Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI)

Spectrum, the therapy has less to do with treating cancer than treating the side effects of cancer drugs.

As you know, many common chemotherapies have severe side effects. In suppressing the existence and growth of cancer cells, some types of chemotherapies also suppress normal cells in our body. This is particularly true of cell lines that are naturally rapidly dividing and growing.

It’s one reason why some chemo patients lose their hair.

Hair loss can be distressing and unsightly, but some other side effects are hidden, and far worse. One of these is neutropenia, caused by the ongoing destruction of neutrophils, an abundant type of white blood cell important for our immune system to function.

The decrease in these white blood cells makes a patient far more vulnerable to infection, since these little soldier cells aren’t around in enough numbers to do perform their defensive duties. Moreover, and ironically, these cells are needed to fight off cancer! Reducing their numbers makes it more likely that a cancer will come back stronger than ever once it has adapted to a chemotherapy drug.

Spectrum’s experimental therapy eflapegrastim is designed to combat neutropenia by increasing the production of neutrophils. The drug contains an analogue of a messaging molecule called granulocyte-colony stimulating factor (G-CSF). G-CSF, when present, stimulates the production of neutrophil precursors. This process is tightly regulated under normal circumstances, so that the number of circulating neutrophils is appropriate for immune system defense.

But this G-CSF analogue is also bound to a targeting molecule derived from antibodies. This targeting molecule helps prolong the half-life of the therapy in the body while also binding to bone marrow cells responsible for neutrophil production. There, they help stimulate production of fresh neutrophils.

Spectrum has successfully completed Phase 3 trials for eflapegrastim showing its ability to support healthier levels of neutrophils, and even submitted for FDA approval.

However, the original date for the FDA to make a decision has passed. The regulator wasn’t able to make its Oct. 24 due date thanks to COVID-19 preventing travel to inspect manufacturing facilities in South Korea, where this therapeutic is manufactured.

While no exact date is available, eventually the FDA will be able to perform site inspection in South Korea. Once this happens, the regulator will then be able to decide on this therapy. Could potentially be just weeks away from this important catalyst, which if navigated successfully could provide a huge boost to SPPI shares.

Moreover, the company is expecting data for a different therapy next month. The drug in question is designed to suppress cancer by binding to endothelial growth factor receptors (EGFRs) in patients with nonsmall-cell lung cancers (NSCLC) with a specific mutation in EGFR or HER2 genes.

Spectrum expects it will have top-line data from the third cohort of a Phase 2 trial by the end of the year. The company plans to update once data are available, and a successful outcome could be used to launch into a Phase 3 trial or even possibly furnish the necessary support for a New Drug Application. Strong data could provide an even bigger boost to SPPI’s valuation than the FDA approval for eflapegrastim.

Totally a speculative bet.

the company is definitely improving though and their pipeline is pretty promising. new drugs possibly coming out in the next few years and their way of aquisitioning other companies is pretty awesome.