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Pain Therapeutics, Inc. (Nasdaq: PTIE) 64.5% LOWER; announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on the resubmission of its new drug application (NDA) for REMOXY ER (oxycodone capsules CII). The CRL informs that REMOXY ER cannot be approved in its present form and specifies additional actions and data that are needed for drug approval.
Array BioPharma (Nasdaq: ARRY) 28% HIGHER; Array and Pierre Fabre jointly announced top-line results from Part 1 of the Phase 3 COLUMBUS (Combined LGX818 Used with MEK162 in BRAF Mutant Unresectable Skin Cancer) study evaluating LGX818 (encorafenib), a BRAF inhibitor, and MEK162 (binimetinib), a MEK inhibitor, in patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The study met its primary endpoint, significantly improving progression free survival (PFS) compared with vemurafenib, a BRAF inhibitor, alone.
DURECT Corporation (Nasdaq: DRRX) 27% LOWER; announced that its licensee, Pain Therapeutics (Nasdaq: PTIE) has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Pain Therapeutics' New Drug Application (NDA) for REMOXY® ER (oxycodone) extended-release capsules CII. Based on its review, the FDA has determined that the NDA cannot be approved in its present form and specifies additional actions and data that are needed for drug approval.
Lipocine Inc. (Nasdaq: LPCN) 18% HIGHER; reported positive top-line results from a Phase 2b clinical study of LPCN 1111, a novel oral testosterone replacement therapy ("TRT") product candidate. The primary objectives of the study were to determine the Phase 3 dose of LPCN 1111 along with the safety and tolerability of LPCN 1111 and its metabolites following oral administration of single and multiple doses in hypogonadal males.
Chemtura Corporation (NYSE: CHMT) 16.2% HIGHER; announced that it has entered into a definitive agreement pursuant to which LANXESS AG (LANXESS), a global specialty chemicals company, will acquire Chemtura in a transaction valued at approximately $2.5 billion. Under the terms of the agreement, Chemtura shareholders will receive $33.50 per share in cash for each outstanding share of common stock held, which represents an 18.9% premium to the stocks closing share price of $28.18 on September 23, 2016. The respective boards of both companies have unanimously approved the transaction.
RetailMeNot Inc. (NASDAQ: SALE) 13.7% LOWER; Stifel downgraded from Hold to Sell with a price target of $9.
GW Pharma (NASDAQ: GWPH) 13% HIGHER; announced positive results of the second randomized, double-blind, placebo-controlled Phase 3 clinical trial of its investigational medicine Epidiolex (cannabidiol or CBD) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy.
Cancer Genetics, Inc. (NASDAQ: CGIX) 12.5% HIGHER; Rodman & Renshaw initiated coverage with a Buy rating and a price target of $6
Acacia Communications (NASDAQ: ACIA) 7% LOWER; files to offer up to $450 million in common stock. Also bumps Q3 outlook higher.
Cal-Maine Foods (NASDAQ: CALM) 7% LOWER; reported Q1 EPS of ($0.64), $0.42 worse than the analyst estimate of ($0.22). Revenue for the quarter came in at $239.8 million versus the consensus estimate of $298.36 million.
Himax Technologies (NASDAQ: HIMX) 6% LOWER; Nomura Securities downgraded from Buy to Neutral with a price target of $10.20 (from $12.00) on lower AR shipment forecasts.
Axovant Sciences Ltd. (NYSE: AXON) 4.7% HIGHER; announced that the company has received Fast Track designation for its Investigational New Drug (IND) application for intepirdine in the treatment of dementia with Lewy bodies from the U.S. Food and Drug Administration (FDA).
Twitter (NYSE: TWTR) 3.8% LOWER; Oppenheimer cut from Perform to Underperform after shares surged amid reports Friday that it's nearing a sale
Fate Therapeutics, Inc. (NASDAQ: FATE) 3.2% HIGHER; announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for ProTmune, the Companys lead product candidate that is currently undergoing Phase 1/2 clinical investigation. The FDA designation is for prevention of graft-versus-host disease in patients undergoing allogeneic hematopoietic cell transplantation and broadly covers diseases, including blood cancers and genetic disorders, for which the procedure is performed.
Lloyds Banking (NYSE: LYG) 3% LOWER; Goldman Sachs downgraded from Neutral to Sell.
ARIAD Pharmaceuticals (NASDAQ: ARIA) 2.8% HIGHER; Leerink Partners initiates coverage with a Outperform rating and a price target of $20.00
NetApp (NASDAQ: NTAP) 2.4% LOWER; Deutsche Bank downgraded from Hold to Sell with a price target of $25
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