Karyopharm Therapeutics Inc. filed SEC Form 8-K: Regulation FD Disclosure
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| Item 7.01 | Regulation FD Disclosure. |
On October 31, 2024, Karyopharm Therapeutics Inc. (the “Company”) issued a press release announcing a change in the co-primary endpoint for its Phase 3 clinical trial in myelofibrosis evaluating a once-weekly dose of 60 mg of selinexor in combination with twice-daily ruxolitinib versus placebo plus ruxolitinib in JAKi naïve patients with platelet counts >100 x 109/L (“SENTRY trial”). A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01 (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
| Item 8.01 | Other Events. |
On October 31, 2024, the Company announced that following feedback from the U.S. Food and Drug Administration, the Company will be replacing total symptom score improvement of ≥ 50%, one of the co-primary endpoints in the SENTRY trial, with absolute total symptom score.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits |
Exhibit 99.1 relating to Item 7.01 shall be deemed to be furnished, and not filed:
| 99.1 | Press release issued by Karyopharm Therapeutics Inc. on October 31, 2024 | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL) | |
SIGNATURES
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.
| KARYOPHARM THERAPEUTICS INC. | ||||||
| Date: October 31, 2024 | By: | /s/ Michael Mano | ||||
| Michael Mano | ||||||
| Senior Vice President, General Counsel and Secretary | ||||||