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Newsfile 25-Jan-2023 4:32 PM
New York, New York--(Newsfile Corp. - January 25, 2023) - Pomerantz LLP announces that a class action lawsuit has been filed against Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI), and certain officers. The class action, filed in the United States District Court for the Southern District of New York, and docketed under 22-cv-10677, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired
If you are a shareholder who purchased or otherwise acquired Spectrum securities during the Class Period, you have until February 3, 2023 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at email@example.com or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
Spectrum purports to be a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted oncology therapies.
The complaint alleges that, before the Class Period, Defendants were conducting a Phase 2 clinical trial called ZENITH20. The ZENITH20 trial was an ongoing, multicenter, multi-cohort, open-label, activity-estimating study evaluating the anti-tumor effects, safety, and tolerability of poziotinib, or "pozi", in patients with locally advanced or metastatic non-small cell lung cancer ("NSCLC") that have certain mutations (HER2 exon 20 insertion mutations) and were previously treated with the standard of care. Before the Class Period, the Company had a pre-NDA meeting with the FDA, during which Spectrum confirmed with the FDA that Cohort 2 data could serve as the basis of a new drug application ("NDA") submission. In Cohort 2, the objective response rate (complete or partial response, which are measures of whether tumors shrink or are eradicated after treatment) was approximately 28% and the median duration of response was 5.1 months.
The HER2 exon 20 insertion mutation occurs in 2-5% of patients with NSCLC. These patients are treated according to the same treatment paradigms as patients with advanced NSCLC without these unique mutations, however, there is an apparent unmet need for these patients because they have a median overall survival of 1.6-1.9 years from the time of diagnosis. According to Defendants, if approved, poziotinib could address an unmet need of NSCLC patients previously treated with the standard of care.
The complaint alleges that, 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.
As later revealed to investors, the data submitted by Defendants in support of the NDA failed to show that pozi provided a meaningful advantage over available therapies and therefore was not likely to provide a clinical benefit. During the Class Period, the FDA expressed concerns regarding pozi's safety and efficacy data, and further, the FDA expressed concern that Defendants' phase 3 confirmatory trial, which was required to be substantially enrolled at the time of AA, had not enrolled a single patient during the Class Period. The FDA communicated to Defendants that given the concerns regarding the totality of evidence supporting the NDA, the significant delay in confirming benefit with a randomized trial heightened the uncertainty around the risk benefit assessment of pozi.
Starting on September 20, 2022, before the market opened, investors began to learn the truth when the FDA Oncologic Drugs Advisory Committee ("ODAC") released a briefing document in anticipation of its September 22, 2022 meeting with Defendants to review poziotinib. ODAC is an independent panel of experts that reviews and evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer. The committee makes appropriate recommendations to the FDA, but these recommendations are not binding and the final decision regarding product approval will be made solely by the FDA.
Investors were surprised when, despite the Company's repeated representations during the Class Period that the data for ZENITH20 were positive, the ODAC briefing document disclosed not only negative data on the safety and efficacy of pozi, but also a failure by the Company to enroll any patients in the required phase 3 confirmatory trial.
As a result of 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% on heavier than usual volume.
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.
Also on September 22, 2022, ODAC conducted its meeting concerning poziotinib in which Defendant Lebel participated. During the meeting, ODAC voted 9-4 not to recommend poziotinib for AA.
On September 23, 2022, trading in Spectrum common stock resumed. As a result of this news, shares of Spectrum common stock further 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 heavier than usual volume.
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." The report further stated that "We believe the ODAC vote is negative for potential approval of poziotinib. We note that the FDA does not have to follow the recommendations of the ODAC; however, the FDA's views in the briefing documents and during the meeting do not bode well for approval, in our opinion."
Also on September 23, 2022, Jefferies released a report titled "Based on Negative Pozi Adcom, We Anticipate CRL; Next Steps for Pozi Unclear". The report noted "Adcom voted 9-4 that pozi benefits do not outweigh risks. Panel agreed w/ FDA concerns on dosing, lack of confirm trial progress, and that pozi data do not show clear benefit vs SOC." Further, the Jefferies report stated that the "Panel decided evidence on efficacy & unmet need did not outweigh concerns, namely: 1) dosing concerns w/ incongruence b/w 16mg QD dose under review and confirmatory trial's 8mg BID; 2) lack of confirmatory trial progress w/ no pts enrolled as of yet and data likely not until 2026, increasing risk to pts."
On November 25, 2022, Defendants caused Spectrum to issue a press release disclosing their receipt of a Complete Response Letter ("CRL") from the FDA regarding Spectrum's NDA for poziotinib.
As of December 5, 2022, Spectrum stock has not recovered, closing at $0.47 per share.
Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com.
Robert S. Willoughby
888-476-6529 ext. 7980
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/152509