Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of Halozyme Therapeutics (HALO 2.40%) climbed as high as 10% on Monday after the company announced that the primary endpoint of noninferiority of A1C levels at six months was met for the CONSISTENT 1 trial.
So what: The trial is evaluating Halozyme's Hylenex recombinant when used as a pre-treatment for Type 1 diabetes patients receiving insulin injections, so today's positive results naturally reinforce management's optimism over the product's full sales potential. In fact, the rate of overall hypoglycemic events in the combined treatment groups was reduced by 12% versus the control group, suggesting that Halozyme is in a strong position to help with "one of the key unmet medical needs in the treatment of type 1 diabetes," lead investigator for the trial Dr. Bruce Code stated in a press release.
Now what: Management said it would continue to work closely with the FDA regarding an update to Hylenex. "The data from CONSISTENT 1 will be part of the data package that we will use to seek an update to the Hylenex label with the FDA to include key efficacy and safety data prior to our commencement of promotion for this use," said Halozyme President and CEO Dr. Helen Torley. "We have initiated a dialogue with the FDA to understand the overall data package that will be required and the path to a label update." So while Halozyme might still be too speculative for conservative investors, today's upbeat news, combined with the stock's sluggish price action of late (off about 40% from its 52-week highs), make it an intriguing opportunity for biotech-savvy Fools.
