( NRMX) were among the worst-performing health-related stocks Monday, falling 33% after the company's Fibrillex treatment failed to meet its primary endpoint in a phase II/III clinical study.
The purpose of the study was to determine Fibrillex's ability to treat Amyloid A Amyloidosis, a disease that typically progresses to end-stage renal failure and death, and to assess safety compared to a placebo.
The primary endpoint called for a 20% absolute difference in the number of patients stabilized/improved between the Fibrillex group and the placebo group. However, preliminary data showed that there was only a 13.4% improvement or stabilization in patients using Fibrillex compared to a placebo.
Despite the disappointing preliminary results, the company said it still intends to pursue regulatory approval of Fibrillex. Shares were trading down $3.66 to $7.41.
fell 20% after the company lowered its third-quarter earnings and sales outlook. The company now expects to earn 15 cents to 17 cents a share on sales of $136 million. Previously, the company expected earnings of 25 cents to 27 cents a share on sales of $145 million to $150 million. Analysts polled by Thomson First Call had been expecting earnings of 26 cents a share on sales of $145.5 million.
Project delays and the timing of contract signatures at a key pharmaceutical client within the company's consulting and marketing services segment contributed to the sales shortfall. Shares were trading down $4.50 to $18.45.
Protein Design Labs
rose 4% after the company reported encouraging results from a phase II clinical study of the natriuretic peptide ularitide in patients with decompensated congestive heart failure. As a result of the interim data, the company said that it intends to further study ularitide as a treatment for patients suffering from decompensated congestive heart failure. Shares were trading up 71 cents to $17.50.
( CVTX) rose 3% after the company said that its Ranexa treatment met its primary endpoint of reducing weekly angina frequency compared to a placebo. The study was conducted in response to an approvable letter the company received from the Food and Drug Administration in October 2003. The company said that it plans to submit data from the trial to the FDA by the end of the third quarter of 2005. A positive FDA outcome would allow the company to launch the product to a restricted patient population by the first half of 2006. Chronic angina, a serious and debilitating heart condition, affects some 6.4 million people in the U.S. Shares were trading up 66 cents to $21.39.
rose 11% after the company said that an animal model of its Tarvacin cancer treatment in combination with chemotherapy or radiation therapy reduced lung-tumor growth by more than 95%. The treatment by itself reduced tumor growth by 62%. In pancreatic preclinical tumor therapy experiments, 3G4 -- along with chemotherapy -- reduced primary tumor growth by 60% and essentially halted metastasis to liver and lymph nodes. Peregrine said it plans to begin patient enrollment in the Tarvacin phase I trial within the next 30 days. Shares were trading up 13 cents to $1.31.
Other health care volume movers included
, down 4 cents to $27.67;
, up 87 cents to $58.94;
, down 52 cents to $34.28;
Johnson & Johnson
, down 73 cents to $68.67;
, down $1 to $58.95;
, down 4 cents to $3.98;
( SGP), down 48 cents to $20.17; and
, down 36 cents to $25.59.