U.S. Food and Drug Administration staff reviewers on Monday raised concerns over unclear benefits of Ardelyx Inc's drug for kidney disease patients, but the company's shares rose 20% on expectations over a possible approval.
Signage is seen outside of the Food and Drug Administration headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly
drug for kidney disease patients, but the company's shares rose 20% on expectations over a possible approval. However, the concerns were in line with expectations, said Citi analysts, adding that the documents set the tone for a positive discussion when the FDA's outside advisers meet on Wednesday to weigh data on the drug.
Ardelyx's oral drug, tenapanor, is aimed at reducing elevated blood phosphate levels in patients with chronic kidney disease .in 2015 for $25 million, and developed it alone following troubles with the drug's initial trials.the FDA following Ardelyx's appeal against the regulator's initial rejection of the drug in July last year, after it identified deficiencies.
Canada Latest News, Canada Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Pet food recall: Stop feeding this food to your dog immediatelyWoody’s Pet Food Deli announced a recall of Raw Cornish Hen “With Supplements” products, as the product might contain traces of Salmonella.
Read more »
Naloxone May Fail for Overdoses Tainted With 'Tranq,' FDA WarnsThe FDA is alerting healthcare professionals about the special management required for opioid overdoses tainted with xylazine, an animal tranquilizer known on the street as tranq, tranq dope, sleep-cut, Philly dope, and zombie drug.
Read more »
Twenty One Pips is combining board games with really good foodTwenty One Pips is a new board room cafe in Ardmore, Pennsylvania
Read more »
Novel Drug Eases Parkinson's-Related Constipation in Early TrialAn investigational drug that targets abnormal clumps of alpha-synuclein protein in the gut safely reduced constipation in patients with Parkinson's disease in a new study. MedTwitter
Read more »
19 Foolish 2022 Food Trends I Refuse To Stand Behind — Please Boycott Them With MeWhoever came up with the “frozen eggs” hack does not deserve happiness.
Read more »