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Spectrum Pharmaceuticals (NasdaqGS: SPPI) announced FDA agreement for NDA submission based on Cohort 2 data from the ZENITH20 trial for poziotinib, evaluating NSCLC patients with HER2 exon 20 mutations. Cohort 3 did not meet its primary endpoint, but preliminary data from Cohort 5 suggests improved tolerability with an 8 mg twice-daily dose. Cohort 2 showed a confirmed objective response rate of 27.8% and promising duration of response metrics. The company is preparing for NDA submission in 2021.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) has announced the appointment of Nora Brennan to its Board of Directors, filling a vacancy left by Elizabeth Czerepak, who retired on December 10, 2020. Ms. Brennan brings over 20 years of experience in the pharmaceutical and medical technology sectors, previously serving as CFO at TELA Bio and Xeris Pharmaceuticals. The Chairman of the Board, William Ashton, expressed enthusiasm regarding her contribution to the company's growth, particularly as Spectrum focuses on developing novel oncology treatments.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) announced the presentation of three posters at the San Antonio Breast Cancer Conference (SABCS) from December 8-11, 2020. The posters include key data on ROLONTIS® (eflapegrastim) and Poziotinib related to metastatic breast cancer treatment. Chief Medical Officer, Francois Lebel, emphasized the importance of sharing these findings with the scientific community. Additionally, ROLONTIS is currently under FDA review for treating chemotherapy-induced neutropenia, indicating potential future growth for Spectrum’s oncology portfolio.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) will present its business strategy and development-stage programs at two upcoming virtual investor conferences. The presentations are scheduled for the Stifel Virtual Healthcare Conference on November 16, 2020, at 2:40 p.m. ET and the Jefferies London Healthcare Conference on November 18, 2020, at 2:20 p.m. ET. A live webcast will be available on the company's investor relations website, with replays accessible post-event. Spectrum focuses on novel oncology therapies and has a robust late-stage pipeline aimed at addressing unmet medical needs.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) reported a net loss of $48.5 million or $0.37 per share for the quarter ending September 30, 2020, compared to a loss of $26.6 million or $0.24 per share in 2019. Research and development expenses rose to $24.5 million, up from $17.2 million. The company is preparing for a pre-NDA meeting with the FDA for poziotinib and is working to expedite FDA inspection for ROLONTIS after a deferral due to COVID-19. Spectrum ended the quarter with $198.3 million in cash and equivalents.
Spectrum Pharmaceuticals (NasdaqGS: SPPI) announced a conference call on November 4, 2020, at 4:30 p.m. Eastern to discuss its Q3 2020 financial results and provide a corporate update. The call can be accessed domestically at (877) 837-3910 and internationally at (973) 796-5077, using Conference ID# 1281757. Spectrum focuses on developing novel oncology therapies and has a late-stage pipeline targeting unmet medical needs. Interested parties can find more details on the company’s Investor Relations page.
Spectrum Pharmaceuticals (SPPI) announced a delay in the FDA's review of its Biologics License Application (BLA) for ROLONTIS due to the need for an inspection at the Hanmi Bioplant in South Korea. The inspection could not occur during the current review cycle because of COVID-19 travel restrictions. Spectrum is actively partnering with the FDA to schedule the inspection. Notably, this announcement is not a Complete Response Letter. ROLONTIS is a long-acting granulocyte colony-stimulating factor aimed at treating neutropenia in cancer patients.