Astrazeneca plc acknowledged receipt of a complete response letter (CRL) from the FDA on its new drug application (NDA) for sodium zirconium cyclosilicate, an oral suspension designed to treat hyperkalemia (HK). The candidate, better known as ZS-9, was the prize in Astrazeneca’s 2015 acquisition of ZS Pharma Inc. for $2.7 billion.
Shares of Ionis Pharmaceuticals Inc. (NASDAQ:IONS) were pummeled Thursday, sinking to a three-year low of $21.09, after the company clarified that “less than a handful of patients” enrolled in its phase III NEURO-TTR study evaluating IONIS-TTRRx in transthyretin (TTR) familial amyloid polyneuropathy (FAP) experienced a serious decline in platelets. The small number of events, in seriously ill patients often taking other medications, might have been a minor blip on the radar screen except that partner Glaxosmithkline plc (GSK), which holds an option to license IONIS-TTRRx exclusively, decided to postpone a phase III cardiovascular study, CARDIO-TTR, that was planned to evaluate IONIS-TTRRx in patients with TTR amyloid cardiomyopathy.
Zenith Epigenetics Corp. closed a $24.56 million private placement with its lead investor, Eastern Capital Ltd., by pricing 24.56 million common shares at $1 apiece. For starters, the funds will finance a phase I trial of the company's pan selective BET (bromodomain and extraterminal domain) inhibitor, ZEN-3694, in the lead indication of metastatic castrate-resistant prostate cancer (mCRPC).
Pricing of prescription drugs has emerged as a cause célèbre in the U.S., especially in the vortex of a contentious presidential race, and an analysis of changes over time in the prices of two dozen approved oral cancer drugs could fan the flames.
Biostage Inc., formerly Harvard Apparatus Regenerative Technology Inc., or HART, said preclinical data from a collaborative large animal study with the Mayo Clinic showed complete regeneration of a segment of the esophagus using its Cellspan organ implants.
After years of taking a back seat to research efforts in indications such as cardiovascular disease, cancer and pulmonary disease, the gastrointestinal space is hot.
Epirus Biopharmaceuticals Inc. is learning the hard way that developers of biosimilars are not immune from the market vagaries affecting the biopharma industry as a whole.
Analysts and investors found plenty to like in first quarter earnings from Regeneron Pharmaceuticals Inc., which beat consensus revenue forecasts with approximately $1.2 billion in global sales, including a 44 percent increase in U.S. and global net sales of Eylea (aflibercept).
Eight years after Ionis Pharmaceuticals Inc. selected then-independent Genzyme Corp. as the partner for its phase III lipid-lowering drug, mipomersen, in a potential $1.9 billion deal, the Carlsbad, Calif.-based company dealt the commercial asset, Kynamro, to start-up Kastle Therapeutics LLC for peanuts.
