- Spectrum is a $550m market cap biotech developing 2 drugs that are close to securing FDA approval but are subject to frustrating delays.
- A PDUFA date for Severe Neutropenia treatment Rolontis has been delayed until the FDA can complete a visit to Spectrum's partner Hanmi's South Korean manufacturing plant.
- A 7 Cohort trial of NSCLC treatment Poziotinib addressing EGFR and HER2 mutations has seen one endpoint missed, and another achieved.
- Spectrum shares traded >$10 prior to the Poziotinib trial miss but are now priced at $3.8.
- Approval of either lead candidate would likely trigger upside momentum, and there may be just enough evidence to support a bull case.
For further details see:
Spectrum Shareholders In Limbo As FDA Delays Rolontis Decision Date, Agrees To Discuss Poziotinib