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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.
Case Status
Inactive Investigation
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
03/01/2022