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Karyopharm (NASDAQ: KPTI) seeks XPOVIO use, flags going-concern risk

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Karyopharm Therapeutics Inc. (KPTI) reported that it has submitted a supplemental New Drug Application (sNDA) to the U.S. FDA seeking Accelerated Approval for XPOVIO (selinexor) in combination with ruxolitinib for patients with myelofibrosis. The company has also requested Priority Review, which, if granted, could shorten the FDA review to about six months.

The submission draws in part on Phase 3 SENTRY trial data, including what the company describes as a promising signal of overall survival and use of spleen volume reduction ≥35% (SVR35) as a surrogate endpoint. Karyopharm plans to use long-term overall survival data from SENTRY to verify clinical benefit for potential conversion from accelerated to traditional approval. The company also reiterates significant risks, including that substantial doubt exists regarding its ability to continue as a going concern.

Positive

  • sNDA for new myelofibrosis indication submitted to the FDA for XPOVIO plus ruxolitinib, with a request for Priority Review, potentially enabling an accelerated six-month review and expanding XPOVIO’s commercial opportunity if approved.
  • Phase 3 SENTRY data support the filing, including a company-described promising signal of overall survival and SVR35 as a surrogate endpoint, providing a clinical basis for seeking Accelerated Approval.

Negative

  • The company states that substantial doubt exists regarding its ability to continue as a going concern, highlighting significant financial and liquidity risk alongside its regulatory initiatives.
  • Karyopharm notes there is no guarantee XPOVIO or its drug candidates will successfully complete development or be commercialized, and that positive developments may not translate into stock price appreciation.

Filing Explained

The sNDA is pending FDA filing acceptance, while June 30 liquidity equaled 237.6 days of last reported operating cash use.

This filing places Karyopharm's submitted sNDA in the FDA's 60-day filing-review process; the company expects an acceptance decision in the fourth quarter of 2026.

The immediate company-level consequence is a pending regulatory pathway for the combination, not a reported acceptance or approval; any accelerated-approval route remains contingent on FDA action.

At June 30, 2026, Karyopharm reported $54,980,000 in cash and equivalents and $10,125,000 in short-term investments.

At the last reported quarterly operating-cash-use rate, those balances equal 237.6 days of the last reported operating cash use, a backward-looking comparison.

Sources and calculations
  • Available liquidity against the last reported quarterly operating outflow, in days at that rate ($54,980,000 + $10,125,000) / ($24,931,000 / 91) = 237.6 days
Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
FDA filing review period 60-day filing review period Period before the FDA decides on sNDA filing acceptance for XPOVIO plus ruxolitinib
SVR35 threshold spleen volume reduction ≥ 35% Surrogate endpoint Karyopharm expects the FDA to accept for Accelerated Approval in myelofibrosis
Priority Review duration six-month review process Potential FDA review length if Priority Review is granted for the sNDA
Expected acceptance decision timing fourth quarter of 2026 When Karyopharm expects FDA notice on sNDA filing acceptance and timelines
Quarter referenced for Risk Factors quarter ended June 30, 2026 Period of the Form 10-Q cited for detailed Risk Factors
Signing date August 31, 2026 Date Karyopharm’s Executive Vice President and Chief Legal Officer signed the report
supplemental New Drug Application regulatory
"announced that it has submitted a supplemental New Drug Application"
A supplemental new drug application is a request submitted to regulatory authorities to make changes to an existing approved medication, such as adding new uses, strengths, or formulations. For investors, it signals that a pharmaceutical company is seeking approval for new product developments or expanded applications, which can impact the company's future sales, market potential, and stock value.
Accelerated Approval regulatory
"seeking Accelerated Approval for XPOVIO (selinexor) in combination"
Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.
Priority Review regulatory
"The Company requested Priority Review of the application"
Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.
Phase 3 SENTRY trial medical
"Following the topline results of the Phase 3 SENTRY trial"
spleen volume reduction ≥ 35% (SVR35) medical
"would require the FDA to agree that spleen volume reduction ≥ 35% (SVR35)"
overall survival medical
"including a promising signal 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.

FAQ

What regulatory step did Karyopharm Therapeutics (KPTI) announce for XPOVIO?
Karyopharm announced submission of an sNDA to the FDA seeking Accelerated Approval for XPOVIO (selinexor) plus ruxolitinib in myelofibrosis, with a concurrent request for Priority Review based partly on Phase 3 SENTRY trial data.

What is KPTI requesting from the FDA regarding review timing?
Karyopharm requested Priority Review for the sNDA. If granted, the company states this could lead to a six-month review period instead of a standard review timeline.

When does KPTI expect FDA feedback on the XPOVIO sNDA filing?
Karyopharm expects to receive notice of the FDA’s decision on sNDA filing acceptance and, if accepted, anticipated review timelines in the fourth quarter of 2026, after the FDA’s 60-day filing review period.

