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Biotech Stocks Facing FDA Decision In September

Spectrum Pharmaceuticals
Spectrum Pharmaceuticals

Spectrum Pharmaceuticals Inc. (SPPI) has two regulatory events to watch, related to its drug candidates, Eflapegrastim and Poziotinib, in the month of September.

Eflapegrastim is proposed for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs.

Last August, the FDA had declined to approve Eflapegrastim – citing deficiencies related to manufacturing and indicated that a reinspection would be necessary.

Following remediation of manufacturing deficiencies, the company resubmitted the Biologics License Application for Eflapegrastim in March of this year and now awaits the FDA decision, which is expected on September 9.

If approved, Eflapegrastim would have to compete with Amgen's Neupogen and Neulasta and their biosimilars.

As for Poziotinib, it is scheduled to be scrutinized by an FDA panel on September 22.

Poziotinib is proposed for the treatment of patients with previously treated, locally advanced, or metastatic non-small cell lung cancer harboring HER2 exon 20 insertion mutations.

The final FDA decision on Poziotinib is expected on November 24, 2022.

If approved, Poziotinib could achieve peak sales of over $300 million, according to analysts.

SPPI closed Friday’s trading at $1.24, down 6.06%.