ARTICLE | Clinical News

Incyte falls after dropping DFC

April 4, 2006 12:25 AM UTC

INCY fell $2.44 (41%) to $3.58 on 13 million shares on Monday after the company said it will discontinue development of dexelvucitabine (DFC) for HIV because of grade IV hyperlipasemia seen in a long-term Phase IIb extension study (Study 901). The marker for pancreatic inflammation was observed in about 40% of patients given 200 mg DFC without 3TC or FTC background therapy, which INCY said was "well above" the 10-15% that the company felt was acceptable. Lower doses of the nucleoside analog reverse transcriptase inhibitor lacked efficacy. The company also halted a recently started Phase IIb trial (Study 204), in which no patients had begun DFC dosing. INCY will work with FDA to determine the best approach for patients in Study 901 who may be benefiting from DFC and have limited treatment alternatives. ...