Relypsa got good news and bad news from the FDA Wednesday. The good: Its hyperkalemia drug patiromer, now dubbed Veltassa, won agency approval. The not-so-good: Its label isn't quite as "clean" as the company might have hoped; it includes a black-box warning of interactions with oral meds. Analysts say that could give ZS Pharma an advantage if and when its potential competitor gets an FDA nod next year.
After a long and expensive clinical journey, Relypsa won FDA approval to commercialize patiromer--to be sold as Veltassa--for hyperkalemia. And then the biotech promptly ran straight into a brick wall of negative reactions to the restrictive label that came with the regulatory OK.
Relypsa and Sanofi are raring to go for a prospective launch of patiromer, a treatment for hyperkalemia. All they need is an FDA approval, and that yea-or-nay decision is expected today.
Relypsa is raring to go on its treatment for hyperkalemia, patiromer. It needs to get going, considering a competitor med might hit the market in mid-2016. All it needs is an FDA approval, and that decision is expected Wednesday.
Sanofi has signed up to help Relypsa bring its lead drug patiromer to market. The treatment for hyperkalemia, pegged as a $1.4 billion blockbuster by analysts, is due for an FDA thumbs-up in October.
In a fresh sign that the big biotech IPO wave that triggered a long lineup of dazzling debuts may have crested, two new California contenders have had to significantly scale down their expectations and a third has decided to bow out for now.
Fresh off posting some positive Phase III results for its lead drug, California's Relypsa has scaled-up its proposed IPO, seeking $138 million to carry it toward FDA approval.
Just weeks away from reporting key endpoint data from a Phase III trial of its lead therapy, Relypsa has mapped out plans to go public, shooting for a $126.5 million payday to help complete a prospective transformative leap into marketing.
Welcome to this week's roundup of hirings and firings throughout the industry. Please send the good word (or the bad) from your shop to Alison Bryant (email | Twitter) and we will feature it...
The life sciences industry gained a blast of good news on the venture front today. The National Venture Capital Association and PricewaterhouseCoopers outlined a buoyant set of numbers for the...