Health stocks looked vibrant Wednesday after a plethora of regulatory and clinical updates. First, a Food and Drug Administration advisory panel on Tuesday
voted against the setting targets that would have further restricted the use of Amgen's ( AMGN) anemia drug Epogen and Johnson & Johnson's ( JNJ) Procrit in dialysis and predialysis patients, instead opting for a range to guide the use of the drugs in those patients. Amgen shares were up $2.02, or 3.8%, to $55.94 Wednesday. A smaller-cap company, Vision-Sciences ( VSCI), took off Wednesday after announcing that it received 510(k) clearance from the FDA to market a new line of digital, video-based flexible endoscopes, which come with an integrated "built-in" light source so that a separate camera head, light cable and optical coupler aren't needed. The ENT (ear, nose and throat) and TNE (transnasal esophagoscopy) scopes are the first two in a series to be introduced by Vision-Sciences. Shares rose 48 cents, or 26%, to $2.26. And for the second time in two weeks, investors fueled Cardica ( CRDC) shares. The company said Wednesday that it received European CE Mark approval for its C-Port Flex A Anastomosis System, which attaches blood vessels and grafts in less-invasive coronary artery bypass graft (CABG) procedures. Cardica added $1.28, or 14.9%, to $9.93. In the clinical update arena, biopharmaceutical company Novavax ( NVAX) said that several candidates have emerged from an ongoing discovery program to create a novel vaccine to prevent disease associated with the varicella zoster virus (VZV) in older adults, and that the candidates are now targeted for preclinical development. Shares climbed 31 cents, or 9.2%, to $3.72.
Also, Cell Therapeutics ( CTIC) (CTI) gained 26 cents, or 7%, to $3.97, after announcing that it launched a phase III trial on pixantrone for patients with indolent non-Hodgkin's lymphoma (NHL) who have relapsed following first-line therapy. CTI has a special protocol assessment (SPA) in place with the FDA for the trial, and Pixantrone has received fast-track designation from the FDA for the indication. CTI and Novavax are both components of the Nasdaq biotechnology index, which increased 6.18, or 0.73, to 845.54. In another clinical update, Alfacell ( ACEL), a biopharmaceutical company focused on therapeutic drugs for the treatment of cancer and other pathological conditions, said that enough patient deaths that are considered evaluable events haven't occurred in its phase IIIb study on its lead compound Onconase to conduct the formal statistical analysis required to complete the new-drug application (NDA). The study requires 316 evaluable events, and while there have been 316 total, the company has learned that only 290 are evaluable. Enrollment for the trial is scheduled to close on Sept. 30 -- with 425 patients enrolled to date -- and the company anticipates that the required number of evaluable events will take place before the end of the year. The company said it expects that it has sufficient cash resources available to complete the Onconase phase III program and the rolling NDA submission. Shares slid 15 cents, or 6.6%, to $2.14 on news. Elsewhere Wednesday, Clinical Data ( CLDA) announced a 3-for-2 split of the company's common stock in the form of a stock dividend of one share for every two shares outstanding. The record date for the stock split is Sept. 24, distribution of the stock dividend will be made on Oct. 1, and trading of Clinical Data shares on a split-adjusted basis will begin on Oct. 2. After the split, the number of outstanding shares will increase to about 20.5 million shares. Clinical Data was trading up 97 cents, or 3.4%, to $29.39.