What clinical data support KPTI’s myelofibrosis sNDA for XPOVIO?
The sNDA is supported in part by data from the Phase 3 SENTRY trial, which Karyopharm believes show a positive benefit-risk profile for XPOVIO plus ruxolitinib, including a promising signal of overall survival and spleen volume reduction endpoints.

What surrogate endpoint is central to KPTI’s Accelerated Approval strategy?
Karyopharm expects Accelerated Approval would require the FDA to agree that spleen volume reduction ≥35% (SVR35) is a reasonably likely surrogate endpoint to predict overall survival in myelofibrosis.

What major risk does KPTI disclose about its financial condition?
Karyopharm discloses that substantial doubt exists regarding its ability to continue as a going concern, citing financial and operational uncertainties alongside its development and regulatory risks.

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

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false 0001503802 0001503802 2026-08-31 2026-08-31
 
 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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): August 31, 2026

 

 

Karyopharm Therapeutics Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

 

Delaware   001-36167   26-3931704

(State or Other Jurisdiction

of Incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification No.)

 

85 Wells Avenue, 2nd Floor

Newton, Massachusetts

   02459
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (617) 658-0600

 

(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 (see General Instruction A.2. below):

 

☐

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, $0.0001 par value   KPTI   Nasdaq Global Select Market

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 August 31, 2026, Karyopharm Therapeutics Inc. (the “Company”) announced that it has submitted a supplemental New Drug Application (“sNDA”) to the U.S. Food and Drug Administration (“FDA”) seeking Accelerated Approval for XPOVIO® (selinexor) in combination with ruxolitinib for patients with myelofibrosis. The Company requested Priority Review of the application, which, if granted, could result in a six-month review process. The Company expects to receive notice of the FDA’s decision on sNDA filing acceptance and, if accepted, the anticipated review timelines in the fourth quarter of 2026, following the FDA’s 60-day filing review period.

Following the topline results of the Phase 3 SENTRY trial, the Company has engaged productively with the FDA. The sNDA submitted is based, in part, on data from the SENTRY trial that the Company believes supports a positive benefit-risk profile for the combination, including a promising signal of overall survival. The Company expects approval under the Accelerated Approval pathway would require the FDA to agree that spleen volume reduction ≥ 35% (SVR35) is a reasonably likely surrogate endpoint to predict overall survival. The Company plans to use long-term overall survival data from the Phase 3 SENTRY trial to verify clinical benefit and support conversion from accelerated to traditional approval and expects to continue working with the FDA during its review of the sNDA to finalize the confirmatory evidence plan.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the Company’s expectations with respect to the FDA’s review timing and the completeness and acceptability of its sNDA submission for selinexor in combination with ruxolitinib in myelofibrosis; Karyopharm’s ongoing engagement with the FDA; the potential availability of the accelerated approval pathway; whether long-term overall survival data from the SENTRY trial will verify clinical benefit; the potential availability of priority review of the sNDA; and the ability of selinexor to treat patients with multiple myeloma, myelofibrosis, and other diseases. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the Company’s control, that may cause actual events or results to differ materially from the Company’s current expectations. For example, there can be no guarantee that the Company will successfully commercialize XPOVIO or that any of the Company’s drug candidates, including selinexor, will successfully complete necessary clinical development phases or that development of any of the Company’s drug candidates will continue. Further, there can be no guarantee that any positive developments in the development or commercialization of the Company’s drug candidate portfolio will result in stock price appreciation. Management’s expectations and, therefore, any forward-looking statements in this Current Report on Form 8-K could also be affected by risks and uncertainties relating to a number of other factors, including the following: the adoption of XPOVIO in the commercial marketplace, the timing and costs involved in commercializing XPOVIO or any of the Company’s drug candidates that receive regulatory approval; the ability to obtain and retain regulatory approval of XPOVIO or any of the Company’s drug candidates that receive regulatory approval; the Company’s results of clinical trials and preclinical trials, including subsequent analysis of existing data and new data received from ongoing and future trials; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, including with respect to the need for additional clinical trials; the ability of the Company or its third party collaborators or successors in interest to fully perform their respective obligations under the applicable agreement and the potential future financial implications of such agreement; the Company’s ability to enroll patients in its clinical trials; unplanned cash requirements and expenditures; substantial doubt exists regarding the Company’s ability to continue as a going concern; development or regulatory approval of drug candidates by the Company’s competitors for products or product candidates in which the Company is currently commercializing or developing; and the Company’s ability to obtain, maintain and enforce patent and other intellectual property protection for any of its products or product candidates. These and other risks are described under the caption “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, which was filed with the Securities and Exchange Commission (SEC) on August 13, 2026, and in other filings that the Company may make with the SEC in the future. Any forward-looking statements contained in this Current Report on Form 8-K speak only as of the date hereof, and, except as required by law, the Company expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

 

2

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: August 31, 2026     By:  

/s/ Michael Mano

      Michael Mano
      Executive Vice President, Chief Legal Officer and Secretary

 

3

Source: View Original Filing on SEC EDGAR

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