the drug showed some concerns for patients displaying Liver Function Test -- LFT -- abnormalities. With this clinical hold now removed by the FDA, Geron plans to launch a phase 2 trial with Imetelstat targeting myelofibrosis by the 1st quarter of 2015. To facilitate the removal of the clinical hold Geron had to provide data that would refute the fact that Imetelstat caused such drastic safety concerns. The company first submitted data from another ongoing phase 2 trial with Imetelstat showing that the patients that had shown LFT abnormalities eventually subsided back down to normal baseline levels. Geron also submitted to the FDA additional data from a pre-clinical trial of Imetelstat in animals, displaying that long term use of Imetelstat showed no sign of chronic liver damage. With this data available, the FDA decided to remove the full clinical hold of Imetetlstat, and now the company can continue in its efforts to reverse the rare form of blood cancer.

We believe that shares of Geron should continue to climb as more people catch on that Imetelstat is a great cancer drug that has the ability to reverse the effects of certain blood cancers. Therefore the company has a bright future ahead but it will take time to get there as the phase 2 trial is set to start in early 2015. Investors will need to have a long-term approach to investing in this biotech as the trial will take about a year or more to display results from the time it resumes. With further positive confirmation of Imetelstat we believe that Geron's share price should continue to rise over time, establishing itself as a great biotechnology company in the competitive blood cancer space. The company can eventually initiate additional clinical trials in other forms of blood cancer that should also substantially increase its future value over time.

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