Halozyme Therapeutics Inc (HALO)

[maumar]

BLA for SC DARZALEX was submitted on July 12. I am surprised it has not been accepted yet, or at least there's been no press release about it that I can find.

Good results from the PLEIADES study:

"In addition to GRIFFIN, data from the Phase 2 PLEIADES (MMY2040) study, presented during an oral session at the IMW meeting, showed that an investigational DARZALEX® subcutaneous (SC) formulation delivered in combination with standard-of-care treatment regimens showed similar clinical activity and safety to DARZALEX® intravenous (IV) regimens.2 The study is the first to evaluate SC DARZALEX® in different combination regimens for patients with newly diagnosed multiple myeloma as well as those who were relapsed/refractory to current treatment options.2

"We're excited about the opportunity to progress the innovation represented by the DARZALEX® subcutaneous formulation, which can be administered over the course of minutes and has the potential to offer a reduction in infusion-related events as compared to the approved intravenous formulation," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. "Data from the PLEIADES study demonstrates that the DARZALEX® subcutaneous formulation can also be safely administered in combination with standard backbone regimens used for treatment naïve and relapsed/refractory patients with multiple myeloma. It has been included in our recent submission of a Biologics License Application to the U.S. Food and Drug Administration seeking approval of a new DARZALEX® subcutaneous formulation for patients with multiple myeloma."

https://www.biospace.com/article/releases/new-darzalex-daratumumab-data-from-griffin-study-show-high-response-rate-and-depth-of-response-in-patients-with-newly-diagnosed-multiple-myeloma-who-are-transplant-eligible/