Tag:
Genasense
Latest Headlines
Latest Headlines
Cash-strapped Genta slashes staff in restructuring
A cash-strapped Genta announced this morning that a late-stage trial for Genasense failed to show a statistically significant benefit for the co-primary endpoint of progression-free survival, or for
Genta tanks on Genasense data
Genta's stock took a nosedive yesterday on news that its lead drug Genasense, a Phase III candidate for melanoma, did not show a statistically significant benefit for its co-primary endpoint of
In survival mode, Genta hunts for funds
NJ Biz examines Genta, which has gone into survival mode as it seeks a way to gain FDA approval of its lead cancer therapy, Genasense. The FDA turned thumb's down on the therapy in 2004, and the
FDA extends review time for Genta's appeal
Genta is going to have to wait a little longer before it gets final word on its appeal of the FDA's rejection
ALSO NOTED: Genitope's MyVax misses Phase III endpoint; Report: Pfizer looks at Danish biotechs; and much more...
> Genitope's MyVax, a treatment for follicular B-cell non-Hodgkin's lymphoma, has flunked a Phase III trial. There was no difference in progression-free survival between patients taking the drug
ALSO NOTED: Medicure raises $40M; FDA wants more data on Creon; Genta launches Phase III; and much more...
> Medicure has struck two deals to raise $40 million. Release > The FDA has
ALSO NOTED: Kosan forges deal with Pfizer; Genta cuts staff; and much more...
> Kosan stock surged on the news that it had inked a deal with Pfizer to develop a therapy for gastrointestinal diseases. Kosan gets $12.5 million up front and up to $72.5 million in milestones. Pfizer gains worldwide rights to KOS-2187, a compound that helps spur production of a hormone that promotes movement in the gastrointestinal tract. Release
> Fast on the heels of its announcement that the FDA …
SPOTLIGHT: FDA rejects Genasense
Already hammered by poor trial data, Genta announced today that the FDA had formally rejected its leukemia therapy Genasense. Genta's stock dropped more than 20 percent to 54 cents a share. Its stock had already been hurt by the news several days ago that the therapy had failed a trial. "We are keenly disappointed by this decision," Raymond Warrell, Genta's chief executive, said in a statement. "We believe that Genasense has amply demonstrated its efficacy and safety in patients with …
Press Release: Genta Receives Non-Approvable Notice for Application of Genasense
Press Release: Genta Receives Non-Approvable Notice for Application of Genasense
Genta bullish on news of FDA delay
The FDA has extended its review period for Genta's Genasense application by 90 days. Normally, that would be a sign of trouble for a drug developer. But Genta is distinctly bullish about the news, given the FDA advisory committee's recommendation against approving the leukemia therapy. The committee questioned the significance of Genta's primary endpoint, an event which sent Genta's stock plunging 63 percent. Genta, …
