Unusual 11 Mid-Day Movers 9/7: (CGNT) (RTRX) (AGIO) Higher; (SHLO) (ADPT) (HDS) Lower
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Retrophin, Inc. (Nasdaq: RTRX) 33.0% HIGHER; announced positive top-line results from the Phase 2 DUET study of sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS), a rare kidney disorder without an approved pharmacologic treatment that often leads to end-stage renal disease. The study achieved statistical significance in the primary efficacy endpoint for the overall sparsentan treatment group, demonstrating a greater than two-fold reduction of proteinuria compared to irbesartan after the eight-week, double-blind treatment period.
Agios Pharma (Nasdaq: AGIO) 33.0% HIGHER; disclosed the following in a U.S. SEC filing on Wednesday:
Agios Pharmaceuticals, Inc., announced that its collaboration partner Celgene Corporation expects to submit a new drug application to the U.S. Food and Drug Administration for enasidenib (AG-221), a first-in-class, oral, selective, potent inhibitor of mutant isocitrate dehydrogenase-2, in relapsed and/or refractory acute myeloid leukemia (“AML”). The NDA will be based on data from the ongoing phase 1/2 study of AG-221 in patients with advanced hematologic malignancies with an IDH2 mutation. The NDA submission is expected to occur by year-end 2016.
Shiloh Industries, Inc. (Nasdaq: SHLO) 18.9% LOWER; reported Q3 results. Revenue for the third quarter was $248.8 million, down from $266.1 million in the third quarter of 2015, due mainly to changes in customer production schedules and fewer shipping days in the quarter. Income before tax was $1.0 million with a net loss of $0.3 million, or $0.02 per share, after higher tax expense compared with net income of $2.0 million, or $0.11 per share, in the third quarter of 2015.
Scientific Games Corporation (Nasdaq: SGMS) 17.8% HIGHER; announced it has designated the Company's wholly owned interactive social gaming subsidiaries, including Dragonplay Ltd. and Phantom EFX, LLC, as unrestricted subsidiaries under its debt agreements, with the goal of maximizing growth for the company. The Company will consider a range of options to solidify its leadership in this fast growing segment, including potential new joint ventures, acquisitions, IPO, and other growth options.
Adeptus Health Inc. (NYSE: ADPT) 16.9% LOWER; announced that Thomas S. Hall has informed the Board of Directors of his intention to retire as Chief Executive Officer.
Evoke Pharma, Inc. (Nasdaq: EVOK) 16.3% HIGHER; announced that it has completed a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead product candidate, Gimoti™, its patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women. The focus of this pre-NDA meeting with the FDA was the content of the regulatory, chemistry, manufacturing, and control (CMC), and non-clinical sections of the Company’s planned 505(b)(2) NDA for Gimoti.
Calavo Growers (Nasdaq: CVGW) 15.0% HIGHER; reported Q3 EPS of $0.73, $0.14 better than the analyst estimate of $0.59. Revenue for the quarter came in at $263.15 million versus the consensus estimate of $243.8 million.
HD Supply Holdings (Nasdaq: HDS) 15.0% LOWER; reported Q2 EPS of $0.85, in-line with the analyst estimate of $0.85. Revenue for the quarter came in at $2 billion versus the consensus estimate of $2.03 billion. HD Supply Holdings sees Q3 2016 EPS of $0.77 - $0.82, versus the consensus of $0.91. HD Supply Holdings sees Q3 2016 revenue of $1.985 - $2.035 billion, versus the consensus of $2.06 billion.
Applied Optoelectronics, Inc. (Nasdaq: AAOI) 13.6% HIGHER; announced updated guidance for its third quarter ended Sept. 30, 2016. Revenue in the range of $63.0 million to $65.0 million, above the prior outlook of $56.0 million to $59.0 million. (The Street sees revenue of $58.2 million.) Non-GAAP fully diluted earnings per share in the range of $0.26 to $0.29, using a weighted-average fully diluted share count of approximately 18.0 million shares. This is above the prior outlook of $0.16 to $0.21 per share. (The Street sees EPS of $0.19.)
Clean Diesel Technologies Inc. (Nasdaq: CDTI) 13.0% LOWER; pulling back following a 22 percent gain on Tuesday.
Sprouts Farmers Market, Inc. (Nasdaq: SFM) 13.0% LOWER; said it now sees FY16 adjusted EPS of $0.83 - $0.86, with the consensus at $0.94.
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