lifts hold on Achillion's hepatitis C drug, shares jump
Send a link to a friend
[June 10, 2014]
(Reuters) - Achillion
Pharmaceuticals Inc said the U.S. Food and Drug
Administration allowed it to resume the development of
one of its hepatitis C drugs, lifting a clinical hold
that was imposed nearly a year ago.
The company's shares jumped about 38 percent in premarket trading.
The U.S. health regulator placed a hold on the development of the
drug, sovaprevir, in July last year after data from an early-stage
study showed elevated liver enzymes - a sign of liver damage - in
some patients who received the drug.
Achillion submitted additional data on the drug in September, but
the FDA maintained the hold.
The company said on Tuesday that the FDA had allowed it to test the
drug in a maximum daily dose of 200 mg for hepatitis C patients and
in single dose trials for healthy volunteers.
The regulator, however, maintained a hold on multiple dose studies
on healthy volunteers.
Achillion's shares were trading at $5.85 before the bell.
The stock closed nearly 48 percent higher on Monday after Merck & Co
said it would buy another hepatitis C drug developer, Idenix
[to top of second column]
(Reporting by Natalie Grover in Bangalore; Editing by Kirti Pandey)
[© 2014 Thomson Reuters. All rights
Copyright 2014 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.