What is the expected timeline for any potential regulatory submissions or approvals related to selinexor following the trial outcomes?

Regulatory timeline outlook for selinexor (XPOVIO®)

• Phase‑3 SENTRY trial in myelofibrosis: The patient‑screening period is slated to close this week and the top‑line data are expected in March 2026.
  
• Post‑data read‑out: Assuming the March 2026 results are positive, Karyopharm would need to compile a supplemental New‑Drug Application (sNDA) or a supplemental Biologics License Application (sBLA) for the myelofibrosis indication. Historically, companies file such submissions 2–4 months after a read‑out to allow for data cleaning, statistical validation and preparation of the regulatory dossier.
  
• Regulatory review: The FDA’s standard review clock for supplemental oncology filings is 6 months (standard review) or 3 months (priority review, if granted). Even with a priority pathway, the earliest a decision could be expected would be late 2026; under a standard review the window stretches to mid‑2027.
  

Trading implications

• Short‑term catalyst (Q2 2025‑Q1 2026): The March 2026 data release will be a high‑volatility event. A clear efficacy signal could trigger a 10‑15 % rally in Karyopharm’s stock, while a neutral or negative read‑out may depress the price.
  
• Mid‑term catalyst (late 2026–mid 2027): Anticipate a second price move around the time of the sNDA filing and subsequent FDA decision. Positioning ahead of the filing (e.g., buying on pull‑backs after the data read‑out) could capture upside if the agency grants a supplemental approval.
  
• Technical view: The stock is currently trading near its Q2‑2025 high with a mid‑term uptrend on the 50‑day SMA. A breakout above the 20‑day SMA with volume could signal the start of the March 2026 rally, while a breach below the 20‑day SMA may signal a short‑term correction ahead of the data release.
  

Bottom line: Expect the first regulatory filing for the myelofibrosis indication in mid‑2026, with the earliest possible FDA decision late 2026 (priority) and a more realistic timeline mid‑2027 (standard). These dates should frame your entry/exit points around the March 2026 data read‑out and the subsequent filing window.