Ardelyx Stock Collapses After FDA Rejects Its Kidney Disease Candidate Pitch
Three months after revealing that the FDA had asked for more information to support tenapanor application for a…
Ardelyx Receives FDA Letter Regarding NDA For Tenapanor Indicating Deficiencies That Preclude Discussion Of Labeling And Post-marketing Requirements/Commitments At This Time; Co. Says Request For Meeting To Discuss Deficiencies Was Denied
Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal
Attention Biotech Investors: Mark Your Calendar For July PDUFA Dates
June was a month of plenty and also turned out to be a fruitful one from the perspective of Food and Drug Administration approvals. Regulatory reviews mostly produced positive verdicts, and rejections or no-decisions were few and far between.
Week Ahead In Biotech (May 2-8): ChemoCentryx Adcom, Ophthalmology Conference Presentations, Earnings Deluge
Biopharma stocks experienced volatility in the week ended April 30, as stocks reacted to earnings, data readouts and a handful of FDA decisions.
15 Stocks Moving In Thursday’s After-Hours Session
Gainers
Amazon (NASDAQ: AMZN) shares are trading higher after the company reported better-than-expected Q1 EPS and sales results. The company also issued Q2 sales guidance above estimates.