Reeling after the Phase IIb failure of its "breakthrough" gene therapy for heart failure, Celladon is slashing its budget and payroll, vowing to find a way forward that preserves value for its investors.
Celladon's lead program--as well as its stock price--crashed after the biotech announced Sunday evening that its heart therapy Mydicar failed the primary and secondary endpoints in a Phase IIb trial, losing out in a full lineup of efficacy tests.
San Diego-based Celladon has nabbed a "breakthrough" drug designation from the FDA for its heart failure drug Mydicar. The gene therapy uses a benign virus to insert the Serca2a gene into heart cells.
Back in January, at the annual J.P. Morgan Healthcare Conference, across hotel lobbies and crowded hallways and standing-room-only cafes, one could hardly escape talk about the biotech IPO boom.
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.
2012 Fierce 15 member Celladon has boosted its IPO goals, seeking as much as $92 million to help get its gene therapy for heart failure through a Phase IIb study and into Phase III.
Celladon and Xencor have cast lines into the still-blazing biotech IPO scene, seeking a combined $155.3 million and betting that the recent Wall Street excitement for drug developers will hold firm.
San Diego-based Celladon has made a big splash in the U.K. British scientists are playing a prominent role in a pair of clinical trials of Celladon's Mydicar, a gene therapy for heart failure which uses a benign virus to insert the Serca2a gene into heart cells.
Now, more than ever, the life sciences industry is all about innovative and disruptive technologies. Every year for the past decade, FierceBiotech has made its picks on which companies hold the best odds for success in our Fierce 15 report. This year, though, we've added another Fierce 15 to focus on medical devices and diagnostics. I'd like to encourage readers to consider the differences by comparing the companies in each report.
Nick Leschly, the CEO of Bluebird Bio, playfully dubbed the ambitious spirit of biotechs Levin Syndrome, a fictional affliction named after Third Rock Ventures' Mark Levin that compels biotech entrepreneurs to, as they say, go big or go home. Our Fierce 15 companies are all "going big." They also went home… with trophies. Check out the slideshow below.