Spectrum Pharmaceuticals, Inc. - SPPI STOCK NEWS

Spectrum Pharmaceuticals (NASDAQ: SPPI) announced a conference call to review the fourth quarter and full year 2021 financial results on March 17, 2022, at 4:30 p.m. Eastern. The call can be accessed domestically at (877) 837-3910 and internationally at (973) 796-5077 with Conference ID# 4573715. Investors can also listen via their website. The company focuses on novel oncology therapies and has a late-stage pipeline aimed at addressing unmet medical needs. Detailed information will be available post-call on their website.

Spectrum Pharmaceuticals has appointed Juhyun Lim to its Board of Directors, enhancing its strategic partnership with Hanmi. With 20 years of experience in life sciences, Lim is currently the President of Global Strategy and Planning at Hanmi Science. Spectrum aims to advance oncology therapies, specifically Rolontis and poziotinib, leveraging Lim’s guidance to navigate its next chapter. This appointment is seen as a pivotal move towards strengthening the company's pipeline and commitment to innovative cancer treatments.

Spectrum Pharmaceuticals (NASDAQ: SPPI) presented data from Cohort 4 of the ZENITH20 clinical trial at the ESMO TAT Congress 2022. The study involved 70 treatment-naïve patients with non-small lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations receiving oral poziotinib. The trial met its primary endpoint with a confirmed objective response rate (ORR) of 41%, exceeding the 20% threshold. Secondary endpoints showed a disease control rate of 73% and a median progression-free survival of 5.6 months. Safety profiles aligned with TKI class standards.

Spectrum Pharmaceuticals announced an oral presentation on poziotinib at the ESMO Targeted Anticancer Therapies Congress 2022, scheduled for March 7-8, 2022. The presentation will discuss the efficacy and safety of poziotinib in treating HER2 exon 20 insertion mutated non-small cell lung cancer. Dr. Sophie Sun will present findings during a mini oral session on March 7, 2022, at 5:50 p.m. CET. Attendees can access the presentation online post-event on the ESMO website and Spectrum's official site.

Spectrum Pharmaceuticals (SPPI) announced that the FDA has accepted its New Drug Application (NDA) for poziotinib, targeting non-small cell lung cancer (NSCLC) with HER2 exon 20 insertion mutations. This NDA acceptance follows positive Phase 2 study results, showing a confirmed objective response rate of 27.8% among treated patients. The FDA has set a PDUFA date for November 24, 2022, and emphasized the need for a substantially enrolled confirmatory trial prior to approval. The treatment has received Fast Track designation, highlighting its significance in addressing unmet medical needs in lung cancer therapy.

Spectrum Pharmaceuticals (NASDAQ: SPPI) announced its participation in the B. Riley Securities 2022 Virtual Oncology Conference, with a fireside chat scheduled for January 27, 2022, at 9:30 a.m. ET. Investors can access a live webcast on the company's Investor Relations webpage, with a replay available post-event. Spectrum focuses on developing novel oncology therapies and has a late-stage pipeline aimed at unmet medical needs. For more information, visit www.sppirx.com.

Spectrum Pharmaceuticals (NASDAQ: SPPI) announced a strategic restructuring aiming to enhance focus on its late-stage assets, poziotinib and ROLONTIS (eflapegrastim). This restructuring includes a workforce reduction of approximately 30% and a 20-25% decrease in operating cash burn, extending the company's cash runway into 2023. By deprioritizing early-stage programs, Spectrum seeks to concentrate resources on its most promising development opportunities.

Spectrum Pharmaceuticals (NASDAQ: SPPI) announced a $20 million equity investment from Hanmi Pharmaceutical, priced at $1.60 per share. This investment is aimed at strengthening their partnership and advancing FDA approvals for ROLONTIS^® and poziotinib. Amendments to licensing agreements will convert upfront milestone payments to deferred royalties, lowering royalty obligations for ROLONTIS to mid-single digits. Additionally, an amended supply arrangement is expected to reduce Spectrum's cost of goods sold. This move signals confidence in Spectrum's strategic direction.

Spectrum Pharmaceuticals has submitted a New Drug Application (NDA) for poziotinib to the U.S. FDA targeting HER2 exon 20 insertion mutations in previously treated non-small cell lung cancer (NSCLC) patients. This submission follows positive results from Cohort 2 of the ZENITH20 clinical trial, which showed a confirmed objective response rate (ORR) of 27.8%. With the Fast Track designation, this marks a pivotal step towards addressing an unmet medical need, as no approved treatments exist for this indication.