BioCentury on BioBusiness, Finance
Regulatory, clinical and other milestones
Highlights of weekly biotech stock moves
-- Andrew Fisher & Jon Wolleben
Published on Monday, January 23, 2012
Regulatory
milestones
Allos Therapeutics Inc. (NASDAQ:ALTH) was off $0.15 to $1.51 on Friday after
EMA's CHMP recommended against conditional approval of Folotyn pralatrexate to
treat relapsed or refractory peripheral T cell lymphoma. The MAA was based on
data from the single-arm Phase II PROPEL trial, which evaluated a primary
endpoint of objective response rate. CHMP said it could not assess Folotyn's
benefit because it was not compared with placebo or any other treatment and
because the trial did not allow the agency to assess Folotyn's effect on
overall survival or progression-free survival.
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