Colorado recently passed a "right to try" bill that allows people to use an experimental drug when the company agrees to give it, without federal approval, according to a report from NBC News. And now other states are beginning to discuss similar legislation, as The Goldwater Institute presses for such laws from coast to coast.
Just weeks after enduring a storm of controversy triggered by his initial refusal to provide a potent but experimental antiviral to a dying child under a compassionate use program, Chimerix CEO Ken Moch is out. The company announced that Moch had resigned--completely unexpectedly--to "pursue other interests" as the board introduced a new CEO to run the company.
Last week the parents of 7-year-old Josh Hardy managed to whip up a media tempest big enough to get the biotech Chimerix and the FDA to work out a pilot study so that their child could be treated after their compassionate use request was denied, alongside many others. Now the parents of another young boy afflicted by a terrible disease are using some interesting PR tactics in an attempt to achieve a much larger goal.
Chimerix will evidently have no trouble finding the 20 patients it is recruiting for the pilot study of its antiviral brincidofovir. And it still isn't willing to provide its therapy under the FDA's "compassionate use" regulations.
On Tuesday morning, Chimerix CEO Ken Moch was at the center of a media storm, maintaining that there was no way the biotech could responsibly provide its experimental antiviral to a dying child named Josh Hardy, a drug the boy's parents vowed was all that could save the child's life. By Tuesday night, though, Moch had found a way to give the treatment to the 7-year-old after all, as part of the clinical development program for the drug.
Anyone in the industry who knows Ken Moch, the CEO of a little biotech in Durham, NC, named Chimerix, is likely to describe him as personable, chronically cheerful and an outspoken champion of all things Chimerix.
After a slight lull in the biotech IPO arena, new offerings came barreling back this week with some fresh breakouts. In particular Foundation Medicine priced over the range and immediately soared more than 80%. And Ophthotech also crested its range, erasing any lingering doubts about the short-term sustainability of the biotech IPO frenzy. Together they raised $273 million in a 24-hour pop. Read the report >>
Investigators tested the antiviral among hematopoietic cell transplant recipients with early adenovirus infection, but said--well into its release--that the therapy fell short on achieving statistical significance on efficacy in the "progression to possible or probable AdV disease or significant changes in AdV viremia.
During all of last year there were only 11 biotech IPOs. But even that weak number looked pretty good compared to the barren years leading away from the 2008 financial crisis. In the last 6 months, though, the industry has seen a tremendous rebound, with almost twice that number of IPOs in half the time. And there's no sign that the great leap into the public market is waning, with 10 more IPOs in the queue. Read the full report >>
The Durham, NC-based drug developer's stock soared on its first day of trading, with an initial price of $14 per share that shot up 34% to $18.79 per share by the end of the day.