Spectrum Pharmaceuticals Inc. (SPPI) shares declined 3.77% in after-hours on Monday, January 03, 2022, and closed at $1.53. However, in the regular trading session on Monday, SPPI’s stock surged 25.20%. SPPI shares have fallen 54.05% over the last 12 months, and they have moved up 13.57% in the past week. Over the past three months, the stock has lost 22.82%, while over the past six months, it has plummeted 55.21%.
Let’s see what’s going on with the company?
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SPPI facing legal challenges for ROLONTIS
Shareholder rights law firm Robbins LLP and other firms are investigating Spectrum Pharmaceuticals, Inc. (SPPI) to determine whether certain Spectrum officers and directors violated the Securities Exchange Act of 1934 and breached fiduciary duties to shareholders.
Spectrum submitted a Biologics License Application to FDA for ROLONTIS as a treatment for chemotherapy-induced neutropenia in December 2018. Spectrum voluntarily withdrew its BLA in March 2019 and resubmitted the application in October 2019. The company claimed that the viability of ROLONTIS and the preparations the Company had made in advance of the FDA’s inspection of its manufacturing facility. In reality, the ROLONTIS manufacturing facility maintained deficient controls which decreased the prospects that the FDA would approve the ROLONTIS BLA in its current form.
On August 6, 2021, FDA issued a Complete Response Letter stating deficiencies related to manufacturing and indicated that a reinspection of the Company’s manufacturing facility would be necessary. After this news, Spectrum’s stock price fell over 21% on August 6, 2021.
SPPI New Drug Application for Poziotinib
On December 06, 2021, Spectrum Pharmaceuticals (SPPI) submitted its New Drug Application (NDA) for poziotinib to the U.S. Food and Drug Administration. Poziotinib is used in patients with previously treated locally advanced or metastatic non-small cell lung cancer with HER2 exon 20 insertion mutations. The NDA is submitted after positive results of Cohort 2 from the ZENITH20 clinical trial, which assessed the safety and efficacy of poziotinib.
SPPI corporate changes
On December 01, 2021, Spectrum Pharmaceuticals, Inc. (SPPI), promoted Tom Riga, currently Chief Commercial and Chief Operating Officer, to next President and CEO. Mr. Riga also joined the company’s Board of Directors.
The company also announced the retirement of Mr. Turgeon after nine years with the company. Accordingly, he will also be stepping down from Spectrum’s Board of Directors. Mr. Turgeon joined the Company in October 2012 and was appointed President and Chief Executive Officer in December 2017.
Well, the company is facing some legal battles and that may be the reason behind its decline in the after-markets, but there was no positive development behind its surge in the regular trading session on Monday.