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Spectrum Pharmaceuticals (NasdaqGS: SPPI) received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application for ROLONTIS® (eflapegrastim). The CRL pointed out manufacturing deficiencies and requires reinspection. Spectrum is seeking clarification from the FDA and plans to meet with them soon. ROLONTIS is a long-acting granulocyte colony-stimulating factor aimed at treating neutropenia in cancer patients. Clinical trials indicated non-inferiority to pegfilgrastim. Spectrum remains committed to addressing the FDA's concerns and bringing ROLONTIS to market.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) announced a conference call scheduled for August 12, 2021, at 4:30 p.m. Eastern to discuss its second quarter 2021 financial results and corporate updates. Investors can join the call domestically at (877) 837-3910 or internationally at (973) 796-5077, using Conference ID# 2398834. Additionally, the call will be available for replay on the company’s Investor Relations website. Spectrum focuses on developing targeted oncology therapies, aiming to address unmet medical needs.
Spectrum Pharmaceuticals (SPPI) presented data from the ZENITH20 clinical trial on the CNS activity of poziotinib in NSCLC patients with EGFR or HER2 exon 20 mutations. Among 36 patients with brain metastases, 8% achieved complete responses. The trial enrolled 284 patients, with brain metastasis affecting up to 25% of NSCLC patients, indicating a significant unmet need. These findings were showcased at the 2021 ASCO Annual Meeting.
Francois Lebel, CMO, emphasized the promising CNS activity for poziotinib in this patient group.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) announced that the FDA is conducting an inspection of its ROLONTIS® (eflapegrastim) manufacturing facility. This follows a deferral of the Biologics License Application (BLA) decision due to travel restrictions from the COVID-19 pandemic affecting an inspection in South Korea. ROLONTIS aims to treat neutropenia in cancer patients undergoing chemotherapy and has shown non-inferiority in clinical trials compared to pegfilgrastim. The company continues to focus on expanding its oncology portfolio.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) announced a poster presentation on the CNS activity of poziotinib for NSCLC patients with EGFR or HER2 exon 20 mutations. This will be showcased at the 2021 ASCO Annual Meeting from June 4-8, 2021. The poster, titled 'CNS activity of poziotinib in NSCLC with exon 20 insertion mutations', features speaker Xiuning Le, M.D., Ph.D. It is scheduled for on-demand viewing starting June 4, 2021, at 9 a.m. ET, with abstract number 9093. Registered attendees can view the presentation via the ASCO website.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) is set to present its business strategy and development-stage programs at two virtual investor conferences. The Jefferies Virtual Healthcare Conference 2021 will feature a fireside chat on June 3, 2021, at 9:30 a.m. ET, followed by the JMP Securities Life Sciences Conference 2021 on June 16, 2021, at 1:30 p.m. ET. Live webcasts will be available on the company's Investor Relations page. Spectrum focuses on novel oncology therapies and has a promising late-stage pipeline aimed at unmet medical needs.
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI) reported a net loss of $35.7 million, or $0.25 per share, for the quarter ending March 31, 2021, showing improvement from a $40.6 million loss in Q1 2020. The company is prioritizing the NDA submission for poziotinib based on promising data from the ZENITH20 trial. Research and development expenses increased to $19.4 million. Cash and marketable securities stood at $162.9 million. The FDA's pre-approval inspection for ROLONTIS is scheduled for later this month. A conference call will be held on May 13, 2021.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) will host a conference call on May 13, 2021, at 4:30 p.m. Eastern to discuss Q1 2021 financial results and provide a corporate update. The call can be accessed domestically at (877) 837-3910 or internationally at (973) 796-5077, using Conference ID# 1373243. The event will be available for replay on the company's Investor Relations website. Spectrum focuses on developing novel oncology therapies and has a robust late-stage pipeline aimed at addressing unmet medical needs.
Spectrum Pharmaceuticals (NASDAQ: SPPI) presented update data on poziotinib for NSCLC patients with EGFR or HER2 mutations at the AACR Virtual Meeting 2021. The findings from the ZENITH20 trial's Cohort 5 highlight improved tolerability and reduced adverse events with 8mg BID dosing compared to QD dosing. This cohort reported a 31.6% partial response rate in 8mg BID patients. The company plans to expand this dataset and evaluate the drug's effects on additional tumors.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) announced poster presentations at the AACR Virtual Annual Meeting from April 10-15, 2021, highlighting the safety and tolerability of twice-daily administered poziotinib for patients with EGFR or HER2 exon 20 mutations, alongside a study on same-day dosing of ROLONTIS in neutropenic rats and early-stage breast cancer patients. Key details include presentations by Xiuning Le, M.D., Ph.D., and John A. Barrett, with specific session details available on the AACR website during the conference.
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