SAN DIEGO–(BUSINESS WIRE)–Class: Robbins LLP reminds investors that a stockholder has filed a class action lawsuit on behalf of all purchasers of Spectrum Pharmaceuticals, Inc. common stock. (NASDAQ: SPPI) between December 6, 2021 and September 22, 2022 for violating the Securities Exchange Act of 1934. Spectrum is a biopharmaceutical company focused on the acquisition, development and commercialization of novel and targeted oncology therapies.
What now: Similarly-situated shareholders may be entitled to participate in a class-action lawsuit against Spectrum Pharmaceuticals. Shareholders who wish to act as the lead plaintiff for the class must submit their filings by February 2, 2023. The lead plaintiff is a representative party acting on behalf of other class members in the litigation. You do not have to participate in the event to be eligible for a refund. For more information click here.
All representation is on a contingent fee basis. Shareholders do not pay fees or expenses.
What this case is about: Spectrum Pharmaceuticals Inc. he misled investors about the viability and effectiveness of his new drug
According to the lawsuit, prior to the lectures, the 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 who have certain mutations and were previously treated with the standard of care.
On December 6, 2021, Spectrum issued a press release announcing that it had submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for the use of poziotinib in patients with previously treated locally advanced or metastatic NSCLC HER2. exon 20 insertion mutations. The NDA filing was based on allegedly “positive group 2 results from the ZENITH20 clinical trial, which evaluated the safety and efficacy of poziotinib.”
During class, the defendants argued that 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 the investors, this was not true.
On September 20, 2022, the FDA published an information document in advance of the scheduled meeting of the Oncology Drug Advisory Committee (“ODAC”) related to poziotinib on September 22, 2022. In stark contrast to Defendants’ claims that the ZENITH20 data were positive and required confirmatory Phase 3 trial initiated and patients randomized, the briefing document identified material adverse concerns with the efficacy and safety data supporting the poziotinib NDA and disclosed that Defendants’ Phase 3 Confirmatory Trial did not enroll any patients.
On this news, shares of Spectrum common stock fell from a closing price of $1.06 per share on September 19, 2022 to a close of $0.66 per share on September 20, 2022, a decrease of $0.40 per share or over 37%. Analysts began reporting negatively on the ODAC meeting.
Then, according to Reuters, on September 22, 2022, before the market opened, Spectrum stock was halted at $0.63 per share pending the outcome of the FDA ODAC meeting. On the same day, the ODAC voted 9-4 not to recommend poziotinib for accelerated approval.
On September 23, 2022, when trading in Spectrum’s common stock resumed, the stock fell from its closing price of $0.63 per share on September 21, 2022, before trading was halted, to close at $0.43 per share on September 23, 2022, down $0.20 per share or over 31%.
On November 25, 2022, the defendants caused Spectrum to issue a press release disclosing that the Company had received a CRL from the FDA stating that the NDA for poziotinib could not be approved in its current form.
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