Anthera Pharmaceuticals Inc. (ANTH) on Wednesday said it has initiated a phase III study of Blisibimod for lupus. The phase III study, dubbed CHABLIS-SC1, will enroll about 400 patients from Latin America, Asia Pacific and Commonwealth of Independent States who will be randomized to receive Blisibimod or placebo for 52 weeks after which they will have the option to receive Blisibimod therapy in an open-label, long-term, follow-up safety study.
ANTH closed Wednesday's trading at $0.64, down 1.54%. In the after-hours, the stock was up 9.38% to $0.70.
Shares of Aastrom Biosciences Inc. (ASTM) dropped more than 38% to $0.71 on Wednesday after the company announced a corporate restructuring and revealed a strategic change in its R&D programs.
As a result of the strategic change, the company will stop enrollment and end a phase III study of ixmyelocel-T in the treatment of patients with critical limb ischemia, dubbed REVIVE. The company will now focus solely on a phase 2b study of ixmyelocel-T in the treatment of dilated cardiomyopathy.
As part of the restructuring, Aastrom will be reducing its staff and operating expenses by approximately 50 percent.
Shares of Biogen Idec (BIIB) touched a new 52-week high of $184.17 on Wednesday, following the approval of its oral drug TECFIDERA as a first-line oral treatment for people with relapsing forms of multiple sclerosis in the U.S.
The drug has also been recommended for marketing by the Committee for Medicinal Products for Human Use in the European Union, and it now awaits the final decision of the European Medicines Agency.
TECFIDERA represents the fourth therapy for multiple sclerosis from the stables of Biogen Idec.
Catalyst Pharmaceutical Partners Inc. (CPRX) said it has been advised by the independent Data Monitoring Committee to continue the ongoing pivotal phase III clinical evaluating Firdapse for the treatment of Lambert-Easton Myasthenic Syndrome. The company expects to complete enrollment in the trial by the end of the fourth quarter of 2013 and to announce top line data from the trial during the second quarter of 2014.
CPRX closed Wednesday's trading at $0.50, down 4.77%.
Navidea Biopharmaceuticals Inc. (NAVB) has commenced enrollment in its phase IIb positron emission tomography imaging study of NAV4694 for detection of cerebral ß-amyloid plaque in subjects diagnosed with Mild Cognitive Impairment. The company said that the first patient has been enrolled by the Alzheimer's Disease Center at Quincy Medical Center in Quincy, MA.
POZEN Inc. (POZN) has submitted a New Drug Application for PA32540/PA8140 to the FDA, seeking approval in the indication of secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers. The company said it looks forward to completing a commercial deal for PA32540/PA8140 with a partner in the upcoming months.
POZN closed Wednesday's trading 3.05% higher at $5.40.
RedHill Biopharma Ltd. (RDHL), an emerging Israeli biopharmaceutical company, has submitted a New Drug Application to FDA for RHB-103 for the treatment of acute migraine.
RHB-103, co-developed with IntelGenx Corp. (IGXT.OB) is an oral thin film formulation of Rizatriptan, which is based on IntelGenx' proprietary VersaFilm technology. Rizatriptan is a 5-HT1 agonist triptan drug developed by Merck & Co. for the treatment of migraine headaches, sold under trade name Maxalt.
The RHB-103 NDA represents RedHill Biopharma's first NDA. A second NDA is expected to be submitted by the company in Q4 2013, seeking approval for RHB-102 for the prevention of nausea and vomiting in cancer patients.
RDHL closed Wednesday's trading at $11.95, up 41.29%.
Repros Therapeutics Inc.'s (RPRX) first pivotal study of its lead investigational drug Androxal for the treatment of secondary hypogonadism, dubbed ZA-301, has met both co-primary endpoints namely primary testosterone endpoint and sperm count endpoint.
The phase III program of Androxal includes two pivotal phase III studies - ZA-301 and ZA-302. Study ZA-302 is currently enrolling participants.
A conference call is scheduled for 8 am Central Time on Thursday March 28, 2013.
Soligenix Inc. (SNGX.OB) rose over 9% to $1.45 on Wednesday following the receipt of Investigational New Drug clearance from FDA to initiate clinical program to evaluate SGX942 for the treatment of oral mucositis. The clearance of the IND paves way for the company to initiate a phase II dose-escalating clinical study of SGX942 in patients being treated for head and neck cancer. The trial is expected to be initiated in the second half of 2013.
For comments and feedback contact: editorial@rttnews.com
Business News
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.