Updated from 12:17 p.m. EST
rose sharply Friday after federal regulators told the company it didn't need to conduct additional tests on a proposed artificial blood product.
Shares of the Cambridge, Mass.-based drug company closed up 22.3%, or $1.33, at $7.30 -- after rising as high as $9.03 -- after the company said it received a letter from the Food and Drug Administration seeking some additional information on Hemopure.
"The letter focuses primarily on clarification of clinical and preclinical data and includes some comments on labeling," Biopure said in a prepared statement. "It does not request additional clinical trials."
Biopure is seeking FDA approval of Hemopure for the treatment of acutely anemic adults undergoing orthopedic surgery and for the elimination of red blood cell transfusions in these patients. Anemia is caused by the absence of enough healthy red blood cells to carry the oxygen.
"We're encouraged that the FDA has finished its review and provided comprehensive feedback in advance of the formal action due date," said Thomas A. Moore, Biopure's president and chief executive.
Biopure noted that 30 days had remained on the current review cycle for its application seeking FDA marketing approval, adding that the FDA had stopped the clock on the deadline until Biopure responds to the agency's request.
That's a good sign, Moore said. "The FDA is encouraging us to work with them to complete the approval process as quickly as possible."
Douglas Sayles, director of corporate communications, said Biopure's management was meeting Friday to analyze the FDA's letter, adding that 30 to 60 days "would be a reasonable estimate" for Biopure's response.
Once Biopure answers the questions, the FDA's review clock starts running again. The company submitted its application to the FDA 12 months ago.
Hemopure is an oxygen therapeutic, an intravenous drug that helps deliver oxygen to the body's tissues. It's made with stabilized bovine hemoglobin in a salt solution. Hemoglobin is a protein carried by red blood cells that picks up oxygen in the lungs and transports the oxygen to the body's tissues.
Hemopure has been approved for human use in South Africa. A similar Biopure drug, Oxyglobin, is approved in the U.S. and the European Union for treating anemia in dogs.
The FDA's letter comes just a week after Biopure raised $17.2 million -- excluding transaction fees -- by issuing 3.08 million shares at $5.58 a share. The net proceeds of approximately $16.2 million will be used for general corporate purposes and working capital needs, the company said.
The extra money will help. Biopure noted in a second-quarter financial statement filed with the Securities and Exchange Commission on June 16 that it had $15.1 million in cash and cash equivalents as of April 30 and that it had raised another $10.2 million in May and June. Those funds, the company said, would be sufficient to keep Biopure operating until November under Biopure's current operating plan.
For the three months ended April 30, Biopure lost $11.65 million, or 35 cents a share, compared with a loss of $12.73 million, or 49 cents, for the same period last year. Revenue for the second quarter rose to $2 million from $928,000. Results for the quarter ended July 31 have not been announced.
Earlier this week, a Biopure competitor,
raised $10.6 million in a registered director offering of common stock, with the option of raising another $3.2 million withing 60 days of the initial share purchase.
Northfield, which has no products and no revenue, continues to test its artificial blood product PolyHeme, which is a chemically modified human hemoglobin.
The money will be used to help Evanston, Ill.-based Northfield conduct a crucial Phase III trial -- the final clinical test on the path to FDA approval -- of PolyHeme. The company announced in June that it had reached agreement with the FDA on measurement guidelines for the test which will be held at approximately 20 trauma centers across the United States and enroll 720 patients.
Northfield's stock ended down 2.5%, or 20 cents, at $7.80.