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Geron to discontinue Phase 3 IMpactMF trial

The study enrolled 327 patients with JAK inhibitor-relapsed or refractory myelofibrosis and compared imetelstat with best available therapy.

(Moderate)

Sentiment and the balance of points

Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.

Form Type
8-K

Rhea-AI Filing Summary

Geron Corporation announced its decision to discontinue the Phase 3 IMpactMF trial of imetelstat in patients with myelofibrosis relapsed or refractory to a JAK inhibitor. The independent Data Monitoring Committee advised that the trial was unlikely to meet its primary endpoint of overall survival.

The trial evaluated 327 patients with intermediate-2 or high-risk disease in an open-label, controlled study, randomized 2:1 between imetelstat and best available therapy. Patients in the imetelstat arm received 9.4 mg/kg intravenously every three weeks. No new safety signals were observed that change imetelstat’s known safety profile or require additional safety monitoring. Geron plans a detailed data analysis and says it will share findings with the scientific community at a future date.

0 points · 0 major

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

1 major · 1 point

Hollow bars mark forward-looking points. How the balance works

Positive

  • None.

Negative

  • Major point. Forward-looking: it has not happened yet and may not happen.Phase 3 IMpactMF trial to be discontinued after the committee advised it was unlikely to meet the overall-survival endpoint.
Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Patients evaluated 327 patients IMpactMF trial
Randomization ratio 2:1 IMpactMF trial
Imetelstat dose 9.4 mg/kg Patients in the imetelstat arm
Dosing interval Every three weeks Patients in the imetelstat arm
Data Monitoring Committee medical
"recommendation from the independent Data Monitoring Committee (DMC)"
A data monitoring committee is a group of experts responsible for reviewing and overseeing important information during a project or study to ensure everything is proceeding safely and correctly. For investors, it provides an extra layer of oversight, helping to identify potential issues early and ensuring that decisions are based on accurate, unbiased data. This helps maintain trust and safety throughout the process.
overall survival medical
"primary endpoint of overall survival"
Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.
best available therapy medical
"compared to best available therapy"
JAK inhibitor medical
"relapsed or refractory to a JAK inhibitor"
A JAK inhibitor is a type of medicine that blocks Janus kinase enzymes, which help cells send signals that drive inflammation and immune activity. By turning down that cellular “volume knob,” these drugs can reduce symptoms in autoimmune diseases and certain blood disorders. Investors watch JAK inhibitors because their effectiveness, safety profile, approval status, and patent position directly affect drug sales, market competition, and regulatory risk for companies developing or selling them.
open label, controlled trial medical
"randomized 2:1, in an open label, controlled trial"

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

Why is Geron (GERN) discontinuing the IMpactMF trial?

The independent Data Monitoring Committee advised Geron that the trial was unlikely to meet its primary endpoint of overall survival. Geron announced its decision to discontinue the study of imetelstat in myelofibrosis relapsed or refractory to a JAK inhibitor.

How was the GERN IMpactMF trial designed and dosed?

The trial evaluated 327 patients in an open-label, controlled study with 2:1 randomization between imetelstat and best available therapy. Patients in the imetelstat arm received 9.4 mg/kg intravenously every three weeks.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR Accepted by SEC EDGAR Learn about SEC filing dates
GERON CORP false 0000886744 0000886744 2026-10-28 2026-10-28
 
 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): October 28, 2026

 

 

GERON CORPORATION

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   000-20859   75-2287752
(State or other jurisdiction
of incorporation)
 

(Commission

File Number)

  (IRS Employer
Identification No.)

 

919 E. HILLSDALE BLVD., SUITE 250
FOSTER CITY, California 94404
(Address of principal executive offices, including zip code)

(650) 473-7700

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading
Symbol(s)

 

Name of each exchange
on which registered

Common Stock, $0.001 par value   GERN   The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 
 


Item 8.01

Other Events

On October 28, 2026, Geron Corporation (the “Company”) issued a press release announcing an update on the Phase 3 IMpactMF trial evaluating imetelstat in JAK inhibitor relapsed/refractory myleofibrosis. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit
No.
   Description
99.1    Press release titled “Geron Corporation Provides Update on Phase 3 IMpactMF Clinical Trial of Imetelstat in Relapsed/Refractory Myelofibrosis,” dated October 28, 2026
104    Cover Page Interactive Data File (the cover page XBRL tags are embedded within the Inline XBRL document)


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

      GERON CORPORATION
Date: October 28, 2026     By:  

/s/ Timothy Williams

    Name:   Timothy Williams
    Title:  

Executive Vice President,

Chief Legal Officer and Corporate Secretary

Exhibit 99.1

 

LOGO

Geron Corporation Provides Update on Phase 3 IMpactMF Clinical Trial of Imetelstat in

Relapsed/Refractory Myelofibrosis

FOSTER CITY, Calif., – October 28, 2026 – Geron Corporation (Nasdaq: GERN), a commercial-stage hematology biopharmaceutical company, today announced the decision to discontinue the Phase 3 IMpactMF trial evaluating imetelstat in JAK inhibitor relapsed/refractory myelofibrosis. This decision was based on a recommendation from the independent Data Monitoring Committee (DMC).

