Spectrum Pharmaceuticals, Inc.
| Company Name | Spectrum Pharmaceuticals, Inc. |
| Stock Symbol | SPPI |
| Class Period | December 27, 2018 to August 05, 2021 |
| Lead Plaintiff Motion Deadline | November 01, 2021 |
In December 2018, Spectrum submitted a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for ROLONTIS as a treatment for chemotherapy-induced neutropenia.
On August 6, 2021, Spectrum announced that it had received a Complete Response Letter (“CRL”) from the FDA regarding the BLA, citing deficiencies related to manufacturing and requiring a reinspection of the Company’s manufacturing facility.
On this news, Spectrum’s stock price fell $0.70 per share, or nearly 22%, to close at $2.55 per share on August 6, 2021.
The complaint filed alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) the ROLONTIS manufacturing facility maintained deficient controls and/or procedures; (2) the foregoing deficiencies decreased the likelihood that the FDA would approve the ROLONTIS BLA in its current form; (3) Spectrum had therefore materially overstated the ROLONTIS BLA’s approval prospects; and (4) as a result, Defendants' statements about its business, operations, and prospects, were materially false and misleading and/or lacked a reasonable basis at all relevant times.
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