MLV: We're Reiterating A Buy On Halozyme

In a report published Wednesday, MLV & Co analysts maintained a Buy rating for Halozyme Therapeutics, Inc HALO, with a price target of $20.

Following a meeting with the FDA in 1Q15, the company has now announced its plans to commence a global registration based Phase 3 pancreatic cancer study in 1Q16. The pivotal trial is to be conducted in patients with pancreatic tumors that have high levels of hyaluronan (HA), and regulatory approval could be based on either overall survival (OS) or progression free survival (PFS).

In the report MLV & Co noted, "We continue to expect overall survival (OS) data from the ongoing Phase 2 Study 202 assessing the addition of PEGPH20 to gemcitabine + Abraxane at ASCO…HALO also plans to file an investigational device exemption (IDE) for the accompanying diagnostic, which we expect to be validated in the Phase 3 trial."

Survival data from Study 202 could be announced this year. Halozyme Therapeutics had indicated that interim overall survival (OS) data was discussed with the FDA. "As of March 3, the OS data was still maturing, putting the median follow-up of Study 202 patients at ~8.5 months currently. Since OS was 8.5 months in the pivotal Abraxane + gemcitabine trial, we expect Study 202 OS data could be presented at the American Society for Clinical Oncology meeting in May/June," the analysts wrote.

By the end of this year, the company is expected to be able to complete enrollment for the 114-patient Stage 2 portion of Study 202, Phase 1b dose and tolerability results from the PRIMAL study of PEGPH20 + docetaxel in HA high second-line NSCLC, followed by the commencement of the Phase 2 portion of the trial, and initiation of a PD-1 inhibitor + PEGPH20 combination study in second-line NSCLC.

"Additionally, we anticipate initiation of PEGPH20 combination trials with small molecules, monoclonal antibodies, and immunotherapy agents in multiple tumor types," the report mentioned.

The analysts mentioned the upcoming catalysts as:
For PEGPH20

• Preliminary Phase 1b/2 PRIMAL dose and tolerability data of PEGPH20 + docetaxel in HA high, second line NSCLC in 3Q15
• Preliminary results from the NSCLC immunotherapy trial in 1Q16
• Commencement of the pivotal trial in high HA pancreatic cancer patients in 1Q16

For UltraFast Insulin

• Clarity on a regulatory pathway to pave the way for a potential partnership in 2015