Halozyme Study Clinical Hold Lifted by FDA - Analyst Blog

By
A A A

Halozyme Therapeutics, Inc. ( HALO ) announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold from a phase II study (Study 202) evaluating PEGPH20 as a first-line therapy in patients suffering from stage IV metastatic pancreatic cancer.

We remind inventors that in Apr 2014, the FDA had placed a clinical hold on Study 202 following Halozyme's temporary halt on patient enrollment and dosing of PEGPH20. Halozyme's action was based on a recommendation by an independent Data Monitoring Committee (DMC), which indicated a possible difference in the rate of thromboembolism (movement of blood clot from the original source to another blood vessel blocking blood flow in the process) between the patient groups treated with the Abraxane/Gemzar combination, with or without PEGPH20.

Halozyme will resume patient enrollment and dosing of PEGPH20 once the Independent Review Boards at different study sites review and approve the amended protocol for the study. Under the amended protocol, Halozyme will exclude those patients who could be at higher risk of thromboembolic events.

Moreover, low-molecular weight heparin will be administered to patients as a prophylaxis to prevent thromboembolic events. A second primary endpoint has been added under which the rate of thromboembolic events in the patient group treated with PEGPH20 following the amended protocol will be assessed.

Halozyme intends to enroll more than 100 patients in the study in addition to the patients already enrolled.

Our Take

The lifting of the clinical hold on Study 202 by the FDA is a major positive for Halozyme and we expect investors to react positively to this news. We expect investor focus to remain on further updates on the status of this program.

Halozyme carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Gilead Sciences Inc. ( GILD ), and ANI Pharmaceuticals, Inc. ( ANIP ) and Alexion Pharmaceuticals, Inc. ( ALXN ). While Gilead and ANI Pharmaceuticals carry a Zacks Rank #1 (Strong Buy), Alexion holds a Zacks Rank #2 (Buy).


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

HALOZYME THERA (HALO): Free Stock Analysis Report

ANI PHARMACEUT (ANIP): Free Stock Analysis Report

ALEXION PHARMA (ALXN): Free Stock Analysis Report

GILEAD SCIENCES (GILD): Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research



The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: HALO , ANIP , ALXN , GILD

Zacks.com

Zacks.com

More from Zacks.com:

Related Videos

How to Save Money at Bars
How to Save Money at Bars           

Stocks

Referenced

Most Active by Volume

44,823,339
  • $75.19 ▲ 0.28%
43,744,171
  • $3.44 ▼ 0.29%
42,340,022
  • $97.671 ▲ 0.66%
34,178,145
  • $17.62 ▼ 1.23%
34,028,998
  • $15.59 ▼ 0.19%
32,055,708
  • $21.23 ▼ 2.41%
31,539,235
  • $3.76 ▲ 0.80%
30,434,619
    $34.25 unch
As of 7/25/2014, 04:03 PM