Boston, MA 03/13/2014 (wallstreetpr) – Geron Corporation (NASDAQ:GERN) is facing a crisis and its stock price has tumbled in recent days primarily as the result of FDA halting the clinical trials of its new drug under development, Imetelstat. With Imetelstat being the only drug in the pipeline for Geron, this comes as a major blow.
Telomerase Inhibitors And Imtelstat
Telomerase inhibitors are a new class of drugs to fight certain types of cancers. Imetelstat was one of the leading investigational drugs in that category. However, the FDA has temporarily halted all ongoing trials involving the drug due to the occurrence of persistent low-grade liver function test (LFT) abnormalities. Imetelstat was being tested as a drug to fight multiple myeloma and myelofibrosis.
Outlook For Imtelstat
It’s unusual for the FDA to stop clinical trials of Investigational New Drugs because of low grade LFTs. There were no acute liver abnormalities during the Imtelstat trials. Hence it’s possible that the FDA may allow the trials to resume after the data is analyzed and understood properly.
Telomerase inhibitors belong to a new class of drugs including monoclonal antibodies and tyrosine-kinase inhibitors. There are already a lot of drugs in the market that are used to treat various cancers and autoimmune diseases that are either monoclonal antibodies or TKIs. And there is a lot of research happening to develop more of similar drugs. Attempts to develop drugs that are telomerase inhibitors continue to remain a promising therapeutic strategy.
In the short term, Geron’s fortunes have taken a beating with the FDA’s actions. However, one successful launch of a drug such as Imtelstat can easily turn things around for the company.
Back in November 2013, the company had reported a net loss of $8.3 million for 3Q2013 and total net loss of $29.1 million for the first nine months of 2013. Total operating expenses for the same nine months of 2013 were $30.7 million compared to $55.3 million for the comparable nine months of 2012. The company reported having $67.0 million in cash and investments. With heavy R&D expenses for 2014 as well, it remains to be seen whether the company is able to take care of all its expenses using its existing resources.
