Geron reported cash and marketable securities totaling $162.3 million at the end of June. Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube Subscribe to FDA RSS feeds FDA Homepage Contact Number 1-888-INFO-FDA (1-888-463-6332) Geron Corporation (GERN) today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to imetelstat for the treatment of …

MF patients have shortened survival, and their disease may transform to acute myeloid leukemia.The number of people living with MF in the United States is estimated at 13,000 patients, with approximately 3,000 new cases diagnosed each year. FDA scientists will need the information to decide whether approval of the vaccine for general use is justified. Key secondary endpoints are safety and overall survival. The company would also be a likely acquisition target for a bigger drugmaker.The challenge for Geron, though, is in funding operations until the pivotal study wraps up. I think so. Each CVR share will pay $9 if three things happen by specified dates: The FDA must approve ozanimod by Dec. 31, 2020; it must approve liso-cel by Dec. 31, 2020; and it must approve ide-cel (bb2121) by March 31, 2021.Will these approvals come by those dates? The drug could have blockbuster sales potential assuming it proves to be both effective and safe. The company also plans to talk with the FDA in the first quarter of 2020 after the phase 2 study of imetelstat in treating myelofibrosis wraps up. Ongoing clinical studies of imetelstat consist of IMerge, a Phase 2/3 trial in lower risk myelodysplastic syndromes (MDS), and IMbark, a Phase 2 trial in Intermediate-2 or High-risk myelofibrosis (MF). If all goes well, Geron could be in a position to move forward with a pivotal study of its lead drug in the additional indication.If imetelstat is successful in its phase 3 study targeting MDS, Geron could turn out to be a gold mine for investors who bought the stock early. Founded in 1993 by brothers Tom and David Gardner, The Motley Fool helps millions of people attain financial freedom through our website, podcasts, books, newspaper column, radio show, and premium investing services.For the most part, biotech stocks aren't having a great year with only a little over two months left in 2019. See you at the top! Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment.Geron is a late-stage clinical biopharmaceutical company focused on the development and potential commercialization of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. MF patients can also suffer from debilitating constitutional symptoms, such as fever, weight loss, night sweats, and itching (pruritus). These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. With Geron's market cap currently around $280 million, its shares would soar on a positive outcome from the MDS study. (TMFFishBiz) The other reason to buy Celgene now is the potential for solid returns after BMS completes its acquisition of the biotech. The investing argument for Geron centers around the potential for its lead candidate imetelstat. Bristol-Myers Squibb's acquisition of Celgene will result in a stock that should be able to deliver solid long-term returns, with respectable growth plus a strong dividend. Here's what you need to know. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.Kodak Boosted Lobbying Effort in Months Leading to LoanCara Therapeutics Inc (CARA) Q2 2020 Earnings Call TranscriptCoronavirus stimulus checks: Here's why there's no second round in Trump's executive ordersWhy Nautilus’ blowout quarter could be good news for PelotonPapa John's CEO: Franchisees think our brand is 'pandemic proof'Retail investors have seen huge gains as S&P 500 nears pre-pandemic highWhy this NYC restaurant is closing its doors and relocating to DenverGundlach, who called Trump's 2016 election, predicts he'll win againStock market news live updates: Stock futures open higher; Moderna, Tesla shares soar in late trading Celgene expects the FDA will approve ozanimod in treating relapsed multiple sclerosis by March 25, 2020. Investing Basics People with MF may have abnormally low or high numbers of red blood cells, white blood cells or platelets in the blood or bone marrow. Once patients discontinue treatment with this drug due to failure or lack of response, there are no specifically approved therapies, and the median overall survival for these MF patients is approximately 14 to 16 months, representing a significant unmet medical need.IMbark is a Phase 2 clinical trial to evaluate two starting dose levels of imetelstat (either 4.7 mg/kg or 9.4 mg/kg administered by intravenous infusion every three weeks) in patients with Intermediate-2 or High-risk MF who have relapsed after or are refractory to prior treatment with a JAK inhibitor.
If given FDA approval, he said, it had the potential to be “absolutely a gamechanger”. Keith began writing for the Fool in 2012 and focuses primarily on healthcare investing topics. Here's how Geron and Celgene compare.

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