Shares of AbbVie Inc (NYSE:ABBV) ended Monday session in green amid volatile trading. The shares closed up +0.38 points or 0.60% at $63.31 with 3.14 million shares getting traded. Post opening the session at $63.07, the shares hit an intraday low of $62.92 and an intraday high of $63.66 and the price vacillated in this range throughout the day. The company has a market cap of $103.27 billion and the numbers of outstanding shares have been calculated to be 1.63 billion shares.
AbbVie Inc (ABBV) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including therapy with an NS5A inhibitor and/or protease inhibitor.
The BTD is supported by positive results seen in AbbVie’s Phase 2 MAGELLAN-1 clinical study. According to the FDA, BTD is intended to expedite the development and review of therapies for serious or life threatening conditions.
“AbbVie is committed to advancing HCV care and addressing areas of continued unmet need for people living with chronic HCV,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “The FDA’s Breakthrough Therapy Designation is an important step in our effort to bring our pan-genotypic regimen to market, which we are also investigating as an eight week path to virologic cure for the majority of patients.”
Shares of Skyline Medical Inc (NASDAQ:SKLN) ended Monday session in red amid volatile trading. The shares closed down -0.009 points or -5.73% at $0.140 with 1.49 million shares getting traded. Post opening the session at $0.14, the shares hit an intraday low of $0.14 and an intraday high of $0.15 and the price vacillated in this range throughout the day. The company has a market cap of $12.11 million and the numbers of outstanding shares have been calculated to be 81.80 million shares.
Skyline Medical Inc (SKLN) announced the signing of a partnership and exclusive reseller agreement with GLG Pharma, LLC (“GLG”).
Under the terms of the agreement, GLG intends to develop rapid diagnostic tests that utilize fluid and tissue collected by the STREAMWAY System during procedures. Skyline Medical will issue common stock to GLG in four separate tranches, with each tranche released after the achievement of certain development milestones. In addition, Skyline will pay a royalty to GLG on the sale of individual tests.
Initial tests are anticipated to include cancer biomarkers and infectious diseases. The oncology test panels will feature GLG’s patented inhibitors of Signal Transducers and Activators of Transcription 3 (STAT3), which are in preclinical development for a new generation of targeted therapies.