NEW YORK, NY / ACCESSWIRE / December 12, 2022 / Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Spectrum Pharmaceuticals, Inc. ("Spectrum" or the "Company") (NASDAQ:SPPI) and reminds investors of the February 3, 2023 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.
If you suffered losses exceeding $100,000 investing in Spectrum stock or options between December 6, 2021 and September 22, 2022 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). You may also click here for additional information: www.faruqilaw.com/SPPI.
There is no cost or obligation to you.
Faruqi & Faruqi is a leading minority and Woman-owned national securities law firm with offices in New York, Pennsylvania, California and Georgia.
According to the complaint, before the class period, defendants were conducting a Phase 2 clinical trial called ZENITH20 to evaluate the safety and tolerability of poziotinib in patients with locally advanced or metastatic non-small cell lung cancer that have certain mutations and were previously treated with the standard of care.
On December 6, 2021, Spectrum issued a press release announcing it submitted a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for poziotinib's use in patients with previously treated locally advanced or metastatic NSCLC with HER2 exon 20 insertion mutations. The NDA submission was based on purportedly "positive results of Cohort 2 from the ZENITH20 clinical trial, which assessed the safety and efficacy of poziotinib."
During the class period, defendants represented the safety and efficacy data from the ZENITH20 trial were positive and that they had initiated the required confirmatory phase 3 study. However, unknown to investors, this was not true.
On September 20, 2022, the FDA released a briefing document ahead of its scheduled September 22, 2022 Oncologic Drugs Advisory Committee ("ODAC") meeting regarding poziotinib. In sharp contrast to defendants' representations that the ZENITH20 data was positive and that the required confirmatory Phase 3 trial was initiated and patients were being randomized, the briefing document identified material negative concerns about the efficacy and safety data supporting the poziotinib NDA, and revealed that defendants' Phase 3 confirmatory trial had not enrolled a single patient.
On this news, shares of Spectrum common stock declined from a closing price of $1.06 per share on September 19, 2022, to a close at $0.66 per share on September 20, 2022, a decline of $0.40 per share, or over 37%. Analysts began reporting negatively regarding the ODAC meeting.
Then, according to Reuters, on September 22, 2022, before the opening of the market, trading in Spectrum shares was halted at $0.63 per share pending the outcome of the FDA ODAC meeting. That same day, ODAC voted 9-4 not to recommend poziotinib for Accelerated Approval.
On September 23, 2022, when trading in Spectrum common stock resumed, shares declined from a closing price of $0.63 per share on September 21, 2022 before trading was halted, to a close at $0.43 per share on September 23, 2022, a decline of $0.20 per share, or over 31%.
On November 25, 2022, defendants caused Spectrum to issue a press release disclosing that the Company received a CRL from the FDA indicating the poziotinib NDA cannot be approved in its present form.
The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not.
Faruqi & Faruqi, LLP also encourages anyone with information regarding Spectrum's conduct to contact the firm, including whistleblowers, former employees, shareholders and others.
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SOURCE: Faruqi & Faruqi, LLP