Spectrum Pharmaceuticals, Inc. ($SPPI) Investor Settlement

The parties have reached an agreement to settle the case, but the terms are still being finalized. You can submit your application now, and it will be processed once claims filing opens.

S.D. New York

Court

1:22-cv-10292

Case number

05/12/2022

Class period Start

09/22/2022

Class period End

Spectrum Pharmaceuticals has reached a tentative settlement to resolve investor claims that it misled the market about poziotinib’s dosing, its FDA interactions, and the status of the PINNACLE confirmatory study.

Outline:

On March 17, 2022, Spectrum said it had optimized poziotinib’s tolerability with twice-daily dosing. On May 12, 2022, the company said the PINNACLE confirmatory study was underway and that patients were being randomized at 8 mg twice daily. On September 20 and 22, 2022, FDA briefing materials and an advisory committee meeting exposed those issues, and the case has now moved to a tentative settlement.

Timeline:
November 24, 2021: Spectrum completed its NDA submission for poziotinib and sought accelerated approval based on Cohort 2 data.
March 17, 2022: Spectrum said it had learned to optimize poziotinib’s tolerability with BID dosing.
May 12, 2022: Spectrum said the PINNACLE confirmatory study had been initiated and that patients were being randomized to 8 mg BID versus docetaxel.
August 11, 2022: Spectrum again said the confirmatory study was underway.
September 20, 2022: $SPPI fell more than 37% after the FDA briefing materials were released.
September 23, 2022: $SPPI fell about 31% after trading resumed.
November 25, 2022: Spectrum disclosed that the FDA had issued a complete response letter and said it would deprioritize the poziotinib program.
Background:

Spectrum was developing poziotinib as a treatment for previously treated non-small cell lung cancer patients with HER2 exon 20 insertion mutations. The company sought accelerated approval based on Phase 2 Cohort 2 results using a 16 mg once-daily dose.

At the same time, Spectrum planned to use a different dosing approach in its confirmatory PINNACLE study, with patients receiving 8 mg twice daily. Investors say that the switch mattered because the FDA had repeatedly questioned whether Spectrum had enough data to show the dose was properly optimized and whether the drug’s efficacy and safety supported approval.

Even so, Spectrum told investors in 2022 that it had learned to optimize dosing, was aligned with the FDA, and had the confirmatory study moving forward. Investors say those statements were misleading because the FDA had not agreed on the study design, had warned the company it was proceeding at its own risk, and no patients had been enrolled in PINNACLE.

The market learned more in September 2022, when FDA briefing materials and the advisory committee meeting laid out the agency’s concerns about limited efficacy, high toxicity, poor dose optimization, and the delayed confirmatory study. The advisory committee voted against the drug’s benefit-risk profile, shares fell sharply, and the FDA later issued a complete response letter. The matter has now moved to a tentative settlement.

What Can Investors Expect Now?

Spectrum Pharmaceuticals has reached a tentative settlement to resolve investor claims that it misled the market about poziotinib’s dosing, its FDA interactions, and the status of the PINNACLE confirmatory study.

If you were damaged due to this situation, you can file for a payout and get your share of the settlement. You can check if you are eligible and other details in the FAQ section.

Case Type

US Securities Class Action

Case Status

Tentative Settlement

Alleged Offence

Misleading Statements,

Fraud,

Failure to Disclose,

Omissions

Suspected Party

Directors,

Management

Security Type

Stocks

Trade Direction

Long

Filing date

12/05/2022

Plaintiffs

Steven B. Christiansen

Attorneys

Kaplan Fox & Kilsheimer LLP

Defendants

Thomas J. Riga ; Francois J. Lebel ; Nora E. Brennan

Trades matching type

FIFO

Frequently Asked Questions

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