Geron Corporation (NASDAQ: GERN) was set for big things on the markets Tuesday, after the company reported that the U.S. Food and Drug Adminisration has granted Fast Track designation to imetelstat for lower risk myelodysplastic syndromes.
Geron initially developed imetelstat, which is exclusively licensed to Janssen Biotech worldwide. Janssen sponsored the application for Fast Track designation using preliminary data from IMerge, the ongoing clinical trial being conducted by Janssen in lower risk MDS. The expanded part 1 of the IMerge trial is currently open for patient enrollment.
Imetelstat is being evaluated in an ongoing Phase 2/3 clinical trial (IMerge) in transfusion dependent patients with Low or Intermediate-1 risk MDS who have relapsed after or are refractory to prior treatment with an ESA. IMerge is designed in two parts: Part 1 is a Phase 2, open-label, single-arm design and Part 2 is designed to be a Phase 3, randomized, controlled trial.
In November 2014, Geron entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc., to develop and commercialize imetelstat for oncology, including hematologic myeloid malignancies, and all other human therapeutics uses.
Under the terms of the agreement, Geron received an upfront payment of $35 million and is eligible to receive additional payments up to a potential total of $900 million for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales.
The news had a stimulating effect on shares, which climbed 12 cents, or 6.1%, to $2.19 by noon hour ET Tuesday.
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