Sign In
Step 1
Unite with Fellow Investors
Step 2
Choose the Best Attorney
Step 3
Provide Documents
Step 4
Follow Case Progress
Step 5
Get Payout
KPTI.US
id: 501

KPTI sell off after negative feedback from the FDA on Selinexor Case

On March 1, 2022, Karyopharm Therapeutics (KPTI) plunged after negative feedback from the FDA on its supplemental New Drug Application submission based on the Phase 3 SIENDO study data of Selinexor as front-line maintenance therapy following chemotherapy in advanced or recurrent endometrial cancer.

On this news, KPTI stock dropped over 39% and the Company lost more than $330 million of its capitalization, seriously damaging investors.

  • The FDA outlined that the current SIENDO study topline results would not support an NDA approval as Karyopharm and the FDA participants had differing views on the study’s significance and overall clinical benefit for the whole population.
  • As a result, the FDA did not accept both partial and full applications for Selinexor against common practice, business standards, and previous similar trial cases which led to a sharp stock drop on the day of the Company's respective announcement.
Taking all the facts and previous discussions between KPTI and the FDA into account, Investors have all grounds to suspect that their rights were grossly violated whether the Company conducted negligently, or the Regulator breached its standards.
Alleged Offence
Mismanagement
Misleading Statements
Failure to Disclose
Malpractice
Negligence
Breach of Fiduciary duty
Omissions
Suspected Party
Directors
Management
Government Authority
Service Provider
Security Type
Stocks
Trade Direction
Long
Shock Event Date
01 March 2022
Collecting participants…

Karyopharm Therapeutics Inc

Karyopharm Therapeutics Inc., a commercial-stage pharmaceutical company, discovers, develops, and commercializes drugs directed against nuclear export for the treatment of cancer and other diseases...

    Ticker
    KPTI.US
    ISIN
    US48576U1060
    CIK
    1503802
    Sector
    Healthcare
    Industry
    Biotechnology
    Country
    USA
    Address
    85 Wells Avenue, Newton, MA, United States, 02459-3298