Morning Movers 06/21: (ONXX) (SUNH) (EGLE) (CHTP) Higher; (POZN) (BBBY) (CELG) Lower
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Onyx Pharma (Nasdaq: ONXX) 36.8% HIGHER; the FDA's Oncologic Drugs Advisory Committee offered a positive benefit-risk opinion on the company's Kyprolis. The ODAC determined by a vote of 11-0 [with 1 abstention] that, in patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent, Kyprolis should show a benefit.
Sun Healthcare (Nasdaq: SUNH) 35.9% HIGHER; Genesis Healthcare will acquire the company for $8.50/share.
Eagle Bulk Shipping Inc. (Nasdaq: EGLE) 35.8% HIGHER; announced that it has reached an agreement with a syndicate of its lenders led by Royal Bank of Scotland plc. This agreement resolves all outstanding issues with the Company's lenders and significantly improves the Company's position amid the ongoing, cyclical downturn in the shipping markets. Click here to see the full report.
Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) 29.8% HIGHER; today announced results from an integrated dataset of two phase 3 studies, Study 301 and Study 302, which showed that patients treated with Northera (droxidopa) experienced improvements in their symptoms of Neurogenic Orthostatic Hypotension (also known as NOH or Neurogenic OH) as measured by the Orthostatic Hypotension Questionnaire (OHQ) composite score (p=0.001) and a number of individual symptoms, including dizziness (p=0.004).
Federal Signal Corporation (NYSE: FSS) 17.3% HIGHER; today announced that it has signed a definitive agreement to sell its Federal Signal Technologies, LLC business to 3M Company (NYSE: MMM) for $110 million in cash.
StemCells, Inc. (Nasdaq: STEM) 17% HIGHER; has initiated a Phase I/II clinical trial of the Company's proprietary HuCNS-SC product candidate (purified human neural stem cells) in dry age-related macular degeneration (AMD) referred to as Geographic Atrophy. There are no approved treatments for dry AMD.
POZEN Inc. (NASDAQ: POZN) 15.7% LOWER; today announced that it has received an Advice/Information Request letter from the U.S. FDA which indicates that the FDA has made a preliminary review of the study results and POZENâs summary analyses of a Phase 1 study (115 Study) to assess the bioequivalence of PA32540 to enteric-coated (EC) aspirin 325 mg using acetylsalicylic acid (ASA) as the analyte. Based on its preliminary assessment, the FDA does not agree that bioequivalence of PA32540 to EC aspirin 325 mg was demonstrated based on the information available to the FDA at this time.
Bed Bath & Beyond, Inc. (NASDAQ: BBBY) 15.4% LOWER; reported Q1 EPS of $0.89, $0.05 better than the analyst estimate of $0.84. Revenue for the quarter came in at $2.22 billion versus the consensus estimate of $2.25 billion. Bed Bath & Beyond, Inc. sees Q2 2012 EPS of $0.97-$1.03, versus the consensus of $1.08.
Celgene (Nasdaq: CELG) 11.9% LOWER; the company's Celgene International Sarl unit said it has withdrawn the new indication submission to the Committee for Medicinal Products for Human Use for REVLIMID. Click here to see the full report.
Key Energy Services, Inc. (NYSE: KEG) 10.3% LOWER; expects Q2 results to be below prior expectations with consolidated revenue from continuing operations now forecast to increase 5% to 7% compared to the first quarter 2012. Key also expects second quarter 2012 earnings from continuing operations to be $0.18 to $0.20 per diluted share. Key's prior second quarter guidance anticipated sequential consolidated revenue growth of 10% to 15% and earnings from continuing operations of $0.31 to $0.33 per diluted share. The Street is looking for EPS of $0.31.
Rite Aid (NYSE: RAD) 9.5% HIGHER; reported Q1 EPS of ($0.03), in-line with the analyst estimate of ($0.03). Revenue for the quarter came in at $6.47 billion versus the consensus estimate of $6.44 billion. Same-store sales were up 2.5 percent. Rite Aid sees FY2013 EPS of $-0.13-$-0.29, versus views calling for -$0.20. Rite Aid sees FY2013 revenue of $25.3-$25.7 billion, compared with estimates of $25.53 billion. Prior guidance was for a loss of $0.13-$0.31 and sales of $25.4-$25.8 billion. Looking for same-store sales to be down 0.5% to up 1%.
