CYDY - Immunomedics Competitor Threatens To Leapfrog Approval With Breakthrough Therapy Designation
Immunomedics (IMMU) is in the final phase of its approval pathway with its antibody-drug conjugate ((ADC)) called sacituzumab govitecan, or IMMU-132. The company filed its amended BLA (Biologics License Application) on December 3rd 2019. It was accepted and its PDUFA target action date is June 2, 2020. On the surface, it looks like it is back on track for approval, but platform technology competitor CytoDyn (CYDY) has snatched the spotlight with its recent BTD filing. IMMU also has a BTD in metastatic triple-negative breast cancer (mTNBC), but there are only 22,000 patients worldwide