NEW YORK, Jan. 21, 2023 (GLOBE NEWSWIRE) — 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 arranged under 22-cv-10677 represents a class of all persons and entities other than Defendants purchased or otherwise acquired.
If you were a shareholder who purchased or acquired Spectrum Securities during the class action period, you have until February 3, 2023 to ask the court to appoint you as the lead plaintiff in the class action. A copy of the complaint is available at: www.pomerantzlaw.comTo discuss this action, please contact Robert S. Willoughby. newaction@pomlaw.com or 888.476.6529 (or 888.4-POMLAW), toll-free, ext. 7980. When contacting us by email, we recommend that you include your mailing address, phone number and number of shares purchased.
[Click here for information about joining the class action]
Spectrum claims to be a biopharmaceutical company focused on acquiring, developing and commercializing novel targeted oncology therapies.
The complaint alleges that prior to the class action period, defendants were conducting a Phase 2 clinical trial called ZENITH20. The ZENITH20 trial is an ongoing, multicenter, multicohort, open-label, putative activity study evaluating the antitumor efficacy, safety and tolerability of poziotinib or “positive” in patients with locally advanced or metastatic non-small tumors. increase. Lung cell carcinoma (“NSCLC”) with a specific mutation (HER2 exon 20 insertion mutation) and previously treated with standard therapy. Prior to the class period, we had his pre-NDA meeting with the FDA. Meanwhile, Spectrum has confirmed with the FDA that Cohort 2 data may serve as the basis for New Drug Application (“NDA”) submissions. In Cohort 2, the objective response rate (complete or partial response, a measure of whether the tumor shrinks or is eradicated after treatment) was approximately 28%, with a median duration of response of 5.1 months.
HER2 exon 20 insertion mutations occur in 2-5% of NSCLC patients. These patients are treated according to the same treatment paradigm as patients with advanced NSCLC who do not have these unique mutations, but are clearly unmet, with a median overall survival from diagnosis of 1.6–1.9 years. There are no needs. If approved, the defendant said poziotinib could address an unmet need in her NSCLC patients previously treated with standard of care.
The complaint alleges that during the class action period, defendants had positive safety and efficacy data from the ZENITH20 trial and initiated the necessary confirmatory Phase 3 trials. However, unbeknownst to investors, this was not true.
As it was later revealed to investors, the data submitted by the defendants in support of the NDA failed to show that the posi provided a significant advantage over available treatments, and thus was clinically unacceptable. Unlikely to provide benefit. During the class, FDA expressed concerns about pozi’s safety and efficacy data We expressed concern that one patient was not enrolled in the confirmatory phase 3 trial. during class. Given concerns about the totality of the evidence supporting the NDA, FDA informed defendants that significant delays in confirming benefit from randomized trials increased uncertainty regarding the risk-benefit assessment of pozi. .
Beginning September 20, 2022, before the market opens, investors will be briefed in anticipation that the FDA’s Oncology Drug Advisory Committee (“ODAC”) will consider poziotinib at its September 22, 2022 meeting with defendants. I started learning the truth when I released the document. ODAC is an independent panel of experts that reviews and evaluates data on the efficacy and safety of commercial and investigational products used to treat cancer. The committee will make appropriate recommendations to FDA, but these recommendations are not binding and final decisions regarding product approval will be made solely by FDA.
Investors believe that, despite repeated statements during the company’s class period that the Zenith 20 data are positive, the ODAC briefing documents show not only negative data on the safety and efficacy of pozi, but also negative data by the company. We were surprised to learn that the patient’s failure to enroll was also disclosed in the required phase 3 confirmatory trial.
As a result of this news, the stock price of Spectrum’s common stock declined from a September 19, 2022 closing price of $1.06 per share to a September 20, 2022 closing price of $0.66 per share, down to a price of $0.40 per share. Down, i.e. above $37. % of heavier than normal volume.
Then, according to ReutersOn September 22, 2022, before the market opened, Spectrum stock was halted at $0.63 per share pending the outcome of the FDA ODAC meeting.
Also on September 22, 2022, ODAC held a meeting on poziotinib in which defendant Lebel participated. During the meeting, the ODAC voted him 9 to 4 not to recommend poziotinib to AA.
On September 23, 2022, Spectrum’s common stock resumed trading. As a result of this news, the stock price of Spectrum’s common stock declined further from its closing price of $0.63 per share on September 21, 2022, prior to the trading halt, to $0.43 per share on September 23, 2022. , down $0.20 per share. 31% or more in shares, or heavier than normal volume.
On Sept. 23, 2022, HC Wainwright announced, “ODAC Vote Against Poziotinib. Debt Deal Announced. Lowers PT by $3.” cited issues of dosing cited as “nonsensical benefits over existing therapies…issues related to the confirmatory phase 3 trial of poziotinib were also raised….not yet started.” The report further states: FDA does not require him to follow ODAC recommendations. However, in our opinion, the briefing document and the FDA’s position during the meeting are not predictive of approval.”
Also on September 23, 2022, Jefferies forecasts CRL based on “Negative Pozi Adcom. Next Steps for Pozi Unclear”. Voted 9 to 4 No. The panel agreed with the FDA’s concerns about dosing, the inability to confirm trial progress, and the pozi data showing no clear benefit to SOC Furthermore, the Jefferies report states: 2) Patients are at increased risk as there is no progress in confirmatory trials, no patients are enrolled at this time, and data will likely not be available until 2026. ”
On November 25, 2022, Defendants caused Spectrum to issue a press release disclosing receipt of a Complete Response Letter (“CRL”) from the FDA regarding Spectrum’s NDA for poziotinib.
As of December 5, 2022, Spectrum’s stock price has not recovered, closing at $0.47 per share.
With offices in New York, Chicago, Los Angeles, London, Paris and Tel Aviv, Pomerantz LLP is recognized as one of the leading law firms in the corporate, securities and antitrust class action fields. Founded by the late Abraham L. Pomerantz, known as the Chief of the Class Action Tribunal, Pomeranz is a pioneer in the field of securities class actions. Today, more than 85 years later, Pomeranz continues the tradition he established by fighting for the rights of victims of securities fraud, fiduciary breaches and corporate misconduct. The firm has collected numerous multi-million dollar damages on behalf of members of class action lawsuits.look www.pomlaw.com.
contact:
Robert S. Willoughby
Pomerantz LLP
rswilloughby@pomlaw.com
888-476-6529 ext. 7980
