San Diego’s Halozyme Therapeutics (NASDAQ: [[ticker:HALO]]) told analysts and investors today it cannot provide a new timeline for its derailed HyQ program until company officials can meet with FDA regulators. But when the company will meet with regulators was not addressed during a conference call this afternoon.
The price of Halozyme’s stock plunged by 50 percent last week, closing Thursday at $4.30 a share, after the company said the FDA had asked for more pre-clinical data about HyQ, which combines Baxter’s immunoglobulin with Halozyme’s recombinant human hyaluronidase, or rHuPH20. The stock has regained some lost ground since then, and closed at $4.82 today, after gaining 21 cents, or less than 5 percent in regular trading.
Halozyme has been working with Baxter on HyQ for treating immune deficiency, but the company developed rHuPH20 to be used with a wide variety of drugs. It is an enzyme designed to accelerate the distribution and cellular absorption of large-molecule, biologic drugs.
During this afternoon’s call, Halozyme CEO Greg Frost reiterated that the company does not expect the FDA’s concerns to extend to the company’s work with Roche, in which Halozyme’s proprietary enzyme is combined with the cancer drugs trastuzumab (Herceptin) and rituximab (Rituxan).
As a result, Halozyme CFO Kurt Gustafson told analysts said the company should still be able to meet its profitability goal of achieving profitability by 2014. “The major drivers for us to achieve
Author: Bruce V. Bigelow
In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here.
Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University.
Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.
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