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Geron Plunges As Johnson & Johnson Unit Discontinues Blood Cancer Drug Collaboration

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Geron Plunges As Johnson & Johnson Unit Discontinues Blood Cancer Drug Collaboration

Geron Corporation (NASDAQ: GERN), which is given to volatility due to heavy short interest, made a wild swing to the downside Thursday.

What Happened

Geron announced ahead of the market open that Johnson & Johnson (NYSE: JNJ)'s Janssen unit has decided to terminate a collaboration and licensing agreement it had with Geron since 2014 for its myelofibrosis treatment candidate Imetelstat, effective Sept. 28.

Consequently, Geron now regains the rights to develop and commercialize the telomerase inhibitor.

The decision to snap the licensing deal apparently resulted from a strategic portfolio evaluation and prioritization of assets on Janssen's part, according to Geron. 

Imetelstat is being studied in two separate Phase 2 trials dubbed IMbark and IMerge, with the former testing the candidate for myelofibrosis and the latter for myelodysplastic syndromes.

Primary analysis of data from the IMbark Phase 2 study that evaluated two starting doses of Imetelstat showed that the higher dosage did not meet both co-primary endpoints.

A 4.7mg/Kg or 9.4/,g/Kg dose was administered intravenously every three weeks in 200 patients with intermediate-2 or high-risk myelofibrosis who have relapsed after or are refractory to prior treatment with a JAK inhibitor. 

The safety profile was consistent with prior clinical trials of Imetelstat in hematologic malignancies, according to the biotech. 

"At the time of the primary analysis, median overall survival had not been reached after 23 months of median follow-up." 

What's Next

Geron said it intends to discuss the results of the IMbark primary analysis with experts in myelofibrosis as well as regulatory authorities, which it said will provide information on the scope and design of any potential future clinical trials.

Based on combined data from the initial and expansion cohorts for the target population of myelodysplastic syndrome patients in the Phase 2 IMerge study, Geron said it plans to initiate a Phase 3 portion of the study after the trials have been transferred from Janssen. The company expects to begin patient screening and enrollment for the study by mid-2019.

Geron upwardly revised its 2018 operating expenses guidance from $30 million to $37 million in the wake of the licensing agreement termination. The higher costs are projected for the hiring of additional personnel and external service providers to develop Imetelstat. 

Geron shares were falling 66.77 percent to $2.07 at the time of publication Thursday morning. Johnson & Johnson shares were down 0.28 percent at $137.78. 

Related Links:

The Daily Biotech Pulse: Hologic Goes Shopping, Johnson & Johnson Snaps Ties With Geron

The Week Ahead In Biotech: Conferences, PDUFA Dates, Clinical Trial Results And IPOs

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