The independent DMC advised Geron that the trial was unlikely to meet its primary endpoint of overall survival. There were no new safety signals observed in the trial that change the known safety profile of imetelstat or require additional safety monitoring. A detailed analysis of the data will be conducted, and study findings will be shared with the scientific community at a future date.

“Given the recommendation from the DMC, we believe discontinuing our Phase3 IMpactMF trial at this time is the right course of action. We are deeply grateful to the patients and families, as well as the investigators and clinical teams whose dedication made this research possible,” said Joseph E. Eid, M.D., Executive Vice President, Research and Development and Chief Medical Officer of Geron. “Hematologic malignancies are complex diseases, with distinct biological characteristics and treatment challenges across patient populations. We remain committed to thoroughly evaluating the data, understanding what we can learn, and sharing insights that may help inform future research and address the significant unmet needs that remain.”

IMpactMF evaluated 327 patients with intermediate-2 or high-risk myelofibrosis who were relapsed or refractory to a JAK inhibitor. Patients were randomized 2:1, in an open label, controlled trial of imetelstat designed to evaluate a potential improvement in overall survival compared to best available therapy. Patients in the imetelstat arm received 9.4 mg/kg IV every three weeks.

“As we fully analyze the data from the IMpactMF trial, we remain committed to growing RYTELO demand in the U.S. and broadening access to eligible LR-MDS patients outside the U.S.,” said Harout Semerjian, President and Chief Executive Officer of Geron. “We have a growing commercial business, a strong financial foundation, and a clear strategy to pursue innovation to create long-term value and build a leading hematology company.”

About Geron

Geron is a hematology-focused biopharmaceutical company pursuing more meaningful moments for people living with blood cancer. Because patients cannot wait, we approach our work with urgency, bringing together deep expertise in telomerase biology with patient perspectives and insights from clinical research and real-world care. Our medicine, RYTELO® (imetelstat), is approved in the United States and European Union for certain patients with lower-risk myelodysplastic syndromes (LR-MDS). Geron is a commercial-stage company with offices in Parsippany, New Jersey and Foster City, California. To learn more, visit www.geron.com or follow us on LinkedIn.


Use of Forward-Looking Statements

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. These forward-looking statements include, without limitation, statements regarding: (i) Geron’s plans to discontinue the Phase 3 IMpactMF trial; (ii) the ongoing analysis of IMpactMF data and the timing and plans for sharing study findings with the scientific community; (iii) the potential for insights from these analyses to inform future research; (iv) Geron’s plans and efforts to grow RYTELO demand in the United States and expand access for eligible patients; (v) Geron’s strategy and ability to create long-term value and build a leading hematology company; and (vi) other statements that are not historical facts. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements, including risks and uncertainties relating to: (a) the timing, costs and execution of discontinuing IMpactMF; (b) whether further analyses of IMpactMF data yield additional or different findings, including regarding efficacy and safety, and the timing and extent of disclosure of those findings; (c) whether insights from clinical data translate into future research or clinical benefits; (d) the impact of the IMpactMF results and discontinuation on Geron’s development plans, business and financial condition; (e) Geron’s ability to grow RYTELO demand, achieve market acceptance and expand patient access in the United States, including risks relating to competition, coverage and reimbursement; (f) regulatory requirements and actions affecting imetelstat’s development and commercialization; (g) failures or delays in manufacturing or supplying sufficient quantities of RYTELO or clinical trial materials; and (h) Geron’s ability to execute its strategy and maintain sufficient financial resources to support its business. Additional information regarding these and other risks and uncertainties is contained in Geron’s filings and periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors” and elsewhere, including Geron’s annual report on Form 10-K for the year ended December 31, 2025, and subsequent filings and reports. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying them may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.

CONTACT:

Dawn Schottlandt

Senior Vice President, Investor Relations and Corporate Affairs

dschottlandt@geron.com

###

Filing Exhibits & Attachments

4 documents

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