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Spectrum Pharmaceuticals (SPPI) reported financial results for Q4 and the full year 2020, highlighting a net loss of $49.9 million for Q4 and $171.3 million for the full year. The company received Fast Track designation from the FDA for poziotinib to treat non-small cell lung cancer. They have scheduled a pre-approval inspection for ROLONTIS in May 2021. Cash and marketable securities decreased to approximately $180 million by year-end.
Despite challenges posed by the pandemic, R&D efforts continue, with the NDA submission for poziotinib planned later in 2021.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) announced a conference call scheduled for March 30, 2021, at 4:30 p.m. Eastern. The call will discuss the fourth quarter and full year 2020 financial results, alongside a corporate update. Interested parties can access the call via phone or through the Investor Relations section of their website. Spectrum focuses on developing targeted oncology therapies and aims to provide insights into its late-stage pipeline and future direction during the call.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) announced that the FDA will conduct a pre-approval inspection of the ROLONTIS® manufacturing site in May 2021. This follows a deferred decision on the Biologics License Application (BLA) due to travel restrictions from the COVID-19 pandemic. ROLONTIS, designed to treat neutropenia in cancer patients, has shown non-inferiority to pegfilgrastim in clinical trials. The completion of this inspection is seen as a crucial step towards potential approval, enhancing the company's prospects in the oncology market.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) announced that the FDA granted Fast Track designation for poziotinib to treat non-small cell lung cancer (NSCLC) in patients with HER2 exon 20 mutations. This designation allows expedited drug development and review, a significant breakthrough as there are no approved therapies for this mutation.
The company plans to submit a new drug application (NDA) for poziotinib later this year. Recent presentations suggest improved anti-tumor activity with a twice-daily dosing strategy. Spectrum aims to address unmet medical needs in oncology with this innovative treatment.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) reported preliminary results from the ZENITH20 clinical trial regarding poziotinib, indicating improved tolerability and anti-tumor activity with a twice-daily (BID) dosing compared to once-daily (QD). The 8mg BID dosing showed a reduction in serious adverse events and dose interruptions. Overall, 30% of patients in Cohort 5 achieved a partial response. These findings, presented at the ESMO TAT Virtual Congress, support the hypothesis that BID dosing could enhance treatment efficacy for non-small cell lung cancer patients with specific mutations.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) announced a poster presentation detailing the interim safety evaluation of ROLONTIS® (eflapegrastim) for early-stage breast cancer patients receiving docetaxel and cyclophosphamide. The presentation will occur during the 38th Annual Miami Breast Cancer Conference® on March 4, 2021, at 6:00 PM EST, by Dr. Lee S. Schwartzberg. Spectrum focuses on developing targeted oncology therapies and has a promising late-stage pipeline addressing unmet medical needs, potentially transforming its future business landscape.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) announced two presentations at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Virtual Congress 2021, scheduled for March 1-2, 2021. The oral presentation will discuss safety and efficacy data for poziotinib in EGFR/HER2 Exon 20 mutant non-small cell lung cancer, while another session will cover the effects of IGN002 in non-Hodgkin lymphoma. Access to these presentations will be available for ESMO members.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) announced its participation in a fireside chat at the Guggenheim Healthcare Talks 2021 Oncology Day. The event is scheduled for February 11, 2021, at 4 p.m. EST. A live webcast will be available on the company’s Investor Relations page, with a replay accessible shortly after the event.
The company focuses on developing targeted oncology therapies, with a late-stage pipeline aimed at unmet medical needs, potentially transforming its market position in the near future.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) announced two oral presentations regarding the efficacy and safety of poziotinib in treating NSCLC patients with atypical EGFR mutations. These will occur at the IASLC 2020 World Conference on Lung Cancer from January 28-31, 2021. The presentations include data from the ZENITH20 trial and a structural classification of EGFR mutations. The company emphasizes its focus on novel oncology therapies and a strong late-stage pipeline aimed at unmet needs. For more, visit sppirx.com.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) announced participation in three virtual investor conferences to showcase its business strategy and development-stage programs. Highlights include a fireside chat at the H.C. Wainwright BioConnect Conference available on-demand from January 11, 2021, a live presentation at the ICR Conference 2021 on January 14 at 1:45 p.m. ET, and another live fireside chat at the B. Riley Oncology Investor Conference on January 21 at 1 p.m. ET. Archived webcasts will be accessible on the company's investor relations website.
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