Halozyme (HALO) is expecting to hear from the Committee for Medicinal Products for Human Use (CHMP) for MabThera Subcutaneous (MabTheraSC.)

MabTheraSC is a subcutaneous applied (injected) chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. MabTheraSC is designed to destroy B cells and is therefore used to treat diseases which are characterized by excessive numbers of B cells, overactive B cells, or dysfunctional B cells. This includes many lymphomas, leukemias, transplant rejection, and autoimmune disorders. Halozyme uses its proprietary ENHANZE Technology as the platform for the delivery of proprietary small and large molecules.

The committee meets October 21st through the 24th, and many investors are expecting the news to be released before the end of this month. The CHMP is like a European version of an FDA Advisory Committee Meeting (ADCOMM), in the sense that a recommendation or opinion is given for approval or rejection.

We expect this announcement to mirror what happened with Halo's approved product, Herceptin. In June, the CHMP announced a positive opinion for Herceptin and the stock rallied nearly $2 in one day. A similar situation is setting up for Halo with MabTheraSC and we feel it has yet to be valued into the stock.

Additionally, on September 30th, the company announced mature patient progression free survival (PFS) and ongoing overall survival (OS) data from its Phase 1b trial of PEGPH20 (PEGylated Recombinant Human Hyaluronidase) in combination with gemcitabine for the treatment of patients with stage IV metastatic pancreatic cancer. The data from both PFS and OS indicates a potential breakthrough clinical benefit of using PEGPH20 with gemcitabine in patients with high levels of tumor associated hyaluronan (HA).

Also of note, company director Kathryn E. Falberg bought $681.6K of the company's stock, at an average cost of $6.82 a share. At StockMatusow, we strongly believe when a high level company insider buys these many shares in the open market, it represents a very bullish sentiment for the company's long-term prospects. Falberg is also a director at Jazz Pharma (JAZZ), when in 2010, she bought 50,000 shares of Jazz in the open market for $8.72. Currently, Jazz trades for $84.76 a share.

Investors might be interested in an in-depth video we found on Halozyme's pancreatic treatment potential. After watching it, we were very impressed with the product's potential.