Geron had teamed up with Geron hopes to report primary results from the late-stage MDS study in 2022. BMS already has blockbuster winners with anticoagulant Eliquis and cancer immunotherapy Opdivo, both of which are expected to rank among the top four Celgene will bring enormously successful blood cancer drugs Revlimid and Pomalyst to BMS' lineup. Additional information on the above-stated risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors,” including Geron’s quarterly report on Form 10-Q for the quarter ended June 30, 2019. 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. However, there's a long way to go before we'll know if that's the case.Meanwhile, Celgene already has multiple blockbuster drugs with more probably on the way from its pipeline. The biotech also anticipates filing for FDA approval of liso-cel soon followed by a regulatory filing for ide-cel in the first half of next year. Cumulative Growth of a $10,000 Investment in Stock AdvisorBetter Buy: Geron vs. Celgene @themotleyfool #stocks $CELG $GERN $BMY 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.
The biotech also anticipates filing for FDA approval of liso-cel soon followed by a regulatory filing for ide-cel in the first half of next year.
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 … Geron's a huge gamble; Celgene isn't.Stock Advisor launched in February of 2002. Returns as of 08/12/2020.
(TMFFishBiz) The Ascent is The Motley Fool's new personal finance brand devoted to helping you live a richer life. 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.
As a result, normal blood production in the bone marrow is impaired and may shift to other organs, such as the spleen and liver, which can cause them to enlarge substantially.
Through the Fast Track Program, a product candidate may be eligible for priority review, if supported by the clinical data, and for the ability to submit completed sections of a New Drug Application (NDA) on a rolling basis as data become available prior to completion of the full application.Myelofibrosis (MF), a type of myeloproliferative neoplasm, is a chronic blood cancer in which abnormal or malignant precursor cells in the bone marrow proliferate rapidly, causing scar tissue to form (fibrosis). 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. 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. For more information about Geron, visit www.geron.com.Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Here's what you need to know. With Geron's market cap currently around $280 million, its shares would soar on a positive outcome from the MDS study. 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) Biotech stocks with key binary events/catalysts - FDA Approval/PDUFA dates, Advisory Committee and Phase 2 & 3 trial data releases dates are noted. The top biotech-focused exchange-traded funds (ETFs) are trailing the Which of these two high-flying biotech stocks is the better pick for long-term investors? Investors are cautioned that statements in this press release regarding: (i) Geron’s plan to conduct an End of Phase 2 meeting with the FDA by the end of the first quarter of 2020; (ii) that imetelstat may have disease-modifying activity; and (iii) other statements that are not historical facts, constitute forward-looking statements. 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.
Phase 1 catalysts for small-cap companies only are listed. 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. There are currently only two drugs approved by the FDA for treating MF patients. About Us Key secondary endpoints are safety and overall survival.
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