Geron Corp 8-K, filed Aug 22, 2023
Geron Corp (GERN)
About this 8-K
Geron Corp filed this 8-K on August 22, 2023, reporting on events of August 21, 2023.
Items reported
- Item 8.01: Other events
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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Item 8.01 Other Events
On August 21, 2023, Geron Corporation (“Geron” or the “Company”) announced that its New Drug Application (“NDA”) for the use of imetelstat for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes has been accepted for filing by the U.S. Food and Drug Administration (“FDA”). On August 22, 2023, the Company announced that the FDA has assigned a standard review and a Prescription Drug User Fee Act (“PDUFA”) action date of June 16, 2024 to the NDA, and that the FDA informed the Company that it is currently planning to hold an advisory committee meeting as part of the NDA review.
Use of Forward-Looking Statements
Except for the historical information contained herein, this Current Report on Form 8-K contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such statements, including, without limitation, those regarding the PDUFA action date for Geron’s imetelstat NDA and that the FDA is currently planning to hold an advisory committee meeting as part of the NDA review, constitute forward-looking statements. These forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: uncertainty of regulatory actions, approvals or clearances, including the risks that the PDUFA action date for the NDA may be extended and that the FDA may ultimately determine not to approve the NDA in its present form or at all; whether the FDA will hold an advisory committee meeting and the discussions at and outcomes of that meeting; the future development of imetelstat, including any future efficacy or safety results that may cause the benefit risk profile of imetelstat to become unacceptable; Geron’s need for additional capital to support the development and commercialization of imetelstat and to otherwise grow Geron’s business; establishing and maintaining imetelstat manufacture and supply; enforcement of Geron’s patent and proprietary rights; managing Geron’s business growth; the effects of the COVID-19 pandemic or geopolitical events, and potential competition. Additional information on the above 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 filings and periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors” and elsewhere in such filings and reports, including Geron’s quarterly report on Form 10-Q for the quarter ended June 30, 2023 and future filings and reports by Geron. Undue reliance should not be placed on forward-looking statements, which speak only as of the date of this Current Report on Form 8-K, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
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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
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August 22, 2023 |
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By: |
/s/ Scott A. Samuels |
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Name: |
Scott A. Samuels |
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Title: |
Executive Vice President, |
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Chief Legal Officer and |
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Corporate Secretary |
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