Geron(GERN)

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Geron(GERN) - 2024 Q2 - Quarterly Results
2024-08-08 11:10
Exhibit 99.1 & geron Geron Corporation Reports Second Quarter 2024 Financial Results and Business Highlights U.S. commercial launch of RYTELO™ (imetelstat) began in June 2024 for patients with lower-risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia who are relapsed/refractory to or ineligible for etythropoiesisstimulating agents (ESAs), regardless of ring sideroblast (RS) status NCCN Guidelines® updated to include the use of RYTELO in both RS+ and RS- patients for second-line treatme ...
Geron (GERN) Wins FDA Approval for Blood Cancer Drug, Stock Up
ZACKS· 2024-06-10 17:01
Geron Corporation (GERN) obtained FDA approval for pipeline candidate imetelstat for the treatment of adult patients with low to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks. Shares of the company rose 18% on Jun 7, on the news. The FDA approved imetelstat, a telomerase inhibitor, under the brand name Rytelo for the above-mentioned indication. Current treatment options for those failing ESA are limited to s ...
Is Geron Stock a Buy Following Its First New Drug Approval?
The Motley Fool· 2024-06-08 10:37
Shares of Geron (GERN 18.00%) finished the week ended June 7 about 32% higher. The market was reacting to news the company's investors had been waiting to hear for decades. Rytelo is a new treatment for an underserved population. That's generally a recipe for success in the biotechnology industry, but independent companies launching their first commercial product tend to miss expectations. Reasons to buy Geron Corp stock The FDA approved Rytelo for patients with low- to intermediate-risk myelodysplastic syn ...
Geron Corporation: FDA Approval Fuels Stock Price Surge
MarketBeat· 2024-06-07 16:57
Geron Today Geron $4.73 +0.84 (+21.59%) 52-Week Range $1.64 ▼ Price Target $6.10 Add to Watchlist The recent FDA approval of RYTELO™ (imetelstat) has propelled Geron Corporation NASDAQ: GERN into the spotlight, sparking a surge in Geron's stock price and attracting heightened attention from investors seeking opportunities within the healthcare sector and biotech sector. This momentous achievement marks a turning point for Geron and underscores the company's commitment to developing innovative therapies for ...
Why Is Geron (GERN) Stock Up 18% Today?
Investor Place· 2024-06-07 15:02
Core Viewpoint - Geron Corporation (NASDAQ: GERN) received FDA approval for its drug RYTELO, leading to a significant increase in its stock price [1][3]. Company Summary - RYTELO is designed for adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) who have transfusion-dependent anemia, a condition that often results in anemia, fatigue, and reduced survival [4]. - The clinical benefits of RYTELO include sustained and durable transfusion independence and increases in hemoglobin levels, all while maintaining a manageable safety profile [5]. Stock Performance - Following the FDA approval, GERN stock rose by 18.4% on Friday morning and has increased by 114.9% since the beginning of the year [3]. - Heavy trading activity was noted, with over 54 million shares traded, significantly surpassing the average daily trading volume of approximately 12.9 million shares [5].
Geron Corporation: A High-Risk Deal With A Good Chance Of Success
seekingalpha.com· 2024-05-23 21:49
Company Overview - Geron Corporation is a late-stage biopharmaceutical company focused on developing therapies for hematological diseases, particularly through its product Imetelstat, a telomerase inhibitor [5][9] - The company's research is based on Nobel Prize-winning discoveries related to telomeres and telomerase, which play a critical role in cell division and aging [5][6] - Imetelstat is the first telomerase inhibitor to advance in clinical development, with potential commercialization in the coming months [9] Product Development and Clinical Trials - Imetelstat has shown promising results in the IMerge Phase 3 clinical trial, demonstrating a 60% transfusion reduction rate and a 40% response rate compared to 15% for placebo [14][16] - The drug targets low-risk Myelodysplastic Syndrome (MDS) and has shown broad efficacy across various MDS subtypes [15][16] - Geron is also conducting a Phase 3 trial called IMpactMF for intermediate or high-risk Myelofibrosis (MF), with results expected in 2025 and 2026 [18] Regulatory and Market Potential - The FDA accepted Geron's New Drug Application (NDA) for Imetelstat in August 2023, with a Prescription Drug User Fee Act (PDUFA) date set for June 16, 2024 [10] - The European Medicines Agency (EMA) is expected to review the Marketing Authorization Application (MAA) in 2025, with a potential launch in the EU the same year [11] - The total addressable market (TAM) for Imetelstat is estimated at $7 billion by 2031, with Geron potentially capturing 20% of this market [3][21] Financial Projections - Geron's revenue is projected to grow from $175 million in 2025 to $1.4 billion in 2031, assuming a 20% market share [26] - The company is expected to achieve positive net profit starting in 2028, with an estimated EPS of $0.13, growing to $0.39 by 2031 [28][29] - The compound annual growth rate (CAGR) for EPS from 2028 to 2031 is projected at 32.5% [29] Competitive Landscape - Imetelstat's mechanism of action, which focuses on transfusion independence, differentiates it from current standard treatments like erythropoiesis-stimulating agents (ESAs) and blood transfusions [19][20] - There are currently no similar treatments on the market that offer transfusion independence, giving Imetelstat a unique competitive advantage [20] Hedge Fund and Insider Activity - Hedge fund interest in Geron has increased significantly, with 29 funds holding positions in Q1 2024, a 50% increase compared to the 2023 average [33][34] - The company has approximately $465 million in cash and marketable securities, which is expected to fund operations until Q1 2026 [35][36] Intellectual Property and Future Prospects - Geron holds patents for Imetelstat in the US and EU, providing protection until 2033 for MDS and MF treatments [30] - The company's future growth is contingent on the successful approval and commercialization of Imetelstat, with potential for significant returns if the product gains market traction [32][42]
Geron(GERN) - 2024 Q1 - Quarterly Report
2024-05-02 20:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 000-20859 GERON CORPORATION (Exact name of registrant as specified in its charter) DELAWARE 75-2287752 (State or other jurisdictio ...
Geron(GERN) - 2024 Q1 - Earnings Call Transcript
2024-05-02 16:32
Geron Corporation (NASDAQ:GERN) Q1 2024 Earnings Conference Call May 2, 2024 8:00 AM ET Corporate Participants Aron Feingold - VP of IR and Corporate Communications John Scarlett - Chairman, President and Chief Executive Officer Faye Feller - Executive Vice President and Chief Medical Officer Anil Kapur - Executive Vice President, Corporate Strategy and Chief Commercial Officer Michelle Robertson - Executive Vice President, Chief Financial Officer and Treasurer Conference Call Participants Tara Bancroft - T ...
Geron (GERN) Reports Q1 Loss, Tops Revenue Estimates
Zacks Investment Research· 2024-05-02 13:21
Geron (GERN) came out with a quarterly loss of $0.09 per share versus the Zacks Consensus Estimate of a loss of $0.10. This compares to loss of $0.07 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 10%. A quarter ago, it was expected that this drugmaker would post a loss of $0.10 per share when it actually produced a loss of $0.09, delivering a surprise of 10%.Over the last four quarters, the company has surpassed consensus EP ...
Geron(GERN) - 2024 Q1 - Quarterly Results
2024-05-02 11:09
Exhibit 99.1 Geron Corporation Reports First Quarter 2024 Financial Results and Business Highlights June 16, 2024 PDUFA date for imetelstat NDA for the treatment of transfusion-dependent anemia in adult patients with lower-risk MDS FOSTER CITY, Calif., May 2, 2024 -- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing investigational first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported financial results and business highl ...