Pre-Open Movers 10/02: (RIGL) (SNCR) (TRN) Higher; (JWN) (GNW) (ROKU) Lower (more...)
Today's Pre-Open Stock Movers
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) 18.1% HIGHER; announced that during the company's mid-cycle meeting with the U.S. Food and Drug Administration (FDA) the FDA indicated that, at this point, it is not planning to hold an Oncology Drugs Advisory Committee (ODAC) meeting to discuss the New Drug Application (NDA) for fostamatinib in patients with chronic or persistent immune thrombocytopenia (ITP). Additionally, the FDA indicated that it anticipates meeting the Prescription Drug User Fee Act (PDUFA) action date for the application review, which is April 17, 2018. In an earlier communication, the FDA had conditionally approved the proprietary name TavalisseTM.
Synchronoss Technologies, Inc. (NASDAQ: SNCR) 16.9% HIGHER; Board of Directors continues to be committed to enhancing value for all shareholders. The Board’s strategic alternatives process remains underway and it continues to explore a full range of strategic, operational and financial alternatives.
VBL Therapeutics (NASDAQ: VBLT) 14.9% HIGHER; announced that the independent Data Safety Monitoring Committee (DSMC) met on September 28, 2017 to conduct its third and final safety review of the Phase 3 GLOBE Study investigating ofranergene obadenovec (VB-111) in recurrent glioblastoma (GBM). The DSMC is an independent multidisciplinary group that conducts detailed reviews of un-blinded study data, discusses potential safety concerns and provides recommendations regarding trial continuation. The committee reviewed the GLOBE safety data, including mortality data, collected through a cutoff date in August 2017 and stated that they did not identify any safety concerns. The DSMC confirmed that no additional follow up will be necessary. Accordingly, the DSMC unanimously recommended that the study continue as planned, to completion.
Endocyte, Inc. (NASDAQ: ECYT) 12.8% HIGHER; announced the completion of an exclusive worldwide license of PSMA-617 from ABX GmbH. Endocyte intends to move quickly into Phase 3 development of 177Lu-PSMA-617, a radioligand therapeutic (RLT) that targets the prostate-specific membrane antigen (PSMA), present in approximately 80% of patients with metastatic castration-resistant prostate cancer (mCRPC).
Trinity Industries, Inc. (NYSE: TRN) 10.9% HIGHER; announced today that on September 29, 2017, the United States Court of Appeals for the Fifth Circuit has ruled that Trinity Industries, Inc. and Trinity Highway Products, LLC did not commit fraud, reversing the District Court’s $682.4 million False Claims Act judgment and rendering judgment for the Company.
Veritone, Inc. (NASDAQ: VERI) 10.2% HIGHER; announced that it has signed an expanded, two-year agreement with iHeartMedia, the leading audio company with the largest reach of any radio or television outlet in America. The agreement gives iHeartMedia a license to Veritone aiWARE platform for more than 200 of its radio stations in the top 50 markets. This expanded relationship will enable iHeartMedia to seamlessly and automatically process, transform, and review audio data in near-real time, with enhanced ad and content tracking, comprehensive analytics, faster content extension, and smarter media management.
MannKind Corporation (Nasdaq: MNKD) 9% HIGHER; announced that the U.S. Food & Drug Administration (FDA) has approved an update to the Afrezza prescribing information to include new clinical data that was presented at the American Diabetes Association's 76th Scientific Sessions in June 2016. Afrezza (insulin human) inhalation powder is approved by the FDA to improve glycemic control in adult patients with type 1 and type 2 diabetes mellitus. It is the only inhaled rapid-acting mealtime insulin available in the United States. Afrezza is dosed at the beginning of a meal and begins to appear in the blood in approximately one minute¹.
Arbutus Biopharma Corporation (Nasdaq: ABUS) 6.5% HIGHER; signed a share purchase agreement with Roivant Sciences for the sale of convertible preferred shares (Preferred Shares) for gross proceeds of $116.4 million. Arbutus intends to use the proceeds to further develop and advance its clinical and preclinical HBV pipeline programs.
Nordstrom (NYSE: JWN) 6% LOWER; Talks to take Nordstrom (NYSE: JWN) private are faltering, according to the New York Post. The family behind the retailer has struggled to cobble together financing an may not be able to close the deal.
Genworth Financial, Inc. (NYSE: GNW) 5.2% LOWER; Genworth Financial and China Oceanwide Holdings Group Co., Ltd. (Oceanwide) today reported that they have withdrawn their joint voluntary notice with the Committee on Foreign Investment in the United States (CFIUS), with an intent to refile the transaction with additional mitigation approaches, including potentially working with a U.S. third- party service provider. Both parties are fully committed to continuing to work on robust mitigation proposals.
Roku (NASDAQ: ROKU) 4.9% LOWER; recent hot IPO sees profit taking
Seattle Genetics, Inc. (NASDAQ: SGEN) 4.8% HIGHER; announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. The positive topline results of the phase 3 ECHELON-1 clinical trial were announced in June 2017 and full data will be presented at the upcoming American Society of Hematology (ASH) annual meeting, December 9-12, 2017 in Atlanta, Georgia. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma. ADCETRIS is being evaluated globally as the foundation of care for CD30-expressing lymphomas in more than 70 corporate- and investigator-sponsored clinical trials. ADCETRIS is currently not approved as a frontline therapy for Hodgkin lymphoma.
bluebird bio (NASDAQ: BLUE) 4.3% LOWER; Morgan Stanley downgraded from Equalweight to Underweight with a price target of $105.00.
American Outdoor Brands (NASDAQ: AOBC) 4.3% HIGHER; gun stocks higher after deadliest ever mass shooting in Las Vegas.
Zynerba Pharmaceuticals (NASDAQ: ZYNE) 4.2% HIGHER; Cantor Fitzgerald upgraded from Neutral to Overweight with a price target of $17.00 (from $4.00).
Alnylam Pharmaceuticals (NASDAQ: ALNY) 3.6% HIGHER; Goldman Sachs upgraded from Neutral to Buy with a price target of $163.00 (from $62.00).
Sturm Ruger (NYSE: RGR) 3.5% HIGHER; gun stocks higher after deadliest ever mass shooting in Las Vegas.
MGM Resorts (NYSE: MGM) 3.4% LOWER; casino stocks down after deadliest ever mass shooting in Las Vegas
Sarepta Therapeutics (NASDAQ: SRPT) 3.2% HIGHER; Morgan Stanley upgraded from Equalweight to Overweight with a price target of $60.00 (from $33.00).
Las Vegas Sands (NYSE: LVS) 1.8% LOWER; casino stocks down after deadliest ever mass shooting in Las Vegas.
Wynn Resorts (NASDAQ: WYNN) 1.2% LOWER; casino stocks down after deadliest ever mass shooting in Las Vegas.