On Thursday, Keryx Biopharmaceuticals (NASDAQ:KERX)’s shares inclined 1.53% to $3.98.
Keryx Biopharmaceuticals declared that the European Commission has approved Fexeric(R) (ferric citrate coordination complex) for the control of elevated serum phosphorus levels, or hyperphosphatemia, in adults with chronic kidney disease (CKD), counting both dialysis and pre-dialysis patients. The European Commission considered ferric citrate coordination complex a New Active Substance, which provides 10 years of data and marketing exclusivity in Europe.
The European Commission’s decision is based on evidence from about 1900 patients, counting two key clinical trials: a Phase 2, non-dialysis study and a 58-week, Phase 3 registration trial. In the Phase 3 trial, ferric citrate effectively reduced serum phosphorus levels to within the KDOQI guidelines range of 3.5 mg/dL to 5.5 mg/dL (p<0.0001), the primary endpoint. These data were published in 2014 in the Journal of the American Society of Nephrology.
The most commonly stated adverse reactions in dialysis-dependent CKD patients during treatment were discolored feces (18%) and diarrhea (13%). All serious adverse reactions were gastrointestinal in nature (abdominal pain, constipation, diarrhea, gastritis, gastritis erosive, and hematemesis). The most commonly stated adverse reactions in CKD non-dialysis patients during treatment were discolored feces (27%) constipation (13%) and diarrhea (11%).
Keryx Biopharmaceuticals, Inc. is a biopharmaceutical company. The Company is focused on the development of products for the treatment of renal diseases. Its lead product Auryxia (ferric citrate), an oral, absorbable iron-based compound, received marketing approval from the United States Food and Drug Administration (FDA), for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.
Southwest Airlines Co (NYSE:LUV)’s shares dropped -1.06% to $38.17.
Southwest Airlines declared a new tentative agreement with the Southwest Airlines Pilots’ Association (SWAPA), the Union that represents the Company’s Pilots. SWAPA’s Board of Directors reviewed an Agreement in Principle that negotiators reached earlier this month and decided to conduct a ratification vote that could end more than three years of negotiations.
The Company said the agreement offers wage improvements and work-rule changes that will benefit the pilot group and position Southwest to continue its expansion both domestically and internationally.
Union Leaders will communicate with Pilots over the next few weeks to share the details and terms of the agreement. The ratification vote will close November 4. If Pilots approve the deal, the contract will become amendable April 1, 2019.
Southwest Airlines Co. operates Southwest Airlines (Southwest). Southwest is a passenger airline that provides planned air transportation in the United States and near-international markets. The Company serves around 93 destinations in 40 states and runs international services to Montego Bay, Nassau, Oranjestad, Cabo San Lucas/Los Cabos, Cancun, Mexico City and Punta Cana.
At the end of Thursday’s trade, CF Industries Holdings, Inc. (NYSE:CF)‘s shares dipped -2.75% to $46.42.
CF Industries Holdings declared that its partner CF Industries, Inc. has accomplished a $1.0 billion private placement of senior notes comprising $250 million aggregate principal amount of 4.49% senior notes due 2022, $500 million aggregate principal amount of 4.93% senior notes due 2025 and $250 million aggregate principal amount of 5.03% senior notes due 2027. The senior notes will be guaranteed by CF Industries Holdings, Inc.
CF Industries intends to use the net proceeds from the offering of senior notes to fund its capital expenditure programs and for other general corporate purposes, counting working capital.
CF Industries Holdings, Inc. is the manufacturer and distributor of nitrogen fertilizer and other nitrogen products. The Company’s nitrogen fertilizer products comprise ammonia, granular urea and urea ammonium nitrate solution (UAN). The Company’s other nitrogen products comprise ammonium nitrate (AN), diesel exhaust fluid (DEF), urea liquor and aqua ammonia.
Eli Lilly and Co (NYSE:LLY), ended its Thursday’s trading session with -1.55% loss, and closed at $85.35.
Eli Lilly and Co, hosted a webcast on September 24 to discuss data from EMPA-REG OUTCOME®, a long-term clinical trial investigating cardiovascular (CV) outcomes for Jardiance® (empagliflozin) in more than 7,000 adults with type 2 diabetes at high risk for CV events. Detailed study results are presented on Thursday, September 17 at the 51st European Association for the Study of Diabetes (EASD) Annual Meeting in Stockholm, Sweden. JARDIANCE is part of the Boehringer Ingelheim and Lilly Diabetes Alliance.
Eli Lilly and Company (Lilly) is engaged in drug manufacturing business. The Company discovers, develops, manufactures and market products in two segments: human pharmaceutical products and animal health products.
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