Geron Announces Fast Track Designation Granted to Imetelstat for Relapsed/Refractory Myelofibrosis
Geron Corporation (GERN)
Last geron corporation earnings: 3/12 04:05 pm
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Source: GlobeNewswire
MENLO PARK, Calif., Sept. 30, 2019 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq: GERN) today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to imetelstat for the treatment of adult patients with Intermediate-2 or High-risk myelofibrosis (MF) whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment, or relapsed/refractory MF. The Fast Track designation includes patients with primary MF and MF developed after essential thrombocythemia or polycythemia vera. This is the same patient population that was studied in Geron’s IMbark Phase 2 clinical trial. There are currently no marketed drugs specifically approved for relapsed/refractory MF, representing a significant unmet medical need. Geron plans to conduct an End of Phase 2 meeting with the FDA by the end of the first quarter of 2020 to determine if there is a regulatory path forward for imetelstat in relapsed/refractory MF. The FDA's Fast Track
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GERN
News
- Geron Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business Wire
- Considering The Merits Of A Gamble On Geron Corporation [Seeking Alpha]Seeking Alpha
- Geron Corporation (NASDAQ:GERN) Is Expected To Breakeven In The Near Future [Yahoo! Finance]Yahoo! Finance
- Geron Co. (NASDAQ: GERN) had its "buy" rating re-affirmed by analysts at Needham & Company LLC. They now have a $5.00 price target on the stock.MarketBeat
- Geron Co. (NASDAQ: GERN) had its "outperform" rating re-affirmed by analysts at Wedbush. They now have a $6.00 price target on the stock.MarketBeat
GERN
Earnings
- 2/28/24 - Beat
GERN
Sec Filings
- 3/27/24 - Form ARS
- 3/27/24 - Form DEFA14A
- 3/27/24 - Form DEF
- GERN's page on the SEC website