Shares of Vertex Pharmaceuticals Inc (VRTX) are higher by 7.18% to $132.99 in pre-market trading on Wednesday after the company’s cystic fibrosis treatment Orkambi won the backing of FDA Advisory Panel which voted 12 to 1 to recommend approval of the drug.
The Food and Drug Administration is expected to make a decision on the approval of Orkambi by July 5, 2015 under the Prescription Drug User Fee Act. The FDA is not bound by the committee’s recommendation but often follows its advice. If approved, Orkambi will be the first and only medicine to treat the underlying cause of CF for eligible people with CF ages 12 and older with two copies of the F508del mutation in the CFTR gene.
Orexigen Therapeutics, Inc. (OREX) shares plunged nearly 10% to $5.38 in pre-market trading after the company and its marketing partner, Takeda Pharmaceutical, announced the termination of a cardiovascular outcomes trial of anti-obesity drug Contravene, from which interim results were inadvertently released earlier this year.
Shares of Fibrocell Science, Inc. (FCSC) are up $0.70, or over 19%, at $4.26, after the company this morning announced that the U.S. Food and Drug Administration has granted rare pediatric disease designation for FCX-007, to treat recessive dystrophic epidermolysis bullosa.
“We are pleased that the FDA has granted our request to designate FCX-007 for the treatment of RDEB as a drug for a rare pediatric disease,” commented David Pernock, Chairman and CEO of Fibrocell. “FCX-007 may offer RDEB patients and their families the first therapy to treat the underlying cause of the disease, bringing hope and relief to what is today a painful, disabling and often fatal congenital disorder.”
Star Bulk Carriers Corp. (SBLK) shares declined 6.90% to $3.51 in pre-market trading after the company announced today that it plans to make a public offering of $150 million of its common shares. Star Bulk said it intends to use the net proceeds from the offering for its newbuilding program and general corporate purposes (including additions to working capital, capital expenditures, repayment of debt or the financing of possible acquisitions and investments).