Auxilium Soars On Solid Trial Results (AUXL, ARIA, FM, CONN)
Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) shares gained 1.85% to $16 in the pre-market hour after the company announced updated clinical data from the pivotal PACE trial of its investigational pan-BCR-ABL inhibitor, ponatinib, in patients with chronic myeloid leukemia (CML) or Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL), who are resistant or intolerant to dasatinib or nilotinib or who have the T315I mutation.
These data show that 54% of chronic-phase CML patients in the trial, including 70% of patients who have a T315I mutation, achieved a major cytogenetic response. ARIAD expects to file for regulatory approval of ponatinib in the U.S. and the EU in the third quarter of 2012 based on these clinical data.
Auxilium Pharmaceuticals, Inc. (NASDAQ:AUXL) stock surged 19.36% to $22.50 in the pre-market hour after the company announced positive top-line results from its IMPRESS (The Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies) trials, the phase III studies that assessed XIAFLEX (collagenase clostridium histolyticum or CCH), a novel, in-office, first-in-class biologic therapy for the potential treatment of Peyronie’s disease (PD).
PD can be a physically and psychosocially devastating disorder that results in varying degrees of penile curvature deformity, disease bother, sexual dysfunction, emotional distress, loss of self-esteem and depression.
General Motors Company (NYSE:GM) shares increased 0.45% to $22.11 in the pre-market hour after the company said Friday that it will shut down a vehicle assembly line at its Oshawa, Ont., plant next year, leaving just a small fraction of what was once a huge manufacturing presence there. Canadian manufacturing has taken a hit in recent months as the U.S. firms have moved production at several sites out of the country.
CONN’S, Inc. (NASDAQ:CONN) posted a first quarter profit of $11.56 million or $0.35 per share, as compared to $4.4 million or $0.14 per share in the same quarter last year. Total revenues grew to $200.85 million from $191.98 million in the prior-year quarter. Analysts expected the company to report earnings of $0.33 per share on revenues of $202.10 million.
Looking forward, the company increased earnings guidance for the fiscal year 2013, to earnings per share of $1.30 to $1.40 from $1.20 – $1.30 per share range provided earlier. Analysts expect the company to earn $1.32 per share.