NEW YORK (TheStreet) -- Shares of Geron (GERN) surged 21.08% to $2.70 in morning trading Monday after the FDA removed its full clinical hold on the company's investigational new drug application for imetelstat.
The FDA also said Geron's proposed clinical development plan for imetelstat, which focuses on high-risk myeloid malignancies such as myelofibrosis (MF), is acceptable.
The FDA demanded Geron offer follow-up information from patients treated with imetelstat who experienced liver function test (LFT) abnormalities until those abnormalities returned to normal or baseline. Furthermore, the FDA required information from Geron on the reversibility of liver toxicity after chronic imetelstat administration in animals.
More than 11.8 million shares had changed hands as of 10:26 a.m., compared to the average volume of 2,021,640.