Updated from 2:44 p.m. EDT
were among the worst-performing health and pharmaceutical stocks Wednesday, falling 38.4% after the company suggested in a regulatory filing that its myopia product won't be getting U.S. marketing approval in the next month.
The company said the Food and Drug Administration filed a report taking issue with certain procedures at a Monrovia, Calif., facility. The company said the agency may take further actions, "which could include conducting another inspection, seizure of the company's products, injunction of the Monrovia facility to compel compliance (which may include suspension of production operations and/or recall of products), or other actions."
Until the FDA is satisfied with the company's response, it is unlikely that Staar's ICL product -- which is used for correcting myopia -- will be approved in the U.S. for marketing, the company said. Shares traded down $1.93 to $3.10.
rose 35.3% after the company's BLP25 liposome vaccine was granted fast-track status by the FDA. BLP25 is designed to induce an immune response to cancer cells in patients who are receiving treatment of non-small-cell lung cancer. The liposome highlights the cancer antigen by the immune system, which facilitates better delivery. The FDA grants fast-track status when new drugs offer treatment for serious or life-threatening conditions that aren't currently being met in the marketplace. Shares traded up 41 cents to $1.57.
rose 3.5% after the company announced an expanded licensing agreement with
. Under the deal, Novo will buy manufacturing equipment and leasehold improvements utilized by Aradigm in the AERx iDMS program for about $55 million. Aradigm will also receive adjusted royalty payments that are tied to sales. Shares of Aradigm traded up 4 cents to $1.20.
( PDX) fell 16.3% after it cut its third- and fourth-quarter earnings outlook. The company now expects third-quarter earnings of $1.04 to $1.06 a share, down from its previous guidance of $1.11 to $1.13 a share. For the fourth quarter, Pediatrix now expects earnings of $1.02 to $1.04 a share, below its previous guidance of $1.11 to $1.13 a share. Analysts polled by Thomson First Call were expecting third-quarter earnings of $1.12 a share and fourth-quarter earnings of $1.13 a share. For the year, the company expects earnings of $3.90 to $3.94 a share. Analysts were expecting earnings of $4.09 a share. Shares traded down $11.27 to $58.01.
( BLUD) rose 8% after the company posted first-quarter earnings that beat expectations and said that full-year earnings would be above expectations. The company earned 16 cents a share on sales of $32.1 million. Analysts were expecting earnings of 15 cents a share on sales of $31.6 million. Looking ahead, Immucor forecast full-year earnings of 73 cents to 75 cents a share on sales of $133 million to $135 million. Analysts are expecting earnings of 67 cents a share on sales of $137.3 million. Shares traded up $1.78 to $24.15.
Other health care volume movers included
, up 10 cents to $30.18;
( SGP), down 15 cents to $18.50;
( GDT), up $3.02 to $66.67;
, up 64 cents to $57.99;
Johnson & Johnson
, down 7 cents to $57.03; and
( DNA), up 12 cents to $52.14.