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Can Geron Corporation maintain momentum following FDA's backing?
Invezz· 2024-03-17 12:31
Friday saw an unprecedented surge in the stock of Geron Corporation (NASDAQ:GERN), with shares ending the day up a staggering 92%. This surge, marking a historic milestone for the company, was ignited by a momentous announcement earlier in the day.An FDA advisory committee’s resounding endorsement of Geron’s lead asset, Imetelstat, sent shockwaves through the market, propelling the stock to new heights. Imetelstat, positioned as a potential breakthrough in the treatment landscape, received a commendation fo ...
Why Is Geron (GERN) Stock Up 94% Today?
InvestorPlace· 2024-03-15 14:47
Geron (NASDAQ:GERN) stock is rocketing higher on Friday following news that advisors to the Food and Drug Administration (FDA) are backing its blood disorder drug, imetelstat.According to a press release from late-stage clinical biopharmaceutical company, the Oncologic Drugs Advisory Committee (ODAC) voted 12 to two in favor of imetelstat. The ODAC specifically noted that the benefits of the drug outweigh the risks.The ODAC reached its conclusion on imetelstat after reviewing data from a Phase 3 clinical tr ...
Geron (GERN) Gets ODAC Votes for Blood Disorder Drug, Shares Up
Zacks Investment Research· 2024-03-15 14:01
Geron Corporation (GERN) announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted in favor of the clinical benefit/risk profile of pipeline candidate, imetelstat, for the treatment of transfusion-dependent (TD) anemia in adult patients with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS) who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs).The ODAC voted 12:2 in favor of imetelstat’s benefits over risks.Consequently, sh ...
Geron Announces FDA Oncologic Drugs Advisory Committee Votes in Favor of the Clinical Benefit/Risk Profile of Imetelstat for the Treatment of Transfusion-Dependent Anemia in Patients with Lower-Risk MDS
Businesswire· 2024-03-14 19:54
FOSTER CITY, Calif.--(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing investigational first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to 2 in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent (TD) anemia in adult patients with low-to-intermediate-1 ...
Geron Post 2023 Earnings - Gearing Up For Critical Imetelstat AdCom, PDUFA
Seeking Alpha· 2024-03-05 15:30
ktsimage Investment Overview I last updated on Geron Corporation (NASDAQ:GERN), the Foster City, California-based biotech primarily focused on securing commercial approval in the U.S. for its lead candidate, imetelstat, in the indication of transfusion-dependent anemia in adult patients, with low-to-intermediate-1 risk myelodysplastic syndromes ("MDS"), in a note for Seeking Alpha back in early December last year. I gave the company and its stock a "Buy" rating, based on my belief that the FDA is likely to ...
Geron(GERN) - 2023 Q4 - Annual Report
2024-02-28 21:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 000-20859 For the transition period from to . GERON CORPORATION (Exact name of registrant as specified in its charter) | Delaware | | 75-2287752 | | --- | --- | --- | | ( ...
Geron(GERN) - 2023 Q3 - Earnings Call Presentation
2023-11-02 17:07
*Mutation data were available for 18/21 patients receiving imetelstat with ≥1-year TI LR-MDS: lower-risk myelodysplastic syndromes; TI: transfusion independence; VAF: variant allele frequency Conclusion • With a median TI duration over 2 years, • Elimination of MDSassociated mutations suggests the potential of imetelstat to have disease-modifying activity. ASH 2023: Durable TI Associated with Better Survival Abstract #2440 Conclusion For transfusion dependent patients achievement of TI with second line trea ...
Geron(GERN) - 2023 Q3 - Quarterly Report
2023-11-01 16:00
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 September 30, 2023 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 jurisdi ...
Geron(GERN) - 2023 Q2 - Quarterly Report
2023-08-02 16:00
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 June 30, 2023 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 jurisdiction ...
Geron(GERN) - 2023 Q1 - Earnings Call Transcript
2023-05-11 17:38
Geron Corporation (NASDAQ:GERN) Q1 2023 Results Conference Call May 11, 2023 10:30 AM ET Company Participants Aron Feingold - VP, IR and Corporate Communications Dr. John Scarlett - Chairman and CEO Olivia Bloom - EVP and CFO Dr. Faye Feller - EVP and CMO Anil Kapur - EVP, Corporate Strategy and Chief Commercial Officer Conference Call Participants Stephen Willey - Stifel Kalpit Patel - B. Riley Joel Beatty - Baird Gil Blum - Needham & Company Corinne Jenkins - Goldman Sachs Operator Good morning. My name i ...