Enrique Osorio-Franco, et al. v. Spectrum Pharmaceuticals Case

Both parties are exchanging evidence and gathering information for the case.

S.D. New York

Court

22-CV-10292

Case number

03/17/2022

Class period Start

09/22/2022

Class period End

On September 22, 2022, the FDA Oncologic Drugs Advisory Committee(ODAC) voted 9-4 not to recommend Spectrum's (SPII) poziotinib for Accelerated Approval.

On September 23, 2022, H.C. Wainwright released a report titled “ODAC Votes Against Poziotinib; Debt Deal Announced; Lower PT by $3”. The report noted that the 9 “no” voters from the ODAC cited “non-meaningful benefit over existing therapies and cited dosing issues… Issues related to the Phase 3 confirmatory trial for poziotinib were also raised… as that study has not yet started.”
Going back through 2021 -2022, the Company and its Leaders represented the safety and efficacy data from the ZENITH20 trial were positive and that they had initiated the required confirmatory phase 3 study.

Taking all representations into account, Investors have reasons to suspect that they were misled by the Company and its management on the prospects of its drug candidate.

Case Type

US Securities Class Action

Case Status

Case Discovery

Alleged Offence

Misleading Statements,

Failure to Disclose,

Negligence,

Omissions

Suspected Party

Directors,

Management,

Government Authority,

Service Provider

Security Type

Stocks

Trade Direction

Long

Shock Event Date

09/22/2022

Filing date

12/05/2022

Judge

Hon. Valerie E. Caproni