Despite winning a reluctant yea vote from the Cardiovascular and Renal Drugs Advisory Committee last month, Chelsea Therapeutics International Inc.'s neurogenic orthostatic hypotension (NOH) candidate Northera (droxidopa) failed to win FDA approval, sending shares of the Charlotte, N.C.-based firm falling 28.6 percent.
GlaxoSmithKline plc is expected to file for approval of Relovair in both the U.S. and Europe in the middle of this year for chronic obstructive pulmonary disease (COPD), following the completion of the Phase III program. Commercialization of the potentially multi-billion-dollar product could be a boon for long-time partner Theravance Inc.
Shares of Talon Therapeutics Inc. fell 22.7 percent Monday after the FDA released briefing documents ahead of Wednesday's Oncologic Drugs Advisory Committee (ODAC) meeting to discuss a new drug application (NDA) seeking accelerated approval for Marqibo (vincristine sulfate liposomes injection) based on a single-arm study in Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). The stock (OTCQB:TLON) lost 22 cents to close at 75 cents.
Awaiting much-anticipated data from its pivotal Fabry disease program later this year, Amicus Therapeutics Inc. is doubling its cash balance via a $57 million public offering.
Given the 125 percent stock surge after last week's positive FDA panel review for obesity candidate Qnexa (phentermine/topiramate), Vivus Inc.'s plan for a public offering comes as little surprise.
Nearly three months into its pivotal study of lead immunotherapy candidate rindopepimut in a subset of glioblastoma multiforme (GBM) patients, Celldex Therapeutics Inc. is pulling in about $40.4 million in a public offering to help support that study and advance earlier pipeline programs.
With data from at least seven clinical trials due this year, along with a Phase III go/no-go decision on its most advanced partnered program, Array Biopharma Inc. is bolstering its cash position with a $52 million public offering.
Gilead Sciences Inc.'s fourth-quarter earnings fell short of expectations, but the Foster City, Calif.-based firm's stock jumped Friday on promising early data from newly acquired hepatitis C virus (HCV) drug GS-7977.
Amylin Pharmaceuticals Inc. can (finally) put another check in the win column, with the FDA's approval of Bydureon, a once-weekly version of exenatide, a move that puts the San Diego-based biotech on solid footing for a lucrative ex-U.S. partnering deal – even a potential buyout isn't out of the question.
