National Law Firm Investigating Spectrum Pharmaceuticals, Inc. Over Alleged False/Misleading Statements Regarding New Drug Application

Complaint Alleges Spectrum Pharmaceuticals Failed to Disclose Negative Data from Clinical Trials

ONTARIO, Calif., Dec. 9, 2022 /PRNewswire/ -- McCune law Group, McCune Wright Arevalo Vercoski Kusel Weck Brandt APC (MLG) – a national law firm specializing in Securities Litigation , Commercial Litigation , and Class Actions, - is investigating bringing claims on behalf of purchasers of Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) ("Spectrum" or the "Company") common stock between December 6, 2021, and September 22, 2022, both dates inclusive (the "Class Period"). The complaint alleges that during the Class Period, Spectrum made false and/or misleading statements and/or failed to disclose negative data on the safety and efficacy of pozi, and the Company's failure to enroll patients in an FDA-required phase 3 confirmatory trial. The complaint has been filed in the United States District Court for the Southern District of New York, and is captioned Osorio-Franco v. Spectrum Pharmaceuticals, Inc. et al., No. 1:22-cv-10292 (S.D.N.Y. Dec 05, 2022).

The complaint also alleges that Spectrum was conducting a phase 2 clinical trial called ZENITH20 evaluating poziotinib, or "pozi", in patients with locally advanced or metastatic non-small cell lung cancer ("NSCLC") with certain mutations and who were previously treated with the standard of care and had submitted a New Drug Application ("NDA") to the United States Food and Drug Administration ("FDA"). 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 a required confirmatory phase 3 study.

The truth began to emerge when, on September 20, 2022, pre-market open, the FDA released a briefing document ahead of its scheduled September 22, 2022, ODAC meeting regarding pozi. The briefing document identified significant negative concerns regarding the efficacy and safety data supporting the pozi NDA and revealed that Spectrum's Phase 3 confirmatory trial failed to enroll a single patient.

On this news, Spectrum's common stock price declined from $1.06 per share on September 19, 2022, to close at $0.66 per share on September 20, 2022, i.e., a 0.40 per share or over 37% decrease. Then, on September 22, 2022, Spectrum issued a press release that the FDA's ODAC committee voted 9-4 against Spectrum, finding that the benefits of pozi did not outweigh its risks. Because of this news, Spectrum's common stock price declined from $0.63 on September 22, 2022, to close at $0.43 per share on September 23, 2022, i.e., a $0.20 or approximately 31% decrease.

About MLG's Securities Litigation Practice: The Securities Litigation attorneys of MLG provide representation for investors who have been wronged through fraud, scams, and schemes. Our team has many years of experience bringing claims on behalf of investors and pursues all avenues of compensation to maximize our clients' recovery as they navigate this tumultuous time. With hard-hitting tactics and dedicated legal professionals protecting our clients' interests, MLG's Securities Litigation Practice Group hopes to hold companies accountable for their unfair or illegal financial practices.

About McCune Law Group, McCune Wright Arevalo Vercoski Kusel Weck Brandt APC: McCune Law Group has a deep history of success for its clients. MLG maintains California offices in Ontario, San Bernardino, Calimesa, Palm Desert, and Irvine and supports its national practice with offices in Illinois and New Jersey. Visit mccunewright.com for more information. 

SOURCE McCune Law Group, McCune Wright Arevalo Vercoski Kusel Weck Brandt, APC