Spectrum Pharmaceuticals Inc. (SPPI) shares surged 24.28% in after-hours on Friday, September 17, 2021, and closed the weekly trading at $3.02. In the regular trading session of Friday, SPPI’s stock gained 4.29%. SPPI shares have fallen 46.94% over the last 12 months, and they have moved up 9.95% in the past week. Over the past three months, the stock has lost 43.09%, while over the past six months, it has declined 30.97%.
Let’s see what’s going on recently with the company?
SPPI ZENITH20 Data Presentation
On September 16, 2021, Spectrum Pharmaceuticals, Inc. (SPPI) presented safety and efficacy results from Cohort 4 of the ZENITH20 clinical trial, at the European Society for Medical Oncology (ESMO) Congress 2021 taking place in Paris on September 16-20, 2021.
This data is from 48 first-line patients with non-small cell lung cancer (NSCLC) with HER2 exon 20 insertion mutations who received 16mg of oral poziotinib once daily. These results showed a confirmed objective response rate (ORR) of 44%, as evaluated centrally by an independent image review committee using RECIST 1.1 criteria.
SPPI recent financial results announcement
On August 12, 2021– Spectrum Pharmaceuticals, Inc. (SPPI) announced its financial results for the three months ended June 30, 2021.
Q2 2021 financial highlights
- SPPI generated no revenue in Q2 2021 and 2020.
- In Q2 2021, selling, general and administrative expenses were $15.0 million compared to $14.7 million in Q2 2020.
- Research and development expenses were $29.1 million in Q2 2021 compared to $21.7 million in the same period in 2020.
- It suffered a GAAP net loss of $49.9 million, or $0.32 loss per basic and diluted share in Q2 2021 compared to a net loss of $32.2 million, or $0.29 loss per basic and diluted share, in the comparable period in 2020.
CRL from FDA for ROLONTIS
On August 6, 2021, Spectrum Pharmaceuticals (SPPI) received receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company’s Biologics License Application (BLA) for ROLONTIS® (eflapegrastim).
The CRL pointed out the deficiencies and FDA said that a reinspection will be necessary.
SPPI Poziotinib Data presentation at ASCO
On June 4, 2021– Spectrum Pharmaceuticals (SPPI) presented an e-poster on poziotinib CNS activity in patients with NSCLC with EGFR or HER2 exon 20 mutations, at ASCO Annual Meeting. These data from Cohorts 1, 2, and 3 of the ongoing ZENITH20 clinical trial assessed the results from 36 patients with brain metastases at baseline with three patients (8%) achieving intracranial complete responses.
Conclusion
The recent ZENITH20 data presentation could be the reason behind its good performance on Friday and we hope that it will continue its momentum on Monday as well.