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Sun Healthcare (Nasdaq: SUNH) 35.9% HIGHER; Genesis Healthcare will acquire the company for $8.50/share.
Eagle Bulk Shipping Inc. (Nasdaq: EGLE) 35.8% HIGHER; announced that it has reached an agreement with a syndicate of its lenders led by Royal Bank of Scotland plc. This agreement resolves all outstanding issues with the Company's lenders and significantly improves the Company's position amid the ongoing, cyclical downturn in the shipping markets. Click here to see the full report.
Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) 29.8% HIGHER; today announced results from an integrated dataset of two phase 3 studies, Study 301 and Study 302, which showed that patients treated with Northera (droxidopa) experienced improvements in their symptoms of Neurogenic Orthostatic Hypotension (also known as NOH or Neurogenic OH) as measured by the Orthostatic Hypotension Questionnaire (OHQ) composite score (p=0.001) and a number of individual symptoms, including dizziness (p=0.004).
Federal Signal Corporation (NYSE: FSS) 17.3% HIGHER; today announced that it has signed a definitive agreement to sell its Federal Signal Technologies, LLC business to 3M Company (NYSE: MMM) for $110 million in cash.
StemCells, Inc. (Nasdaq: STEM) 17% HIGHER; has initiated a Phase I/II clinical trial of the Company's proprietary HuCNS-SC product candidate (purified human neural stem cells) in dry age-related macular degeneration (AMD) referred to as Geographic Atrophy. There are no approved treatments for dry AMD.
POZEN Inc. (NASDAQ: POZN) 15.7% LOWER; today announced that it has received an Advice/Information Request letter from the U.S. FDA which indicates that the FDA has made a preliminary review of the study results and POZENâs summary analyses of a Phase 1 study (115 Study) to assess the bioequivalence of PA32540 to enteric-coated (EC) aspirin 325 mg using acetylsalicylic acid (ASA) as the analyte. Based on its preliminary assessment, the FDA does not agree that bioequivalence of PA32540 to EC aspirin 325 mg was demonstrated based on the information available to the FDA at this time.
Bed Bath & Beyond, Inc. (NASDAQ: BBBY) 15.4% LOWER; reported Q1 EPS of $0.89, $0.05 better than the analyst estimate of $0.84. Revenue for the quarter came in at $2.22 billion versus the consensus estimate of $2.25 billion. Bed Bath & Beyond, Inc. sees Q2 2012 EPS of $0.97-$1.03, versus the consensus of $1.08.
Celgene (Nasdaq: CELG) 11.9% LOWER; the company's Celgene International Sarl unit said it has withdrawn the new indication submission to the Committee for Medicinal Products for Human Use for REVLIMID. Click here to see the full report.
Key Energy Services, Inc. (NYSE: KEG) 10.3% LOWER; expects Q2 results to be below prior expectations with consolidated revenue from continuing operations now forecast to increase 5% to 7% compared to the first quarter 2012. Key also expects second quarter 2012 earnings from continuing operations to be $0.18 to $0.20 per diluted share. Key's prior second quarter guidance anticipated sequential consolidated revenue growth of 10% to 15% and earnings from continuing operations of $0.31 to $0.33 per diluted share. The Street is looking for EPS of $0.31.
Rite Aid (NYSE: RAD) 9.5% HIGHER; reported Q1 EPS of ($0.03), in-line with the analyst estimate of ($0.03). Revenue for the quarter came in at $6.47 billion versus the consensus estimate of $6.44 billion. Same-store sales were up 2.5 percent. Rite Aid sees FY2013 EPS of $-0.13-$-0.29, versus views calling for -$0.20. Rite Aid sees FY2013 revenue of $25.3-$25.7 billion, compared with estimates of $25.53 billion. Prior guidance was for a loss of $0.13-$0.31 and sales of $25.4-$25.8 billion. Looking for same-store sales to be down 0.5% to up 1%.
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