For Immediate Release: June 07, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA announced that it has advised the manufacturers of the licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 Formula) for use in the United States should be monovalent (single strain) JN.1 vaccines to more closely match cu

Submission status for GERON CORP's drug RYTELO (ORIG-1) with active ingredient IMETELSTAT has changed to 'Approval' on 06/06/2024. Application Category: NDA, Application Number: 217779, Application Classification: Type 1 - New Molecular Entity

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RYTELO™ (imetelstat) is FDA approved for the treatment of low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemiaTransaction increases Royalty Pharma's synthetic royalty funding to $925 million in 2024, highlighting the significant opportunity for this attractive funding modality NEW YORK, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Royalty Pharma plc (NASDAQ:RPRX) today announced that it will acquire a synthetic royalty on U.S. sales of Geron Corporation's (NASDAQ:GERN) RYTELO for $125 million in cash upfront. RYTELO was approved by the U.S. Food and Drug Administration in June 2024 for the treatment of certain adult patients with low- to intermediate-1 risk myelod

Achieved $28.2 million in RYTELO™ (imetelstat) net product revenue in first full quarter of sales Received $250 million in gross proceeds from synthetic royalty and debt financings with Royalty Pharma and Pharmakon Advisors, with access to an additional $125 million in debt Geron Corporation (NASDAQ:GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today reported financial results for the third quarter of 2024 and recent business highlights. "This has been a transformative year for Geron, following our first FDA approval and commercial launch of RYTELO in June. The initial full quarter of product revenue from our U.S. launc

Geron Corporation (NASDAQ:GERN), a commercial-stage biopharmaceutical company, today announced that it will release its third quarter 2024 financial results and business highlights before the market opens on Thursday, November 7, 2024 via press release, which will be available on the Company's website at www.geron.com/investors. Geron will host a conference call to discuss the financial results as well as business highlights at 8:00 a.m. ET the same day. A live webcast of the conference call and related presentation will be available on the Company's website at www.geron.com/investors/events. An archive of the webcast will be available on the Company's website for 30 days. Participants ma

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 erythropoiesis-stimulating 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 treatment of symptomatic anemia in patients with lower-risk MDS and for first-line treatment of patients who are ESA ineligible (serum EPO >500 mU/mL) Geron Corporation (NASDAQ:GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today

Geron Corporation (NASDAQ:GERN), a commercial-stage biopharmaceutical company, today announced that it will release its second quarter 2024 financial results and business highlights before the market opens on Thursday, August 8, 2024 via press release, which will be available on the Company's website at www.geron.com/investors. Geron will host a conference call to discuss the financial results as well as business highlights at 8:00 a.m. ET the same day. A live webcast of the conference call and related presentation will be available on the Company's website at www.geron.com/investors/events. An archive of the webcast will be available on the Company's website for 30 days. Participants m

Approval across ESA ineligible and ESA relapsed/refractory patients with LR-MDS with transfusion-dependent anemia, regardless of ring sideroblast (RS) status Durable and sustained red blood cell transfusion independence, increases in hemoglobin levels and reduction in transfusion burden observed across key LR-MDS subgroups in the IMerge Phase 3 clinical trial; the most common Grade 3/4 adverse reactions were thrombocytopenia and neutropenia, which were generally manageable and short-lived Lower-risk MDS is a progressive blood cancer with high unmet need, where many patients with anemia become dependent on red blood cell transfusions, which can be associated with clinical consequences

Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that it will release its first quarter 2024 financial results and business highlights before the market opens on Thursday, May 2, 2024 via press release, which will be available on the Company's website at www.geron.com/investors. Geron will host a conference call to discuss the financial results as well as business highlights at 8:00 a.m. ET the same day. A live webcast of the conference call and related presentation will be available on the Company's website at www.geron.com/investors/events. An archive of the webcast will be available on the Company's website for 30 days. Participants ma

Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that it will release its fourth quarter and full-year 2023 financial results and business highlights before the market opens on Wednesday, February 28, 2024 via press release, which will be available on the Company's website at www.geron.com/investors. Geron will host a conference call to discuss the financial results as well as business highlights at 8:00 a.m. ET the same day. A live webcast of the conference call and related presentation will be available on the Company's website at www.geron.com/investors/events. An archive of the webcast will be available on the Company's website for 30 d

Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that it will release its third quarter 2023 financial results and business highlights before the market opens on Thursday, November 2, 2023 via press release, which will be available on the Company's website at www.geron.com/investors. Geron will host a conference call to discuss the financial results as well as business highlights at 9:00 a.m. ET the same day. A live webcast of the conference call and related presentation will be available on the Company's website at www.geron.com/investors/events. An archive of the webcast will be available on the Company's website for 30 days. Participan

Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that it will release its second quarter 2023 financial results on Thursday, August 3, 2023 at 4:00 p.m. Eastern Time via press release, which will be available on the Company's website at www.geron.com/investors. Geron will host a conference call to discuss the financial results, as well as business highlights, at 4:30 p.m. Eastern Time the same day. A live webcast of the conference call and related presentation will be available on the Company's website at www.geron.com/investors/events. An archive of the webcast will be available on the Company's website for 30 days. Participants may acce

Geron Corporation (NASDAQ:GERN), a commercial stage biopharmaceutical company, today reported that it has granted non-statutory stock options to purchase an aggregate of 72,000 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company. The stock options were granted on December 18, 2024, at an exercise price $3.77 per share, which is equal to the closing price of Geron common stock on the date of grant. The stock options have a 10-year term and vest over four years, with 12.5% of the shares underlying the options vesting on the six-month anniversary of commencement of employment for the respective employees and the

Geron Corporation (NASDAQ:GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of RYTELO (imetelstat) for the treatment of adult patients with transfusion-dependent (TD) anemia due to very low, low or intermediate risk myelodysplastic syndromes (LR-MDS) without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy. The European Commission (EC), which has the a

Analyses pooling data from IMerge Phase 2, Phase 3 and the QTc substudy suggest patients who were ESA ineligible or who had prior treatment with luspatercept or lenalidomide experienced clinical benefit from imetelstat similar to prior results from the IMerge pivotal trial Data from the QTc substudy reinforce imetelstat as a second-line treatment option for LR-MDS patients with transfusion-dependent anemia regardless of prior therapies, including luspatercept and lenalidomide A patient-reported outcome analysis from IMerge Phase 3 showed sustained improvement in fatigue and maintenance of quality of life and anemia symptoms with imetelstat compared with placebo Geron Corporation (

In the dose escalation Part 1 of the study, no dose-limiting toxicities were observed and the PK profiles were similar to those reported for previous monotherapy studies of imetelstat and ruxolitinib Based on the safety profile, imetelstat 9.4 mg/kg dosed every four weeks with ruxolitinib was the selected dose for the dose expansion Part 2 of the study, which is currently enrolling patients Geron is also evaluating the potential of imetelstat in the separate Phase 3 IMpactMF trial of patients with JAKi relapsed/refractory MF, which is >70% enrolled Geron Corporation (NASDAQ:GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood c

Geron Corporation (NASDAQ:GERN), a commercial-stage biopharmaceutical company, today announced that members of the management team are scheduled to participate in a fireside chat at the 7th Annual Evercore ISI HealthCONx Conference, in Coral Gables, Florida on Wednesday, December 4, 2024, at 8:20 a.m. ET. A webcast of the fireside chat will be available through the Investors and Media section of Geron's website under Events following the presentation. The webcast will be archived and available for replay for a period of 30 days. About Geron Geron is a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer. Our first-in-class telomerase

