Spectrum Pharmaceuticals, Inc. - SPPI STOCK NEWS

Spectrum Pharmaceuticals (SPPI) announced the commercial launch of ROLVEDON™ (eflapegrastim-xnst), targeting a $2 billion market for adult patients undergoing myelosuppressive anti-cancer treatments. The company reported a significant reduction in research and development expenses, down to $13.3 million from $20.9 million year-over-year. Spectrum's cash position is solid at $100.3 million, extending its runway through 2024. However, the company's poziotinib faced setbacks with a 9-4 ODAC vote deeming its risks outweigh its benefits, with a PDUFA date set for November 24, 2022.

Spectrum Pharmaceuticals (NASDAQ: SPPI) will host a conference call on November 10, 2022, at 4:30 p.m. Eastern to discuss its Q3 2022 financial results and provide a corporate update. Investors can access the call via registration link or through a live webcast on the company’s Investor Relations website. The call will be archived for future access.

Spectrum Pharmaceuticals (NASDAQ: SPPI) announced the commercial launch of ROLVEDON™ (eflapegrastim-xnst), a long-acting treatment designed to reduce febrile neutropenia in adult patients undergoing myelosuppressive chemotherapy. ROLVEDON, approved by the U.S. FDA in September 2022, enters a lucrative $2 billion market. With distribution partners ready, Spectrum aims to capitalize on this market opportunity, marking a significant shift to a commercial stage.

Spectrum Pharmaceuticals, Inc. (SPPI) has entered into a five-year debt financing agreement with SLR Capital Partners, providing up to $65 million to support its commercial launch of ROLVEDON™. This funding is expected to extend the company's cash runway through 2024, enhancing operational flexibility. The first $30 million tranche was drawn on September 21, 2022, with remaining funds dependent on achieving specific milestones. The loan facility matures on September 1, 2027, featuring interest-only payments for the first three years.

Spectrum Pharmaceuticals announced that the FDA's Oncologic Drugs Advisory Committee (ODAC) voted against the approval of poziotinib for treating patients with advanced non-small cell lung cancer (NSCLC) with HER2 exon 20 insertion mutations. The vote was 9-4, indicating that the risks of the drug did not outweigh its benefits. CEO Tom Riga expressed disappointment and stated plans to evaluate options ahead of the November 24, 2022, PDUFA date. Poziotinib is a targeted therapy currently in mid-stage clinical trials for solid tumors.

Spectrum Pharmaceuticals (NASDAQ: SPPI) announced promising data for poziotinib targeting G778_P780dup HER2 exon 20 insertion mutations in non-small cell lung cancer (NSCLC). Presented at the ESMO 2022 conference, the study included 90 treated patients, demonstrating an objective response rate (ORR) of 85.7%. 100% ORR was observed in previously treated patients, and the median duration of response (DOR) was 5.5 months. These findings suggest a significant treatment opportunity for patients with these rare mutations.

Spectrum Pharmaceuticals announces the FDA approval of ROLVEDON™ (eflapegrastim-xnst), its novel long-acting G-CSF product. This marks the first approval of a long-acting G-CSF in over 20 years, targeting a $2 billion market for reducing the incidence of febrile neutropenia in adult patients undergoing myelosuppressive chemotherapy. The product is set to be commercially available in Q4 2022, supported by positive clinical trial data showing non-inferiority to pegfilgrastim.

Spectrum Pharmaceuticals (NASDAQ: SPPI) announced a poster presentation for its drug Poziotinib, aimed at treating patients with HER2 exon 20 insertion mutations in non-small cell lung cancer (NSCLC). The presentation will occur at the European Society for Medical Oncology (ESMO) Congress in Paris from September 9-13, 2022. Poziotinib is an oral epidermal growth factor receptor tyrosine kinase inhibitor, essential for targeting specific cancer mutations. This rare mutation accounts for 2-4% of NSCLC cases, highlighting the significance of the company's ongoing efforts in oncology.

Spectrum Pharmaceuticals, Inc. (SPPI) reported a net loss of $29 million for Q2 2022, reducing from a loss of $49.9 million in Q2 2021. Research and development expenses decreased to $16 million from $29.1 million, while selling, general and administrative expenses fell to $9.4 million from $15 million. The company has a cash reserve of approximately $68 million, ensuring a runway into 2023. The FDA is reviewing the Biologics License Application for eflapegrastim with a decision expected by September 9, 2022, and the New Drug Application for poziotinib is also in review with an ODAC meeting set for September 22, 2022.