Pre-Open Movers 05/18: (QTNT) (AFSI) (CERN) Higher; (AGRX) (ARQL) (CPB) Lower (more...)
Today's Pre-Open Movers
Agile Therapeutics, Inc., (Nasdaq: AGRX) 60% LOWER; announced the content of the official minutes from its Type A meeting with the U.S. Food and Drug Administration (FDA) held on April 16, 2018 to discuss the complete response letter (CRL) issued by the FDA on December 21, 2017 relating to the New Drug Application (NDA) for Twirla (AG200-15), the Company’s investigational low-dose, non-daily, combination hormonal contraceptive patch. In the CRL, the FDA informed the Company that the Twirla NDA could not be approved due to deficiencies related to the manufacturing process and facility for Twirla, and because of questions the FDA had on the in vivo adhesion properties of Twirla and their potential relationship to the Company’s Phase 3 clinical trial results. In the official minutes, the FDA informed the Company that it continues to have significant concerns regarding the adhesion of Twirla, which the FDA believes cannot be addressed through the Company’s proposed patient compliance programs, and that the Company needed to address the Twirla adhesion properties by reformulating the transdermal system and conducting a formal adhesion study with the new formulation. The FDA also informed the Company that it would need to demonstrate bioequivalence to the data and information for the original formulation.
Quotient Limited (NASDAQ: QTNT) 13% HIGHER; reported that it has completed the verification and validation (V&V) phase for its initial blood grouping MosaiQ microarray (IH I) and has commenced its European field trials.
ArQule (NASDAQ: ARQL) 11.9% LOWER; filed to offer up to 10,629,000 shares of our common stock that may be offered for sale by the selling stockholders named in this prospectus under “Selling Stockholders.
Campbell Soup (NYSE: CPB) 11% LOWER; reported Q3 EPS of $0.70, $0.09 better than the analyst estimate of $0.61. Revenue for the quarter came in at $2.13 billion versus the consensus estimate of $2.14 billion. Campbell Soup sees FY2018 EPS of $2.85-$2.90, may not compare to the consensus of $3.13. CEO Denise Morrison to retire.
Eiger BioPharma (NASDAQ: EIGR) 9.5% HIGHER; adds to Thursday's gains.
voxeljet AG (NYSE: VJET) 7.7% HIGHER; Total revenues for the first quarter increased 11.5% to kEUR 5,052 from kEUR 4,530
VIVUS (NASDAQ: VVUS) 7.5% HIGHER; CEO, John Amos, bought another 540,000 shares
AmTrust Financial (NASDAQ: AFSI) 7.2% HIGHER; Carl Icahn files 13D showing 9.4%, or 18,418,732 shares, stake and said he "strongly opposes" the $13.50/sharegoing-privatee deal.
Nordstrom (NYSE: JWN) 6.7% LOWER; reported Q1 EPS of $0.51, $0.07 better than the analyst estimate of $0.44. Revenue for the quarter came in at $3.56 billion versus the consensus estimate of $3.46 billion. Nordstrom sees FY2018 EPS of $3.35-$3.55, versus the consensus of $3.43.
Cerner Corporation (Nasdaq: CERN) 6.2% HIGHER; The Department of Veterans Affairs (VA) announced an agreement with Cerner Government Services, Inc., a wholly owned subsidiary of Cerner Corporation (Nasdaq: CERN), a global leader in health care technology, for the VA to use off-the-shelf Cerner solutions to provide veterans, transitioning service members and their care providers access to their medical history through a single electronic health record (EHR) system. Using technology that has been deployed successfully at Department of Defense (DoD) medical facilities and thousands of provider sites globally, Cerner plans to provide seamless care across the VAs high-performing integrated network, including VA facilities, community providers and DoD facilities.
Insys Therapeutics (NASDAQ: INSY) 6% LOWER; The FDA posted briefing documents ahead of a May 22 panel review of Insys Therapeutics' (NASDAQ: INSY) Buprenorphine sublingual spray for management of acute pain.
Baidu, Inc. (NASDAQ: BIDU) 5.5% LOWER; announced that Qi Lu will no longer serve as chief operating officer of the company starting in July 2018 and will continue to serve as vice chairman of the board of directors.
Applied Materials (NASDAQ: AMAT) 4.7% LOWER; reported Q2 EPS of $1.22, $0.08 better than the analyst estimate of $1.14. Revenue for the quarter came in at $4.57 billion versus the consensus estimate of $4.45 billion. In the third quarter of fiscal 2018, Applied expects net sales to be in the range of $4.33 billion to $4.53 billion; the midpoint of the range would be an increase of approximately 18 percent, year over year. Non-GAAP adjusted diluted EPS is expected to be in the range of $1.13 to $1.21; the midpoint of the range would be an increase of approximately 36 percent, year over year. (*** the consensus is $4.53 billion and $1.16)
Yelp (NYSE: YELP) 3.4% HIGHER; B.Riley/FBR upgraded from Neutral to Buy with a price target of $58.00 (from $42.00).
Boot Barn (NASDAQ: BORN) 3.2% LOWER; 7.21 million shares said offered at $23.50-$24
Square (NYSE: SQ) 2.8% LOWER; PayPal agreed to acquire European rival iZettle for $2.2 billion.
AMD (NASDAQ: AMD) 2.6% HIGHER; Cowen initiates coverage on with an Outperform rating and a price target of $18.00.
Synaptics (NASDAQ: SYNA) 2.1% HIGHER; JPMorgan reiterated an Overweight rating and $52.00 price target after adding the stock to the Analyst Focus List as a "short-term trade idea.
IQVIA Holdings Inc. (NYSE: IQV) 2% HIGHER; announced today that in light of recent market conditions, it and the selling stockholders will not proceed with the previously announced secondary public offering and concurrent repurchase of common stock.
Mattel (NASDAQ: MAT) 2% HIGHER; told MGA Entertainment in a letter that it's not interested in further discussions, according to MGA CEO Issac Larian, as reported by Bloomberg.
AMD (NASDAQ: AMD) 1.9% HIGHER; Cowen initiates coverage with an Outperform rating and a price target of $18.00.
Dicerna Pharma (NASDAQ: DRNA) 1.7% HIGHER; Treatment of primary hyperoxaluria Granted Orphan Status