Geron Corporation (NASDAQ:GERN), a commercial stage biopharmaceutical company, today reported that it has granted non-statutory stock options to purchase an aggregate of 1,017,000 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company. The stock options were granted on November 20, 2024, at an exercise price $3.99 per share, which is equal to the closing price of Geron common stock on the date of grant. The stock options have a 10-year term and vest over four years, with 12.5% of the shares underlying the options vesting on the six-month anniversary of commencement of employment for the respective employees and t

Geron Corporation (NASDAQ:GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today announced the appointment of Joseph Eid, M.D. as Executive Vice President, Research and Development, effective today, November 11, 2024. In this role, Dr. Eid will lead our Research and Development organization comprised of medical, clinical, and safety/pharmacovigilance teams and be responsible for driving innovative medical and scientific strategies that support RYTELO™ commercially and sustain important research and development opportunities for Geron. Dr. Eid has more than two decades of medical affairs, clinical development, and drug life-cy

Geron Corporation (NASDAQ:GERN), a commercial-stage biopharmaceutical company, today announced members of the management team are scheduled to participate in a fireside chat at the Stifel 2024 Healthcare Conference, in New York City, on Monday, November 18th, 2024, at 1:50pm ET. A webcast of the fireside chat will be available through the Investors and Media section of Geron's website under Events following the presentation. The webcast will be archived and available for replay for a period of 30 days. About Geron Geron is a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer. Our first-in-class telomerase inhibitor RYTELO™ (imetelstat

RYTELO™ (imetelstat) is FDA approved for the treatment of low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemiaTransaction increases Royalty Pharma's synthetic royalty funding to $925 million in 2024, highlighting the significant opportunity for this attractive funding modality NEW YORK, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Royalty Pharma plc (NASDAQ:RPRX) today announced that it will acquire a synthetic royalty on U.S. sales of Geron Corporation's (NASDAQ:GERN) RYTELO for $125 million in cash upfront. RYTELO was approved by the U.S. Food and Drug Administration in June 2024 for the treatment of certain adult patients with low- to intermediate-1 risk myelod

Geron received $250 million in gross proceeds at closing, with access to an additional $125 million in debt Strengthens balance sheet to support the commercial launch of RYTELO™ in the U.S. and potential launch in the EU, the ongoing Phase 3 IMpactMF trial in relapsed/refractory myelofibrosis, and other uses Geron Corporation (NASDAQ:GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today announced up to $375 million in synthetic royalty and debt financings with Royalty Pharma and investment funds managed by Pharmakon Advisors, LP, of which $250 million in cash was provided at closing and another $125 million in debt is avai

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H.C. Wainwright initiated coverage of Geron with a rating of Buy and set a new price target of $8.00

Scotiabank initiated coverage of Geron with a rating of Sector Outperform

Leerink Partners initiated coverage of Geron with a rating of Outperform and set a new price target of $7.00

Robert W. Baird downgraded Geron from Outperform to Neutral and set a new price target of $4.50

TD Cowen initiated coverage of Geron with a rating of Buy and set a new price target of $10.00

Needham reiterated coverage of Geron with a rating of Buy and set a new price target of $5.00 from $4.00 previously

Goldman upgraded Geron from Neutral to Buy and set a new price target of $4.00

Goldman initiated coverage of Geron with a rating of Neutral and set a new price target of $3.00

Wedbush initiated coverage of Geron with a rating of Outperform and set a new price target of $5.00

B. Riley Securities resumed coverage of Geron with a rating of Buy and set a new price target of $4.00

Geron Corporation (NASDAQ:GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today announced the appointment of Joseph Eid, M.D. as Executive Vice President, Research and Development, effective today, November 11, 2024. In this role, Dr. Eid will lead our Research and Development organization comprised of medical, clinical, and safety/pharmacovigilance teams and be responsible for driving innovative medical and scientific strategies that support RYTELO™ commercially and sustain important research and development opportunities for Geron. Dr. Eid has more than two decades of medical affairs, clinical development, and drug life-cy

