Early clinical data suggest imetelstat may have disease-modifying activity through the suppression of malignant progenitor cell clone proliferation, which allows potential recovery of normal hematopoiesis. Biotech stocks with key binary events/catalysts - FDA Approval/PDUFA dates, Advisory Committee and Phase 2 & 3 trial data releases dates are noted. See you at the top!
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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.
The drug could have blockbuster sales potential assuming it proves to be both effective and safe. 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. 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? FDA approved vs. FDA cleared: Why you need to know the difference. Fast Track designation provides opportunities for frequent interactions with FDA review staff, including meetings to discuss the drug's development plan and to ensure the collection of appropriate data needed to support approval. MF patients can also suffer from debilitating constitutional symptoms, such as fever, weight loss, night sweats, and itching (pruritus). 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.
These risks and uncertainties include, without limitation, risks and uncertainties related to: (i) Geron may not be able to prepare timely for an End of Phase 2 meeting by the end of the first quarter of 2020; and (ii) imetelstat may not actually demonstrate disease-modifying activity in clinical trials. There are currently only two drugs approved by the FDA for treating MF patients. Phase 1 catalysts for small-cap companies only are listed. 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. Biotech Stock Catalyst and FDA Calendar for your biotech stock investing.
Geron had teamed up with Geron hopes to report primary results from the late-stage MDS study in 2022.
The company will likely need to raise more cash by mid-2021 if not sooner, which means that a dilution-causing stock offering probably isn't too far down the road.You might wonder whether Celgene is worth buying at this point. If given FDA approval, he said, it had the potential to be “absolutely a gamechanger”. Even better, Celgene's pipeline includes candidates that are likely to become big winners, including ozanimod, liso-cel, ide-cel, and luspatercept.Geron could ultimately have a winner on its hands with imetelstat. 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
With Geron's market cap currently around $280 million, its shares would soar on a positive outcome from the MDS study. 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). 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.
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