FDA grants orphan status for multiple myeloma (9/09); Fast-track designation granted 12/09; positive phase II data reported in metastatic colon cancer (1/10); SPA for phase III approved by FDA in colorectal cancer (2/10); fast-track designation granted by FDA (4/10); phase III registration trial in refractory advanced colorectal cancer; shares fall despite encouraging clinical data at ASCO (6/10); received orphan drug designation for neuroblastoma in 7/10
Brand N/A Generic perifosine (KRX-0401)
Company name Keryx Biopharmaceuticals Product type Speciality
Therapeutic category Antineoplastics Key uses colorectal cancer
Other Uses multiple myeloma, renal cell carcinoma, brain cancer Drug Class Akt modulator
Dosage From oral Expected Approval 2012+
FDA Filing N/A Last Update date July 15,2010
Link to pipeline report
Link to news article
Link to clinicaltrials.gov
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