Geron Corporation (NASDAQ:GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, announced the appointment of Jim Ziegler as Executive Vice President, Chief Commercial Officer, effective today, September 9, 2024. In this role, Mr. Ziegler will spearhead Geron's global commercial strategy and operations, lead the commercial organization and be responsible for driving growth of RYTELO™. Mr. Ziegler has more than 25 years of commercial experience in the biopharmaceutical industry, spanning leadership, strategic and operational roles in both large and smaller organizations. "Jim brings to Geron an impressive track record of operationa

For Immediate Release: June 07, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA announced that it has advised the manufacturers of the licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 Formula) for use in the United States should be monovalent (single strain) JN.1 vaccines to more closely match cu

Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced the appointment of Gaurav Aggarwal, M.D., to the Company's Board of Directors. Dr. Aggarwal has been a prominent investor in the life sciences sector for more than two decades and has a history of expertise in financial and corporate strategy, as well as business development, in companies with which he has been affiliated at both an operational and board level. "Gaurav brings extensive strategic leadership to Geron, and we believe his demonstrated track record in both corporate strategy and capital formation will add tremendous value as we look forward to a potential commercial launch in 2024

Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced the appointment of Michelle Robertson as Executive Vice President, Chief Financial Officer (CFO) and Treasurer, effective September 25, 2023. Ms. Robertson's appointment follows the retirement of Olivia Bloom, Geron's incumbent CFO, also effective September 25, 2023. Ms. Bloom's retirement brings to a close a remarkable career of nearly 30 years on Geron's finance team, including serving the last twelve years as CFO. "On behalf of the Board and our entire team, I would first like to express our deep appreciation and admiration for the countless contributions Olivia has made during her extraor

Circle Pharma, a company focused on developing macrocycle therapeutics against targets previously considered to be undruggable, has appointed Stephen Kelsey as an independent member of its Board of Directors. Dr. Kelsey has extensive experience in oncology clinical development. He currently serves as president, head of research and development and chief medical officer at Revolution Medicines (NASDAQ:RVMD), and previously held roles including president of Onkaido Therapeutics, the oncology-focused unit of Moderna (NASDAQ:MRNA), senior vice president of new products at Medivation (acquired by Pfizer (NYSE: PFE)), executive vice president and chief medical officer at Geron Corporation (NASDAQ

Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced the appointment of John F. McDonald as an independent member of its Board of Directors, effective September 7, 2022. "With his three decades in the biopharmaceutical industry across business development and investment and corporate strategy, John is a highly respected and seasoned R&D executive with valuable pharmaceutical and biotechnology experience. We enthusiastically welcome him to the Board," said John A. Scarlett, M.D., Geron's Chairman and Chief Executive Officer. "We believe John's expertise will add commercial and strategic perspectives in guiding our objectives to advance imetelstat

Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced the appointment of Faye Feller, M.D., to Executive Vice President and Chief Medical Officer, effective July 9, 2022. Dr. Feller will succeed Dr. Aleksandra Rizo, Geronʻs current Chief Medical Officer, who will transition to a consultant role to the Company, as Senior Medical and Regulatory Advisor. Outside of Geron, Dr. Rizo has accepted a leadership position with a privately held discovery and preclinical-stage platform biotechnology company. Dr. Feller has been instrumental in the design, execution and management of the imetelstat development program for the past seven years, starting when s

Geron Corporation (NASDAQ:GERN), a late-stage biopharmaceutical company focused on the development and commercialization of treatments for hematologic malignancies, today announced the appointment of Edward Koval as Executive Vice President and Chief Business Officer. "Ed Koval's business development expertise, extensive industry network and successful track record in corporate deal-making further strengthens our executive team," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "With top-line results from our IMerge Phase 3 trial in lower risk MDS expected 13 months from now, and an interim analysis of our ongoing IMpactMF Phase 3 trial in refractory myelofibrosis expecte